Catalyst Biosciences, a producer of novel biopharmaceutical products based on engineered human proteases, and Isu Abxis, a biologics manufacturing and development company based in Korea, have formed a strategic collaboration to develop Catalyst's next-generation Factor IX development candidate FIX-NG (CB 2679d) for the prevention and treatment of bleeding in hemophilia B patients. The collaboration will advance FIX-NG through IND-enabling preclinical studies, manufacturing and the completion of phase I clinical studies designed to establish proof-of-mechanism for the molecule in hemophilia B patients.
Isu Abxis will use its biologics manufacturing and development experience to advance FIX-NG through preclinical and phase I studies and both companies will collaborate and share in profits on the development and commercialization of FIX-NG worldwide. Isu will pay Catalyst an upfront licensing fee and milestone payments through the end of the phase I clinical trial and holds an option to exclusively commercialize FIX-NG in Korea. Catalyst retains development and commercial ownership rights of the program outside of Korea.
Catalyst has built a hemostasis franchise consisting of next generation FVIIa, FIX and FXa coagulation factors. The most advanced of these improved second-generation variants is CB 813d (PF-05280602), a potent and long-acting FVIIa that is in phase I clinical development in hemophilia patients in collaboration with Pfizer. Catalyst's FIX-NG has demonstrated greater potency and longer duration of effect compared with published data for BeneFIX and competing second-generation FIX molecules in hemophilia B animal bleeding models.