Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a trailblazer in the oncology sector specializing in the development of next-generation radiopharmaceuticals, has announced a landmark exclusive worldwide license agreement with Heidelberg University and Euratom, represented by the European Commission, Joint Research Centre. This pivotal agreement confers upon Fusion the exclusive worldwide rights to develop, manufacture, and commercialize compounds covered by the patent, specifically 225Ac-PSMA I&T (“FPI-2265”), targeting PSMA-expressing cancers. This development represents a significant stride in the treatment of prostate cancer, promising a new horizon of precision medicine in oncology.

In addition to securing exclusive licensing rights, Fusion Pharmaceuticals and the licensors have reached a resolution concerning a dispute related to an inter partes review (IPR) of a U.S. patent owned by the licensors, highlighting Fusion’s commitment to overcoming regulatory hurdles and advancing its research and development initiatives. Fusion’s President and Chief Business Officer, Mohit Rawat, expressed optimism about the collaboration, emphasizing Fusion’s advantageous position due to its expertise in alpha-emitting radiopharmaceuticals, operational manufacturing capabilities, and a reliable supply of actinium.

The licensing deal is not just a testament to Fusion’s strategic vision but also a leap forward in the fight against prostate cancer. FPI-2265 stands out as the most advanced actinium-based PSMA targeted radiotherapy under development, indicating a promising future for patients battling PSMA-expressing cancers. Fusion’s collaboration with Heidelberg University and Euratom is poised to catalyze advancements in precision medicine, with significant updates expected in 2024, including results from the TATCIST study in April and the initiation of a Phase 2/3 registrational study.

The financial terms of the agreement include an upfront payment of €1.0 million by Fusion to the licensors, along with potential regulatory milestone payments upon approval and low single-digit royalties on future net sales. This investment underscores the potential of FPI-2265 in transforming prostate cancer treatment and Fusion’s role in pioneering radiopharmaceuticals as precision medicines.

As Fusion Pharmaceuticals progresses towards the anticipated clinical milestones, the oncology community watches closely. The alignment with the U.S. Food and Drug Administration on the Phase 2/3 protocol for FPI-2265 heralds a new chapter in the treatment of metastatic castration-resistant prostate cancer (mCRPC), especially for patients who have progressed following treatment with lutetium-based radiopharmaceuticals. With a Phase 2 dose optimization lead-in expected to complete enrollment by the end of 2024 and a Phase 3 registrational trial set to begin in 2025, Fusion is at the forefront of delivering innovative solutions for cancer patients worldwide.

The exclusive licensing agreement between Fusion Pharmaceuticals Inc. and Heidelberg University and Euratom is a monumental step towards revolutionizing prostate cancer treatment. It not only underscores the importance of collaboration between academic institutions and the pharmaceutical industry in advancing medical research but also highlights the potential of radiopharmaceuticals in offering targeted, precision treatments for cancer patients. As Fusion Pharmaceuticals advances through its clinical milestones, the oncology field is poised for significant developments in the treatment of PSMA-expressing cancers. This collaboration exemplifies how strategic partnerships can accelerate the pace of innovation in oncology, bringing hope to patients and potentially setting new standards in cancer therapy.

  Euratom, European Commission, FPI-2265, Fusion Pharmaceuticals, Heidelberg University, Mohit Rawat, Oncology, Prostate cancer