Actinium Pharmaceuticals, Inc - ATNM STOCK NEWS

Actinium Pharmaceuticals (NYSE AMERICAN: ATNM) announced that the FDA has determined the Phase 3 SIERRA trial for Iomab-B is not adequate to support a Biologics License Application (BLA) filing, despite meeting its primary endpoint with statistical significance. The FDA requires an additional head-to-head randomized clinical trial demonstrating overall survival benefit to support a BLA filing.

Key points:

• Actinium will request a meeting with the FDA to discuss specifics of the additional trial
• The company will seek a strategic partner for Iomab-B in the U.S. after completing FDA interactions
• Actinium will focus development efforts on Actimab-A, Iomab-ACT, and preclinical programs

Actinium Pharmaceuticals (NYSE AMERICAN: ATNM) has expanded its patent coverage for Iomab-ACT, a targeted radiotherapy conditioning agent, with the issuance of U.S. Patent No. 11,912,780. This patent, extending to 2040, covers methods using Iomab-ACT for conditioning patients before gene-edited hematopoietic stem cell therapy for non-malignant disorders such as sickle cell disease, SCID, β-thalassemia, and Fanconi's anemia.

Iomab-ACT targets CD45, aiming to replace non-targeted chemotherapy in conditioning for cell and gene therapies. The company is conducting clinical trials with Memorial Sloan Kettering Cancer Center, the University of Texas Southwestern, and Columbia University to explore Iomab-ACT's potential in various applications, including CAR-T therapy and sickle cell disease treatment.

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.