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Actinium Pharmaceuticals, Inc. (ATNM) is a clinical-stage biopharmaceutical leader pioneering targeted radiotherapies for advanced cancers, with a focus on acute myeloid leukemia (AML) and stem cell transplant conditioning. This page provides investors and healthcare professionals with timely updates on the company’s clinical trials, regulatory milestones, and scientific advancements.
Access verified news about Actinium’s antibody radiation conjugate (ARC) pipeline, including Iomab-B and Actimab-A, alongside strategic partnerships in oncology. Our curated repository ensures efficient tracking of developments in targeted radiotherapy, clinical research collaborations, and progress toward addressing unmet needs in hematologic malignancies.
Explore updates across key categories: clinical trial results, FDA communications, intellectual property expansions, and scientific presentations. Bookmark this page to stay informed on Actinium’s innovative approaches to minimizing treatment toxicity while improving outcomes for high-risk cancer patients.
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.
Actinium Pharmaceuticals announced that multiple abstracts highlighting its Antibody Radiation Conjugates Iomab-B and Actimab-A, along with novel linker technology for solid tumors, have been accepted for presentation at the 2024 Society of Nuclear Medicine & Molecular Imaging Annual Meeting. The abstracts feature improved survival with both Iomab-B and Actimab-A in high-risk acute myeloid leukemia patients, including TP53 mutations. Actinium's presence at the SNMMI showcases its leadership in developing ARCs, with a focus on targeted radiotherapy for blood cancers and solid tumors.