Catalyst Biosciences announced they have entered into a manufacturing agreement with AGC Biologics for the process transfer and commercial scale cGMP manufacturing of CB 2679d, Catalyst’s next-generation coagulation Factor IX (FIX) variant being developed for the treatment of severe hemophilia B.
“AGC Biologics is a world-renowned company with deep expertise in recombinant biologics manufacturing and has successfully worked with Catalyst on our commercial scale FVIIa marzeptacog alfa program,” said Andrew Hetherington, senior vice president of technical operations at Catalyst. “We are confident that their manufacturing expertise will allow us to continue our development and advancement of CB 2679d through the clinic in a timely manner. We plan to initiate a Phase 2b study of CB 2679d in individuals with severe hemophilia B in the third quarter of 2018.”
AGC Biologics was formed from a merger of Asahi Glass Company (AGC) Bioscience, Biomeva GmbH and CMC Biologics. Catalyst had previously entered into a manufacturing agreement with CMC Biologics for its next-generation Factor VIIa product marzeptacog alfa (activated) in May 2016, making this the second manufacturing agreement Catalyst has with the company.
CB 2679d is designed as a best-in-class high potency recombinant Factor IX product. Phase 1/2 results from a study of CB 2679d in individuals with severe hemophilia B demonstrated that CB 2679d may provide a subcutaneous prophylactic treatment by achieving high-mild hemophilia activity levels in blood. CB 2679d was awarded orphan drug designations by the European Commission in June 2017 and by the U.S. Food and Drug Administration (FDA) in September 2017.