Actinium Pharmaceuticals, Inc. (ATNM)

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Actinium Pharmaceuticals, Inc. Awarded Grant by National Institutes of Health to Study Novel Iomab-ACT Targeted Conditioning with a CD19 CAR T-Cell Therapy

NIH grant to support first of its kind clinical trial to use Antibody Radio-Conjugate for targeted conditioning prior to CAR T-cell therapy in patients with acute lymphoblastic leukemia and diffuse large B-cell lymphoma

 

ARC-based targeted lymphodepletion is intended to improve CAR T-cell patient outcomes by selectively depleting immune cells, including those implicated in CAR T-cell toxicities

 

Actinium to host Iomab-ACT program update call on October 22, 2020 at 8:00 AM EST

  

NEW YORK, NY – October 21, 2020 – Actinium Pharmaceuticals, Inc.  (NYSE AMERICAN: ATNM) (“Actinium” or the “Company”) today announced that the National Institutes of Health has awarded Actinium a Small Business Technology Transfer grant to support a clinical collaboration with Memorial Sloan Kettering Cancer Center (“MSK”) to study Iomab-ACT, Actinium’s CD45-targeting Antibody Radio-Conjugate, for targeted conditioning to achieve lymphodepletion prior to administration of a CD19-targeted CAR T-cell therapy developed at MSK.  The CD19 CAR-T has been previously studied by MSK in a Phase 2 trial with chemotherapy conditioning in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) or diffuse large B-cell lymphoma (DLBCL).  MSK will lead this first of its kind study to utilize targeted radiopharmaceutical ARC-based lymphodepletion to replace chemotherapy-based conditioning prior to CAR T-cell therapy.  The study will assess the feasibility of using Iomab-ACT targeted lymphodepletion prior to MSK’s 19-28z CAR-T and assess safety and efficacy outcomes relative to results with MSK’s CAR-T 19-28z in patients who had received chemotherapy-based lymphodepletion prior to CAR-T administration.

 

Results published in the New England Journal of Medicine with MSK’s 19-28z CD19 CAR-T in 53 patients with R/R B-ALL reported complete remissions in 83% (44/53) of patients. Median event-free survival (EFS) was 6.1 months and median overall survival (OS) was 12.9 months at a median follow up period of 29 months (range 1 – 65 months) for all patients.  Patients with low disease burden, defined as less than 5% blasts in the bone marrow, had markedly enhanced outcomes with increased median EFS of 10.6 months and median OS of 20.1 months.  There was a 26% (14/53) rate of Grade 3 of greater cytokine release syndrome (CRS), with 1 patient death as a result, and 42% of patients experienced Grade 3-4 immune effector cell-associated neurotoxicity syndrome (ICANS).  In addition to improved duration of response and survival, patients with low disease burden prior to receiving CAR T-cell therapy had lower rates of CRS and neurotoxicity.1

 

“We are excited to be collaborating with MSK on this trial as they are a leader in the field of cellular therapies.  We selected MSK’s 19-28z CAR T-cell therapy for this NIH grant funded collaboration because it has produced high response rates in patients with relapsed or refractory B-ALL who have previously undergone several lines of standard therapy.  However, toxicities such as cytokine release syndrome and neurologic toxicity, as well as durability of response, remain a challenge as is the case with many other CAR T-cell therapies” commented Dr. Mark Berger, Actinium’s Chief Medical Officer.  “Iomab-ACT enables the delivery of targeted radiation that selectively and specifically targets immune cells, including those implicated in the CAR-T-associated toxicities of cytokine release syndrome and neurotoxicity.  We are hopeful that this study will demonstrate improvements in safety and outcomes with MSK’s CAR 19-28z as a result of Iomab-ACT targeted lymphodepletion and that this will allow clinicians to make important improvements in patients’ ability to receive CAR T-cell therapies.”

 

CAR-T is a type of cellular therapy in which a patient’s own (autologous) T-cells are genetically engineered outside of the body to target the patient’s cancer cells and which are then reinfused back into the patient to seek out and kill cancer cells.  Currently there are 2 approved CD19 targeted CAR-T therapies, which both require chemotherapy-based conditioning to deplete the patient’s lymphocytes, known as lymphodepletion, and many other CAR-T constructs in development that also use chemotherapy conditioning for lymphodepletion.

