Moleculin Biotech, Inc.

NASDAQ:MBRX

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Moleculin Announces Additional Positive Interim Results from Phase 1/2 Clinical Studies of Annamycin in Acute Myeloid Leukemia

No evidence of cardiotoxicity to date; 40% of 10 patients dosed at ³ 120 mg/m2 demonstrate efficacy; trial progresses in Europe to 210 mg/m2

 

Houston, TX – December 4, 2019 – Moleculin Biotech, Inc., (NASDAQ: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, today announced additional positive interim safety and efficacy data from one of the Company’s two ongoing open label, single arm Phase 1/2 studies of Annamycin for the treatment of relapsed or refractory acute myeloid leukemia (“AML”).

 

The Phase 1 portion of these clinical trials, which are described in more detail later in this press release, is designed to establish the safety of Annamycin and to determine the Recommended Phase 2 Dose to be used in the Phase 2 portion of the trials.  While the Primary Endpoint of the Phase 1 portion is safety, a Secondary Endpoint is the assessment of efficacy generally defined as an improvement in bone marrow biopsy results sufficient to qualify patients for a potentially curative bone marrow transplant.  The Company cautions not to place undue reliance on interim results.

 

The third cohort in Poland receiving a single dose of 180 mg/m2 in the Phase 1 dose escalation portion of the trial was completed with no adverse events and the trial will continue to the next cohort of 210 mg/m2.  In the US trial, one patient has completed treatment in the second cohort at 120 mg/m2.  This brings the total number of patients treated and evaluated at or above 120 mg/m2 to 10.  An additional patient in the US has begun treatment at 120 mg/m2 but has yet to complete post-treatment evaluation.  The interim results for these 10 patients are 1 CRi (defined as a complete response with incomplete recovery of white blood cells and/or platelets) and 2 partial responses (“PRs” or where bone marrow blasts are reduced 50% and to below 25%).  One additional patient was bridged to bone marrow transplant (“BT”) based on a sufficient reduction in bone marrow blasts, bringing the total to 4 out of 10 patients at or above 120 mg/m2 who have demonstrated efficacy.

 

In the latest cohort in Poland, 1 of the 3 patients treated at 180 mg/m2 had a PR sufficient to qualify for a potentially curative bone marrow transplant. The results for all 3 patients were reviewed by the Safety Review Committee, which determined that no drug-related adverse events were observed that would prevent advancing the trial to the next higher dose level of 210 mg/m2.  To date in the European trial, only one adverse event related to Annamycin has been reported; a patient experienced grade 2 mucositis (which resolved to grade 1 within 2 days).  In the Company’s parallel US clinical trial, one new patient (the first of cohort #2) achieved a “morphologically leukemia free state” or MLFS, which also constitutes a CRi, after receiving a single dose of 120 mg/m2.

 

We refer to Annamycin as a “next generation anthracycline,” because it is designed to provide enhanced therapeutic benefits when compared with traditional anthracyclines (like doxorubicin) while reducing the potential for unwanted cardiotoxicity, or damage to the heart. This design intent has previously been validated with preclinical toxicology studies in animal models (as required by FDA) demonstrating Annamycin has little to no cardiotoxicity when compared with doxorubicin. Of the 14 patients treated thus far in both trials, none has shown any evidence of cardiotoxicity.  This includes 7 patients in Poland who were treated at levels above the US maximum allowable cumulative anthracycline dose level (550 mg/m2), a limitation not imposed on our trial in Europe.  If upheld in further studies, this lack of toxicity could be an important differentiator between Annamycin and the currently approved anthracyclines, for which cardiotoxicity is a well-known treatment limitation.

 

For example, a recent review published in Cardiovascular Drugs and Therapy (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5346598/) reported that 65% of patients who received the equivalent of 550 mg/m2 of doxorubicin (a current standard of care anthracycline) exhibited sub-clinical cardiotoxicity, defined as a reduction in left ventricular ejection fraction >10% points to a value <50%.  Of the 5 patients mentioned above who were treated in our European trial above 550 mg/m2, no evidence of cardiotoxicity was detected.  The same published review also suggested that a better long-term indicator of cardiotoxicity may be the measurement of an increase in a biomarker called Troponin.  When measured as an early biomarker of cancer therapy-related cardiotoxicity, Troponin rise occurs consistently in 21% – 40% of patients after treatment with current standard of care anthracycline chemotherapy and, per the published review, such an increase in Troponin is associated with an increased risk of heart disease later in life.  Of the 14 patients treated thus far in both of our Annamycin clinical trials, none has shown an increase in Troponin levels.

 

“The interim data from our early-stage clinical trials of Annamycin continues to meet or exceed our expectations, from both a safety and efficacy perspective,” commented Walter Klemp, Moleculin’s Chairman and CEO.  “We believe the activity we are seeing – with 40% of patients treated at or above 120 mg/m2 responding with CRi’s, PR’s and/or bridging to a potentially curative bone marrow transplant – is encouraging, especially since we have yet to reach a maximum tolerable dose.  Although the data is preliminary, we are excited by the results to date, and to continue moving forward.  Importantly, recruitment continues to be much faster in Europe than in the US.  We believe this is because Europe has imposed fewer regulatory constraints on the level of anthracycline dosing allowed and because there are far fewer competing AML clinical trials in Poland, where our clinical testing sites are located.”

 

“We should also point out,” Mr. Klemp continued, “that there are two particularly important aspects of our development program that distinguish the potential prospects for Annamycin.  First, we are studying the potential benefits of Annamycin in all AML patients, not just a subset of the AML population based on a particular gene mutation or other biomarker.  Second, Annamycin is being investigated not as an adjuvant to other therapies, but as a single agent to treat relapsed or refractory AML patients, primarily as a bridge to transplant.  We also believe the absence of cardiotoxicity, if it is borne out, would be especially important for pediatric patients, in addition to possibly suggesting Annamycin as an attractive alternative to currently approved anthracyclines for treating cancers beyond AML.”

 

Dr. Robert Shepard, Moleculin’s Chief Medical Officer for Annamycin added: “Although it is still early and the data are preliminary, I believe we may see that Annamycin has significant activity against relapsed and refractory AML.  To have a 40% response rate this early in the dose-escalating process is very encouraging.  And if the product ultimately is shown to have little or no cardiotoxicity – as the preliminary data suggest – there is a real potential for Annamycin to become the first approved anthracycline without a dose-limiting cardiovascular risk.  The use of anthracyclines for induction therapy in acute leukemia is often, and unfortunately, limited if such treatment would put them over what is currently considered the ‘lifetime maximum’ anthracycline exposure (or ‘maximum cumulative dose’).  However, authorities in the EU took into account Annamycin’s apparent lack of cardiotoxicity and have allowed us to demonstrate this in patients whose treatment would exceed this maximum cumulative dose.  In fact, 7 of the 9 patients treated to date in Europe substantially exceeded that lifetime maximum based on their treatment with Annamycin and, of course, have shown no cardiotoxicity.”

 

Study Design

 

The Company is studying Annamycin in both the US and Europe in open label, single arm clinical trials to assess the safety and efficacy of Annamycin for the treatment of adults with relapsed or refractory acute myeloid leukemia.  The US and European trials have the same study design, consisting of a Phase 1 intended to establish a “Recommended Phase 2 Dose” (“RP2D”), to which the studies will then proceed.  The Phase 1 studies provide for escalating doses in cohorts of 3 patients each, with each successive cohort receiving the next higher dose level until “dose limiting toxicities” prevent further increases.  Cohorts 1, 2 and 3 in Poland received a dose of 120, 150 and 180 mg/m2, respectively, and the results now permit moving to 210 mg/m2.  Cohort 1 in the US started at 100 mg/m2, and the results supported moving to 120 mg/m2, at which 1 patient has now been treated and evaluated as having achieved a “morphologically leukemia free state” or MLFS, which also constitutes a CRi.   Because one patient in US cohort 1 did not complete the evaluation protocol, a fourth patient was added to complete that cohort.  Once the Company establishes an RP2D, the intent is for each trial to advance to a Phase 2 arm planned to assess the safety and efficacy of Annamycin in 21 additional patients.

 

The data reported here is preliminary as collected by independent CRO site monitors per standard practice and is subject to subsequent quality assurance review.

 

We have been and intend to continue reporting top-line results by cohort in each trial, with each announcement also including an update on the other trial.  Top-line results will include reporting of any drug-related adverse events (“AEs”) and assessment of cardiotoxicity, including ECHO or MUGA scans measuring change in ejection fraction and measuring blood Troponin level, which is considered a biomarker for potential long-term cardiovascular impairment.  To date, one patient experienced grade 2 mucositis (which resolved to grade 1 within 2 days) and no other drug-related AEs have been reported.  Also, no loss of ejection fraction or rise in Troponin levels has been reported.  Top-line results will also include the number of partial responses (“PRs”), complete responses (“CRs”) and patients deemed capable of progressing to a potentially curative bone marrow transplant, which we term “bridge to transplant” (“BTs”), each of which is essentially a function of the magnitude of reduction in a patient’s bone marrow blasts.  For purposes of these clinical trials, a CR means that the patient’s bone marrow blasts reduced to 5% or less (with CRi meaning a CR where there was incomplete recovery of white blood cell and/or platelet counts), a PR means the patient’s bone marrow blasts reduced by 50% and resulted in a blast count of 25% or less, and a BT means patients are deemed capable of progressing to a potentially curative bone marrow transplant.  To date, there has been 1 CRi in the US (@ 120 mg/m2), 2 PRs in Europe (1 @ 120 mg/m2 and 1 @ 180 mg/m2) and 4 BTs (1 in the US and 3 in Europe).

 

The US trial also differs from the European trial in that the FDA would like to review safety data relating to cardiotoxicity from patients treated prior to advancing beyond 120 mg/m2, as exceeding this dose level would require the patient to exceed the established lifetime maximum exposure to anthracyclines (presuming all anthracyclines are cardiotoxic).  To date, 100% of all 14 patients treated in both the US and EU trials have shown no incidence of cardiotoxicity, including 7 patients out of 9 treated in Poland who exceeded the lifetime maximum anthracycline exposure level.  The Company believes that the additional patient safety data gained from the European trial may also assist in the FDA’s review of Annamycin’s cardiac safety.

 

About Moleculin Biotech, Inc.

 

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. The Company’s clinical stage drugs are: Annamycin, a Next Generation Anthracycline, designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic cancer and hematologic malignancies, and WP1220, an analog to WP1066, for the topical treatment of cutaneous T-cell lymphoma. Moleculin is also engaged in preclinical development of additional drug candidates, including additional Immune/Transcription Modulators, as well as compounds capable of Metabolism/Glycosylation Inhibition.

 

For more information about the Company, please visit http://www.moleculin.com.

 

Forward-Looking Statements

 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to successfully recruit patients to complete its clinical trials, the ability of Annamycin to show safety and efficacy in patients, and the ability for Annamycin to be an alternative to currently approved anthracyclines for treating cancers other than AML. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC.  Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. The Company cautions investors not to place undue reliance on the interim results announced today.

 

Source:  Moleculin Biotech, Inc.

Moleculin Announces Beginning of Preclinical Development of New Approach to Pancreatic Cancer

Inhibitor of glycolysis provides opportunity to attack the metabolism of tumors

 

Houston, TX – November 13, 2019 – Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, announced it has begun preclinical testing of its drug candidate, WP1122, which it believes may present a new approach to treating highly glycolytic tumors like pancreatic cancer and glioblastoma.

 

“WP1122 represents an opportunity to attack the metabolism of cancer by exploiting the Warburg principle, which explains that some tumors are highly dependent on glycolysis, a specific metabolism of glucose, for growth and survival,” commented Walter Klemp, Moleculin’s Chairman and CEO.  “What this means in practice is that tumors are vulnerable by being highly dependent on glucose availability. Cancer cells often  to consume up to 18 times as much glucose as their healthy  normal cells neighbors, suggesting that we may be able to starve tumors by supplying them with glucose decoys that would inhibit glucose-based energy production.  However, until the creation of WP1122, glucose decoys like 2-deoxy-D-glucose (‘2-DG’) lacked the drug-like properties to be effective, primarily because of rapid metabolism and a very short circulation time in the body, which then limits desired organ and tumor uptake.”

 

Dr. Don Picker, Chief Science Officer for Moleculin, added: “WP1122 is a prodrug of 2-DG that has been shown in animal models to significantly increase the half-life of 2-DG and allows for increased uptake to targeted organs and tumors like the brain tumors and pancreatic cancer.  Recent discoveries now also suggest that such a glucose decoy could critically impact a process known as glycosylation and glycan formation and that this type of  activity can directly impact the function of PD-L1, enabling increased immune system response to cancer cells. We have been working on the clinical formulation of WP1122 for some time, and we are eager to now be taking the next key steps to getting WP1122 into the clinic.”

 

About Moleculin Biotech, Inc.

 

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. The Company’s clinical stage drugs are: Annamycin, a Next Generation Anthracycline, designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic cancer and hematologic malignancies, and WP1220, an analog to WP1066, for the topical treatment of cutaneous T-cell lymphoma. Moleculin is also engaged in preclinical development of additional drug candidates, including additional Immune/Transcription Modulators, as well as compounds capable of Metabolism/Glycosylation Inhibition.

 

For more information about the Company, please visit http://www.moleculin.com.

 

Forward-Looking Statements

 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of WP1122 to show safety and efficacy in patients. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC.  Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. The Company cautions investors not to place undue reliance on the interim results announced today.

 

Contacts

Joe Dorame, Robert Blum or Joe Diaz

Lytham Partners, LLC

602-889-9700

mbrx@lythampartners.com

 

Moleculin Announces FDA Approval of IND for its STAT3 Inhibitor in Emory University Clinical Trial

Approval gives green light to study of WP1066 for treatment of pediatric brain cancer

 

Houston, TX – November 12, 2019 – Moleculin Biotech, Inc., (NASDAQ: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, announced that the FDA has approved a request for Investigational New Drug (“IND”) status for its drug candidate WP1066 to be used in a Phase 1 clinical trial for the treatment of children with recurrent or refractory malignant brain tumors.  The request was made by physician researchers at Emory University, including Dr. Tobey MacDonald, Professor of the Department of Pediatrics at Emory University School of Medicine, Director of Pediatric Neuro-Oncology at Aflac Cancer and Blood Disorders Center and Principle Investigator for this clinical trial. The trial will be conducted at the Aflac Cancer and Blood Disorders Center at Children’s Healthcare of Atlanta.

 

“This FDA approval gives a green light for Emory University to begin an important clinical trial to explore a new approach to treating pediatric brain cancer,” commented Walter Klemp, Moleculin’s Chairman and CEO.  “WP1066 is currently in a clinical trial for adult patients with glioblastoma and melanoma metastases to the brain at MD Anderson Cancer Center, and this is a logical extension of that research.  WP1066 is an inhibitor of the activated form of a protein called STAT3, a target that has been implicated in a wide range of highly resistant cancers.  Preclinical research at Emory University indicated that WP1066 had a significant anti-tumor effect on medulloblastoma cell lines, so there is a lot of encouragement regarding the opportunity to provide new hope for treating this rare condition.”

 

About Moleculin Biotech, Inc.

 

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. The Company’s clinical stage drugs are: Annamycin, a Next Generation Anthracycline, designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic cancer and hematologic malignancies, and WP1220, an analog to WP1066, for the topical treatment of cutaneous T-cell lymphoma. Moleculin is also engaged in preclinical development of additional drug candidates, including additional Immune/Transcription Modulators, as well as compounds capable of Metabolism/Glycosylation Inhibition.

