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.
Cleveland BioLabs CEO Yakov Kogan said: "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."