BWXT Medical Ltd. and Fusion Pharmaceuticals Inc. (Nasdaq: FUSN) today announced that the companies have entered into an agreement for the supply of generators to produce actinium-225, a medical isotope used to treat cancer in clinical trials.
Under the agreement, BWXT Medical (a subsidiary of BWX Technologies, Inc. (NYSE: BWXT)), will provide Fusion with a preferential supply of radium-225 and access to high-specific activity generator technology (actinium-227-free), enabling Fusion to produce actinium-225 at its Good Manufacturing Practice (GMP) manufacturing facility for the benefit of its clinical trials. 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 by BWXT Medical.
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.”
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 contractual relationship 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 high-specific activity actinium-225, providing us superior flexibility in our manufacturing schedules and increased capacity to support our clinical pipeline. This readiness is critical as we prepare to advance our lead program, FPI-2265, which is positioned to be the first actinium-based radiopharmaceutical for prostate specific membrane antigen (PSMA) to market, into a Phase 3 clinical trial.”
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 has been providing predetermined amounts of Fusion's actinium supply needs at volume-based pricing.
Forward Looking Statements
BWX Technologies, Inc. (“BWXT”) cautions that this release contains forward-looking statements, including statements relating to expectations for the development, production, performance, demand, timing and impact of Ac-225, Ac-225 generators and Ra-225. These forward-looking statements involve a number of risks and uncertainties, including, among other things, changes in market demand, delays in the development and automation of our production, regulatory approvals and potential supply chain issues. If one or more of these or other risks materialize, actual results may vary materially from those expressed. For a more complete discussion of these and other risk factors, please see BWXT’s annual report on Form 10-K for the year ended December 31, 2022 and subsequent quarterly reports on Form 10-Q filed with the Securities and Exchange Commission. BWXT cautions not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and undertakes no obligation to update or revise any forward-looking statement, except to the extent required by applicable law.
About BWXT Medical
BWXT Medical Ltd. manufactures custom radiopharmaceuticals, radiotherapies and medical isotopes in an 80,000-square-foot cGMP manufacturing facility in Ottawa and at the state-of-the-art commercial cyclotron facility within TRIUMF, Canada’s particle acceleration centre. BWXT Medical Ltd. is a subsidiary of BWX Technologies, Inc. (NYSE: BWXT). BWXT is a manufacturing and engineering innovator that provides safe and effective nuclear solutions for global security, clean energy, environmental restoration, nuclear medicine and space exploration. Follow us on X at @BWXT and learn more at www.bwxt.com.
About Fusion
Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion leases a current Good Manufacturing Practice (GMP) compliant radiopharmaceutical manufacturing facility designed to support manufacturing of the Company's growing pipeline of TATs on the McMaster University campus in Hamilton, Ontario. To support Fusion’s growing pipeline of TATs, the Company has signed strategic actinium supply agreements with TRIUMF, Niowave, Inc. and BWXT Medical.