 

For more information about the Company, please visit http://www.moleculin.com.

 

 

 

Forward-Looking Statements

 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of WP1066 to show safety and efficacy in patients. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC.  Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. The Company cautions investors not to place undue reliance on the interim results announced today.

 

 

Contacts

Joe Dorame, Robert Blum or Joe Diaz

Lytham Partners, LLC

602-889-9700

mbrx@lythampartners.com

 

Source:  Moleculin Biotech, Inc.

Moleculin Announces New Data Confirms Anti-tumor Efficacy of Annamycin in Both Human and Murine AML Models

Data Presented at the AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference

 

Housto, TX – October 29, 2019 – Moleculin Biotech, Inc., (NASDAQ: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, announced the presentation of a poster at the AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference today in Boston, MA.  The poster, entitled “Dose and Schedule-Dependent Efficacy of Liposomal Annamycin in Pre-clinical Models of Acute Myeloid Leukemia,” presents data documenting the high activity of Annamycin against AML, including in vitro studies in a panel of human AML cell lines, as well as in vivo studies in both human and murine AML models developed under the Company’s sponsored research agreement with MD Anderson Cancer Center.

 

“This study highlights an important new finding,” commented Walter Klemp, Moleculin’s Chairman and CEO.  “We’ve known for some time that Annamycin is effective in AML animal models and the activity that we believe is coming from our current AML clinical trials seems to correlate with this.  But, what’s new here is the observation that Annamycin may also be more effective  than other drugs due to its high uptake and effectiveness in eliminating AML cells localized in different organs.  Additional important observations made with these studies indicates that the long-term exposure of healthy mice (at least 12 doses so far) to a highly efficacious dose of 4 mg/kg administered weekly is not toxic and that even two weekly doses of 4 mg/kg are producing a significant increase in survival. And, because Annamycin is designed to be non-cardiotoxic, this extended dosing regimen may prove to be feasible and beneficial in humans.  This potentially opens the door for expanded and improved dosing regimens in future clinical trials.”

 

Quoting from the accepted abstract: “In vivo studies confirmed anti-tumor efficacy of Annamycin in both human and murine AML models. Based on bioluminescence imaging, the liposomal formulation of the drug significantly delayed AML progression in the human OCL-AML3/NSG model at 4 mg/kg with once weekly dosing. Similarly, significant dose-dependent reduction of peripheral blood AML blasts was observed in the murine AML-Turq2 model, and this reduction was strongly correlated with prolongation of animal survival. The median survival of mice receiving four doses of L-Ann once a week at 4 mg/ml was 37 days while mice receiving vehicle lived only 14 days (p=0.0002). Different doses and administration schedules of [Annamycin] were tested in an effort to maximize survival benefits.  In summary [Annamycin] is effective in AML, demonstrating significant activity in both in vitro and in vivo mouse models with a distinct pattern of intracellular uptake and organ distribution using a once a week schedule. This suggests that [Annamycin] with this profile, including a lack of cardiotoxicity and activity against [doxorubicin] resistant tumors, may be an advantageous approach in the treatment of AML.”

 

To see the entire poster, please go to: www.moleculin.com

 

About Moleculin Biotech, Inc.

 

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. The Company’s clinical stage drugs are: Annamycin, a Next Generation Anthracycline, designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic cancer and hematologic malignancies, and WP1220, an analog to WP1066, for the topical treatment of cutaneous T-cell lymphoma. Moleculin is also engaged in preclinical development of additional drug candidates, including additional Immune/Transcription Modulators, as well as compounds capable of Metabolism/Glycosylation Inhibition.

 

For more information about the Company, please visit http://www.moleculin.com.

 

 Forward-Looking Statements

 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of Annamycin, with either the current or modified dosing regimens, to show safety and efficacy in patients. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC.  Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. The Company cautions investors not to place undue reliance on the interim results announced today.

 

Contacts

Joe Dorame, Robert Blum or Joe Diaz

Lytham Partners, LLC

602-889-9700

mbrx@lythampartners.com

 

Source:  Moleculin Biotech, Inc.

Moleculin Increases Annamycin Production Due to Positive Clinical Trial Activity and Expanded Potential Indications

Expansion of potential indications includes lung-localized tumors

 

Houston, TX – October 22, 2019 – Moleculin Biotech, Inc., (NASDAQ: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, today announced the expansion of Annamycin production commitments in response to management’s assessment of positive AML clinical trial activity and the potential expansion of indications for use to include lung-localized tumors.  The purchase commitment arranged through Davos Pharmaceuticals includes moving final production of Annamycin to a larger-scale suite within BSP Pharmaceuticals S.p.A. (“BSP”) in Latina, Italy.  Until now, BSP has been producing the clinical supplies of Annamycin in a smaller pilot-scale suite.

 

“Our clinical trials of Annamycin in relapsed and refractory acute myeloid leukemia (“AML”) have been going better than expected, as it now appears we will be able to reach a higher maximum tolerable dose than what was established in previous clinical trials,” commented Walter Klemp, Moleculin’s Chairman and CEO.  “That not only increases our chances for improved patient outcomes, it places a higher demand on drug supply.  Coupled with the recent discovery in animal models that Annamycin may be well suited to treat lung-localized tumors because of its ability in such models to accumulate in the lungs at nearly 6 times the level of the current standard of care anthracycline, we are clearly going to need more drug.”

 

Dr. Donald Picker, Moleculin’s Chief Science Officer added: “With management’s view of success in clinic and the expectation of wider demand resulting from additional clinical trials in lung-localized tumors, it’s time for Moleculin to start preparing for an eventual drug approval process.  That requires the development and validation of commercial scale methods and this move with BSP marks the beginning of that process.  In addition to increasing the scale of clinical supply production, we will be working with BSP and with our manufacturer of API to develop the commercial scale synthesis and drug production methods we will need to ultimately prepare for New Drug Approval.”

 

About Moleculin Biotech, Inc.

 

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. The Company’s clinical stage drugs are: Annamycin, a Next Generation Anthracycline, designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic cancer and hematologic malignancies, and WP1220, an analog to WP1066, for the topical treatment of cutaneous T-cell lymphoma. Moleculin is also engaged in preclinical development of additional drug candidates, including additional Immune/Transcription Modulators, as well as compounds capable of Metabolism/Glycosylation Inhibition.

 

For more information about the Company, please visit http://www.moleculin.com.

 

Forward-Looking Statements

 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of Annamycin to show safety and efficacy in patients and the ability of the Company and its contractors to develop commercial scale production of Annamycin and to receive New Drug Approval. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC.  Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. The Company cautions investors not to place undue reliance on the interim results announced today.

 

 

Contacts

Joe Dorame, Robert Blum or Joe Diaz

Lytham Partners, LLC

602-889-9700

mbrx@lythampartners.com

 

Source:  Moleculin Biotech, Inc.

Moleculin Announces its Sponsored Research at MD Anderson Cancer Center Has Resulted in the Filing of Patent Protection for New Discovery

Houston, TX – September 16, 2019 – Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, today announced its sponsored research at MD Anderson Cancer Center has resulted in the filing of a new patent on behalf of MD Anderson Cancer Center covering the combination of its immune-stimulating/transcriptional-modulator, WP1066, with well-known immune checkpoint inhibitors.

 

“We had previously announced preliminary preclinical data showing beneficial therapeutic effect from WP1066 when used in combination with PDL-1 and CTLA-4 immune checkpoint inhibitors in pancreatic cancer models,” commented Walter Klemp, Moleculin’s Chairman and CEO.  “We are pleased to report the filing of a patent on behalf of MD Anderson Cancer Center for this new discovery that opens new potentially effective approaches to utilize check point inhibitors for treatment of pancreatic cancer and other types cancers that are unresponsive to current immunotherapies. These studies were supported by our sponsored research agreement with MD Anderson Cancer Center.  Pursuant to the terms of our Sponsored Research Agreement, we intend to add this to our already diverse list of technology licenses.”

 

About Moleculin Biotech, Inc.

 

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. The Company’s clinical stage drugs are: Annamycin, a Next Generation Anthracycline, designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic cancer and hematologic malignancies, and WP1220, an analog to WP1066, for the topical treatment of cutaneous T-cell lymphoma. Moleculin is also engaged in preclinical development of additional drug candidates, including additional Immune/Transcription Modulators, as well as compounds capable of Metabolism/Glycosylation Inhibition.

 

For more information about the Company, please visit http://www.moleculin.com.

 

Forward-Looking Statements

 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of parties acting on behalf of MD Anderson Cancer Center to successfully prosecute the patent application and the ability of WP1066 to show safety and efficacy in combination with immune checkpoint inhibitors in humans. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC.  Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. The Company cautions investors not to place undue reliance on the interim results announced today.

 

Contacts

Joe Dorame, Robert Blum or Joe Diaz

Lytham Partners, LLC

602-889-9700

mbrx@lythampartners.com

 

Source:  Moleculin Biotech, Inc.

Moleculin Announces CTRC Approval of WP1066 Pediatric Brain Tumor Trial

Houston, TX – August 20, 2019 – Moleculin Biotech, Inc., (NASDAQ: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, today announced approval by the Emory University Clinical Trial Review Committee (CTRC) to move forward with an Investigator Initiated clinical trial of Moleculin’s immune-stimulating/transcriptional-modulator, WP1066, for the treatment of pediatric brain tumors. The trial will take place at the Aflac Cancer and Blood Disorders Center at Children’s Healthcare of Atlanta.

 

“Continued progress with the MD Anderson clinical trial of WP1066 in brain tumors has now cleared the way for a pediatric brain tumor trial with investigators from Emory University School of Medicine,” commented Walter Klemp, Moleculin’s Chairman and CEO.  “With CTRC approval, the investigators can now submit a request for IND from the FDA for this indication referencing the MD Anderson IND already in place.  Consistent with one of our stated development milestones, we continue to expect this IND to be submitted before year end.”

 

Dr. Tobey MacDonald, Professor of the Department of Pediatrics at Emory University School of Medicine, Director of Pediatric Neuro-Oncology at Aflac Cancer and Blood Disorders Center and Principle Investigator for this clinical trial commented: “We’ve done a lot of preclinical research suggesting that WP1066 may be beneficial in treating pediatric brain tumors, including medulloblastoma, where there continues to be a critical unmet need for more effective therapies.  We are excited to finally get this trial moving.”

 

About Moleculin Biotech, Inc.

 

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. The Company’s clinical stage drugs are: Annamycin, a Next Generation Anthracycline, designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic cancer and hematologic malignancies, and WP1220, an analog to WP1066, for the topical treatment of cutaneous T-cell lymphoma. Moleculin is also engaged in preclinical development of additional drug candidates, including additional Immune/Transcription Modulators, as well as compounds capable of Metabolism/Glycosylation Inhibition.

 

For more information about the Company, please visit http://www.moleculin.com.

 

Forward-Looking Statements

 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of WP1066 to show safety and efficacy in humans. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC.  Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. The Company cautions investors not to place undue reliance on the interim results announced today.

 

 

Contacts

Joe Dorame, Robert Blum or Joe Diaz

Lytham Partners, LLC

602-889-9700

mbrx@lythampartners.com

 

Source:  Moleculin Biotech, Inc

Moleculin Announces Completion of Lymphoma Trial Enrollment

Houston, TX  – August 13, 2019 – Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, today announced its proof of concept clinical trial to evaluate its p-STAT3 inhibitor, WP1220, for the topical treatment of Cutaneous T-Cell Lymphoma (CTCL) has reached full enrollment.

 

“We believe there continues to be an unmet need for an improved topical therapy for Stage I-III CTCL skin lesions,” commented Walter Klemp, Moleculin’s Chairman and CEO, “especially one that may avoid significant unwanted side effects.  CTCL is known to frequently involve the upregulation of the activated form of STAT3 (p-STAT3), which has been linked to a range of tumor-related transcriptional activity.  This proof of concept, if successful, could be an important first demonstration of a therapeutic effect in humans from such a p-STAT3 inhibitor.  We are pleased with how quickly this trial reached full recruitment and we are hopeful to be able to announce results from this trial yet this year. This trial represents one of four clinical trials that we have underway.”

 

Mr. Klemp concluded: “notwithstanding the relatively rare nature of CTCL, we believe showing activity with one of our STAT3 inhibitors, within our WP1066 family of molecules, could be an indicator of both the value of p-STAT3 as a target and the potential for our drugs in other cancers where STAT3 is highly activated.”

 

About Moleculin Biotech, Inc.

 

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. The Company’s clinical stage drugs are: Annamycin, a Next Generation Anthracycline, designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic cancer and hematologic malignancies, and WP1220, an analog to WP1066, for the topical treatment of cutaneous T-cell lymphoma. Moleculin is also engaged in preclinical development of additional drug candidates, including additional Immune/Transcription Modulators, as well as compounds capable of Metabolism/Glycosylation Inhibition.

 

For more information about the Company, please visit http://www.moleculin.com.

 

Forward-Looking Statements

 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of WP1220 to demonstrate safety and efficacy in humans and the ability of Moleculin to announce results from the trial during 2019. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC.  Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

 

 

Contacts

Joe Dorame, Robert Blum or Joe Diaz

Lytham Partners, LLC

602-889-9700

mbrx@lythampartners.com

 

Source:  Moleculin Biotech, Inc

Moleculin Announces Breakthrough Discovery: WP1066 Potentially Capable of Immune Reprogramming in Glioblastoma Animal Models

Data to be presented at the Inaugural Conference on Brain Metastases, August 16-17, 2019

 

Houston, TX – August 6, 2019 – Moleculin Biotech, Inc., (NASDAQ: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, today announced that a paper entitled “Immunological Reprogramming in the CNS Tumor Microenvironment and Therapeutic Efficacy of Radiotherapy with STAT3 Blockade” will be presented at the Inaugural Conference on Brain Metastases, in New York City, August 16-17, 2019.

 

“As the scientific community is increasingly focused on the potential of STAT3 inhibition for the treatment of cancer, this is a very timely discovery,” Walter Klemp, Moleculin’s Chairman and CEO, remarked.  “Dr. Martina Ott, of MD Anderson Cancer Center, will be presenting the findings of research she conducted in collaboration with Dr. Amy Heimberger (the Principle Investigator of the current investigator-initiated clinical of WP1066 for brain tumors) in combining WP1066 with radiation therapy in glioblastoma animal models.  One of the findings of her research that is especially encouraging is that immune-competent mice treated with both radiation and WP1066 developed an immunological memory that enabled them to prevent regrowth of the tumor after these tumor cells were reintroduced. The result was the development of long-term survivors, leading to an increase in overall survival in these models. Of note was that mice with a compromised immune system did not show this effect.”

 

Dr. Sandra Silberman, Moleculin’s Chief Medical Officer for New Projects, commented: “Making any kind of impact in treating glioblastoma is exciting, and we think Dr. Heimberger’s findings will have a profound impact on understanding the role of STAT3 inhibition, as well as help focus our continued development of WP1066 in this disease.  This study was also particularly interesting because it showed the most robust immunological responses were located in the CNS (Central Nervous System) tumor microenvironment rather than peripheral non-tumor tissue.  Importantly, the study indicated that the combination of STAT3 inhibition with whole brain radiotherapy had the capacity to enhance the therapeutic effect against established tumors based on immunological competence.  We’re now very eager to explore this potential in human clinical trials.”

 

About Moleculin Biotech, Inc.

