Fusion Pharmaceuticals provides manufacturing update
by CM Staff
Fusion reported on Jan. 4 that it has completed validation of its good manufacturing practice (GMP) manufacturing facility and produced the first clinical dose of a TAT.
HAMILTON and BOSTON — Fusion Pharmaceuticals Inc., a clinical-stage oncology company focused on developing radiopharmaceuticals as precision medicines, announced progress with its FPI-2265 development program, an update on FPI-1434 Phase 1 Cohort 2 data and the production of the first clinical doses at the Company’s proprietary manufacturing facility.
“We begin 2024 with strong momentum, given a potential registration-enabling path for FPI-2265, encouraging results in our FPI-1434 program, including first signs of antitumor activity, and a fully operational TAT manufacturing facility that has already begun to produce clinical doses for our actinium-based PSMA lead program,” said Chief Executive Officer John Valliant, Ph.D.
“We achieved alignment with the U.S. Food and Drug Administration (FDA) on a protocol and development plan for FPI-2265, providing our team with a potential path to registration and positioning FPI-2265 to be the first actinium-based PSMA targeting radioligand therapy to market, if approved. Given the significant and growing market for PLUVICTO™, we believe that FPI-2265 will address an important unmet need for patients who progress on or after lutetium-based therapy.”
Fusion reported on Jan. 4 that it has completed validation of its good manufacturing practice (GMP) manufacturing facility and produced the first clinical dose of a TAT.
Dr. Valliant continued, “The initiation of production at our own facility, and the diversification afforded by our external partnerships, positions us for execution on our multiple clinical programs. We built Fusion on a foundation of end-to-end manufacturing expertise, including experience with global radiopharmaceutical logistics and distribution. We also now have one of the first in-house TAT manufacturing facilities with access to a generator technology that allows for convenient onsite production of actinium-225, providing us with additional capacity and flexibility in our manufacturing programs.”
Fusion’s facility, which has clinical and commercial scale manufacturing capabilities, is designed to support the Company’s growing pipeline of TATs and expected to be capable of producing up to 100,000 doses per year. Doses produced out of Fusion’s manufacturing facility are expected to support FPI-2265 manufacturing and are expected to be expanded to include Fusion’s other proprietary and partnered programs.