 

Iomab-ACT targets cells that express CD45, an antigen found on immune cells such as lymphocytes and macrophages as well as leukemia and lymphoma cancer cells and delivers the radioisotope warhead iodine-131 to achieve cell depletion.  Iomab-ACT is intended to deplete CD45+ immune cells such as macrophages that are implicated in CAR-T related toxicities and may also have an anti-tumor effect on chemo-refractory cancers.  Iomab-ACT is a low dose extension of Actinium’s lead program, Iomab-B, which is being studied in a pivotal Phase 3 trial for targeted conditioning prior to a bone marrow transplant. Preclinical data supporting Iomab-ACT’s application in targeted lymphodepletion prior to ACT such as CAR-T was recently published in the journal Oncotarget (https://www.oncotarget.com/archive/v11/i39/).  In addition, clinical data with trace doses of Iomab-B has shown transient, reversible lymphodepletion in patients and drug clearance pharmacokinetics that fit within the vein to vein time of CAR-T manufacturing and administration.

 

Sandesh Seth, Actinium’s Chairman and CEO, said, “This clinical trial collaboration with MSK is a strong step forward for Actinium and our targeted conditioning program. The 19-28z CAR-T has already produced promising data and we look forward to working with MSK to explore Iomab-ACT’s potential to reduce toxicities and improve patient outcomes.  As we advance towards the SIERRA interim analysis in the fourth quarter, we are focused on the continued expansion of our ARC-based targeted conditioning program for bone marrow transplant and cell and gene therapies with the goal of providing targeted conditioning regimens that are less toxic and more effective than current chemotherapy-based conditioning.  With these therapies being administered in a select number of concentrated centers, we see a large and growing market opportunity where our ARC-based targeted conditioning can improve outcomes and increase access to these important curative treatment options.”

 

Iomab-ACT Program Update Call Details

Webcast link: https://ir.actiniumpharma.com/presentations-webinars

Date: October 21, 2020

Time: 8:00 AM EST

 

Source:

Park et al. Long-Term Follow-up of CD19 CAR Therapy in Acute Lymphoblastic Leukemia. N Engl J Med 2018;378:449-59. DOI: 10.1056/NEJMoa1709919

 

About Actinium Pharmaceuticals, Inc.

 

Actinium Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing ARCs or Antibody Radiation-Conjugates, which combine the targeting ability of antibodies with the cell killing ability of radiation. Actinium’s lead application for our ARCs is targeted conditioning, which is intended to selectively kill patient’s cancer cells and certain immune cells prior to a BMT or Bone Marrow Transplant, CAR-T and other cell therapies or gene therapy to enable engraftment of these transplanted cells with minimal toxicities. With our ARC approach, we seek to improve patient outcomes and access to these potentially curative treatments by eliminating or reducing the non-targeted chemotherapy that is used for conditioning in standard practice currently. Our lead product candidate, Iomab-B is being studied in the ongoing pivotal Phase 3 Study of Iomab-B in Elderly Relapsed or Refractory Acute Myeloid Leukemia (SIERRA) trial for BMT conditioning. The SIERRA trial is over fifty percent enrolled and promising single-agent, feasibility and safety data has been highlighted at ASH, TCT, ASCO and SOHO annual meetings. Beyond Iomab-B, we are developing a multi-disease, multi-target pipeline of clinical-stage ARCs targeting the antigens CD45 and CD33 for targeted conditioning and as a therapeutic either in combination with other therapeutic modalities or as a single agent for patients with a broad range of hematologic malignancies including acute myeloid leukemia, myelodysplastic syndrome and multiple myeloma. Underpinning our clinical programs is our proprietary AWE (Antibody Warhead Enabling) technology platform. This is where our intellectual property portfolio of over 120 patents, know-how, collective research and expertise in the field are being leveraged to construct and study novel ARCs and ARC combinations to bolster our pipeline for strategic purposes. Our AWE technology platform is currently being utilized in a collaborative research partnership with Astellas Pharma, Inc.