 

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. The Company’s clinical stage drugs are: Annamycin, a Next Generation Anthracycline, designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic cancer and hematologic malignancies, and WP1220, an analog to WP1066, for the topical treatment of cutaneous T-cell lymphoma. Moleculin is also engaged in preclinical development of additional drug candidates, including additional Immune/Transcription Modulators, as well as compounds capable of Metabolism/Glycosylation Inhibition.

 

For more information about the Company, please visit http://www.moleculin.com.

 

Forward-Looking Statements

 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of WP1066 to show safety and efficacy in combination with other treatments in humans. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC.  Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. The Company cautions investors not to place undue reliance on the pre-clinical findings announced today.

 

 

Contacts

Joe Dorame, Robert Blum or Joe Diaz

Lytham Partners, LLC

602-889-9700

mbrx@lythampartners.com

 

Source:  Moleculin Biotech, Inc

Moleculin Announces Annamycin in Acute Myeloid Leukemia in Poland Advances to 3rd Cohort

Houston, TX  – July 18, 2019 – Moleculin Biotech, Inc., (NASDAQ: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, today announced additional positive interim safety and efficacy data from its ongoing open label, single arm Phase 1/2 study of Annamycin in Poland.  3 patients were treated at dose level of 150 mg/m2 with no drug-related adverse events, including no signs of cardiotoxicity.  The results for all 3 patients were reviewed by the Drug Safety Review Committee, which determined that the trial could progress to the next higher dose level of 180 mg/m2.  To date in Poland, one patient experienced grade 2 mucositis (which resolved to grade 1 within 2 days) and no other adverse events related to Annamycin have been reported.  One patient has completed treatment in the 120 mg/m2 (second) cohort in the Company’s parallel US clinical trial (the US trial started at a lower initial dose of 100 mg/m2).

 

“Recruitment in Poland continues to move rapidly,” commented Walter Klemp, Moleculin’s Chairman and CEO.  “And, moving beyond the 150 mg/m2 dosing level is quite significant, as the prior developer of Annamycin was unable to dose beyond this level.  We remain optimistic that new methods for reducing the onset of mucositis (the dose limiting toxicity for Annamycin in prior clinical trials) will allow us to safely increase dosing to 180 mg/m2 or potentially even higher.”

 

Mr. Klemp continued: “It’s also important to remind people that one of the advantages we believe Annamycin will offer is a lack of cardiotoxicity.  We continue to see no evidence of cardiotoxicity in any of the patients treated thus far.  We intend to advance the clinical study of Annamycin with the goal of ultimately demonstrating the drug’s safety and effectiveness to support regulatory approval in both the US and European Union.”

 

Study Design

 

The Company is studying Annamycin in both the US and Poland in open label, single arm clinical trials to assess the safety and efficacy of Annamycin for the treatment of adults with relapsed or refractory acute myeloid leukemia.  Both the US and Polish trials have the same study design, providing for a Phase 1 intended to establish a “Recommended Phase 2 Dose,” (“RP2D”) with cohorts of 3 patients each where the first cohort starts at a low beginning dose and each successive cohort receives the next higher dose level until “dose limiting toxicities” prevent further increases.  In the case of cohort 1 in the US, one patient did not complete the evaluation protocol, so a fourth patient was added to complete that cohort.

 

A key difference in the US is that the starting dose was 100 mg/m2, whereas, in Poland, the starting dose was 120 mg/m2.  Having completed the first cohort in the US, the Company is seeking patients for the second cohort at a dose level of 120 mg/m2 and 1 of the 3 patients required to fill the cohort has now been treated.  Now that 3 patients have completed the safety evaluation period of the second cohort in Poland, the third cohort will begin there at a dose level of 180 mg/m2.  Once the Company establishes an RP2D, the intent is for each trial to advance to a Phase 2 arm planned to assess the safety and efficacy of Annamycin in 21 additional patients.

 

The US trial also differs from the Polish trial in that the FDA would like to review safety data relating to cardiotoxicity from patients treated prior to advancing beyond 120 mg/m2.  The Company believes that the additional patient safety data gained from the Polish trial will assist in the FDA’s review of cardiac safety.

 

About Moleculin Biotech, Inc.

 

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. The Company’s clinical stage drugs are: Annamycin, a Next Generation Anthracycline, designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic cancer and hematologic malignancies, and WP1220, an analog to WP1066, for the topical treatment of cutaneous T-cell lymphoma. Moleculin is also engaged in preclinical development of additional drug candidates, including additional Immune/Transcription Modulators, as well as compounds capable of Metabolism/Glycosylation Inhibition.

 

For more information about the Company, please visit http://www.moleculin.com.

 

Forward-Looking Statements

 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to successfully recruit patients to complete its clinical trials and the ability of Annamycin to show safety and efficacy in patients. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC.  Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. The Company cautions investors not to place undue reliance on the interim results announced today.

 

Contacts

Joe Dorame, Robert Blum or Joe Diaz

Lytham Partners, LLC

602-889-9700

mbrx@lythampartners.com

 

Source:  Moleculin Biotech, Inc

Moleculin Files for New Patents for Annamycin After Receiving FDA Approval of Fast Track Designation

Houston, TX – July 10, 2019 – Moleculin Biotech, Inc., (NASDAQ: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, today announced it has filed new patents covering the production and reconstitution of Annamycin, which is currently in two clinical trials for the treatment of relapsed or refractory acute myeloid leukemia (AML).

 

“Annamycin already has Orphan Drug Designation for the treatment of AML,” commented Walter Klemp, Moleculin’s Chairman and CEO,  “but these new patent applications, if these patent applications are approved, would give us 20 years of protection for our drug.”

 

Mr. Klemp continued: “Since we have recently announced promising preclinical data showing the potential for Annamycin to become an important treatment for lung metastases, having this broad coverage should add considerable value to this asset.”

 

About Moleculin Biotech, Inc.

 

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. The Company’s clinical stage drugs are: Annamycin, a Next Generation Anthracycline, designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic cancer and hematologic malignancies, and WP1220, an analog to WP1066, for the topical treatment of cutaneous T-cell lymphoma. Moleculin is also engaged in preclinical development of additional drug candidates, including additional Immune/Transcription Modulators, as well as compounds capable of Metabolism/Glycosylation Inhibition.

 

For more information about the Company, please visit http://www.moleculin.com.

 

Forward-Looking Statements

 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of Moleclin to be awarded patents based on the applications announced and the ability for Annamycin to demonstrate safety and efficacy in patients. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC.  Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. The Company cautions investors not to place undue reliance on the interim results announced today.

 

 

Contacts

Joe Dorame, Robert Blum or Joe Diaz

Lytham Partners, LLC

602-889-9700

mbrx@lythampartners.com

 

Source:  Moleculin Biotech, Inc

Moleculin Announces Additional Positive Interim Results in First Cohort of Phase 1/2 Clinical Studies of Annamycin in Acute Myeloid Leukemia in Europe

2 of 3 patients qualify to proceed to a potentially curative bone marrow transplant; trial advances to next higher dose level

 

Houston, TX – May 7, 2019 – Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, today announced additional positive interim safety and efficacy data from its ongoing open label, single arm Phase 1/2 study of Annamycin in Poland.  After receiving a single starting dose of 120 mg/m2 in the first cohort of the dose escalation phase of the trial, 2 of 3 patients treated responded sufficiently to qualify for a potentially curative bone marrow transplant.  The results for all 3 patients were reviewed by the Safety Review Committee, which determined that no drug-related adverse events were observed that would prevent advancing the trial to the next higher dose level of 150 mg/m2.  To date in the European trial, one patient experienced grade 2 mucositis (which resolved to grade 1 within 2 days) and no other adverse events related to Annamycin have been reported.  No additional patient data have been developed in the Company’s parallel US clinical trial, which is currently recruiting its second cohort to be given a dose level of 120 mg/m2 (the US trial started at a lower initial dose of 100 mg/m2).

 

“The progress in Europe, specifically Poland, continues to be encouraging,” commented Walter Klemp, Moleculin’s Chairman and CEO.  “In just a few months, we have completed the first cohort and we’ve seen a partial response from 2 out of 3 patients sufficient to qualify them for a potentially curative bone marrow transplant.  It’s important to remember that these are relapsed or refractory patients for whom the standard of care failed.  So, to see this kind of response at the starting dose level in the dose-ranging phase, we believe is quite remarkable.  And, although this data is still preliminary and may not be indicative of the ultimate outcome of the trial, the improvement in activity at 120 mg/m2 in Poland as compared with the 100 mg/m2 cohort in the US is consistent with our expectations for Annamycin.”

 

Mr. Klemp continued: “Recognizing that cardiotoxicity is a significant limitation of existing therapies, we are pleased that we continue to see no evidence of cardiotoxicity in any of the patients treated thus far.  Specifically, there was no observed reduction in left ventricle ejection fraction, which is the standard metric for acute cardiotoxicity, nor any change in biomarkers that would indicate the potential for long-term cardiovascular impairment.  This is an important step in the ongoing clinical study of Annamycin and toward our goal of ultimately demonstrating the drug’s safety and effectiveness to support regulatory approval in both the US and European Union.”

 

Dr. Robert Shepard, Moleculin’s Chief Medical Officer for Annamycin added: “With the Polish trial now progressing to 150 mg/m2, we expect to see even better results.  And, although 150 mg/m2 was the maximum tolerable dose established by the prior developer of Annamycin due to the incidence of mucositis in patients above that dose level, now that the cryotherapy protocol is well understood to mitigate the potential for dose-limiting mucositis, there is a good opportunity for dose levels to progress even beyond 150 mg/m2, so the potential to help patients is very exciting.”

 

Study Design

 

The Company is studying Annamycin in both the US and Poland in open label, single arm clinical trials to assess the safety and efficacy of Annamycin for the treatment of adults with relapsed or refractory acute myeloid leukemia.  The US and Polish trials have the same study design, consisting of a Phase 1 intended to establish a “Recommended Phase 2 Dose” (“RP2D”), to which the studies will then proceed.  The Phase 1 studies provide for escalating doses in cohorts of 3 patients each, with each successive cohort receiving the next higher dose level until “dose limiting toxicities” prevent further increases.  Cohort 1 in Poland received a dose of 120 mg/m2, and the results permit moving to 150 mg/m2.  Cohort 1 in the US started at 100 mg/m2, and the results support moving to 120 mg/m2, and the Company is now seeking patients for the second cohort in both studies.   (Because one patient in US cohort 1 did not complete the evaluation protocol, a fourth patient was added to complete that cohort.)  Once the Company establishes an RP2D, the intent is for each trial to advance to a Phase 2 arm planned to assess the safety and efficacy of Annamycin in 21 additional patients.

 

We plan to report top-line results by cohort in each trial, with each announcement also including an update on the other trial.  Top-line results will include reporting of any drug-related adverse events (“AEs”) and assessment of cardiotoxicity, including Echo or MUGA scans measuring change in ejection fraction and measuring blood troponin level, which is considered a biomarker for potential long-term cardiovascular impairment.  To date, one patient experienced grade 2 mucositis (which resolved to grade 1 within 2 days) and no other drug-related AEs have been reported.  Also, no loss of ejection fraction or reduction in Troponin levels has been reported.  Top-line results will also include the number of partial responses (“PRs”), complete responses (“CRs”) and patients deemed capable of progressing to a potentially curative bone marrow transplant, which we term “bridge to transplant” (“BTs”), each of which is essentially a function of the magnitude of reduction in a patient’s bone marrow blasts.  For purposes of these clinical trials, a CR means, primarily, that the patient’s bone marrow blasts reduced to 5% or less, a PR means the patient’s bone marrow blasts reduced, but not to the level of a CR, and a BT means patients are deemed capable of progressing to a potentially curative bone marrow transplant.  To date, there have been no PRs, CRs or BTs in the US trial, which has treated 4 patients at 100 mg/m2, and 2 PRs and BTs out of 3 patients treated in the Polish trial at 120 mg/m2.

 

The US trial also differs from the Polish trial in that the FDA would like to review safety data relating to cardiotoxicity from patients treated prior to advancing beyond 120 mg/m2.  The Company believes that the additional patient safety data gained from the Polish trial may also assist in the FDA’s review of cardiac safety.

 

About Moleculin Biotech, Inc.

 

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. The Company’s clinical stage drugs are: Annamycin, a Next Generation Anthracycline, designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic cancer and hematologic malignancies, and WP1220, an analog to WP1066, for the topical treatment of cutaneous T-cell lymphoma. Moleculin is also engaged in preclinical development of additional drug candidates, including additional Immune/Transcription Modulators, as well as compounds capable of Metabolism/Glycosylation Inhibition.

 

For more information about the Company, please visit http://www.moleculin.com.

 

Forward-Looking Statements

 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to successfully recruit patients to complete its clinical trials and the ability of Annamycin to show safety and efficacy in patients. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC.  Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. The Company cautions investors not to place undue reliance on the interim results announced today.

 

 

Contacts

Joe Dorame, Robert Blum or Joe Diaz

Lytham Partners, LLC

602-889-9700

mbrx@lythampartners.com

 

Source:  Moleculin Biotech, Inc.

Moleculin Receives FDA Approval of Fast Track Designation for Annamycin

Houston, TX – April 18, 2019 – Moleculin Biotech, Inc., (NASDAQ: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, today announced that the U.S. Food and Drug Administration (“FDA”) has approved its request for Fast Track Designation for its drug, Annamycin, for the treatment of relapsed or refractory acute myeloid leukemia (“AML”).

 

“We are thrilled that Annamycin has been granted Fast Track Designation,” commented Walter Klemp, Moleculin’s Chairman and CEO. “Not only does this make us eligible for accelerated approval and priority review, but it serves as an important validation of the significant unmet need we are trying to address. Currently, Annamycin is in separate Phase I/II trials in the U.S. and Europe for the treatment of AML and the Company has recently announced positive interim top line data.”

 

A drug that receives Fast Track designation is eligible for some or all of the following:

 

  • More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval
  • More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
  • Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
  • Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA

 

About Moleculin Biotech, Inc.

 

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. The Company’s clinical stage drugs are: Annamycin, a Next Generation Anthracycline, designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic cancer and AML, and WP1220, an analog to WP1066, for the topical treatment of cutaneous T-cell lymphoma. Moleculin Biotech is also engaged in preclinical development of additional drug candidates, including additional Immune/Transcription Modulators, as well as compounds capable of Metabolism/Glycosylation Inhibition.

 

For more information about the Company, please visit http://www.moleculin.com. 

 

Forward-Looking Statements

 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of Annamycin to benefit from an accelerated approval pathway or ultimate approval from the FDA for Annamycin. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC.  Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

 

Contacts

Joe Dorame, Robert Blum or Joe Diaz

Lytham Partners, LLC

602-889-9700

mbrx@lythampartners.com

 

Source:  Moleculin Biotech, Inc.

Moleculin Announces Significant Discovery in Lung Cancer Models

Annamycin Found to be Active Against Metastatic Lung Cancer in Pre-Clinical Testing

 

Houston, TX – April 17, 2018 – Moleculin Biotech, Inc., (NASDAQ: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, today announced that its ongoing sponsored research at The University of Texas MD Anderson Cancer Center has now demonstrated that Annamycin is able to significantly improve survival in an aggressive form of triple negative breast cancer metastasized to the lungs in animal models.

 

“We know that Annamycin was previously shown to be significantly more potent than doxorubicin in both Lewis lung carcinoma in vivo and small cell lung cancer in vitro models,” commented Walter Klemp, Moleculin’s Chairman and CEO.  “Now we are seeing significant activity against triple negative breast cancer that has metastasized to the lungs.  This particular animal model used in our testing is considered to represent a very aggressive form of cancer. We believe our success in increasing the survival rate in mice with this tumor model in combination with the previously observed high uptake of Annamycin by the lungs is a promising indication that supports additional clinical research in lung and metastatic lung cancers.”

