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Actinium Pharmaceuticals, Inc. (NYSE MKT: ATNM) is a New York-based biopharmaceutical company focused on developing innovative targeted radiotherapies for the treatment of advanced cancers. Leveraging its proprietary delivery platform, Actinium utilizes alpha-emitting Actinium-225 and Bismuth-213, as well as certain beta-emitting radiopharmaceuticals, in conjunction with monoclonal antibodies to target and kill cancer cells. The company’s leading product candidate, Iomab™-B, is designed to prepare patients for hematopoietic stem cell transplants (bone marrow transplants) by delivering targeted radiotherapy directly to the bone marrow. Iomab™-B is currently in a pivotal, multicenter Phase 3 clinical study for refractory and relapsed acute myeloid leukemia (AML) patients over the age of 55, focusing on durable complete remission as its primary endpoint.
Actinium's second key program, Actimab-A, is undergoing clinical development in Phase 1/2 trials for newly diagnosed AML patients. This program utilizes Actinium-225 and aims to improve outcomes for patients who have failed existing therapies. Actinium is also involved in numerous partnerships and collaborations, such as with Astellas Pharma, AVEO Oncology/LG Chem Life Sciences, and others, to expand its reach in the realm of radiotherapy for solid tumors.
The company has demonstrated promising results in various studies, including the Phase 3 SIERRA trial for Iomab™-B, which showed significant improvements in survival rates among high-risk AML patients, particularly those with TP53 mutations. Further, Actinium's proprietary cyclotron technology for producing Actinium-225 at commercial scale holds potential for reducing production costs and enhancing supply for clinical and commercial purposes. With a robust pipeline and a strong patent portfolio comprising over 230 patents and applications, Actinium Pharmaceuticals continues to make strides in the field of targeted radiotherapies.
For more information, visit Actinium Pharmaceuticals, Inc.
Actinium Pharmaceuticals (NYSE AMERICAN: ATNM) announced FDA clearance for an IND application to study Iomab-ACT for targeted conditioning prior to bone marrow transplant (BMT) in sickle cell disease patients. The study, in collaboration with Columbia University, aims to evaluate Iomab-ACT's safety and potentially inform future gene therapy conditioning trials. Iomab-ACT, an Antibody Radiation Conjugate targeting CD45, could replace current non-targeted chemotherapy and total body irradiation conditioning methods, potentially reducing severe side effects and broadening access to curative cellular therapies. This initiative addresses the high unmet need among approximately 100,000 U.S. sickle cell patients annually. The study aligns with Actinium's strategy to expand Iomab-ACT's applications in transplant, cell therapy, and gene therapy conditioning, tapping into a growing market for CAR-T and gene therapies expected to reach 93,000 U.S. patients by 2030.
Actinium Pharmaceuticals (NYSE AMERICAN: ATNM) will present at the 3rd Annual Targeted Radiopharmaceuticals Summit US in San Diego from July 30 - August 1, 2024. The presentation, titled 'Overcoming Adverse Cytogenetics, TP53, Other Mutations & Treatment Resistant Disease in Relapsed/Refractory AML Using Antibody Radiation Conjugates,' will take place on July 31, 2024.
The presentation will highlight:
- Iomab-B, a CD45 I-131 ARC, enabling bone marrow transplant in otherwise ineligible patients
- Actimab-A, a CD33 Ac-225 ARC, demonstrating strong anti-leukemic activity
- Responses in heavily pretreated patients, including those with prior venetoclax treatment or TP53-mutated disease
- Preclinical data showing benefits of combining Actimab-A with targeted therapies like FLT3 inhibitors
Both Iomab-B and Actimab-A are the only clinical stage antibody radiation conjugates in development for acute myeloid leukemia patients.
Actinium Pharmaceuticals (NYSE: ATNM) has made significant strides in developing its blood cancer treatment pipeline, focusing on Antibody Radiation Conjugates (ARCs) and targeted radiotherapies. Recent highlights include the presentation of preclinical data combining Actimab-A with menin inhibitors at the European Hematology Association (EHA) Congress, and positive Phase 3 SIERRA trial results for Iomab-B in relapsed/refractory AML patients. The SIERRA trial showed a 92% 1-year survival and 69% 2-year survival for patients receiving Iomab-B led bone marrow transplants. Actinium also plans to extend Iomab-B for other blood cancers and introduce Iomab-ACT for enhanced cell and gene therapy outcomes. These advancements are important as biopharma companies work to address the rising incidence of blood cancers globally.
Actinium Pharmaceuticals (NYSE: ATNM) has unveiled promising preclinical data for its Antibody Radiation Conjugate (ARC) Actimab-A, in combination with menin inhibitors, at the 2024 European Hematology Association Congress. The study showed enhanced AML cell death and a synergistic anti-tumor effect in AML models with KMT2A rearrangements and NMP1 mutations, affecting around 40% of AML patients. These results suggest potential as a combination therapy across various AML treatment stages. This news, alongside the broader USD 2.1 billion AML treatment market expected to grow at a CAGR of 10.7% by 2024, highlights Actinium's growing footprint in the AML therapeutic landscape.
