GET TOP RATED STOCK ALERTS ACTIVE TRADERS DEPEND ON
SIGN UP TODAY FOR FREE NEWS DRIVEN ALERTS
– Iomab-B met the primary endpoint of durable Complete Remission (dCR) of 6-months following initial complete remission after BMT with high statistical significance (p-value of <0.0001), 22% of patients achieved dCR in the Iomab-B arm compared to 0% in the control arm
– In patients achieving 6-month dCR with Iomab-b, 1-year survival of 92% and 2-year survival of 60% was achieved; median overall survival (OS) has not been reached in these patients
– Iomab-B demonstrated significant improvement in Event Free Survival (EFS) with a Hazard Ratio = 0.22, p<0.0001
– Iomab-B doubled 1-year survival and median overall survival compared to control arm patients who did not crossover
– Iomab-B was well tolerated with a favorable safety profile – 4 times lower rate of sepsis than control arm
– Company to host conference call and webcast on Saturday, February 18, 2023 at 6:00 PM EST to highlight full SIERRA results
New York, NY – February 22, 2023 – Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of targeted radiotherapies, announced positive results for the primary and secondary endpoints from its pivotal Phase 3 SIERRA trial of Iomab-B in patients age 55 and above with active relapsed or refractory acute myeloid leukemia (r/r AML). Iomab-B met the primary endpoint of durable Complete Remission (dCR) of 6-months following initial complete remission following BMT with a high degree of statistical significance (p<0.0001). Additionally, Iomab-B produced a significant and clinically meaningful improvement in the secondary endpoint of Event-Free Survival (EFS), with a 78% reduction in the probability of an event (Hazard Ratio=0.22, p<0.0001). Iomab-B doubled 1-year survival compared to the control arm excluding cross over patients (26.1% vs 13.1%) as well as median overall survival (6.4 months vs. 3.2 months). Iomab-B was well tolerated with four times lower rates of sepsis (6.1% vs 28.6%) and lower rates of febrile neutropenia, mucositis and acute graph versus host disease (aGVHD). Iomab-B enabled unprecedented access to BMT with 100% engraftment in patients receiving a therapeutic dose of Iomab-B compared to 18% of patients in the control arm and Iomab-B produced a 75% post-BMT Complete Remission (CR) rate compared to 6.3% post-BMT CR in the control arm. These high rates of access and post-BMT CR enabled the highly significant primary endpoint results. The full SIERRA results were presented in the late-breaker session at the 2023 Tandem Meetings: Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR).
Dr. Sergio Giralt , Deputy Head, Division of Hematologic Malignancies, Attending Physician, Adult BMT Service at Memorial Sloan Kettering Cancer Center, stated, “The SIERRA trial results are an exciting advancement for older patients with active r/r AML and will be practice changing in how we treat these patients. I am thrilled to see a high percentage of Iomab-B patients who achieved durable remissions reaching the critical 2-year survival mark. Significant improvement in event-free survival and overall survival, with an excellent safety profile in the SIERRA trial, demonstrate the potential of Iomab-B becoming a new standard of care for active, r/r AML.”
SIERRA Trial Results
The pivotal Phase 3 SIERRA trial is a 153-patient, randomized, multi-center, controlled trial, where Iomab-B is compared to the control arm that allowed physician’s choice of over 20 available agents including chemotherapies and/or targeted therapies such as Venetoclax (Bcl-2), FLT3 inhibitors, IDH inhibitors and Mylotarg. The control arm reflects current best practices for the treatment of r/r AML patients. SIERRA was conducted at 24 of the leading BMT centers in the United States and Canada . SIERRA enrolled older, heavily pre-treated patients with active disease and high-risk characteristics who would not be offered BMT in standard practice outside of a clinical trial and therefore have dismal survival outcomes of two to three months.