 

About Moleculin Biotech, Inc.

 

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on discoveries made at M.D. Anderson Cancer Center. The Company’s clinical stage drugs are Annamycin, an anthracycline designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, and WP1066, an immuno-stimulating STAT3 inhibitor targeting brain tumors, pancreatic cancer and AML. Moleculin Biotech is also engaged in preclinical development of additional drug candidates, including additional STAT3 inhibitors and compounds targeting the metabolism of tumors.

 

For more information about the Company, please visit http://www.moleculin.com.

 

Forward-Looking Statements

 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of Annamycin to show safety and efficacy in patients. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC.  Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

 

Contacts

Joe Dorame, Robert Blum or Joe Diaz

Lytham Partners, LLC

602-889-9700

mbrx@lythampartners.com

 

Source:  Moleculin Biotech, Inc.

Moleculin Announces Agreement with Emory University to Conduct Pediatric Brain Tumor Trial

Houston, TX – April 11, 2019 – Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, today announced it has entered into an agreement with Emory University to conduct a Phase 1 clinical trial of WP1066 in children with recurrent or refractory malignant brain tumors. The study will be conducted at the Aflac Cancer & Blood Disorders Center at Children’s Healthcare of Atlanta.

 

“Given the exciting data Emory University researchers presented at the recent Society for Neuro Oncology conference, we have been working closely with them to begin a trial in pediatric brain tumors,” commented Walter Klemp, Moleculin’s Chairman and CEO.  “WP1066 was shown to have a significant anti-tumor effect on medulloblastoma cell lines, so there is a lot of encouragement regarding the opportunity to provide new hope for treating this rare condition.  This will also give us yet another opportunity to develop human proof of concept data, bringing our total number of clinical trials to five.  This clinical trial is expected to begin recruitment in the second half of this year.”

 

About Moleculin Biotech, Inc.

 

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on discoveries made at M.D. Anderson Cancer Center. The Company’s clinical stage drugs are Annamycin, an anthracycline designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, and WP1066, an immuno-stimulating STAT3 inhibitor targeting brain tumors, pancreatic cancer and AML. Moleculin Biotech is also engaged in preclinical development of additional drug candidates, including additional STAT3 inhibitors and compounds targeting the metabolism of tumors.

 

For more information about the Company, please visit http://www.moleculin.com.

 

Forward-Looking Statements

 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of WP1066 to show safety and efficacy in patients. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC.  Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

 

Contacts

Joe Dorame, Robert Blum or Joe Diaz

Lytham Partners, LLC

602-889-9700

mbrx@lythampartners.com

 

Source:  Moleculin Biotech, Inc.

Moleculin Announces Successful Expansion of its Leukemia Drug Program

Houston, TX – April 9, 2019 – Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, today announced it has successfully expanded the clinical supply of Annamycin for its on-going clinical trials via BSP Pharmaceuticals S.p.A. (www.bsppharmaceuticals.com) in Latina, Italy.

 

“Securing production supply for a liposomal anthracycline like Annamycin is no trivial matter, which is why we partnered last year with a quality supplier like BSP, who will be able to supply Annamycin in commercial quantities going forward,” commented Walter Klemp, Moleculin’s Chairman and CEO. “They have worked diligently to establish production capability and are now supplying our Annamycin drug for our clinical trials in the U.S. and the EU. We believe having a partnership with a pharmaceutical manufacturer the caliber of BSP mitigates our development risk and better positions us to further advance the clinical development of Annamycin as we work to develop effective solutions for the treatment of acute myeloid leukemia.”

 

About Moleculin Biotech, Inc.

 

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on discoveries made at M.D. Anderson Cancer Center. The Company’s clinical stage drugs are Annamycin, an anthracycline designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, and WP1066, an immuno-stimulating STAT3 inhibitor targeting brain tumors, pancreatic cancer and AML. Moleculin Biotech is also engaged in preclinical development of additional drug candidates, including additional STAT3 inhibitors and compounds targeting the metabolism of tumors.

 

For more information about the Company, please visit http://www.moleculin.com.

 

Forward-Looking Statements

 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of Moleculin to successfully recruit sufficient patients to complete this clinical trial and that ability of WP1220 to show safety and efficacy in patients. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC.  Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

 

Contacts

Joe Dorame, Robert Blum or Joe Diaz

Lytham Partners, LLC

602-889-9700

mbrx@lythampartners.com

 

Source: Moleculin Biotech, Inc.

Moleculin Announces Positive Interim Results in First Cohort of Phase 1/2 Clinical Studies of Annamycin in Acute Myeloid Leukemia in the US and in Poland

One patient to proceed to potentially curative bone marrow transplant; no cardiotoxicity observed

 

Houston, TX – March 26, 2019 – Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, today announced positive interim safety and efficacy data from two ongoing open label, single arm Phase 1/2 studies of Annamycin.  In the first study, being conducted in the US, four patients have completed treatment at 100 mg/m2 with no significant adverse events related to Annamycin, and the study will now proceed to the next higher dose of 120 mg/m2. The second trial, taking place in Poland, started at a 120 mg/m2 dose of Annamycin and has treated three patients. The first patient treated in that trial received a single course of Annamycin and his bone marrow blasts have reduced from 60% to 11%. Our principal investigator considers this response sufficient for the patient to proceed to consolidation therapy, with the goal of receiving a potentially curative bone marrow transplant. To date in Poland, one patient experienced grade 2 mucositis (which resolved to grade 1 within 2 days) and no other adverse events related to Annamycin have been reported.  Trial results for the other two patients treated in Poland will not be known until the second quarter of this year.

 

“We are very pleased to have completed the treatment of patients in cohort 1 of the US trial and move to the next higher dose,” commented Walter Klemp, Moleculin’s Chairman and CEO.  “In Poland, we are pleased to have such a positive response at the starting dose level in this trial. Of course the response of a single patient doesn’t necessarily predict the outcome of the trial, but this is a great way to begin and it’s consistent with our expectations for Annamycin.”

 

Mr. Klemp continued: “One of the advantages we believe Annamycin will offer is a lack of cardiotoxicity.  We have seen no evidence of cardiotoxicity in any of the patients treated thus far.  We intend to advance the clinical study of Annamycin with the goal of ultimately demonstrating the drug’s safety and effectiveness to support regulatory approval in the US and European Union.”

 

Dr. Robert Shepard, Moleculin’s Chief Medical Officer for Annamycin added: “A prior clinical trial for Annamycin in acute leukemia demonstrated activity at its Maximum Tolerable Dose of 150 mg/m2, so we are pleased for the US trial to move to the next higher dose in cohort 2  of 120 mg/m2. In Poland, we consider reducing bone marrow blasts for Patient 1 down to 11% with a single course of Annamycin to be very encouraging.    Of course, significant additional study is necessary to definitively demonstrate causality.”

 

“We have begun a second course of Annamycin as a consolidation phase for Patient 1,” commented Dr. Lidia Gil, Principal Investigator in the Polish Annamycin clinical trial.  “Considering that this patient was refractory to standard of care induction therapy, I am very pleased to see that Annamycin appears to be showing activity.  While this is considered a ‘Partial Response,’ I believe it’s enough of a reduction to serve as a ‘bridge to transplant’ for this patient.  Importantly, with the first course of Annamycin, no toxicities have been observed that would limit continued dosing with Annamycin.”

 

Study Design

 

The Company is studying Annamycin in both the US and Poland in open label, single arm clinical trials to assess the safety and efficacy of Annamycin for the treatment of adults with relapsed or refractory acute myeloid leukemia.  Both the US and Polish trials have the same study design, providing for a Phase 1 intended to establish a “Recommended Phase 2 Dose,” (“RP2D”) with cohorts of 3 patients each where the first cohort starts at a low beginning dose and each successive cohort receives the next higher dose level until “dose limiting toxicities” prevent further increases.  In the case of cohort 1 in the US, one patient did not complete the evaluation protocol, so a fourth patient was added to complete that cohort.

 

A key difference in the US is that the starting dose was 100 mg/m2, whereas, in Poland, the starting dose was 120 mg/m2.  Having completed the first cohort in the US, the Company is seeking patients for the second cohort at a dose level of 120 mg/m2.  Once 3 patients have completed the safety evaluation period of the first cohort in Poland, the second cohort will begin there at a dose level of 150 mg/m2.  Once the Company establishes an RP2D, the intent is for each trial to advance to a Phase 2 arm planned to assess the safety and efficacy of Annamycin in 21 additional patients.

 

The US trial also differs from the Polish trial in that the FDA would like to review safety data relating to cardiotoxicity from patients treated prior to advancing beyond 120 mg/m2.  The Company believes that the additional patient safety data gained from the Polish trial may also assist in the FDA’s review of cardiac safety.

 

About Moleculin Biotech, Inc.

 

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. The Company’s clinical stage drugs are: Annamycin, a Next Generation Anthracycline, designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic cancer and hematologic malignancies, and WP1220, an analog to WP1066, for the topical treatment of cutaneous T-cell lymphoma. Moleculin is also engaged in preclinical development of additional drug candidates, including additional Immune/Transcription Modulators, as well as compounds capable of Metabolism/Glycosylation Inhibition.

 

For more information about the Company, please visit http://www.moleculin.com.

 

Forward-Looking Statements

 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to successfully recruit patients to complete its clinical trials and the ability of Annamycin to show safety and efficacy in patients. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC.  Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. The Company cautions investors not to place undue reliance on the interim results announced today.

 

 

Contacts

Joe Dorame, Robert Blum or Joe Diaz

Lytham Partners, LLC

602-889-9700

mbrx@lythampartners.com

 

Source:  Moleculin Biotech, Inc.

Moleculin Announces First Patients Enrolled in Lymphoma Clinical Trial

Houston, TX – March 19, 2019 – Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, today announced that the first two patients have been enrolled in its European clinical trial of WP1220 for the topical treatment of cutaneous T-cell lymphoma (CTCL).

 

“This now marks four clinical trials with patients enrolled,” commented Walter Klemp, Moleculin’s Chairman and CEO. “In this case, we are targeting CTCL with a topical p-STAT3 inhibitor in light of the significant role that STAT3 appears to play in CTCL skin lesions.  Our intent is to take an early read on the first five patients in this trial to assess whether we think topical delivery is viable, so we expect preliminary data to be available during 2019.”

 

About Moleculin Biotech, Inc.

 

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. The Company’s clinical stage drugs are: Annamycin, a Next Generation Anthracycline, designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic cancer and AML, and WP1220, an analog to WP1066, for the topical treatment of cutaneous T-cell lymphoma. Moleculin Biotech is also engaged in preclinical development of additional drug candidates, including additional Immune/Transcription Modulators, as well as compounds capable of Metabolism/Glycosylation Inhibition.

 

For more information about the Company, please visit http://www.moleculin.com.

 

Forward-Looking Statements

 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of WP1220 to show safety and efficacy in patients. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC.  Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

 

Contacts

Joe Dorame, Robert Blum or Joe Diaz

Lytham Partners, LLC

602-889-9700

mbrx@lythampartners.com

 

Source: Moleculin Biotech, Inc.

Moleculin Announces First Patients Treated in European Annamycin Clinical Trial

Houston, TX – March 13, 2019 – Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, today announced the first patients have been treated in the Company’s second clinical trial to study Annamycin for the treatment of relapsed and refractory adults with acute myeloid leukemia.  The Company further reported that the initial treatment of the first patient appeared to be well tolerated.

 

“We are encouraged to see such ready access to qualified patients in Poland,” commented Walter Klemp, Moleculin’s Chairman and CEO.  “We consider it a positive indication to have completed the treatment of the first European patient so soon after beginning recruitment.  In addition, we have already begun treatment of the second patient. We also believe that the higher starting dosage in the European trial as compared to the US trial may be contributing to a faster rate of recruitment.”

 

About Moleculin Biotech, Inc.

 

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. The Company’s clinical stage drugs are: Annamycin, a Next Generation Anthracycline, designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic cancer and AML, and WP1220, an analog to WP1066, for the topical treatment of cutaneous T-cell lymphoma. Moleculin Biotech is also engaged in preclinical development of additional drug candidates, including additional Immune/Transcription Modulators, as well as compounds capable of Metabolism/Glycosylation Inhibition.

 

For more information about the Company, please visit http://www.moleculin.com.

 

Forward-Looking Statements

 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of Moleculin to successfully recruit sufficient patients to complete this clinical trial and the ability of Annamycin to show safety and efficacy in patients. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC.  Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

 

Contacts

Joe Dorame, Robert Blum or Joe Diaz

Lytham Partners, LLC

602-889-9700

mbrx@lythampartners.com

 

Source:  Moleculin Biotech, Inc.

Moleculin Files with FDA for Expedited Approval Pathway for Annamycin

Houston, TX – March 13, 2019 – Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, today announced that it has submitted a request for Fast Track Designation with the US Food and Drug Administration (FDA) for its drug, Annamycin, for the treatment of relapsed or refractory acute myeloid leukemia (AML).

 

“Now that we have some traction in our clinical trials of Annamycin for the treatment of relapsed or refractory AML,” commented Walter Klemp, Moleculin’s Chairman and CEO, “we believe it is appropriate to request Fast Track designation for Annamycin.  Importantly, this is a valuable first step in ultimately qualifying for Accelerated Approval and Priority Review.”

 

A drug that receives Fast Track designation is eligible for some or all of the following:

 

  • More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval
  • More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
  • Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
  • Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA.

 

About Moleculin Biotech, Inc.

 

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. The Company’s clinical stage drugs are: Annamycin, a Next Generation Anthracycline, designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic cancer and AML, and WP1220, an analog to WP1066, for the topical treatment of cutaneous T-cell lymphoma. Moleculin Biotech is also engaged in preclinical development of additional drug candidates, including additional Immune/Transcription Modulators, as well as compounds capable of Metabolism/Glycosylation Inhibition.

 

For more information about the Company, please visit http://www.moleculin.com.

 

Forward-Looking Statements

 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of Annamycin to receive Fast Track designation, an accelerated approval pathway or ultimate approval from the FDA for Annamycin. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC.  Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

 

Contacts

Joe Dorame, Robert Blum or Joe Diaz

Lytham Partners, LLC

602-889-9700

mbrx@lythampartners.com

 

Source:  Moleculin Biotech, Inc.

Moleculin Announces Approval for Third Drug to Commence Clinical Trials

MBRX will now have three distinctive oncology drugs in clinic in four ongoing clinical trials

 

WP1220, a STAT3 inhibitor, to begin clinical trials in Poland for the treatment of Cutaneous T-Cell Lymphona (“CTCL”), a rare and deadly skin cancer

 

HOUSTON – February 7, 2019 – Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced it has received approval to begin clinical trials in Poland for its STAT3 inhibitor, WP1220, for the topical treatment of Cutaneous T-Cell Lymphoma (“CTCL”).

 

“This marks an important milestone for Moleculin.  We now have three unique drug candidates in four ongoing clinical trials for the potential treatment of rare and difficult cancers, ” commented Walter Klemp, Moleculin’s Chairman and CEO.  “We are committed to the strategy of what we call ‘multiple shots on goal,’ and this latest approval to begin trials means we now have three distinctly different therapies in clinical trials for the potential treatment of rare and difficult cancers.”

 

Dr. Don Picker, Moleculin’s Chief Science Officer, added, “CTCL is a potentially deadly form of skin cancer involving skin lesions that often have high levels of activated STAT3 (p-STAT3).  As a potent inhibitor of p-STAT3, we believe WP1220 may be ideally suited to treat these lesions through topical application, which is what this clinical trial is designed to evaluate.”

