Catalyst Biosciences, Inc., a clinical-stage biopharmaceutical company, focuses on engineering proteases as therapeutics for hemophilia, hemeostasis, complement-mediated diseases, and other unmet medical needs. Its product pipeline includes CB 813d, a Factor VIIa drug candidate that completed a Phase I clinical trials evaluating safety and tolerability, as well as pharmacokinetics, pharmacodynamics, and coagulation activity in severe hemophilia A and B patients with and without inhibitors. The company's preclinical development stage drugs comprise CB 2679d/ISU 304, a next-generation Factor IX drug for the treatment of patients with hemophilia B; and a Factor Xa variant. It is also developing CB 2782, an anti-C3 inflammation development candidate for the treatment of delayed graft function in kidney transplants; and an ophthalmic anti-C3 candidate for treatment of dry age-related macular degeneration. The company has collaboration agreement with Pfizer, Inc. for the development of human Factor VIIa products; and ISU Abxis for development and manufacturing of the Factor IX products through Phase I/II clinical trials. Catalyst Biosciences, Inc. is headquartered in South San Francisco, California.
CB 2679d/ISU304, a highly potent next-generation coagulation Factor IX variant, has demonstrated the potential to normalize human Factor IX levels with a daily subcutaneous injection in preclinical studies. Catalyst’s collaborator, ISU Abxis (KOSDAQ:086890), plans to initiate a Phase 1/2 proof-of-concept study with single and multiple subcutaneous injections in individuals with severe hemophilia B in the second quarter of 2017. “We are very pleased with the progress we and our collaborator ISU Abxis have made in advancing this Factor IX candidate towards the clinic and we look forward to the initiation of a Phase 1/2 clinical trial next quarter,” said Nassim Usman, Ph.D., President and Chief Executive Officer of Catalyst. “We believe that stopping bleeding is good, but preventing bleeding is better. CB 2679d/ISU304 has the properties required, including high potency, to allow for daily subcutaneous injection with the potential to achieve stable and normal Factor IX clotting levels.” Catalyst has a collaboration with ISU Abxis to advance the development of CB 2679d/ISU304 through a Phase 1/2 proof-of-concept study in individuals with severe hemophilia B. After Phase 1/2, ISU Abxis has an option for exclusive commercial rights in South Korea and a profit share on ex-South Korean commercialization. Catalyst retains full development and commercial rights for CB 2679d/ISU304 outside of South Korea.
The candidate has the potential advantage of becoming the first FDA-approved drug for Hemophilia B patients as a prophylactic subcutaneous injection. Further, if the candidate succeeds, the candidate has a clear advantage over existing therapies like Bioverativ's ECLOCTATE and APROLIX treatments. Both these are given as intravenous injections and hence require expert assistance.