Iomab-B Patient Characteristics :
- Patients with active, r/r disease
- Median age: 64 (55-77)
- Intermediate and adverse cytogenetics and molecular risk: >90%
- Majority of patients had primary induction failure or first early relapse: 78%
- Median blast count: 30%
- Prior lines of treatment: 3 (1-8)
BMT Access and Engraftment :
All patients receiving the therapeutic dose of Iomab-B were able to access BMT with 100% engraftment. Patients in the Iomab-B arm were able to access a BMT without having to first attain a CR, consequently they were able to access BMT in half the time compared to the control arm as those patients need to attain a CR prior to BMT, which is the norm per current practice.
- Iomab-B treatment provided unprecedented access to BMT and engraftment without delay (less than 20 days for platelets and neutrophils) in all patients who received the therapeutic dose of Iomab-B (66/66), (59/59 for per protocol analysis)
- Iomab-B enabled more than a 6x increase in BMT access compared to the control arm where 17% of patients (11/64) were able to access a BMT per protocol analysis
- Of the 82% of patients (62/76) in the control arm who failed to achieve a CR and access BMT, 67% of patients (40/62) were able to crossover. Crossover patients are counted as failures for the primary endpoint analysis. Of the 40 crossover patients, 100% (40/40) were able to receive Iomab-B and accessed BMT also achieving engraftment without delay
- Iomab-B enabled access to BMT in approximately half the time (median of 29 days) compared to control arm patients (median 66.5 days)
Post-BMT CR :
- 75% of patients (44/59) receiving Iomab-B achieved an initial remission after their BMT compared to 6.3% of patients (4/64) in the control arm which represents a 12x increase in post-BMT CR rates in favor of Iomab-B
Primary Endpoint – dCR 6-months After Initial CR :
- Iomab-B met the primary endpoint of 6 months dCR with a high degree of statistical significance (p<0.0001)
- 22% of patients (13/59) achieved dCR on the SIERRA arm compared to 0% of patients on the control arm
- Patients who achieved 6-month dCR had 92% 1-year survival and 60% 2-year survival. Median OS has not been reached in these patients
Secondary Endpoints – Event Free Survival and Overall Survival :
- Iomab-B demonstrated significant improvement in EFS with a Hazard Ratio = 0.22, p<0.0001, which means Iomab-B reduced the probability of an event by 78%. EFS is not confounded by the SIERRA crossover arm and allows for direct comparison of survival outcomes between Iomab-B and the control arm
- Event is defined as not achieving CR/CRp, crossover, not receiving BMT, relapse or death
- Iomab-B doubled 1-year survival and median overall OS of Iomab-B compared to patients who did not crossover in the control arm was 26.1% vs 13.1% and Median OS was 6.4 months vs 3.2 months
- In the crossover arm, 1-year overall survival was 35.8% in patients who received Iomab-Band median overall survival was 7.1 months
Safety Information :
- Iomab-B was well-tolerated with a favorable safety profile
- In transplanted patients, incidence of sepsis was four times lower in the Iomab-B arm then the control arm (6.1% vs 28.6%)
- Rates of other treatment related adverse events were lower in favor of Iomab-B, including febrile neutropenia (43.9% vs. 50%), mucositis (15.2% vs 21.4%) and aGVHD (26.1% vs 35.7%)
Dr. Avinash Desai , Chief Medical Officer of Actinium, said, “We are excited that Iomab-B met the primary endpoint and produced positive results across all SIERRA trial endpoints with improved safety compared to control arm in such a difficult patient population. In routine clinical BMT practice, patients enrolled on SIERRA would never be considered for transplant and often have dismal outcomes. Iomab-B provides unprecedented BMT access and improved outcomes with better tolerability – opening the promise of better transplant outcomes for the entire universe of relapsed and refractory AML patients. These results clearly demonstrate Iomab-B’s practice expanding opportunity as more patients will be able to access transplant and upon reaching the 100-day post-transplant mark they can return to their referring hematologist for long-term care. We look forward to launching an early access program, completing our BLA submission and initiating life cycle management activities to bring Iomab-B to as broad a patient population as possible.”