 

Dr. Malgorzata Sokolowska-Wojdylo, Dermatology Department Chair at the Medical University of Gdańsk in Poland, and the Principal Investigator running this clinical trial,  concluded, “There is a significant unmet need for improved topical therapies for CTCL, and we are excited to be the first clinic to evaluate this promising new drug in CTCL patients.”

 

About Moleculin Biotech, Inc.

 

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on discoveries made at M.D. Anderson Cancer Center. The Company’s clinical stage drugs are Annamycin, an anthracycline designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, and WP1066, an immuno-stimulating STAT3 inhibitor targeting brain tumors, pancreatic cancer and AML. Moleculin Biotech is also engaged in preclinical development of additional drug candidates, including additional STAT3 inhibitors and compounds targeting the metabolism of tumors.

 

For more information about the Company, please visit http://www.moleculin.com.

 

Forward-Looking Statements

 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of Moleculin to successfully recruit sufficient patients to complete this clinical trial and that ability of WP1220 to show safety and efficacy in patients. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC.  Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

 

Contacts

Joe Dorame, Robert Blum or Joe Diaz

Lytham Partners, LLC

602-889-9700

mbrx@lythampartners.com

 

Source:  Moleculin Biotech, Inc.,

Moleculin Announces the FDA has Granted Orphan Drug Designation for its Brain Tumor Drug

HOUSTON – February 5, 2018 – Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Status for its drug candidate WP1066 for the treatment of glioblastoma, the most aggressive form of brain tumor.

 

“We continue to be encouraged by the progress of the physician-led clinical trial of WP1066,” commented Walter Klemp, Moleculin’s Chairman and CEO,  “and, now having the FDA grant Orphan Drug status for WP1066 positions us well for potential marketing of this drug.  We believe that WP1066 represents a new class of drugs which we call ‘Immune/Transduction Modulators’ because it has demonstrated the ability in preclinical testing in animals to both stimulate a natural immune response to tumors and directly attack tumor cells by inhibiting multiple key oncogenic transcription factors, including STAT3, HIF1-α and c-Myc.”

 

Dr. Sandra Silberman, Chief Medical Officer for New Projects at Moleculin added: “the development of WP1066 is gaining momentum.  In addition to the glioblastoma trial at MD Anderson, we have had interest from additional investigators, including Emory University and Mayo Clinic for conducting clinical trials for the treatment of pediatric brain tumors, as well as others interested in treating a range of highly resistant tumors including AML and pancreatic cancer.  Because we’ve seen strong anti-tumor activity in a wide range of animal models, we believe this represents an important new approach to treating many types of cancer.”

 

The FDA grants orphan drug designation to drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. Orphan drug status is intended to facilitate drug development for rare diseases and may provide several benefits to drug developers, including tax credits for qualified clinical trials costs, exemptions from certain FDA application fees, and seven years of market exclusivity upon regulatory product approval.

 

About Moleculin Biotech, Inc.

 

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on discoveries made at M.D. Anderson Cancer Center. The Company’s clinical stage drugs are Annamycin, an anthracycline designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, and WP1066, an immuno-stimulating STAT3 inhibitor targeting brain tumors, pancreatic cancer and AML. Moleculin Biotech is also engaged in preclinical development of additional drug candidates, including additional STAT3 inhibitors and compounds targeting the metabolism of tumors.

 

For more information about the Company, please visit http://www.moleculin.com.

 

Forward-Looking Statements

 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of WP1066 to show safety and efficacy in patients. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC.  Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

 

Contacts

Joe Dorame, Robert Blum or Joe Diaz

Lytham Partners, LLC

602-889-9700

mbrx@lythampartners.com

 

SOURCE:  Moleculin Biotech, Inc.,

Moleculin Announces Patient Recruitment Begins in Annamycin Clinical Trial In Poland

Received European approval to ship Annamycin into Poland to start treating patients

 

HOUSTON – January 9, 2018 – Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced it has begun in Poland recruiting patients in the Company’s second clinical trial to study Annamycin for the treatment of relapsed and refractory adults with acute myeloid leukemia (“AML”).

 

“We are encouraged to see ready access to qualified patients in Poland,” commented Walter Klemp, Moleculin’s Chairman and CEO.  “Having now cleared the unique European approval process to ship Annamycin, which had delayed the start of the trial in Poland,  clinical supplies are now in country and ready to treat patients. The sites there have begun the patient screening and recruitment process.  Our expectation is that the fewer number of AML clinical trials in Poland as compared with the U.S. will give us an opportunity to complete the Phase 1 arm more quickly here.”

 

About Moleculin Biotech, Inc.

 

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on discoveries made at M.D. Anderson Cancer Center. The Company’s clinical stage drugs are Annamycin, an anthracycline designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, and WP1066, an immuno-stimulating STAT3 inhibitor targeting brain tumors, pancreatic cancer and AML. Moleculin Biotech is also engaged in preclinical development of additional drug candidates, including additional STAT3 inhibitors and compounds targeting the metabolism of tumors.

 

For more information about the Company, please visit http://www.moleculin.com.

 

Forward-Looking Statements

 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of Moleculin to successfully recruit sufficient patients to complete this clinical trial on a timely basis and the ability of Annamycin to show safety and efficacy in patients. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC.  Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

 

Contacts

Joe Dorame, Robert Blum or Joe Diaz

Lytham Partners, LLC

602-889-9700

mbrx@lythampartners.com

SOURCE:  Moleculin Biotech, Inc.,

Moleculin Announces FDA Filing for Orphan Drug Designation for Glioblastoma Drug

HOUSTON – December 6, 2018 – Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced it has filed a request with the U.S. Food and Drug Administration (“FDA”) for Orphan Drug Status for its drug candidate WP1066.

 

“Clinical progress with WP1066 has been encouraging,” commented Walter Klemp, Moleculin’s Chairman and CEO.  “Given its potential to address rare and difficult to treat cancers, including glioblastoma, we believe WP1066 is well positioned to qualify for Orphan Drug Status.”

 

The FDA grants orphan drug designation to drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. Orphan drug status is intended to facilitate drug development for rare diseases and may provide several benefits to drug developers, including tax credits for qualified clinical trials costs, exemptions from certain FDA application fees, and seven years of market exclusivity upon regulatory product approval.

 

About Moleculin Biotech, Inc.

 

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on discoveries made at M.D. Anderson Cancer Center. The Company’s clinical stage drugs are Annamycin, an anthracycline designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, and WP1066, an immuno-stimulating STAT3 inhibitor targeting brain tumors, pancreatic cancer and AML. Moleculin Biotech is also engaged in preclinical development of additional drug candidates, including additional STAT3 inhibitors and compounds targeting the metabolism of tumors.

 

For more information about the Company, please visit http://www.moleculin.com.

 

Forward-Looking Statements

 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of WP1066 to show safety and efficacy in patients and the ability of WP1066 to qualify for and be granted Orphan Drug Status. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC.  Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

 

Contacts

Joe Dorame, Robert Blum or Joe Diaz

Lytham Partners, LLC

602-889-9700

mbrx@lythampartners.com

 

Moleculin Announces Breakthrough Discovery for its WP1066

WP1066 shown to counteract resistance to checkpoint blockades

 

HOUSTON – December 4, 2018 – Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced that its own sponsored research has now confirmed a recent published study demonstrating the ability of its clinical-stage immuno-stimulating STAT3 inhibitor, WP1066, to inhibit a key immune checkpoint target known as PD-L1.

 

“We have known for some time that WP1066 had the potential to stimulate a natural immune response,” commented Dr. Donald Picker, Moleculin’s Chief Science Officer.  “But, this data suggests that our drug may be capable of having a major impact on the field of checkpoint blockades. With this information combined with findings from other recently published studies demonstrating the impotant role of STAT3 in cancer immunology, we plan to run additional in vitro and in vivo studies, some of which are already underway, with WP1066 in combination with well-known checkpoint inhibitors to gather more data on this response.”

 

Walter Klemp, Moleculin’s Chairman and CEO added, “This potential was initially reported in a 2017 Japanese study (Journal of clinical and experimental hematopathology, Vol. 57 No.1, 21-25, 2017), but we have now been able to confirm this activity with our own sponsored research at MD Anderson.  Also, very recent independent research (Front Pharmacol. 2018 May 22;9:536. doi: 10.3389/fphar.2018.00536. eCollection 2018.) has linked STAT3, HIF1-a and c-Myc (all targets of WP1066) to the mechanism (a ligand known as PD-L1) believed to be largely responsible for resistance to current checkpoint blockade therapies.  We believe this could put WP1066 center-stage in the field of immunotherapy.  It’s potentially a tremendous breakthrough for our company.”

 

About Moleculin Biotech, Inc.

 

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on discoveries made at M.D. Anderson Cancer Center. The Company’s clinical stage drugs are Annamycin, an anthracycline designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, and WP1066, an immuno-stimulating STAT3 inhibitor targeting brain tumors, pancreatic cancer and AML. Moleculin Biotech is also engaged in preclinical development of additional drug candidates, including additional STAT3 inhibitors and compounds targeting the metabolism of tumors.

 

For more information about the Company, please visit http://www.moleculin.com.

 

Forward-Looking Statements

 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of WP1066 to show safety and efficacy in patients. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC.  Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

 

Contacts

Joe Dorame, Robert Blum or Joe Diaz

Lytham Partners, LLC

602-889-9700

mbrx@lythampartners.com

 

Moleculin Announces New Data Further Supporting Its Lead Drug for Treating Pancreatic Cancer

WP1732 shown to accumulate beneficially in pancreas

 

HOUSTON – November 28, 2018 – Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced that data from an independent test in animal models confirmed, as previously believed, that its immuno-stimulating STAT3 inhibitor achieves disproportionately high accumulation in the pancreas.

 

“Our own sponsored research suggested that WP1732 might be an ideal candidate for treating pancreatic cancer,” commented Dr. Donald Picker, Moleculin’s Chief Science Officer.  “Now, we have independent testing with radiolabeled drug confirming this in animal models.  The propensity for such enhanced pancreatic  distribution could be highly beneficial for a new pancreatic cancer drug.”

 

Walter Klemp, Moleculin’s Chairman and CEO added, “Published research shows that the growth and survival of pancreatic cancer requires activated STAT3 (p-STAT3) and our own research suggests that WP1732 may be one of the most effective inhibitors of p-STAT3 that has demonstrated activity in in vivo models.  Confirming the disproportionately high accumumulation of WP1732 in the pancreas puts us one step closer to introducing an entirely new approach to treating pancreatic cancer.  This is very encouraging and confirms the direction that Moleculin has taken with WP1732. We are heavily engaged in preparing the data necessary for an Investigational New Drug (IND) application with the FDA which we are targeted to file in 2019.”

 

About Moleculin Biotech, Inc.

 

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on discoveries made at M.D. Anderson Cancer Center. The Company’s clinical stage drugs are Annamycin, an anthracycline designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, and WP1066, an immuno-stimulating STAT3 inhibitor targeting brain tumors, pancreatic cancer and AML. Moleculin Biotech is also engaged in preclinical development of additional drug candidates, including additional STAT3 inhibitors and compounds targeting the metabolism of tumors.

 

For more information about the Company, please visit http://www.moleculin.com.

 

Forward-Looking Statements

 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of WP1732 to receive IND status and to show safety and efficacy in patients. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC.  Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

 

Contacts

Joe Dorame, Robert Blum or Joe Diaz

Lytham Partners, LLC

602-889-9700

mbrx@lythampartners.com

 

Moleculin Requests FDA Meeting Regarding IND for New Cancer Drug

Testing confirms ability of WP1732 to target pancreatic cancer

 

HOUSTON – November 15, 2018 – Moleculin Biotech, Inc., (NASDAQ:MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced it has filed a request with the US Food and Drug Administration (FDA) for a Pre-Investigational New Drug (IND) Meeting to seek FDA’s guidance and concurrence that the WP1732 development plan will meet requirements for an Initial IND filing and initiation of a proposed Phase 1 clinical trial.

 

“Independent animal model testing has now confirmed high uptake and retention of WP1732 in the pancreas,” commented Walter Klemp, Moleculin’s Chairman and CEO.  “Taken together with the previous observations of consistent activity against pancreatic cancer in in vitro and in vivo tumor models, this could make WP1732 ideally suited as a new therapy for treating pancreatic cancer.  Our  request for a Pre-IND Meeting with the FDA represents another important milestone in our effort to begin clinical trials with this promising new drug candidate.”

 

About Moleculin Biotech, Inc.

 

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on discoveries made at M.D. Anderson Cancer Center. The Company’s clinical stage drugs are Annamycin, an anthracycline designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, and WP1066, an immuno-stimulating STAT3 inhibitor targeting brain tumors, pancreatic cancer and AML. Moleculin Biotech is also engaged in preclinical development of additional drug candidates, including additional STAT3 inhibitors and compounds targeting the metabolism of tumors.

 

For more information about the Company, please visit http://www.moleculin.com.

 

Forward-Looking Statements

 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of WP1732 to show safety and efficacy in patients. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC.  Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

 

Contacts

Joe Dorame, Robert Blum or Joe Diaz

Lytham Partners, LLC

602-889-9700

mbrx@lythampartners.com

 

Moleculin Announces New Independent Study Expands Potential Use of Its Pancreatic Drug Candidate WP1122

Documented potential for drug candidate with characteristics like WP1122 to reverse immune suppression

 

HOUSTON – November 8, 2018 – Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced that a new mechanism of action may have been uncovered expanding the potential use of its inhibitor of glycolysis, WP1122.

 

A study recently published in the American Cancer Journal of Cancer Research (Am J Cancer Res 2018;8(9):1837-1846) involving researchers at MD Anderson and the Peking University Cancer Hospital & Institute has found that 2-deoxyglucose (2-DG) has the potential to decrease resistance to immune checkpoint blockade therapy in triple-negative breast cancer (TNBC) in a process known as “glycosylation.”

 

“This study provides a strong rationale for targeting glycosylation with 2-DG in order to improve outcomes for TNBC,” commented Dr. Donald Picker, Moleculin’s Chief Science Officer.  “Historically, 2-DG hasn’t been successfully developed into a drug because of its lack of drug-like properties, including a very short half-life.  Fortunately, based on preclinical data, WP1122, a proprietary prodrug of 2-DG, appears to address that problem and significantly increases the circulation time of 2-DG and its ability to reach specific organs harboring tumors, including the pancreas.”

 

Walter Klemp, Moleculin’s Chairman and CEO added, “The timing of this discovery is perfect for us.  We were already pushing forward with IND-enabling preclinical testing of WP1122 for use in brain tumors and pancreatic cancer and now we see a significant expansion of its potential uses.”

 

About Moleculin Biotech, Inc.

 

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on discoveries made at M.D. Anderson Cancer Center. The Company’s clinical stage drugs are Annamycin, an anthracycline designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, and WP1066, an immuno-stimulating STAT3 inhibitor targeting brain tumors, pancreatic cancer and AML. Moleculin Biotech is also engaged in preclinical development of additional drug candidates, including additional STAT3 inhibitors and compounds targeting the metabolism of tumors.

 

For more information about the Company, please visit http://www.moleculin.com.

 

Forward-Looking Statements

 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of WP1122 to show safety and efficacy in patients and the ability of Moleculin to obtain IND-enabling preclinical data. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC.  Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

 

Contacts

Joe Dorame, Robert Blum or Joe Diaz

Lytham Partners, LLC

602-889-9700

mbrx@lythampartners.com

 

Source:  Moleculin Biotech, Inc.

