Fusion Pharmaceuticals Strengthens Actinium Supply with Onsite Isotope Production through Expanded BWXT Medical Collaboration
HAMILTON, ON and BOSTON, Nov. 16, 2023 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), and BWXT Medical Ltd., a subsidiary of BWX Technologies, Inc. (NYSE: BWXT), today announced 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.
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.
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's clinical portfolio includes: FPI-2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 clinical trial; and FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial. In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop novel targeted alpha therapies (TATs) and combination programs between Fusion's TATs and AstraZeneca's DNA Damage Response Inhibitors (DDRis) and immuno-oncology agents. The Company received IND clearance for FPI-2068, the first novel TAT under the collaboration, which targets EGFR-cMET. Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck's KEYTRUDA® (pembrolizumab) in patients with solid tumors expressing IGF-1R. 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.
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 Fortune 1000 and Defense News Top 100 manufacturing and engineering innovator that provides safe and effective nuclear solutions for global security, clean energy, environmental remediation, nuclear medicine and space exploration. Follow us on Twitter at @BWXT and learn more at www.bwxt.com.
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