Cleveland BioLabs Announces Submission of Pre-EUA Dossier for Entolimod to FDA

Cleveland BioLabs, Inc.

today announced that the company has submitted an application for pre-Emergency Use Authorization (pre-EUA) to the U.S. Food and Drug Administration (FDA) in support of use of entolimod as a medical radiation countermeasure. Entolimod would be indicated for reducing the risk of death following exposure to potentially lethal irradiation occurring as the result of a radiation disaster. Pre-EUA is the regulatory path through which the FDA determines that certain unapproved medical products may be used in an emergency when there are no adequate, approved, and available alternatives. Products with pre-EUA status can be purchased by the US government for stockpiling in the event of a disaster. Achieving pre-EUA status in the United States can also support partnerships and foreign government interest in this program. In July 2014, the Company met with the FDA and confirmed that the entolimod efficacy and safety data and animal-to-human dose conversion are sufficient to proceed with a pre-EUA submission for entolimod. CBLI has now prepared an application under the FDA Animal Rule that demonstrates drug efficacy in animals and safety in humans. A pivotal efficacy study in 179 nonhuman primates showed that a single intramuscular injection of entolimod given 25 hours after high-dose, whole-body irradiation increased survival from 27.5% in control animals to 75% in entolimod-treated animals. Clinical studies of entolimod in 176 human subjects have characterized the safety profile of entolimod and documented dose-dependent effects on the same efficacy biomarkers that were correlated with survival benefit in animals. Yakov Kogan, PhD, MBA, Chief Executive Officer, stated, "We are very pleased to have achieved this significant milestone. We believe that entolimod efficacy and operational feasibility are best in class and that our pre-EUA submission is compelling and aligned with our previous FDA discussions. Our top priority will be to work with the FDA to facilitate their review of our application. There is no Prescription Drug User Fee Act (PDUFA) goal associated with review of a pre-EUA. However, we estimate a 6- to 9-month period for evaluation of our application, depending on the extent of the FDA's comments and questions. We have submitted the dossier electronically with the intent of facilitating the review process. We believe that a positive review of our submission may serve as the basis for the future commercialization of entolimod." In a separate, parallel initiative, CBLI continues negotiations regarding two proposals with the Department of Defense office of Congressionally Directed Medical Research Programs. Awards under these proposals would fund additional studies supportive of future full licensure of entolimod under a Biologics License Application.