Manufacturing Agreement for Radiation-Protection Compound

Cleveland BioLabs, Inc. (CLBI; Cleveland, OH, USA), and SynCo Bio Partners B.V. (Amsterdam, The Netherlands), a leading biopharmaceutical manufacturer, have completed the transfer of technology in their joint effort to produce CBLI's leading radioprotection molecule, under current good manufacturing practices (cGMP) specifications and have signed an agreement to produce sufficient amounts for clinical trials and the commercial market.

Protectan CBLB502, Cleveland BioLabs's major product, demonstrated exceptional effectiveness in a recent study, when it rescued more than 70% of lethally irradiated primates and considerably delayed death for the others.

CBLI's development strategy for CBLB502 complies with recently adopted U.S. Food and Drug Administration (FDA) rules for investigational drugs that address situations, such as radiation injury, where it would be unethical to perform efficacy studies in humans. Whereas phase II and phase III human clinical trials are typically required for the marketing approval of an investigational drug, under the new FDA rule, Protectan CBLB502 would be considered for approval for radiation protection based on phase I safety studies in humans and efficacy studies in relevant primates.

Under the terms of the agreement, SynCo will work with CBLI to develop the manufacturing process based on pilot studies conducted by the company and product CBLB502 under cGMP standards for phase I safety testing in humans and commercial release. The SynCo facility has the capacity to manufacture considerable doses of CBLB502 for potential national stockpiling.

Dr. Michael Fonstein, Cleveland BioLabs's CEO stated, "This is an important milestone for Cleveland BioLabs. We are impressed by SynCo's track record in process development and GMP manufacturing and believe that they are the right manufacturing partner to assist us in the next phases of development. CBLB502's outstanding success as a radioprotectant in mouse and monkey clinical models provides us with confidence that we will have sufficient data to submit an NDA for biodefense applications to the FDA within 24 months.”

SynCo provides a broad range of GMP manufacturing services including bioprocess development, API manufacture for clinical trials and market supply, and aseptic filling and lyophilization. Cleveland BioLabs is a drug discovery and development company utilizing its proprietary discoveries about programmed cell death to treat cancer and protect normal tissues from exposure to radiation and other stresses.



Related Links:
Cleveland BioLabs
SynCo Bio Partners