Moleculin Announces Significant Milestone Achieved in Glioblastoma Trial

WP1066 demonstrating drug bioavailability in on-going Phase 1 clinical trial

 

HOUSTON – November 1, 2018 – Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced positive progress in the Phase 1 clinical trial of its immuno-stimulating STAT3 inhibitor, WP1066, with initial results showing bioavailability of the drug in patients.

 

“Although this data is preliminary, it represents a significant milestone for the development of WP1066,” commented Dr. Donald Picker, Moleculin’s Chief Science Officer.  “In the first two cohorts of the Phase 1 study, we are already seeing measurable levels of the drug in the patient’s plasma resulting from oral administration.  Knowing we can deliver drug this way opens the door for further development and expanded clinical activity.”

 

Walter Klemp, Moleculin’s Chairman and CEO added, “We believe WP1066 is a first-in-class compound capable of stimulating a natural immune response in animal models while directly attacking tumors by modulating transcriptional activity and repressing what we call ‘oncogenic transcription factors.’  Chief among these is STAT3, considered a master regulator of tumor progression.  While activity in animal models has been very promising, one of the goals of this trial was to determine the potential for bioavailability in humans.  The initial positive indications of this clinical trial increase our confidence that WP1066 has the potential to become an important drug in the treatment of certain cancers. The initial demonstration of human bioavilability is an important milestone.”

 

About Moleculin Biotech, Inc.

 

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on discoveries made at M.D. Anderson Cancer Center. The Company’s clinical stage drugs are Annamycin, an anthracycline designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, and WP1066, an immuno-stimulating STAT3 inhibitor targeting brain tumors, pancreatic cancer and AML. Moleculin Biotech is also engaged in preclinical development of additional drug candidates, including additional STAT3 inhibitors and compounds targeting the metabolism of tumors.

 

For more information about the Company, please visit http://www.moleculin.com.

 

Forward-Looking Statements

 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of WP1066 to show safety and efficacy in patients. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC.  Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

 

Contacts

Joe Dorame, Robert Blum or Joe Diaz

Lytham Partners, LLC

602-889-9700

mbrx@lythampartners.com

Source:  Moleculin Biotech, Inc.

Moleculin Announces Positive Data on WP1066 in Pre-Clinical Trials

HOUSTON – October 25, 2018 – Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced that investigators at Emory University will present animal model data supporting the potential of WP1066 to treat pediatric brain tumors at the upcoming Society for Neuro-Oncology Annual Scientific Meeting.

 

“A number of independent institutions have published results supporting the potential for WP1066 to kill tumors in a range of animal models,” commented Walter Klemp, Moleculin’s Chairman and CEO.  “Having this corroborated yet again by data presented from Emory University just adds to the enthusiasm for testing WP1066 in humans.  What makes this particularly important is that our drug showed activity against the most common form of childhood brain tumor, medulloblastoma, for which there is a desperate need for more effective treatments.”

 

Mr. Klemp continued, “we are also proud of the fact that two different Moleculin technologies, WP1066 and WP1122 (see Moleculin press release dated October 10, 2018), are being presented at this prestigious conference on brain tumors.  We believe this is a strong indicator of the breadth and significance of our development pipeline.”

 

About Moleculin Biotech, Inc.

 

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on discoveries made at M.D. Anderson Cancer Center. Our clinical stage drugs are Annamycin, an anthracycline designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, and WP1066, an immuno-stimulating STAT3 inhibitor targeting brain tumors, pancreatic cancer and AML. We are also engaged in preclinical development of additional drug candidates, including additional STAT3 inhibitors and compounds targeting the metabolism of tumors.

 

For more information about the Company, please visit http://www.moleculin.com.

 

Forward-Looking Statements

 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of WP1066 or WP1122 to show safety and efficacy in patients. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC.  Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

 

Contacts

Joe Dorame, Robert Blum or Joe Diaz

Lytham Partners, LLC

602-889-9700

mbrx@lythampartners.com

 

Source:  Moleculin Biotech, Inc.

Moleculin Announces New Data Discovery Confirming Significant Increase in Potential to Starve Cancerous Tumors

Data to be Presented at Neuro-Oncology Annual Scientific Meeting

 

HOUSTON, Oct. 10, 2018- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced that new data relating to its molecule WP1122 will be presented at the upcoming Society for Neuro-Oncology Annual Scientific Meeting.

 

“We continue to make progress in the development of our inhibitor of glycolysis, WP1122,” commented Dr. Donald Picker, Moleculin’s Chief Science Officer.  “We believe that we have discovered new data during our IND-enabling research with animals that confirms a highly beneficial metabolism of WP1122 and  significant organ accumulation of the inhibitor of glycolysis in the brain and also in the pancreas.  This is especially significant because both brain and pancreatic tumors are highly dependent upon glucose for survival and WP1122 appears to have the ability to inhibit glycolysis, the process by which these tumors convert glucose into energy.”

 

Walter Klemp, Moleculin’s Chairman and CEO added, “Metabolic inhibition of tumors is conceptually a very important approach, and we believe we have a clear translational focus. We have been pushing hard to prepare WP1122 for Investigational New Drug (IND) status.  It is encouraging to have discoveries during this process that appear to confirm the initial premise and give us more hope that WP1122 could become an important new way to deal with difficult cancers like glioblastoma and pancreatic cancer.”

 

The Society for Neuro-Oncology is a multidisciplinary organization dedicated to promoting advances in neuro-oncology through research and education.  Now in its twenty fourth year, the Society continues to grow and mature as the premier North American organization for clinicians, basic scientists, nurses and other health care professionals whose focus is central nervous system tumors in children and adults.  This year’s Annual Scientific Meeting will be held November 15 – 18, 2018 at the Marriott Hotel in New Orleans, Louisiana.

 

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development f oncology drug candidates, all of which are based on discoveries made at M.D. Anderson Cancer Center. Our clinical stage drugs are Annamycin, an anthracycline designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, and WP1066, an immuno-stimulating STAT3 inhibitor targeting brain tumors, pancreatic cancer and AML. We are also engaged in preclinical development of additional drug candidates, including additional STAT3 inhibitors and compounds targeting the metabolism of tumors.

 

For more information about the Company, please visit http://www.moleculin.com.

 

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of WP1122 to show safety and efficacy in patients. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC.  Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Contacts
Joe Dorame, Robert Blum or Joe Diaz
Lytham Partners, LLC
602-889-9700
mbrx@lythampartners.com

 

Source: Moleculin Biotech, Inc.

Positive Clinical Trial and R&D Developments Creating Big Opportunities and Big Returns for Biotech Industry

Palm Beach, FL – (September 13, 2018) – Biotech and Big Pharma stocks have been performing very well of lat as the SPDR S&P Pharmaceuticals ETF has risen just about 15% since the beginning of 2018, compared with 8.5% gains for the S&P 500, and up 28% since its low in early May.  Small biotech stocks have earned a great deal of attention lately which is well deserved considering the Nasdaq Biotechnology Index has soared around 13.3% higher this year so far.  Increased investment in research and development is fueling advancements for some biotech companies such as solutions for neurodegenerative disease treatments and anticancer therapies. On pace to surpass $700 billion in revenue by 2025 according to Grand View Research, the biotech sector has become one of the most influential and lucrative forces in the medical market. FDA approvals are also pushing growth in this space as leaders aim to release innovative and unique therapies to battle the various types of diseases and conditions..  Active companies in the markets today include:  Moleculin Biotech, Inc. (NASDAQ:MBRX), Nemaura Medical Inc. (NASDAQ:NMRD), ChromaDex Corporation (NASDAQ:CDXC), Bausch Health Companies Inc. (NYSE:BHC) (TSX:BHC.TO), Geron Corporation (NASDAQ:GERN).

 

Moleculin Biotech, Inc. (NASDAQ:MBRX) BREAKING NEWS:  In the ongoing challenge to combat the almost always deadly brain cancers, namely Glioblastoma and melanoma metastasized to the brain, the pharmaceutical company Moleculin Biotechhas initiated a Phase 1 clinical trial of a new first-in-class cancer drug candidate, a small molecule compound discovered by Prof. Waldemar Priebe at  The University of Texas MD Anderson Cancer Center and known as WP1066. The compound has been shown in animal models to both inhibit an important cell signaling protein STAT3 that is involved in cell growth and proliferation and considered critical to tumor development, while also stimulating an immune response.  The first glioblastoma patient has received the initial doses of WP1066, which were apparently well tolerated, in the physician-sponsored IND (investigational new drug) study at MD Anderson Cancer Center.

 

Built from the chemical backbone of the active ingredient in propolis, a natural product of honey bees, WP1066 is the first anticancer agent with drug-like properties that consistently inhibits the activated form of STAT3 within cancer cells, a target that has been long-sought because of its broad range of tumor promoting effects.   Importantly, activated STAT3 supports the survival and proliferation of tumor cells, evasion of the immune response and metastasis to distant organs, as well as angiogenesis (growth of blood vessels) essential for tumor growth.  Activated STAT3 is not only connected with directly supporting tumor activity, but also suppressing the immune system, making this target even more important to cancer therapy.

 

With the support of extensive preclinical studies demonstrating high antitumor activity  and the critically important ability to cross the blood-brain barrier, WP1066 in this Phase 1 clinical trial will focus on treating aggressive brain tumors which all share a grim prognosis. The intent is to eventually treat up to 15 relapsed brain cancer patients over the next six to eight months. Phase 1 clinical trials typically focus on exploring safe and well tolerated doses, as well as evaluating initial signals of effectiveness. Each treatment is completed over three weeks.

 

“Treating the first brain tumor patient with WP1066 is the start of a very exciting and encouraging program for doctors treating the worst types of brain cancers. There has been very little progress in recent years toward improved therapies for glioblastoma and other aggressive primary or metastatic brain tumors.  WP1066 has shown extremely promising results based on animal studies where we have seen inhibition of tumor growth and improvements in survival,” said Dr. Sandra Silberman, a world-renowned oncologist and Moleculin’s Chief Medical Officer. “This is based on the fact that although STAT3 has long been identified as an important target for treating tumors, for years most efforts have focused on attempts to indirectly inhibit STAT3 from upstream signaling, not from within the cancer cell itself.  WP1066 appears to be unique in its ability in vitro and in animal models to consistently and directly inhibit the activated form of STAT3 and produce significant anticancer effects, including tumor growth inhibition and increased life span of treated animals.”

 

“This represents a major milestone for Moleculin,” commented Walter Klemp, Chairman and CEO.  “There has been tremendous enthusiasm within the oncology community for targeting STAT3, a key molecular hub of multiple pathways promoting tumor growth. Although the industry has been struggling to find a way to target STAT3, we at Moleculin believe that most of these efforts have been mechanistically misguided and ended in failure because their approach would ultimately be ineffective at adequately blocking the activation of STAT3 and lack the necessary drug-like properties to succeed.  The opportunity to test a unique STAT3 therapy in these patients is significant in supporting Moleculin’s mission to provide benefit for those who need new and better treatments.”  Read this and more news for Moleculin Biotech at:  http://www.marketnewsupdates.com/news/mbrx.html 

In other pharma and biotech developments and major influences in the markets of note this week: 

 

Nemaura Medical Inc. (NASDAQ:NMRD) closed up 30% on Wednesday at $2.86 with over 4.3 million shares traded by the market close. The company also announced reported data from an interim analysis of the first of a number of planned studies in support of a submission to the U.S Food & Drug Administration (“FDA”) for approval of its sugarBEAT® product. The interim results consisted of 25 patients, split approximately equally between Type I and Type II diabetics1. The study was conducted in a clinic setting, and blood samples were taken via a catheter every 15 minutes over a 12 hour period for 3 non-consecutive days, for a total of 75 patient days. Blood samples were measured using an Architect c8000 Laboratory Instrument. 9,371 data points were analysed in total, consisting of 4,630 and 4,741 paired data points analysed using 1-point and 2-point calibration respectively. The MARD (Mean Absolute Relative Deviation, @ 30%/30mg/dL) for the 1-point calibration was 12.19% (80% of all data), and for the 2-point calibration the MARD was 10.65% (88% of all data)). The results are in line with the company’s expectations, and compare favorably with competitor products.

 

ChromaDex Corporation (NASDAQ: CDXC) closed Wednesday up 15.43% at $4.04 per share. The company, an integrated, science-based, nutraceutical company devoted to improving the way people age with its flagship ingredient NIAGEN® and consumer product TRU NIAGEN®, today announced it will exhibit at Vitafoods Asia 2018. The sole active ingredient in TRU NIAGEN is nicotinamide riboside, a unique form of vitamin B3 clinically proven to safely increase one’s levels of NAD (nicotinamide adenine dinucleotide). Decreased NAD levels have been associated with many age-related changes in overall health. Vitafoods Asia will take place in Singapore from September 11-12—ChromaDex will exhibit at booth #M25 in the U.S.A. Pavilion. Attendance of Vitafoods is comprised of over 5000 manufacturers, distributors, and buyers from over 60 countries.

 

Bausch Health Companies Inc. (NYSE: BHC) (TSX:BHC) along with its wholly owned subsidiary, Salix Pharmaceuticals (“Salix”), which is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases, together with Salix’s licensors Cedars-Sinai Medical Center and Alfasigma SpA (collectively the “Salix Parties”), have agreed to resolve the outstanding intellectual property litigation with Actavis Laboratories FL, Inc. (“Actavis”), regarding XIFAXAN® (rifaximin) 550 mg tablets. Under the terms of the agreement, the Salix Parties will grant Actavis a non-exclusive license effective Jan. 1, 20281 to the Salix Parties’ intellectual property relating to XIFAXAN 550 mg tablets in the United States.

 

Geron Corporation (NASDAQ: GERN) came to a close at $5.97 up 3.47% with more than 6.8 million shares traded on the day. Geron Corporation operates as a biopharmaceutical company. The company supports the clinical stage development of imetelstat, a telomerase inhibitor for the treatment of hematologic myeloid malignancies. It has collaboration and license agreement with Janssen Biotech, Inc. to develop and commercialize imetelstat worldwide for indications in oncology, including hematologic myeloid malignancies and other human therapeutic uses.

 

DISCLAIMER:  FN Media Group LLC. owns and operates FinancialNewsMedia.com (FNM) and MarketNewsUpdates.com (MNU) is a third party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels.  FNM & MNU is NOT affiliated in any manner with any company mentioned herein.  FNM & MNU and its affiliated companies are a news dissemination solutions provider and are NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security.  FNM & MNU’s market updates, news alerts and corporate profiles are NOT a solicitation or recommendation to buy, sell or hold securities.  The material in this release is intended to be strictly informational and is NEVER to be construed or interpreted as research material.  All readers are strongly urged to perform research and due diligence on their own and consult a licensed financial professional before considering any level of investing in stocks.  All material included herein is republished content and details which were previously disseminated by the companies mentioned in this release.  FNM & MNU is not liable for any investment decisions by its readers or subscribers.  Investors are cautioned that they may lose all or a portion of their investment when investing in stocks.  For current services performed FNM & MNU has been compensated forty four hundred dollars for news coverage of the current press release issued by Moleculin Biotech, Inc. by the company.  FNM & MNU HOLDS NO SHARES OF ANY COMPANY NAMED IN THIS RELEASE.

 

This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “may”, “future”, “plan” or “planned”, “will” or “should”, “expected,” “anticipates”, “draft”, “eventually” or “projected”. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company’s annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and FNM & MNU undertakes no obligation to update such statements.