 

Forward-Looking Statements for Actinium Pharmaceuticals, Inc.

 

This press release may contain projections or other “forward-looking statements” within the meaning of the “safe-harbor” provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update, including but not limited to, statements relating to the Company’s expectations regarding the intended use of proceeds of the public offering. These statements are based on management’s current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium’s products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium’s filings with the SEC, including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time.

 

Investor Contact:

 

Clayton Robertson

Actinium Pharmaceuticals, Inc.

crobertson@actiniumpharma.com

 

Hans Vitzthum

LifeSci Advisors, LLC

Hans@LifeSciAdvisors.com

P: (617) 430-7578

 

Source: Actinium Pharmaceuticals, Inc.

Actinium Pharmaceuticals, Inc. Expands R&D Capabilities with New Research Facility to Enhance Development of Next Generation Antibody Radiation Conjugates Leveraging Its Proprietary AWE Platform

New York, NY – October 14, 2020 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (“Actinium” or the “Company”) today announced the launch of its new research and development lab facility in New York City .  This new research facility expands Actinium’s internal R&D capabilities and will be focused on developing novel Antibody Radiation Conjugate (ARC) candidates, ARC therapeutic combination strategies, and supporting AWE platform research collaborations. Actinium’s R&D efforts will employ a multidisciplinary approach leveraging its team’s expertise and experience in cancer cell biology, radiochemistry, radiation sciences, immunology and oncology drug development.  The proprietary AWE technology platform, protected by over one hundred and twenty-five patents, is the foundation for Actinium’s R&D and exploits multiple different radioisotope payloads including the potent alpha-emitter, Actinium-225.

 

This new research facility will function under the guidance of Dr. Dale Ludwig , Ph.D. the Company’s Chief Scientific & Technology Officer, who has over twenty-five years of oncology discovery research and development experience, including supporting the development and launch of Erbitux®, Cyramza TM , Portrazza®, and Lartruvo TM as well as the clinical advancement of at least 10 additional therapeutic antibodies and Antibody Drug Conjugates while at Eli Lilly and, previously, ImClone Systems Inc.  The research facility will be managed and staffed by Ph.D. level scientists who will contribute their respective expertise in areas of drug discovery, radiation chemistry, and translational research to advance novel ARC programs and investigations into combination therapeutic strategies.

 

“Our new research facility will allow us to significantly accelerate our preclinical and clinical development of novel ARC programs and investigate mechanistic ARC therapeutic combinations, which utilize our expertise in radioimmunobiology, our AWE Technology Platform capabilities, and know-how,” said Dale Ludwig .  “The establishment of an internal research facility was a priority for Actinium’s long-term strategy, as we look to deliver on our pipeline development activities, as well as expand our portfolio of promising product candidates through partnerships and collaborations.  Furthermore, in both preclinical and clinical studies, we have shown mechanistic synergies when our ARCs are combined with novel and approved therapeutic agents in treating cancer.  The addition of this R&D facility will enable more rapid investigation of novel mechanistic drug combinations that can be effectively translated into clinical testing.”

 

Over the last eighteen months, Actinium has advanced its research and discovery activities in three key areas —the development of next generation ARCs, therapeutic combinations with ARCs, and improved targeted conditioning treatments for adoptive cell therapies such as CAR-T.  As presented at the 2018 AACR Annual Meeting, cell death improved as much as thirty-fold and cell death occurred in treatment resistant cell lines when daratumumab, an anti-CD38 directed antibody approved for the treatment of multiple myeloma (MM), was labeled with Ac-225 using Actinium’s AWE Technology Platform.  The power and potency of Actinium’s AWE Technology Platform is also demonstrated in an ongoing Actimab-A combination study with CLAG-M in difficult to treat R/R AML patients. Patients treated with a sub-therapeutic dose of Actimab-A combined with CLAG-M had improved response rates by over 60% versus CLAG-M treatment alone.  In September, preclinical data supporting Iomab-ACT as a viable and effective method for achieving targeted lymphodepletion prior to an adoptive cell therapy such as CAR-T was published in the journal Oncotarget https://www.oncotarget.com/archive/v11/i39/ ).  Leveraging the new laboratory facility, Actinium intends to further its research activities in these areas which will aid in developing next generation targeted conditioning agents and exploring therapeutic combinations with ARCs and of proven oncology and immunooncology agents.

