Cleveland Biolabs Inc., was recently awarded a $9,226,455 cost-plus-fixed-fee multi-year contract for advanced research into mitigating and treating the effects of ionizing radiation.
The Department of Defense (DoD) office of Congressionally Directed Medical Research Programs (CDMRP) Joint Warfighter Medical Research Program (JWMRP) contract supports further development of entolimod, a novel, broad-spectrum investigational drug being developed to mitigate the life-threatening consequences of a radiological attack.
Cleveland Biolabs has submitted an application for pre-Emergency Use Authorization (pre-EUA) to the Food and Drug Administration in support of use of entolimod as a medical radiation countermeasure.
The DoD contract will fund pivotal animal studies designed to support future submission of a Biologics License Application (BLA) 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.
“We are excited to continue our work to advance development of entolimod towards full licensure,” said Yakov Kogan, Ph.D., Chief Executive Officer for Cleveland BioLabs. “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.”
Work will be performed in Buffalo, New York; Bethesda, Maryland; and in Canada, with an estimated completion date of Nov. 30, 2017.
The government solicited bids for the effort and 45 were received. Fiscal 2014 research, development, testing and evaluation funds in the amount of $9,226,455 were obligated at the time of the award.
Sources: Defense.gov, Cleveland Biolabs