 

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SOURCE: Financialnewsmedia.com

MBRX - Developing Cancer Treatment Trials Positive Indication for Biotech Market

Palm Beach, FL – (June 12, 2018) – Clinical trial data is an important catalyst as well as trial results or any positive updates on the clinical studies are often received well these days in the pharma and biotech market. The industry as whole has bounced back in the past month as it rose 6.8%, better than the S&P 500’s increase of 2.9% making it one of the best-performing industries in the U.S. stock market. On the bright side of things, indications are the demand for drugs is rising worldwide due to increasing ailing and elderly population, frequent approval of new drugs as well as line extensions of already marketed drugs and increased healthcare spending. In addition another positive indication for the biotech industry is the U.S. Food and Drug Administration is taking steps to streamline the approval process for cancer drugs, reviewing clinical trial data up front to make sure applications companies submit are complete. Active companies in the markets today include: Moleculin Biotech, Inc. (NASDAQ:MBRX), Aptose Biosciences Inc. (NASDAQ:APTO), Cardiome Pharma Corp. (NASDAQ:CORV), Pfizer Inc. (NYSE:PFE), Endocyte Inc. (NASDAQ:ECYT).

 

Moleculin Biotech, Inc. (NASDAQ:MBRX) BREAKING NEWS: Moleculin Biotech, a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced that it has entered into an agreement with the Jagiellonian University in Krakow, Poland, for the development of its STAT3 inhibitor, WP1732, for the treatment of ocular tumors.

 

“Today there are very limited options for the treatment of ocular tumors,” commented Walter Klemp, Chairman and CEO of Moleculin. “And, these tumors are believed to involve a significant upregulation of the activated form of STAT3. It is important to note that, in addition to the ability of WP1732 to inhibit the proliferation and survival of cancer cells in preclinical studies, as STAT3 inhibitor, it is designed to potently block cancer stem cells and induce immune system function to overcome tumor-induced immune tolerance. This could make WP1732 an ideal candidate for targeting these unique and highly metastatic tumors.”

 

Mr. Klemp continued: “we remain committed to targeting accelerated approval pathways for WP1732 by focusing on significant unmet needs. This includes niche indications like ocular tumors and AML, as well as high-profile indications like pancreatic cancer.” Read this and more news for Moleculin Biotech at: http://www.marketnewsupdates.com/news/mbrx.html

 

In other pharma and biotech developments in the markets:

Aptose Biosciences Inc. (NASDAQ:APTO) came to a close up 6.39% on Monday at $4.33 trading over 1 million shares by the market close. The company also recently annnounced the publication of preclinical data elucidating the mechanism of action of APTO-253, the company’s clinical stage anticancer product candidate. The data are published in two separate articles in the June 2018 issue (Volume 17, Number 6) of Molecular Cancer Therapeutics, a peer-reviewed journal of the American Association for Cancer Research (AACR). The first publication, entitled “APTO-253 stabilizes G-quadruplex DNA, inhibits MYC expression and induces DNA damage in acute myeloid leukemia cells,” demonstrates that the APTO-253 small molecule anticancer agent inhibits expression of the MYC oncogene and depletes cells of the MYC protein, triggers the DNA repair and stress response pathways, and promotes programmed cell death (apoptosis) in acute myeloid leukemia (AML) cell lines and fresh bone marrow samples derived from patients with AML and other hematologic malignancies that often depend on MYC upregulation.

 

Cardiome Pharma Corp. (NASDAQ:CORV) closed up 48.08% on Monday at $3.08 trading oved 5.7 million shares by the market The company also announced that it has received a response from the U.S. Food and Drug Administration (FDA) regarding the regulatory path forward in the US for BRINAVESS® (vernakalant hydrochloride, IV), Correvio’s antiarrhythmic drug for the rapid conversion of recent onset atrial fibrillation (AF). In its written reply, the FDA informed Correvio that it would be permissible to resubmit the BRINAVESS New Drug Application (NDA) and agreed that the Company may schedule a Pre-NDA meeting. Correvio currently expects that the Pre-NDA meeting with the FDA will take place in the fourth quarter of 2018. “In our most recent communication with the FDA, we asked the Agency if the Division of Cardiovascular and Renal Products would be willing to meet to discuss a regulatory path forward for Brinavess,” said William Hunter, MD, CEO and President of Correvio. “We are pleased that the Agency has agreed to discuss Brinavess in a pre-NDA meeting, which we will seek to have in the fourth quarter.”

 

Pfizer Inc. (NYSE:PFE) recently announced that the U.S. Food and Drug Administration accepted for filing and granted Priority Review designation to the company’s New Drug Application for talazoparib. The submission is based on results from the EMBRACA trial, which evaluated talazoparib versus chemotherapy in patients with germline (inherited) BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer (MBC). Talazoparib is an investigational, once-daily, oral poly ADP ribose polymerase (PARP) inhibitor. The European Medicines Agency has also accepted the Marketing Authorization Application for talazoparib in this patient population. “Women with a hereditary BRCA mutation are typically diagnosed with breast cancer at a younger age than the overall breast cancer population and have limited treatment options when they develop advanced disease,” said Mace Rothenberg, M.D., chief development officer, Oncology, Pfizer Global Product Development.

 

Endocyte Inc. (NASDAQ:ECYT) last week announced the enrollment of the first patient in its global phase 3 VISION trial of 177Lu-PSMA-617 in prostate cancer by Dr. Luke Nordquist at Urology Cancer Center in Omaha, NE, a member of Precision Cancer Research. The international, prospective, open-label, multicenter, randomized phase 3 study is evaluating patients with progressive prostate specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC), who have received at least one novel androgen axis drug (abiraterone or enzalutamide) and at least one taxane regimen. “We are pleased to announce the initiation of this important clinical trial so quickly following our end-of-phase 2 meeting with the FDA. This speed of execution is a result of the enthusiasm of participating physicians and the focus and urgency of our clinical operations team,” said Mike Sherman, president and CEO of Endocyte. “Having collaborated with several of the key opinion leaders in prostate cancer around the world, we are confident in the robustness of the VISION trial design and eager to complete enrollment.”

 

DISCLAIMER: MarketNewsUpdates.com (MNU) is a third party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels. MNU is NOT affiliated in any manner with any company mentioned herein. MNU and its affiliated companies are a news dissemination solutions provider and are NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security. MNU’s market updates, news alerts and corporate profiles are NOT a solicitation or recommendation to buy, sell or hold securities. The material in this release is intended to be strictly informational and is NEVER to be construed or interpreted as research material. All readers are strongly urged to perform research and due diligence on their own and consult a licensed financial professional before considering any level of investing in stocks. All material included herein is republished content and details which were previously disseminated by the companies mentioned in this release. MNU is not liable for any investment decisions by its readers or subscribers. Investors are cautioned that they may lose all or a portion of their investment when investing in stocks. For current services performed MNU has been compensated forty four hundred dollars for news coverage of the current press release issued by Moleculin Biotech, Inc. by the company. MNU HOLDS NO SHARES OF ANY COMPANY NAMED IN THIS RELEASE.

 

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MBRX News - Moleculin Signs Agreement with MD Anderson Cancer Center for Leukemia Drug, Annamycin

HOUSTON, TX – (https://www.financialnewsmedia.com News Alert) – Moleculin Biotech, Inc., (NASDAQ: MBRX) (“Moleculin” or the “Company”), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced it has signed a new technology license agreement with MD Anderson Cancer Center based on new patent applications it intends to file relating to its drug Annamycin for the treatment of relapsed or refractory acute myeloid leukemia (AML).

 

“In anticipation of beginning our planned clinical trials for Annamycin,” commented Walter Klemp, CEO of Moleculin, “one of our priorities has been to ensure the best possible protection for our intellectual property. Some key patent applications had yet to be filed and signing a new license agreement with MD Anderson clears the way for those patents.” Read this and more news for MBRX at https://www.financialnewsmedia.com/profiles/mbrx.html

 

Mr. Klemp continued: “we have benefitted greatly from our collaboration with MD Anderson, and this license helps ensure that collaboration continues.”

 

 

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a preclinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, an anthracycline being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two preclinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient’s own immune system. The other portfolio targets the metabolism of tumors.

For more information about the Company, please visit http://www.moleculin.com.

 

Forward-Looking Statements

 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the Company’s IND being filed and permitted, the potential for Moleculin to expand its planned Annamycin clinical trial to Poland, the potential for sites in Poland to increase access to AML patients, accelerate enrollment in and completion of the Annamycin clinical trial, and the ability of Annamycin to demonstrate activity in the treatment of AML. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

 

Contacts
PCG Advisory Group
Investors:
Kirin M. Smith
Chief Operating Officer
D: 646.863.6519
E: ksmith@pcgadvisory.com

Source: Moleculin Biotech, Inc.

 

Disclaimer: FN Media Group LLC (FNMG) owns and operates FinancialNewsMedia.com (FNM) which is a third party publisher that disseminates electronic information through multiple online media channels. FNMG’s intended purposes are to deliver market updates and news alerts issued from private and publicly trading companies as well as providing coverage and increased awareness for companies that issue press to the public via online newswires. FNMG and its affiliated companies are a news dissemination and financial marketing solutions provider and are NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security. FNMG’s market updates, news alerts and corporate profiles are NOT a solicitation or recommendation to buy, sell or hold securities. The material in this release is intended to be strictly informational and is NEVER to be construed or interpreted as research material. All readers are strongly urged to perform research and due diligence on their own and consult a licensed financial professional before considering any level of investing in stocks. The companies that are discussed in this release may or may not have approved the statements made in this release. Information in this release is derived from a variety of sources that may or may not include the referenced company’s publicly disseminated information. The accuracy or completeness of the information is not warranted and is only as reliable as the sources from which it was obtained. While this information is believed to be reliable, such reliability cannot be guaranteed. FNMG disclaims any and all liability as to the completeness or accuracy of the information contained and any omissions of material fact in this release. This release may contain technical inaccuracies or typographical errors. It is strongly recommended that any purchase or sale decision be discussed with a financial adviser, or a broker-dealer, or a member of any financial regulatory bodies. Investment in the securities of the companies discussed in this release is highly speculative and carries a high degree of risk. FNMG is not liable for any investment decisions by its readers or subscribers. Investors are cautioned that they may lose all or a portion of their investment when investing in stocks. This release is not without bias, and is considered a conflict of interest if compensation has been received by FNMG for its dissemination. To comply with Section 17(b) of the Securities Act of 1933, FNMG shall always disclose any compensation it has received, or expects to receive in the future, for the dissemination of the information found herein on behalf of one or more of the companies mentioned in this release. For current services performed FNMG has been compensated three thousand nine hundred dollars for Moleculin Biotech, Inc. news coverage by the company. FNMG HOLDS NO SHARES OF Moleculin Biotech, Inc.

 

This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “may”, “future”, “plan” or “planned”, “will” or “should”, “expected,” “anticipates”, “draft”, “eventually” or “projected”. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company’s annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and FNMG undertakes no obligation to update such statements.

MBRX News - Moleculin Announces Significant Discovery with Potential to Treat Pancreatic Cancer

Metabolic Inhibitor Shows Greater Ability to Kill Pancreatic Cancer Cell Lines – HOUSTON, TX – (https://www.financialnewsmedia.com News Alert) – Moleculin Biotech, Inc., (NASDAQ: MBRX) (“Moleculin” or the “Company”), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced the discovery of a metabolic inhibitor with the potential to treat pancreatic cancer.

 

“We’ve received a lot of attention from the scientific community for our glucose decoy technology (WP1122 Portfolio, Moleculin Presents Preclinical Data of Novel Inhibitor of Glycolysis at 28th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, December 13, 2016) as a potential means to starve tumors to death by exploiting their hyper-dependence on glycolysis for energy production,” commented Walter Klemp, Chairman and CEO of Moleculin, “and now we have identified possible new properties of our compound WP1234, a modification to WP1122. In pre-clinical testing, WP1234 has shown improved drug characteristics when compared with WP1122 and a 20 to 50-fold greater ability to kill pancreatic cancer cell lines when compared with traditional inhibitors of glycolysis. We know that pancreatic cancer thrives even in a reduced oxygen environment, which indicates it may be highly dependent on glycolysis to survive. This discovery now makes WP1234 a promising drug candidate to be studied for the treatment of pancreatic cancer.” Read this and more news for Moleculin Biotech at https://www.financialnewsmedia.com/profiles/mbrx.html

 

Mr. Klemp continued: “Pancreatic cancer is still considered largely untreatable, so even modest gains in treating this disease could represent a significant clinical benefit. WP1234 improves on known inhibitors for glycolysis by increasing drug circulation time, which should increase the potential for drug uptake by and destruction of tumor cells. We are excited about the potential to pursue development opportunities with WP1234 for the treatment of pancreatic cancer. We are also pleased to report that this discovery was the direct result of our ongoing collaboration with M.D. Anderson Cancer Center and the science team there will be presenting detailed findings to the scientific community in the near future.”

 

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a preclinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, an anthracycline being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two preclinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient’s own immune system. The other portfolio targets the metabolism of tumors.

For more information about the Company, please visit http://www.moleculin.com.

 

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of WP1234 to become a safe and effective drug for pancreatic cancer in humans and the potential for that to translate into a significant clinical benefit. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

 

Contacts
PCG Advisory Group
Investors:
Kirin M. Smith
Chief Operating Officer
D: 646.863.6519
E: ksmith@pcgadvisory.com

Source: Moleculin Biotech, Inc.

 

Disclaimer: FN Media Group LLC (FNMG) owns and operates FinancialNewsMedia.com (FNM) which is a third party publisher that disseminates electronic information through multiple online media channels. FNMG’s intended purposes are to deliver market updates and news alerts issued from private and publicly trading companies as well as providing coverage and increased awareness for companies that issue press to the public via online newswires. FNMG and its affiliated companies are a news dissemination and financial marketing solutions provider and are NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security. FNMG’s market updates, news alerts and corporate profiles are NOT a solicitation or recommendation to buy, sell or hold securities. The material in this release is intended to be strictly informational and is NEVER to be construed or interpreted as research material. All readers are strongly urged to perform research and due diligence on their own and consult a licensed financial professional before considering any level of investing in stocks. The companies that are discussed in this release may or may not have approved the statements made in this release. Information in this release is derived from a variety of sources that may or may not include the referenced company’s publicly disseminated information. The accuracy or completeness of the information is not warranted and is only as reliable as the sources from which it was obtained. While this information is believed to be reliable, such reliability cannot be guaranteed. FNMG disclaims any and all liability as to the completeness or accuracy of the information contained and any omissions of material fact in this release. This release may contain technical inaccuracies or typographical errors. It is strongly recommended that any purchase or sale decision be discussed with a financial adviser, or a broker-dealer, or a member of any financial regulatory bodies. Investment in the securities of the companies discussed in this release is highly speculative and carries a high degree of risk. FNMG is not liable for any investment decisions by its readers or subscribers. Investors are cautioned that they may lose all or a portion of their investment when investing in stocks. This release is not without bias, and is considered a conflict of interest if compensation has been received by FNMG for its dissemination. To comply with Section 17(b) of the Securities Act of 1933, FNMG shall always disclose any compensation it has received, or expects to receive in the future, for the dissemination of the information found herein on behalf of one or more of the companies mentioned in this release. For current services performed FNMG has been compensated three thousand nine hundred dollars for Moleculin Biotech, Inc. news coverage by the company. FNMG HOLDS NO SHARES OF Moleculin Biotech, Inc.

 

This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “may”, “future”, “plan” or “planned”, “will” or “should”, “expected,” “anticipates”, “draft”, “eventually” or “projected”. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company’s annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and FNMG undertakes no obligation to update such statements.