 

The Company intends to focus on generating novel ARCs, building on its existing intellectual property, evaluating assets for in-licensing to complement existing clinical pipeline, as well as securing collaborations and partnerships with other biopharmaceutical companies.  By adding research and development capabilities to its clinical development and clinical supply chain capabilities, Actinium will be positioned to enable the rapid translation of radioimmunotherapies into the clinic.  The Company’s AWE platform intellectual property covers various methods of use for ARCs in multiple diseases, including indication, dose and scheduling, radionuclide warhead, and therapeutic combinations.  Actinium’s AWE technology patent portfolio includes 29 patent families comprised of over 130 issued or pending global patent applications, of which 10 are issued and 31 pending in the United States .

 

Sandesh Seth , Chairman and Chief Executive Officer of Actinium, said, “The opening of our R&D facility is an important milestone that will support both internal and collaborative efforts at advancing the field of ARCs.  Our growing and highly talented R&D team is focused on harnessing the power of our AWE Technology Platform to enhance our clinical pipeline and drive current and additional collaborations.  Having these capabilities in house will allow us to more efficiently execute on our multi-disciplinary research efforts and continue to innovate and extend our leadership position in the growing field of ARCs.”

 

About Actinium Pharmaceuticals, Inc. (NYSE: ATNM)

 

Actinium Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing ARCs or Antibody Radiation-Conjugates, which combine the targeting ability of antibodies with the cell killing ability of radiation.  Actinium’s lead application for our ARCs is targeted conditioning, which is intended to selectively deplete a patient’s disease or cancer cells and certain immune cells prior to a BMT or Bone Marrow Transplant, Gene Therapy or Adoptive Cell Therapy (ACT) such as CAR-T to enable engraftment of these transplanted cells with minimal toxicities.  With our ARC approach, we seek to improve patient outcomes and access to these potentially curative treatments by eliminating or reducing the non-targeted chemotherapy that is used for conditioning in standard practice currently.  Our lead product candidate, I-131 apamistamab (Iomab-B) is being studied in the ongoing pivotal Phase 3 Study of Iomab-B in Elderly Relapsed or Refractory Acute Myeloid Leukemia (SIERRA) trial for BMT conditioning.  The SIERRA trial is over fifty percent enrolled and positive single-agent, feasibility and safety data has been highlighted at ASH, TCT, ASCO and SOHO annual meetings.  I-131 apamistamab will also be studied as a targeted conditioning agent in a Phase 1/2 anti-HIV stem cell gene therapy with UC Davis and is expected to be studied with a CAR-T therapy in 2020.  In addition, we are developing a multi-disease, multi-target pipeline of clinical-stage ARCs targeting the antigens CD45 and CD33 for targeted conditioning and as a therapeutic either in combination with other therapeutic modalities or as a single agent for patients with a broad range of hematologic malignancies including acute myeloid leukemia, myelodysplastic syndrome and multiple myeloma.  Ongoing combination trials include our CD33 alpha ARC, Actimab-A, in combination with the salvage chemotherapy CLAG-M and the Bcl-2 targeted therapy venetoclax.  Underpinning our clinical programs is our proprietary AWE (Antibody Warhead Enabling) technology platform.  This is where our intellectual property portfolio of over 100 patents, know-how, collective research and expertise in the field are being leveraged to construct and study novel ARCs and ARC combinations to bolster our pipeline for strategic purposes.  Our AWE technology platform is currently being utilized in a collaborative research partnership with Astellas Pharma, Inc. Website: https://www.actiniumpharma.com/

 

Forward-Looking Statements for Actinium Pharmaceuticals, Inc.

 

This press release may contain projections or other “forward-looking statements” within the meaning of the “safe-harbor” provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are based on management’s current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium’s products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium’s filings with the Securities and Exchange Commission (the “SEC”), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time.