Sandesh Seth , Actinium’s Chairman and CEO, added, “These positive SIERRA results will help to establish Iomab-B as a new standard of care for r/r AML. Iomab-B is a very attractive option for patients due to its excellent safety and strong efficacy profile. It will enable physicians to provide a treatment intervention with potential long-term survival outcomes and will help bring more patients to curative BMTs. We truly believe that Iomab-B enables potentially better value to be unlocked by getting more patients safely to an effective BMT and by increasing the length and quality of life for patients who otherwise would have dismal outcomes using currently available options. The commercial opportunity for Iomab-B is attractive as the majority of relapsed/refractory patients cannot be treated with a BMT today and Iomab-B can enable them to access this potentially curative treatment. These patients comprise of over half of all AML patients. In addition, the lack of current or visible competition for Iomab-B and the concentration of BMT centers imply that successful commercialization of this high-value treatment can be achieved with a streamlined, efficient organization that is sparing to the balance sheet. We look forward to establishing this practice expanding treatment as the standard of care and to updating on our plans to file the BLA and progress toward this goal.”
About Iomab-B and the Pivotal Phase 3 SIERRA Trial
Iomab-B is a first-in-class targeted radiotherapy intended to improve patient access to potentially curative BMT by simultaneously and rapidly depleting blood cancer, immune and bone marrow stem cells that uniquely express CD45. Multiple studies have demonstrated increased survival in patients receiving BMT, however, an overwhelming majority of patients with blood cancers do not receive BMT as current approaches do not produce a remission, which is needed to advance to BMT, or are too toxic. Studied in over 400 patients, prior studies with Iomab-B have demonstrated nearly universal access to BMT, increased survival and tolerability in multiple clinical trials including the recently completed pivotal Phase 3 SIERRA trial in patients with active (leukemic blasts >5%), relapsed or refractory acute myeloid leukemia (r/r AML) age 55 and above.
Iomab-B met the primary endpoint of durable Complete Remission (dCR) of 6 months after initial remission post-BMT in the pivotal Phase 3 SIERRA trial with high statistical significance (p<0.0001). Iomab-B produced a 75% post-BMT CR rate (44/59 patients), which is 12-times greater than the post-BMT rate of 6.3% (4/64 patients) in the control arm. Patients receiving Iomab-B had a 78% lower probability of an event, defined as not achieving a CR/CRp, crossover, not receiving a BMT, relapse or death, with a Hazard Ratio of 0.22 (p<0.0001). Iomab-B doubled 1-year overall survival with 26.1% compared to 13.1% in the control arm for patients who did not crossover as well as median overall survival with 6.4 months vs 3.2 months. Overall survival statistics are confounded by the crossover arm. Crossover patients had a 35.8% 1-year overall survival rate. Due to its targeted nature, Iomab-B was well tolerated with four times lower rates of sepsis compared to the control arm (6.1% vs. 28.6%) and lower rates of BMT associated adverse events including febrile neutropenia, mucositis and graft versus host disease (GVHD). Actinium intends to submit a Biologics License Application (BLA) seeking approval for Iomab-B in 2023 to address patients age 55+ with r/r AML who cannot access BMT with currently available therapies. Iomab-B has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) and has patent protection into 2037.
The pivotal Phase 3 SIERRA (Study of Iomab-B in Elderly relapsed or refractory AML) is a 153-patient, randomized, multi-center clinical trial, studying Iomab-B compared to the control arm of physician’s choice of salvage therapy. Control arm options included chemotherapies like cytarabine and daunorubicin and targeted agents such as a Bcl-2 inhibitor (Venetoclax), FLT3 inhibitors and IDH 1/2 inhibitors. The SIERRA control arm reflects real-world treatment of r/r AML patients with over 20 agents used alone or in combination as no standard of care exists for this patient population. The SIERRA trial enrolled patients at 24 leading transplant centers in the United States and Canada that perform over 30% of AML BMTs.
