Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced the opening of its state-of-the-art radiopharmaceutical manufacturing facility. The 27,000 square foot good manufacturing practice (GMP) compliant facility, which is located adjacent to the Company's research and development labs, has clinical and commercial manufacturing scale capabilities designed to support the Company's growing pipeline of targeted alpha therapies (TATs).
"Manufacturing and supply chain are critical components of radiopharmaceutical development and commercialization. Having spun out of a radiopharmaceutical manufacturer, this is a core competency for Fusion, and we believe we are well-positioned to scale production in support of our pipeline of TATs, which now includes five clinical-stage programs," said Fusion Chief Executive Officer John Valliant, Ph.D. "The location of the facility, adjacent to both our internal research organization and McMaster University, a world-class institution that specializes in medical isotope research and training, enables us to efficiently advance new TATs and hire experienced talent to execute on our clinical and future commercial plans."
The new manufacturing facility, part of a 15-year lease agreement with Hamilton, Ontario-based McMaster University, was built by McMaster and equipped and validated by Fusion. At full capacity, it is expected to produce more than 100,000 doses of TATs per year.
Fusion Pharmaceuticals is a spin out company of the Centre for Probe Development and Commercialization (CPDC) hosted at McMaster and founded by Dr. Valliant, who is also a McMaster chemistry professor.
"McMaster University is a pioneer in medical isotope research and the McMaster Innovation Park is the ideal location to produce the next generation radiopharmaceuticals for cancer therapy," said David Farrar, president of McMaster University. "We're proud to expand on our partnership with Fusion –– and to grow our region's biotechnology and biomanufacturing sector."
To ensure scalability and redundancy, Fusion plans to continue to leverage existing contract development and manufacturing organization (CDMO) relationships with Cardinal Health, SpectronRx, Radiomedix and AtomVie.
"With the complexity of just-in-time manufacturing for radiopharmaceuticals, diversification in supply chain and redundancy in production is vital to ensuring reliable patient access to therapy," said Fusion Chief Technology Officer Eric Burak, Ph.D. "Coupled with our previous investments in actinium supply, this new facility provides further control for our entire supply chain to meet the growing patient demand for targeted alpha therapies."
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 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 trial; FPI-1966, targeting the fibroblast growth factor receptor 3 (FGFR3), currently in a Phase 1 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 recently received IND clearance for 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. To support Fusion's growing pipeline of TATs, the company has signed strategic actinium supply agreements with TRIUMF, Niowave, Inc. and BWXT Medical.