Catalyst Biosciences has formed a strategic collaboration with South Korean biologics manufacturing and development company Isu Abxis 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 studies.
Per the agreement, Isu Abxis will advance FIX-NG through preclinical and Phase I studies, and Catalyst and Isu will collaborate and share in profits on the development and commercialization of FIX-NG worldwide. Isu will pay Catalyst an up-front licensing fee and milestone payments through the end of the Phase I 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 significant experience in the development of next-generation coagulation factors including FVIIa, FIX, and FXa, while Isu has the biologics manufacturing expertise to make complex proteins from research through commercialization,” said Nassim Usman, Ph.D., Catalyst’s CEO, in a statement. “We believe that the collaboration with Isu Abxis will accelerate FIX-NG’s development and ultimately provide improved therapy for hemophilia B patients.”