Chemomab Therapeutics, Ltd. a clinical-stage biotech company focused on the discovery and development of innovative therapeutics for fibrosis-related diseases with high unmet need, and AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), announced an expanded partnership to manufacture CM-101, a Phase II investigational drug targeting Primary Sclerosing Cholangitis, Systemic Sclerosis, and Liver Fibrosis MoA (NASH). Under terms of the agreement, the companies will work together to optimize, upscale and lock the CM-101 manufacturing process towards its testing in pivotal studies while AGC Biologics will manufacture the clinical trial materials at its site in Copenhagen, to support phase II/III clinical testing and launch readiness.
“AGC is a high-quality partner with global manufacturing expertise, and we are pleased to extend our long-standing relationship as we continue to progress in our clinical development,” said Adi Mor, Chief Executive Officer. “CM-101 has tremendous potential in treating fibrosis and inflammation, and we are excited to continue to scale up our manufacturing capacity ahead of our Phase 3 registration-enabling trials.”
Mark Womack, Chief Business Officer at AGC Biologics added, “We are very pleased that Chemomab has entrusted us to manufacture CM-101, following successful delivery of the early phase supply. Our Copenhagen site has the proven experience and expertise to help Chemomab in its journey towards market supply of this important therapy.”
“The Copenhagen team is excited to help advance the manufacturing process for CM-101 to the next phase, and is looking forward to a close collaboration with the Chemomab team,” says AGC Biologics General Manager, Copenhagen, Andrea C. Porchia.
AGC Biologics’ Copenhagen facility has over 20 years’ experience delivering a wide range of mammalian and microbial programs, including several commercially approved products. The news comes less than seven months after the announcement of a €160M expansion project that would double the production capacity in Denmark to address increasing market demand.