On November 16, 2023 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), and BWXT Medical Ltd., a subsidiary of BWX Technologies, Inc. (NYSE: BWXT), reported that the companies have entered into a new agreement for the supply of generators to produce actinium-225, a medical isotope used to treat cancer in clinical trials (Press release, Fusion Pharmaceuticals, NOV 16, 2023, View Source [SID1234637744]).
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Under the agreement, BWXT Medical will provide Fusion with a preferential supply of radium-225 and access to generator technology, enabling Fusion to produce actinium-225 (actinium-227 free) on site at the Company’s good manufacturing practice (GMP) manufacturing facility. In addition, the Companies have expanded their existing actinium-225 supply agreement, supporting Fusion’s advancing pipeline of targeted alpha therapies.
Actinium-225 is an alpha-emitting isotope used in Fusion’s targeted alpha therapies (TATs) that combine the isotope with specific tumor targeting vectors to kill cancer cells while minimizing the impact to healthy tissues. Radium-225 is the parent isotope that undergoes decay to form actinium-225. BWXT’s proprietary generator technology allows for the on-demand isolation of high purity actinium-225 from the radium supplied from BWXT. Generators, which will be shipped to Fusion’s GMP production facility, have been used successfully to produce other types of medical isotopes because they are simple to use and do not require investment in high-cost cyclotrons and associated infrastructure and staffing needs.
Fusion Chief Executive Officer John Valliant, Ph.D., said, "Since our inception, Fusion has made proactive investments to secure actinium-225 supply, creating a robust and diversified supply chain. Our collaboration with BWXT Medical, an established leader in medical isotope manufacturing and supply with proven ability to produce and deliver high purity actinium, is a critical component of our strategy, and we are excited to expand our relationship. Supply of radium-225 and access to BWXT’s generator technology allows Fusion to be one of the first radiopharmaceutical development companies to have onsite production of actinium-225, providing us superior flexibility in our manufacturing schedules and increased capacity to support our clinical pipeline. The addition of the actinium generator technology to our previously announced partnerships for actinium-225 supply is timely as we prepare to advance into a Phase 3 clinical trial our lead program, FPI-2265, which is positioned to be the first actinium-based radiopharmaceutical for prostate specific membrane antigen (PSMA) to market."
BWXT Medical President and Chief Executive Officer Jonathan Cirtain, Ph. D. said, "We’re proud to be expanding our relationship with Fusion, a leading developer of targeted alpha therapies. Our company’s significant investments in infrastructure and intellectual property are demonstrating results for our customers around the world. BWXT Medical’s innovative actinium-225 generator technology will have significant benefits for both clinical and future commercial supply. We look forward to continuing our respective efforts as Fusion’s clinical programs advance, and BWXT Medical helps meet the increasing global demand for actinium."
In January 2023, Fusion and BWXT Medical announced that the companies entered into a preferred partner agreement for the supply of actinium-225. Under that agreement, BWXT Medical provides predetermined amounts of Fusion’s actinium supply needs at volume-based pricing. The agreement was expanded to include future sources of actinium-225.