On December 4, 2025 Alpha-9 Oncology, a clinical-stage radiotherapeutic company developing targeted cancer therapies, reported the initiation of dosing in a Phase 1 study evaluating A9-3408, a novel Actinium-225-based radiotherapeutic targeting melanocortin 1 receptor (MC1R) for the treatment of patients with melanoma. The Phase 1 study is a multi-center, open-label trial designed to evaluate the safety, dosimetry, and dose escalation of A9-3408 in patients with MC1R-positive melanoma, who have progressed on standard-of-care therapies.
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This milestone advances Alpha-9’s melanoma program, which first entered the clinic last year with A9-3202, a Gallium-68-based imaging agent used to assess MC1R expression and identify patients for the A9-3408 therapeutic study.
"Dosing the first patient with our MC1R radiotherapeutic marks an important milestone for the company and validates our internal R&D platform," said Paul Blanchfield, Chief Executive Officer, Alpha-9 Oncology. "We are excited to have initiated trials for our first therapeutic program and look forward to advancing additional best-in-class assets into the clinic as we aim to bring novel, life-improving treatments to people living with cancer."
"MC1R is an ideal target due to its high expression in melanoma and limited presence in healthy tissue," said Robert Meehan, M.D., Chief Medical Officer at Alpha-9. "Despite advances in immunotherapy, significant unmet needs remain for patients who progress on current standard of care. In our A9-3202 imaging study, 92% of patients had strong MC1R expression after progression on immunotherapy, demonstrating the potential for this program to provide a new modality for patients."
Dr. Meehan recently joined Alpha-9 as Chief Medical Officer, bringing progressive leadership experience in biopharma and biotechnology, specializing in the creation of complex, novel development programs. Dr. Meehan is a board-certified physician trained in hematology and oncology, with expertise in all phases of drug development across multiple modalities. Prior to Alpha-9, Dr. Meehan was the Senior Vice President, Clinical Development at Dragonfly Therapeutics, held multiple senior clinical leadership roles at Moderna, and was a staff clinician in the Developmental Therapeutics Clinic at the National Cancer Institute.
Alpha-9’s platform is built on a systematic approach to molecule design, optimizing binders, linkers, and chelators to create radiotherapeutics with superior uptake and retention in tumors while minimizing off-target effects. The advancement of the MC1R program highlights the company’s capability to develop best-in-class molecules and deliver on the promise of precision oncology.
(Press release, Alpha9 Oncology, DEC 4, 2025, View Source [SID1234661138])