Actinium

The market for targeted alpha therapies (TATs) has expanded significantly, with Radium-223 dichloride (Xofigo) as a key milestone. TATs are being explored for various cancers and neurodegenerative diseases, with RYZ101 in Phase 3 trials for neuroendocrine tumors and Actimab-A for leukemia. The TAT market is growing due to clinical advancements, investor interest, and regulatory support, positioning TAT as a key component of precision medicine.

Actinium Pharmaceuticals updates on Phase 2/3 trial for Actimab-A + CLAG-M in relapsed/refractory acute myeloid leukemia, selection for NCI's myeloMATCH program, FDA clearance of Iomab-ACT INDs for CAR-T and sickle cell trials, seeking US strategic partner for Iomab-B, appointment of Dr. June Almenoff to Board, and $78.6 million in cash to fund operations into 2027.

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Companies are developing radiolabeled antibody-drug conjugates (rADCs) to target cancer cells directly, reducing side effects and treatment times. rADCs, which use antibodies to deliver radiation to cancer cells, are seen as an emerging modality in oncology. Despite challenges like supply and delivery hurdles, clinical trials are progressing, with promising interim results and FDA orphan drug designations.

Nurix Therapeutics appoints Anil Kapur to its board of directors, effective October 15, 2024. Kapur brings over 25 years of executive experience in pharmaceutical and biotech companies, with expertise in commercial operations and launching novel drugs in hematology and oncology. His notable achievements include launching blockbuster drugs Imbruvica and Darzalex at Johnson & Johnson. Nurix plans to advance NX-5948 into pivotal clinical testing in 2025 and prepare for future commercialization.

The phase III SIERRA trial reported in the Journal of Clinical Oncology by Gyurkocza et al. showed higher rates of durable complete remissions with the anti-CD45 radioconjugate iodine-131–apamistamab compared to conventional care followed by allogeneic hematopoietic cell transplantation (allo-HCT) in patients aged ≥ 55 years with relapsed or refractory acute myeloid leukemia. The study involved 153 patients randomly assigned to receive I-131–apamistamab or conventional care, with the primary outcome being durable complete remission lasting 180 days. Results indicated a durable complete remission rate of 17.1% in the I-131–apamistamab group versus 0% in the conventional care group (P < .0001). Median overall survival was 6.3 months in the I-131–apamistamab group vs 5.9 months in the conventional care group, with a median event-free survival of 3.2 vs 0 months. The regimen was well tolerated, with grade ≥ 3 treatment-related adverse events occurring in 59.7% of the I-131–apamistamab group and 59.2% of the conventional care group.

The radiopharmaceuticals market was valued at USD 5.0 billion in 2023 and is projected to reach USD 16.6 billion by 2032, growing at a CAGR of 10.4%. The market is driven by increasing cancer cases and advancements in diagnostic and therapeutic radiopharmaceuticals. Technetium-99m dominates the market due to its wide diagnostic applications. North America holds the largest market share, while Asia Pacific is the fastest-growing region. Key players include GE Healthcare, Curium Pharma, and Lantheus.

Iomab-B, a CD45 targeted radiotherapy, demonstrated durable Complete Remission and Event-Free Survival in the SIERRA trial for relapsed/refractory AML patients, but did not meet overall survival endpoint due to high crossover rate. Actinium seeks a strategic partner for further U.S. development.