CLEVELAND, Ohio, October 26 /PRNewswire/ -- Cleveland BioLabs, Inc. , and SynCo Bio Partners B.V., a leading biopharmaceutical manufacturer, today announced that they have completed the transfer of technology in their joint effort to produce CBLI’s lead product, Protectan CBLB502, under cGMP specifications and have signed an agreement to produce sufficient amounts for clinical trials and the commercial market.
Protectan CBLB502, Cleveland BioLabs’s leading radioprotection molecule, demonstrated outstanding efficacy in a recent study, when it rescued more than 70% of lethally irradiated primates and substantially delayed death for the others.
CBLI’s development strategy for CBLB502 complies with recently adopted FDA rules for investigational drugs that address situations, such as radiation injury, where it would be unethical to conduct efficacy studies in humans. While Phase II and Phase III human clinical trials are normally 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 done by the Company and manufacture CBLB502 under cGMP standards for Phase I safety testing in humans and commercial release. The SynCo facility has the capacity to produce significant 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.”
Mr. Pierre Warffemius, CEO of SynCo commented, “We are extremely pleased to be working with Cleveland BioLabs on this important clinical program. This is an exciting product and we look forward to supporting CBLI through their Phase I clinical trial and market approval process. SynCo produces a number of products for clinical trials and the commercial market and this agreement further strengthens SynCo’s position as one of the premier contract manufacturers in the world.”
About SynCo Bio Partners B.V.
SynCo Bio Partners B.V. is licensed by the Dutch authorities for the production of clinical and market supply of biopharmaceuticals. As one of the leading biopharmaceutical manufacturing organizations in Europe, SynCo offers a broad range of GMP manufacturing services including bioprocess development, API manufacture for clinical trials and market supply, and aseptic filling and lyophilization. SynCo’s customers range from major international pharmaceutical companies to smaller biotech start-ups and current activities include early phase process development and production for clinical trials, as well as long term market supply agreements. For further information please visit the company’s website at www.syncobio.com.
About Cleveland BioLabs, Inc.
Cleveland BioLabs, Inc. is a drug discovery and development company leveraging its proprietary discoveries about programmed cell death to treat cancer and protect normal tissues from exposure to radiation and other stresses. The Company has strategic partnerships with the Cleveland Clinic Foundation, ChemBridge Corporation and the Armed Forces Research Radiobiology Institute. To learn more about Cleveland BioLabs Inc., please visit the company’s website at http://www.cbiolabs.com.
This press release contains forward-looking statements that reflect our current view with respect to various aspects of the events described above. Actual results could be significantly different. Factors that could affect results include those set forth in filings made by Cleveland BioLabs, Inc. with the Securities and Exchange Commission. These factors include, but are not limited to, those discussed in our Registration Statement on Form SB-2 under the caption “Risk Factors.”
SynCo Bio Partners B.V.
CONTACT: Contacts: Cleveland BioLabs, Inc., Yakov Kogan, T:+1-(216)-229-2251 x115, E: ykogan@cbiolabs.com. SynCo BioPartners B.V.,Andrew Lewin, T: +31-61000-3675, E: andrew_lewin@synco-biopartners.com. TheGlobal Consulting Group, Rachel Levine, T: +1-(646)-284-9439, E:rlevine@hfgcg.com
