Fusion Pharmaceuticals, clinical-stage oncology company that develops radiopharmaceuticals as precision medicines, has announced a 15-year lease agreement with Hamilton, Ontario-based McMaster University, to build a 27,000 square foot Good Manufacturing Practice (GMP) compliant radiopharmaceutical manufacturing facility.
The facility, to be built by McMaster and equipped and validated by Fusion, will support manufacturing of targeted alpha therapies (TATs). Fusion expects the manufacturing facility will be operational by early 2024.
“Manufacturing and supply chain are critical components of radiopharmaceutical development and commercialisation, and with Fusion’s expertise we believe we are well-positioned to create a facility to scale production in support of our growing pipeline and development collaborations,” Fusion CEO John Valliant said.
“We will continue to prioritise manufacturing and supply chain infrastructure in our long-term plans and this facility is an important milestone in executing those plans.
“The location of the facility, adjacent to our internal research organisation and a world-class university that specialises in medical isotope research and training, enables us to efficiently advance new TATs and hire top tier talent to support our leading portfolio of radiopharmaceuticals,” he said.
Fusion has also entered into a services agreement with long-time partner, the Centre for Probe Development and Commercialisation (CPDC), to provide services relating to certain aspects of the validation of this new manufacturing facility.
Employing a proprietary Fast-Clear linker technology, Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumours.
Fusion’s lead program, FPI-1434 targeting insulin-like growth factor 1 receptor, is currently in a Phase 1 clinical trial. The pipeline includes FPI-1966 targeting the fibroblast growth factor receptor 3 (FGFR3) and FPI-2059, a small molecule recently acquired from Ipsen, targeting neurotensin receptor 1 (NTSR1).
In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to develop up to three novel targeted alpha therapies (TATs) and explore up to five combination programs between Fusion’s TATs and AstraZeneca’s DNA Damage Repair Inhibitors (DDRis) and immuno-oncology agents.