Developed at the Fred Hutchinson Cancer Research Center, a pioneer in the field of BMT, Iomab-B is supported by data in six disease indications including leukemias, lymphomas and multiple myeloma, which afflict over 100,000 patients annually. Actinium intends to pursue additional indications for Iomab-B beyond AML. Actinium also intends to pursue international regulatory approvals independently and through partnerships. In April 2022 , Actinium licensed the European, Middle East and North African commercial rights for Iomab-B to Immedica AB, a fully-fledged independent pharmaceutical company headquartered in Sweden . In exchange, Actinium received an upfront payment of $35 million USD with the potential for an additional $417 million USD in regulatory and sales milestones and mid-twenty percent royalties. Europe represents a commercial opportunity double the size of the United States by number of patients with AML receiving BMT. Iomab-B has been granted Orphan Drug Designation by the European Medicines Agency (EMA) and has received positive Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the EMA indicating that the Phase 3 SIERRA trial design, primary endpoint and planned statistical analysis are acceptable as the basis for a Marketing Authorization Application.
About Actinium Pharmaceuticals, Inc.
Actinium Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing targeted radiotherapies to deliver cancer-killing radiation with cellular level precision to treat patients with high unmet needs. Actinium’s clinical pipeline is led by targeted radiotherapies that are being applied to targeted conditioning, which is intended to selectively deplete a patient’s disease or cancer cells and certain immune cells prior to a bone marrow transplant (BMT), gene therapy or adoptive cell therapy, such as CAR-T, to enable engraftment of these transplanted cells with minimal toxicities. Our lead product candidate, Iomab-B (I-131 apamistamab) has been studied in over four hundred patients, including the pivotal Phase 3 Study of Iomab-B in Elderly Relapsed or Refractory Acute Myeloid Leukemia (SIERRA) trial for BMT conditioning. The SIERRA trial was positive with Iomab-B meeting the primary endpoint of durable Complete Remission of 6-months with high statistical significance (p<0.0001). Iomab-B enabled 100% of patients to access a BMT and produced higher rates of post-BMT CR. Iomab-B produced positive results for the secondary endpoints of the SIERRA trial including reducing the probability of an event by 78% resulting in an Event-Free Survival (EFS) Hazard Ratio of 0.22 (p<0.0001), doubled 1-year overall survival and median overall survival. Iomab-ACT, low dose I-131 apamistamab, is being studied as a targeted conditioning agent in a Phase 1 study with a CD19 CAR T-cell Therapy with Memorial Sloan Kettering Cancer Center with NIH funding. Actimab-A, our second most advanced product candidate has been studied in approximately 150 patients with Acute Myeloid Leukemia or AML, including in combination trials with the chemotherapy regimen CLAG-M and with venetoclax, a targeted therapy. Actimab-A or lintuzumab-Ac225 is an Actinium-225 based antibody radiation conjugate targeting CD33, a validated target in AML. Actinium has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to develop Actimab-A as a single agent or combination with chemotherapy, targeted agents or immunotherapy in Phase 1, 2 or 3 trials. The NCI will fund clinical trial expenses under the CRADA while Actinium will supply Actimab-A. The NCI is currently accepting proposals for non-clinical and clinical studies with Actimab-A. Actinium is a pioneer and leader in the field of Actinium-225 alpha therapies with an industry leading technology platform comprising over 190 patents and patent applications including methods of producing the radioisotope AC-225. Our technology and expertise have enabled collaborative research partnerships with Astellas Pharma, Inc. for solid tumor theranostics, with AVEO Oncology Inc. to create an Actinium-225 HER3 targeting radiotherapy for solid tumors, and with EpicentRx, Inc. to create targeted radiotherapy combinations with their novel, clinical stage small molecule CD47-SIRPα inhibitor. More information is available on Actinium’s website: https://www.actiniumpharma.com/ .
Investors:
Hans Vitzthum
LifeSci Advisors, LLC
Hans@LifeSciAdvisors.com
(617) 430-7578
SOURCE Actinium Pharmaceuticals, Inc.
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.
Hans Vitzthum
LifeSci Advisors, LLC
P: (617) 430-7578
Source: Actinium Pharmaceuticals, Inc.
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 combination 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/
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 forty five hundred dollars for Actinium Pharmaceuticals, Inc. current news coverage by a non-affiliated third party. FNMG HOLDS NO SHARES OF Actinium Pharmaceuticals, 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.