Catalyst Biosciences, Inc., focused on discovering and developing novel biopharmaceutical products based on engineered human proteases, and Isu Abxis, an established biologics manufacturing and development company, 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.

Under the terms of the collaboration, Isu Abxis will use its biologics manufacturing and development expertise to 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 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.

"This strategic collaboration is an excellent fit between our companies. 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., chief executive officer of Catalyst Biosciences. "We believe that the collaboration with Isu Abxis will accelerate FIX-NG's development and ultimately provide improved therapy for hemophilia B patients."

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.

"Isu is pleased to announce this strategic collaboration and expects a successful partnership between our companies. Isu's expertise in drug development has been proven through its three marketed biologics, and our capabilities will clearly facilitate the development of Catalyst's FIX candidate in its first clinical trial in hemophilia B patients," said Seungho Lyu, chief executive officer of Isu Abxis.

Isu Abxis has specialized in the development of biosimilars and therapeutic proteins for difficult-to-treat diseases.

Catalyst Biosciences is developing the next generation of biopharmaceuticals by engineering proteases in the fields of hemostasis and anti-complement.