Cleveland BioLabs, Inc. (NASDAQ:CBLI) today announced that the Department of Defense (DoD) has modified its Joint Warfighter Medical Research Program (JWMRP) contract award number W81XWH-15-C-0101 with CBLI valued at up to $9.2 million which supports further development of entolimod as a medical radiation countermeasure.
The modification changes the original statement of work of the contract by eliminating certain tasks no longer deemed critical for the preparation of a Biologics License Application (BLA) of entolimod as a radiation countermeasure and establishes new tasks to address questions raised by the Food and Drug Administration (FDA) including an aim to conduct a pharmacokinetic/pharmacodynamic (PK/PD) biocomparability study in a nonhuman primate (NHP) model (the Biocomparability Study) along with other drug manufacturing related activities.
The objective of the Biocomparability Study is to compare the historical drug formulation used in prior pre-clinical and clinical studies versus the to-be-marketed drug product lots of entolimod submitted for approval under CBLI’s application for pre-Emergency Use Authorization (pre-EUA). Entolimod is a novel, broad-spectrum investigational drug being developed to mitigate the life-threatening consequences of a radiological attack.
Because this contract modification involves replacement of certain tasks that cost in excess of tasks being eliminated, the aggregate amount of consideration payable to CBLI by the DoD will be unaffected.
Yakov Kogan, Ph.D., Chief Executive Officer for Cleveland BioLabs, stated, ” We are pleased that the DoD program management office remains engaged and flexible to make this critical and value-added contract modification.”
Disclaimer.
The mention of any specific companies, commercial products, processes, or services by trade name, trademark, manufacturer, or otherwise does not necessarily constitute or imply its endorsement, recommendation, or favoring by the United States Government. The views expressed in this press release are those of the authors and may not reflect the official policy or position of the Department of the Army, Department of Defense, or the U.S. Government.
About Cleveland 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
