Cleveland BioLabs Receives Funding Recommendation From Department of Defense for Additional Development Proposal for Entolimod

Cleveland BioLabs, Inc. CBLI today announced that the Company received notice that a second proposal application to support further development of entolimod as a medical radiation countermeasure has been recommended for funding, subject to negotiations, by the Department of Defense (DoD) office of Congressionally Directed Medical Research Programs (CDMRP). This award is subject to successful negotiations and availability of funds. This proposal application aims to conduct an additional clinical study to support submission of a Biological Licensure Application (BLA) to the U.S. Food and Drug (FDA). Entolimod is a novel investigational drug that addresses the Department of Defense concern against radiological threats. Yakov Kogan, Ph.D., Chief Executive Officer for Cleveland BioLabs, stated, "We are grateful for the continued support of the Department of Defense for entolimod's development as a broad spectrum medical readiation countermeasure. We believe entolimod offers a viable solution to protect our military personnel and civilians from the potentially deleterious effects of ionizing radiation and hope to contribute to our nation's preparedness." In January, CBLI announced receipt of notice that a proposal supporting several pivotal animal efficacy studies to support submission of a BLA to the FDA was recommended for funding, subject to negotiations by the DoD office of CDMRP. Negotiations regarding that proposal are ongoing. In September 2014, the Company announced that the minutes from its meeting with the FDA in July confirmed that the Company's existing efficacy and safety data and animal-to-human dose conversion are sufficient to proceed with a pre-Emergency Use Authorization submission for entolimod for reducing the risk of death following exposure to potentially lethal irradiation occurring as the result of a radiation disaster. A pivotal efficacy study conducted in 179 NHPs demonstrated 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 treated animals. These results were obtained without the use of any antibiotics or supportive care. A second, pivotal dose-conversion study conducted in 160 NHPs established the dose-dependent effect of entolimod on biomarkers for efficacy in non-irradiated NHPs. Clinical studies of entolimod in 150 healthy human subjects have demonstrated the safety profile of entolimod and established the dose-dependent effect of entolimod on efficacy biomarkers in humans. In addition, entolimod has been administered to 25 patients with advanced cancer in a Phase 1 study.