Biotech Values

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CBLI Update -

Cleveland BioLabs Provides Update on pre-EUA Review of Entolimod as Radiation Countermeasure

Buffalo, NY – March 16, 2016 – Cleveland BioLabs, Inc. (NASDAQ:CBLI) today announced an update on the regulatory review of its pre-Emergency Use Authorization (pre-EUA) submission for entolimod as a radiation countermeasure following the receipt of minutes from a recent meeting with the U.S. Food and Drug Administration (FDA).

As part of the company’s response to pre-EUA review comments received from the FDA, a meeting was held with the Agency to discuss various aspects of entolimod manufacturing. At this meeting, and subsequently confirmed by the FDA’s official minutes of the meeting, it was determined that an in vivo study will be necessary to establish bio-comparability between the entolimod drug formulation proposed for use under the pre-EUA and the drug formulation used in previously conducted preclinical and clinical studies. The FDA indicated that further review of the pre EUA dossier would not proceed until these bio-comparability data have been evaluated by the Agency. The design of the bio-comparability study is currently in development and will need to be agreed upon with the FDA before the study is executed.

Yakov Kogan, PhD, MBA, Chief Executive Officer of Cleveland BioLabs, commented, “While this FDA request has temporarily slowed our progress, we remain fully committed to the pursuit of pre EUA status and commercialization for entolimod. We will provide further updates regarding the estimated timing for performance and reporting of the study once the design is finalized. Our goals are to satisfy the FDA’s request and facilitate continued regulatory review of the pre-EUA dossier for entolimod as soon as possible.”