(Released 2 September 2015) Buffalo, NY - Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced that the Department of Defense (DoD) office of Congressionally Directed Medical Research Programs (CDMRP) Joint Warfighter Medical Research Program (JWMRP) has awarded CBLI a contract valued at up to $9.2 million to support further development of entolimod as a medical radiation countermeasure. Entolimod is a novel, broad-spectrum investigational drug being developed to mitigate the life-threatening consequences of a radiological attack.
The Company has submitted an application for pre-Emergency Use Authorization (pre-EUA) to the Food and Drug Administration (FDA) in support of use of entolimod as a medical radiation countermeasure. 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 certain US government stakeholders for stockpiling in the event of a disaster.
The DoD contract will fund pivotal animal studies designed to support future submission of a Biologics License Application (BLA) for entolimod for reducing the risk of death following exposure to potentially lethal irradiation occurring as the result of a radiation disaster. BLA approval, if received, would be the final step necessary to reach full marketing authorization.
Yakov Kogan, Ph.D., Chief Executive Officer for Cleveland BioLabs, stated, "We are excited to continue our work to advance development of entolimod towards full licensure. We believe entolimod, if approved, will offer a highly effective solution for protecting our nation's military personnel and civilians from the potentially deadly effects of radiation."
About Cleaveland 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, oncology immunotherapy, and vaccines. The company's most advanced product candidate is entolimod, which is being developed for a biodefense indication and as 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 OJSC 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.