Fusion Pharma's Global License for Actinium-based PSMA Therapy

Fusion Pharmaceuticals Inc., a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, announced that it has entered into an exclusive worldwide license agreement with Heidelberg University and Euratom represented by the European Commission, Joint Research Centre (together, the andLicensorsand). 

The license agreement grants Fusion exclusive worldwide rights to utilize, develop, manufacture, and commercialize compounds covered by the patent, including 225Ac-PSMA IandT (FPI-226) for treating prostate-specific membrane antigen (PSMA)-expressing cancers. In addition, Fusion and the Licensors have signed an agreement to settle the parties dispute related to an inter partes review (IPR) of a U.S. patent owned by the Licensors, which was instituted in August 2023 by the United States Patent and Trademark Board.

Fusion president and chief business officer Mohit Rawat said We are pleased to enter into this exclusive license agreement with Heidelberg University and Euratom for their existing patent as we progress FPI-2265, the most advanced actinium-based PSMA targeted radiotherapy currently in development. We are well-positioned to execute this program with Fusion's expertise in developing and manufacturing alpha-emitting radiopharmaceuticals, an operational radiopharmaceutical manufacturing facility, and our advantageous actinium supply. We expect to provide an update as we reach the projected levels in 2024, including data from the TATCIST study in April and the start of the Phase 2/3 registration study in the second quarter.

It was announced in January 2024 by Fusion and the U.S. The Food and Drug Administration (FDA) has approved Fusionand's Phase 2/3 trial for FPI-2265 in patients with mCRPC that has progressed after treatment with lutetium-based radiopharmaceuticals. The revised development plan includes introducing a Phase 2 dose optimization trial, with registration expected to be completed by the end of 2024, and a Phase 3 registration trial to begin in 2025.

Under the terms of the license agreement, Fusion will pay licensors an upfront fee of 1 million euros plus certain legal awards based on the contract and a minimum one-time payment for future net sales of the product. Fusion Pharmaceuticals is a clinical oncology company focused on developing precision radiation medicine and combining different stimulatory molecules to deliver alpha-emitting payloads to tumors.