Fusion Pharmaceuticals is a spinout of the Centre for Probe Development and Commercialization (CPDC), a leading radiopharmaceutical research and GMP production centre. CPDC has established an international reputation for innovation and excellence in the discovery, development and GMP manufacturing of radiopharmaceuticals for the diagnosis and treatment of disease. Fusion will leverage the CPDC’s technology and infrastructure to access new inventions and optimize its capital efficiency.
Fusion’s deep radiochemistry expertise presents a technology platform that can be replicated to turn internalizing antibodies that have previously demonstrated limited clinical efficacy into highly effective cytotoxic drugs. Fusion’s ability to link the most effective isotopes to the targeting antibody allows for the creation of optimized agents for both diagnostic imaging and radioimmunotherapy (Precision Medicine). Following positive tumor identification with the imaging agent, treatment with the antibody linked to a therapeutic isotope delivers a cytotoxic payload into the cancer cell.
Fusion’s lead product candidate, FPX-01, is a precision RIT that is a product of this innovative approach. FPX-01 has been designed to internalize into targeted cancer cells and deliver a lethal and highly localized radioactive payload. The precise targeting of this radiolabeled antibody causes selective and extremely effective cytotoxicity of tumor cells at relatively low doses of radioactivity.
The recent marketing launch of Xofigo® (radium-223 dichloride) an alpha emitting agent for the treatment of bone metastases associated with mCRPC, has re-invigorated the radiopharmaceutical space. Xofigo® is administered on an out-patient basis in oncology suites overcoming an adoption problem faced with earlier radiopharmaceutical products. Xofigo® is forecast as the first blockbuster radiopharmaceutical with peak annual sales projected in excess of $1.5B.
Fusion believes that FPX-01 will benefit from this positive market environment and defined regulatory pathway and, as FPX-01 has the capacity to treat a broader range of hard-to-treat cancers than Xofigo®, it also has the potential to achieve significant commercial success.