Actinium Pharmaceuticals presented new preclinical data at the 2024 European Hematology Association Congress, demonstrating that Actimab-A, in combination with leading menin inhibitors revumenib and ziftomenib, significantly enhances acute myeloid leukemia (AML) cell death compared to monotherapy.
The combination targets KMT2A rearrangements and NMP1 mutations, affecting 10% and 30% of AML patients respectively. Actimab-A showed potent AML cell-killing activity, enhancing cell death in difficult-to-treat KMT2A mutant AML and triggering increased necrosis and cell death in vivo within 72 hours. The anti-tumor effect of the combination was significantly potentiated in xenograft leukemia models.
CEO Sandesh Seth highlighted the broad potential of this combination therapy across various AML treatment settings, noting its promise in both preclinical studies and potential future clinical trials.
Actinium Pharmaceuticals announced positive results from the Phase 3 SIERRA trial of Iomab-B at the 2024 EHA Congress in Madrid. The trial focused on patients with relapsed or refractory acute myeloid leukemia (r/r AML), particularly those with TP53 mutations. Patients receiving Iomab-B led bone marrow transplants showed a median overall survival (OS) of 5.49 months compared to 1.66 months for those without Iomab-B. The trial met its primary endpoint with 92% one-year survival and 69% two-year survival among those receiving Iomab-B. Additionally, Iomab-B demonstrated a favorable safety profile, with lower rates of sepsis and mucositis.
Actinium Pharmaceuticals (NYSE: ATNM) announced positive results from its Phase 1b trial of the Actimab-A + CLAG-M combination therapy for relapsed or refractory acute myeloid leukemia (r/r AML) at the 2024 Society of Nuclear Medicine & Molecular Imaging Annual Meeting. The study showcased high response rates, bone marrow transplant access, and improved survival outcomes, especially in high-risk patients, including those with TP53 mutations and previous venetoclax treatment. The combination therapy demonstrated no significant safety concerns for major organs and used a validated pharmacokinetic model to estimate biodistribution. The presentation highlighted the dosing, efficacy, and safety profile, with 64% of eligible patients proceeding to bone marrow transplants and median overall survival reaching up to 24 months.
Actinium Pharmaceuticals presented data from the Phase 3 SIERRA trial of Iomab-B at the 2024 Society of Nuclear Medicine & Molecular Imaging Annual Meeting.
Iomab-B, a CD45 targeting ARC, significantly improved survival for high-risk relapsed or refractory AML patients, including those with TP53 mutations. The trial achieved its primary endpoint of durable Complete Remission with high statistical significance (p<0.0001). Patients receiving Iomab-B had a median OS of 5.49 months compared to 1.66 months for the control group.
Actinium also showcased its novel linker technology, demonstrating high tumor uptake and in vivo stability in preclinical models, with significantly lower kidney and liver uptake compared to standard DOTA linkers. This technology supports the expansion of Actinium's ARC pipeline for solid tumors.
The SIERRA trial involved 153 patients, with Iomab-B delivering targeted radiation more effectively and safely than total body irradiation, while sparing healthy organs.
Actinium has two U.S. patents for its linker technology extending into 2043, with a pending international application.
Actinium Pharmaceuticals will host a KOL webinar on May 20, 2024, at 8:00 AM ET to discuss the Iomab-ACT commercial CAR T-cell therapy trial being conducted at the University of Texas Southwestern (UTSW). Dr. Farrukh Awan, an expert in leukemia and lymphoma treatment, will join as the principal investigator. Iomab-ACT, an ARC targeting CD45, aims to replace non-targeted chemotherapy in conditioning prior to cell and gene therapies. Phase 1 trial results showed no immune effector cell-associated neurotoxicity syndrome (ICANS) in treated patients and minimal Cytokine Release Syndrome (CRS). The CAR-T market, projected to grow at an 11% CAGR, presents a significant opportunity for Iomab-ACT, which targets an addressable patient population expected to reach 93,000 in the U.S. by 2030.
Actinium Pharmaceuticals announced that the Phase 3 SIERRA trial results of Iomab-B will be presented at the EHA 2024 Congress. The trial demonstrated significant survival benefits in older patients with relapsed or refractory acute myeloid leukemia (r/r AML) receiving an Iomab-B led bone marrow transplant (BMT). Patients with TP53 mutations saw a median overall survival of 5.49 months compared to 1.66 months for those not receiving Iomab-B. The trial enrolled high-risk patients and showed 92% 1-year survival and 69% 2-year survival rates in those receiving Iomab-B led BMT.
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