 

Contacts:

Investors:
Clayton Robertson
Actinium Pharmaceuticals, Inc.
crobertson@actiniumpharma.com

Hans Vitzthum
LifeSci Advisors, LLC
Hans@LifeSciAdvisors.com
(617) 535-7743

SOURCE Actinium Pharmaceuticals, Inc.

About Actinium Pharmaceuticals


Targeted Therapies for Patients with Unmet Needs

 

Actinium is developing a pipeline of Antibody Radiation Conjugates for targeted conditioning and com

bination therapies

 

Actinium Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing ARC’s or Antibody Radiation-Conjugates, which combine the targeting ability of antibodies with the cell killing ability of radiation. Actinium’s lead application for our ARC’s is targeted conditioning, which is intended to selectively kill patient’s cancer cells and certain immune cells prior to a BMT or Bone Marrow Transplant, CAR-T and other cell therapies. With our ARC approach, we seek to improve patient outcomes and access to these potentially curative treatments by eliminating or reducing the non-targeted chemotherapy that is used for conditioning in standard practice currently. Our lead product candidate, Iomab-B is being studied in the ongoing pivotal Phase 3 Study of Iomab-B in Elderly Relapsed or Refractory Acute Myeloid Leukemia (SIERRA) trial for BMT conditioning. Beyond Iomab-B, we are developing a multi-disease, multi-target pipeline of clinical-stage ARC’s targeting the antigens CD45 and CD33 for targeted conditioning and as a therapeutic either in combination with other therapeutic modalities or as a single agent for patients with a broad range of hematologic malignancies including AML or Acute Myeloid Leukemia, MDS or Myelodysplastic Syndrome MM or Multiple Myeloma. Underpinning our clinical programs is our proprietary AWE or Antibody Warhead Enabling technology platform. This is where our intellectual property portfolio of over 100 patents, know-how, collective research and expertise in the field are being leveraged to construct and study novel ARC’s and ARC combinations to bolster our pipeline and for strategic purposes. Our AWE technology platform is currently being utilized in a collaborative research partnership with Astellas Pharma, Inc.

 

BUSINESS DESCRIPTION

 

Actinium Pharmaceuticals, Inc. (NYSE MKT:ATNM) is a publicly traded biopharmaceutical company developing innovative targeted therapies for patients with cancers lacking effective treatment options. Actinium’s proprietary technology platform utilizes monoclonal antibodies to deliver radioisotopes directly to cells of interest in order to kill those cells both safely and effectively.

 

Actinium’s lead product candidate, Iomab-B, is licensed from the Fred Hutchinson Cancer Research Center and is designed to be used, upon approval, in preparing patients for a hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. A bone marrow transplant is often the only potential cure for patients with blood-borne cancers but the current standard preparation for a transplant requires chemotherapy and/or total body irradiation that result in significant toxicities. We believe Iomab-B will enable a faster and less toxic preparation of patients seeking a bone marrow transplant, leading to increased transplant success and survival rates. We are currently conducting a single pivotal 150-patient, multicenter Phase 3 clinical study of Iomab-B in patients with relapsed or refractory acute myeloid leukemia (AML) age 55 and older. Learn more about Iomab-B and bone marrow transplant for AML here.

 

Actinium is also developing Actimab-A, our lead alpha-particle drug candidate. Actimab-A is currently in a multicenter open-label, 53-patient Phase 2 trial for patients newly diagnosed with AML age 60 and over. Actimab-A is being developed to induce remissions in elderly patients with AML who lack effective treatment options and often cannot tolerate the toxicities of standard frontline therapies. Learn more about Actimab-A here.

 

In addition, Actinium has expanded its alpha-particle approach to include newly created drug candidate Actimab-M, which is being studied in patients with relapsed or refractory multiple myeloma in a Phase 1 clinical trial. Learn more about Actimab-M and the multiple myeloma trial here.

 

Actinium is also utilizing its alpha-particle immunotherapy (APIT) technology platform to generate new drug candidates based on antibodies linked to the element actinium-225 that are directed at various blood-borne or solid cancers. To learn more about Actinium’s APIT or to explore a potential collaboration using this powerful technology please visit the Technology page.

 

Actinium Pharmaceuticals is based in New York, NY.

 

Source:  https://www.actiniumpharma.com/

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