Cleveland BioLabs Announces Commencement of In Vivo Biocomparability Study

BUFFALO, NY--(Marketwired - Apr 17, 2017) -  Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced that the U.S. Food and Drug Administration (FDA) has completed its review of a side-by-side analytical comparison of two formulations of entolimod. The FDA agreed with CBLI that these data indicate the in vitro analytical comparability of the formulations. Based on the outcome of its review, the FDA has provided CBLI with its consent for initiation of an in vivo biocomparability study of these formulations in non-human primates (NHP).

The objective of the in vivo biocomparability study is to compare the historical drug formulation used in prior nonclinical and clinical studies versus the to-be-marketed drug formulation of entolimod submitted for approval under CBLI's application for pre-Emergency Use Authorization (pre-EUA). Entolimod is a novel, broad-spectrum investigational drug being developed to mitigate the life-threatening consequences of a radiological or nuclear attack.

"We are excited to have received agreement from the FDA to commence the in vivo biocomparability study," continued Yakov Kogan, PhD, MBA, Chief Executive Officer. "Following completion of the in vivo study and discussion of the submitted study results with the FDA, we expect the agency to resume the review of our pre-EUA dossier."

The planned biocomparability study is funded in part by the Department of Defense (DoD) Joint Warfighter Medical Research Program (JWMRP) contract award number W81XWH-15-C-0101 to CBLI. The DoD JWMRP contract is valued at up to $9.2 million and supports further development of entolimod as a medical radiation countermeasure.

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About Cleveland BioLabs, Inc.
Cleveland BioLabs, Inc. is an innovative biopharmaceutical company developing novel approaches to activate the immune system and address serious medical needs. The company's proprietary platform of Toll-like immune receptor activators has applications in radiation mitigation, immuno-oncology, and vaccines. The company's most advanced product candidate is entolimod, which is being developed as a medical radiation countermeasure for the prevention of death from acute radiation syndrome, an immunotherapy for oncology and other indications. The company conducts business in the United States and in the Russian Federation through a wholly-owned subsidiary, BioLab 612, LLC, and a joint venture with Joint Stock Company RUSNANO, Panacela Labs, Inc. The company maintains strategic relationships with the Cleveland Clinic and Roswell Park Cancer Institute. To learn more about Cleveland BioLabs, Inc., please visit the company's website at http://www.cbiolabs.com.

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