About Moleculin Biotech

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of oncology drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our clinical stage drugs are Annamycin, an anthracycline designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, and WP1066, an immuno-stimulating STAT3 inhibitor targeting brain tumors, pancreatic cancer and AML. We are also engaged in preclinical development of additional drug candidates, including additional STAT3 inhibitors and compounds targeting the metabolism of tumors.

 

Our lead product candidate is Annamycin, a Phase II clinical stage anthracycline for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML.

 

Unlike current therapies that risk cardiotoxicity and can have their effectiveness limited due to multidrug resistance, Annamycin appears capable of avoiding both of these problems and has already demonstrated the ability to save lives in clinic.  We are now preparing to seek accelerated approval for this game-changing drug.

 

Annamycin

annamycinAnnamycin is an anthracycline intended for the treatment of relapsed or refractory AML. The therapy of combining two chemotherapeutic drugs, which always includes an anthracycline, in inducing a remission of leukemic cells (called “induction therapy”) has not improved since it was first used in the 1970s and we estimate that this induction therapy has the same cure rate of about 20% as at that time. Currently, the only viable long term option for acute leukemia patients is a bone marrow transplant, which is successful in a significant number of patients. However, in order to qualify for a bone marrow transplant, patients must first undergo induction therapy.

 

One of the leading anthracyclines used for induction therapy in acute leukemia patients is doxorubicin, which has reported over $700 million in annual revenues. Despite the importance and success of approved anthracyclines like doxorubicin, they are all unfortunately cardiotoxic, which can result in damage to the heart and limit the dosage amount that may be administered to patients. Additionally, the tumor cells being treated often have or develop resistance to the first line anthracycline, often through what is called “multidrug resistance” making them capable of purging themselves of the current anthracyclines and limiting the effectiveness of the therapy. Consequently, there remains no effective therapy for these patients and most will succumb quickly to their leukemia. This is where we believe Annamycin can be a complete game-changer.

 

Annamycin is a unique liposome formulated anthracycline (also referred to in literature as “L-Annamycin”) that has been designed to eliminate cardiotoxicity and avoid the multidrug resistance mechanisms that often defeat current anthracyclines. In animal models designed to test for cardiotoxicity, Annamycin as shown to be non-cardiotoxic and in human clinical trials focused on leukemia, it showed fewer dose-limiting toxicities than are normally experienced with doxorubicin (one of the leading first-line anthracyclines used for induction therapy).

 

Annamycin demonstrated efficacy in 8 of 16 patients in a Phase I study in adult relapsed or refractory AML patients, with 6 of 14 patients completely clearing leukemic blasts. A 30 patient dose-ranging Phase I/II study in acute lymphocytic leukemia demonstrated a similar efficacy profile, with 3 of 8 patients treated with the maximum tolerable dose clearing their leukemic blasts to a level sufficient to qualify for a bone marrow transplant. One of these patients went on to receive a successful curative bone marrow transplant.

 

We believe Annamycin is better than the currently approved induction therapy drugs in four key ways: (i) it has demonstrated clinical activity in a patient population for whom there are currently no effective therapies, (ii) it appears to be capable of avoiding the “multi-drug resistance” mechanisms that often limit the effectiveness of currently approved anthracyclines; (iii) it has been shown to be non-cardiotoxic in animal models, when compared with doxorubicin; and (iv) in laboratory studies using AML cell lines, it has been shown to be more potent than the leading approved drug.

 

Based on initial conversations with the FDA, and because of this serious unmet medical need, we believe Annamycin may qualify for for accelerated approval. We also believe Annamycin may qualify for Orphan Drug status, which could entitle us to market exclusivity of up to 7 and 10 years from the date of approval of a New Drug Application (NDA) and Marketing Authorization (MA), in the US and the European Union (EU), respectively.

 

WP1066

Cell Signaling And Oncogenic Transcription Factors

 

Cellular biology depends upon signaling mechanisms to regulate functions such as cell growth, death and adaptation. Signal “transduction” is such a mechanism that converts an upstream stimulus to a cell into a specific cellular response. Signal transduction starts with a signal to a receptor or via a compound capable of passing through the cell membrane and ends with a change in cell function.  The end result of this signal is often the activation of “transcription”, whereby genetic information is expressed and, in the case of oncogenic transcription, disease processes are initiated or maintained.

 

Receptors span the cell membrane, with part of the receptor outside and part inside the cell.  See diagram below. When a chemical signal represented by a specific protein binds to the outer portion of the receptor, it conveys another signal inside the cell.  Often there is a cascade of signals within the cell, wherein an upstream inducer starts a chain of events that resembles a domino effect.  Collectively, this sequence is referred to as a “signaling pathway.” Eventually, the signal creates a change in the cell function by changing the expression of specific genes and production of specific proteins within the cell, and again, in the case of tumor development, such expression results in unwanted inflammatory and proliferative processes.

 

Importantly, while normal healthy cell function relies on signaling mechanisms, diseases are capable of co-opting these mechanisms with negative consequences.  Proliferative and inflammatory diseases depend upon signaling pathways that are responsible for coordinating functions such as cell growth, survival and cell differentiation.  A particular class of proteins referred to as Signal Transducers and Activators of Transcription (such proteins are “STATs”) plays an important role in regulating the process of disease cell survival and proliferation, angiogenesis[1] and immune system function and is persistently activated in a large number of human inflammatory processes and in hyper-proliferating diseases.  Because certain of these proteins are known to be co-opted by tumor cells, we refer to them as “oncogenic transcription factors,”  of which certain STATs are a subset.

 

stat

 

Some STATs, such as STAT3, can be activated by any one of many different upstream inducers, making them very difficult to target by blocking just one or more of these upstream inducers. We believe that blocking a targeted STAT directly rather than via its multiple upstream inducers should result in greater efficacy with lower toxicity.

 

In the diagram shown here, any one of many different pathways (some of which are shown here as Growth Factor Receptors, Cytokine Receptors and Non-Receptor Tyrosine Kinases) triggers the activation of STAT3 proteins in a process called “phosphorylation”.  In this process, phosphates attach to corresponding receptors on STAT3 and the two phosphorylated STAT3 (“p-STAT3”) proteins bind together in a pair referred to as a “dimer”.  Once the dimer is formed, it enters the cell nucleus and triggers gene transcription.   Conversely, if we prevent the dimer from forming (i.e., by blocking phosphorylation), we can prevent the triggering of unwanted gene transcription and effectively inhibit the disease process.

 

The upstream effectors shown in this diagram (SRC, JAK and ABL[2]) are just some of those capable of activating STAT3 once they themselves are activated by a variety of signal compounds.  The complexity and diversity of pathways capable of activating STAT3 makes it very difficult to develop safe and effective drugs that attempt to target the upstream effectors.

 

STAT3

 

Published research has identified STAT3 as a master regulator of a wide range of tumors and clearly links STAT3 activation with the progression of these tumors.  For this reason, it is believed that inhibiting the activation of STAT3 should be an effective way to reduce or eliminate the progression of these diseases.

 

Many research efforts have been directed toward development of specific methods to control activation of STAT3, but most have focused on targeting the upstream effectors of these pathways like growth factors, cytokines, and specific kinases including Janus kinases (JAKs). However, we believe that the multifactorial nature of the activation of STAT3 limits the effectiveness of such upstream approaches. Since the activity of p-STAT3 is a final and determinative step in triggering unwanted transcription, we believe it is preferable to inhibit p-STAT3 more directly and independently from upstream effectors.

 

2015-11-21_1147

 

We believe the WP1066 Portfolio represents a novel class of agents capable of hitting multiple targets, including p-STAT3, regardless of their upstream method of activation. By inhibiting the presence of p-STAT3, WP1066 directly attacks tumor cells, as has been demonstrated in numerous preclinical tests involving a wide range of tumor cells. We believe the effectiveness of WP1066 is not only the result of attacking tumors directly, but also indirectly by stimulating the immune system, increasing the patient’s natural ability to fight off tumor development. STAT1 is believed to stimulate T-cell activity and thereby the immune system responsible for fighting tumors. WP1066 has been shown to increase the activity of STAT1 at the same time it inhibits the activity of p-STAT3. We believe this dual activity makes WP1066 a uniquely promising anticancer drug candidate.

 

We believe the combination of the direct and indirect effects of WP1066 are to be credited with significant tumor suppression and increased survival in a number of in vivo cancer models. Below is one example showing a dramatic increase in survival by treating mice with metastatic melanoma with WP1066.

 

In Vivo Activity

 

In experimental biology, in vitro  (Latin for “in glass”) studies are those that are conducted using components of an organism that have been isolated from their usual biological surroundings in order to permit a more detailed or more convenient analysis than can be done with whole organisms. Colloquially, these experiments are commonly called “test tube experiments”.  In contrast, studies that are conducted with living organisms in their normal intact state are referred to as in vivo (Latin for “within the living”). We have shown in vivo that WP1066 inhibits tumor growth and blocks angiogenesis.  As well, we have shown in numerous mouse tumor models that WP1066 dramatically increases survival.

 

In vivo activity has been confirmed in a wide range of tumors, including metastatic melanoma, glioblastoma, head and neck tumors, bladder cancer, renal cancer and pancreatic cancer.

 

WP1122

Metabolic Inhibitors

 

MBI is engaged in developing new drugs to exploit the metabolic differences between tumor cells and normal cells. MBI’s lead compound is targeted specifically for metabolically active brain cancers, taking advantage of the differential utilization of glucose by cancerous tissue versus normal brain tissue. MBI believes that targeting this difference in metabolism is the key technology making its product competitive and applicable to many other cancers.

 

Our current lead metabolism candidates have shown activity against brain tumor cell lines in in vitro testing and, more importantly, in an orthotopic brain tumor (implanted in the brain) animal model. One candidate has been shown to outperform Schering-Plough’s Temodar®, the frontline FDA approved drug, which is considered the standard of care for the treatment of brain tumors. The market for Temodar® has reached nearly $1 billion in annual revenue. We believe that WP1122 and similar compounds address a significant unmet need in the treatment of brain tumors and should be applicable to other difficult-to-treat, glucose dependent tumors, such as pancreatic cancer.

 

The same principle that drives tumor cells to over-consume glucose allows PET scanning to highlight the size and location of tumors by imaging radiolabeled glucose decoys that are taken up by tumor cells in substantially higher concentrations than normal cells.  PET scanning is less effective in brain scans because such decoys have difficulty crossing the blood brain barrier.  For this reason, our compounds may also lead to a significant improvement in diagnostic imaging of the brain.

 

Need For Improved Brain Cancer Drugs

 

MBI’s technology has the potential to target a wide variety of solid tumors, which eventually become resistant to all treatments, and thereby provide a large and important opportunity for novel drugs. Notwithstanding this potential, MBI is focused on the treatment of central nervous system malignancies and especially glioblastoma.  Although less prevalent than some larger categories of solid tumors, cancers of the central nervous system are particularly aggressive and resistant to treatment. The prognosis for such patients can be particularly grim and the treatment options available to their physicians are among the most limited of any cancer.

 

The National Cancer Institute has estimated 22,850 new cases of brain and other nervous system cancers will occur in the United States in 2015, resulting in 15,320 deaths.  Despite the severity and poor prognosis of these tumors, there are few FDA-approved drugs on the market. The market leader is temozolomide (Temodar®, Merck), which is prescribed for glioblastoma and refractory anaplastic astrocytoma. Notwithstanding the rare nature of brain cancer, Merck (who acquired Schering-Plough, the maker of Temodar) reported sales of $882 million worth of the drug in 2012.  The patent for Temodar expired August 31, 2013.

 

The market for drugs to treat brain cancer is clearly open for new entries. MBI is developing a drug that attacks a different target than Temodar® and has shown efficacy in animal models. MBI’s products could be stand-alone treatments or provided in combination with other drugs, surgery and radiotherapy.

 

mriTargeting the Metabolism of Cancer

 

As far back as 1930, science recognized that many cancer cells have a unique metabolism, distinct from that of normal cells.  Dubbed the “Warburg Effect” by its discoverer, “tumors rely preferentially on glycolysis for the metabolism of glucose, even in the presence of abundant oxygen for energy (adenosine triphosphate (ATP)) production.”  This alternative form of energy production makes cancer cells as much as 17 times more dependent on glucose than normal cells.

 

The fundamental mechanism for imaging actively growing tumors using positron emission tomography (PET scans) is the Warburg Effect.  As shown in these images at the left, a radio labeled glucose decoy called F18DG accumulates disproportionately in tumors because of their dramatically increased rate of glucose uptake and accumulation.

 

For decades, researchers have theorized that if you could block a tumor’s access to glucose, you could essentially starve the tumor out of existence. Previous attempts at targeting the metabolism of tumor cells have failed due to the rapid metabolism and short half-life (minutes) of the drugs being investigated. Efforts to target tumor metabolism in the brain were further thwarted by the inability to get glycolytic inhibitors into the brain in sufficient (therapeutic) amounts due to the presence of what is called the “blood brain barrier”.

 

We believe WP1122 and similar molecules provide the potential to develop a technology platform for enabling increased cellular uptake, increased drug half-life and, importantly, an increased ability to cross the blood brain barrier, enabling greater uptake in the brain. Our approach was inspired by the same principle that distinguishes morphine from heroin. Heroin is chemically the diacetyl ester of morphine. While morphine has a limited ability to cross the blood brain barrier (making it a good candidate for pain killing without impairing mental function), its diacetyl form, heroin, has the ability to accumulate in the brain by 10 to 100 fold more than morphine. Once across the blood brain barrier, the acetyl groups shown in this chemical diagram are cleaved off by natural enzyme esterases, leaving pure morphine to accumulate in the brain.

 

wp1122

 

MBI’s scientific founder, Dr. Waldemar Priebe, invented the diacetyl ester of a glucose decoy known as “2-DG”, which became WP1122.  We believe based on pre-clinical testing that, just like heroin, WP1122 crosses the blood brain barrier where its acetyl groups are cleaved off, allowing the resulting 2-DG to accumulate in the brain at a much higher rate than free 2-DG can do by itself.

 

Adding to the difficulty in getting free 2-DG across the blood brain barrier in therapeutic quantities, is the relatively short half-life of 2-DG.  The free form of 2-DG is rapidly metabolized and rendered ineffective within minutes of entering the body.  In contrast, WP1122 has a half-life of approximately 6 hours, making it much more feasible to deliver quantities adequate for a therapeutic effect.

 

[1] Angiogenesis is the physiological process involving the growth of new blood vessels from pre-existing vessels and it is one of four fundamental elements in the progression of inflammatory and proliferative disorders, along with cell survival (where the normal process of cell death is switched off), abnormal or hyper-proliferation (where cells replicate too quickly) and immune system misdirection (where the immune system is either shut down or activated in the wrong way).

 

[2] SRC (pronounced “sarc”, as it is short for sarcoma) represents a family of tyrosine kinases (a type of enzyme that catalyzes the transfer of phosphate groups from high-energy, phosphate-donating molecules to specific substrates) often studied in connection with cancer research where normally healthy cellular signaling has gone awry. JAK represents another family of tyrosine kinases that transduce signals via the JAK-STAT pathway. They were initially named “just another kinase”, but were ultimately published as “Janus kinase” for the two-faced Roman god of doorways.  The Abelson oncogene or ABL is yet another tyrosine kinase linked to cancer and other inflammatory disease activation.  Because there are variations of each of these kinases within their respective families they are further differentiated by number, such as JAK1, JAK2, JAK3 and so on.

 

Source:  http://www.moleculin.com/

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