Sep 7, 2023   SOURCE: BusinessWire

Humanetics Corporation Awarded Contract From Department of Defense to Develop First FDA Approved Drug to Prevent Radiation Injury

Humanetics Corporation (Humanetics) announced today that it was awarded a 5-year contract from the Department of Defense (DOD) to develop its drug, BIO 300, as a medical countermeasure to prevent bodily harm caused by acute exposure to radiation. The contract is in the form of an Other Transaction Authority (OTA) for Prototype Agreement. It includes a base period of $20 million for activities required to gain U.S. Food and Drug Administration (FDA) Emergency Use Authorization for the use of BIO 300 under a potential military emergency. In addition, the OTA agreement provides options for the DOD to fund all activities required to bring BIO 300 to full FDA approval.

The world is facing unprecedented challenges, ranging from nuclear accidents to potential acts of terrorism or the use of nuclear weapons, making the need for effective radioprotectants like BIO 300 an urgent priority. Exposure to radiation from accidental or intentional sources can lead to acute radiation syndrome (ARS), which consists of numerous serious and life-threatening injuries. Currently, there are no FDA-approved drugs that can prevent ARS when administered prior to radiation exposure. The only available options are for treatment of the hematopoietic syndrome of ARS with certain therapeutics, all of which must be administered as soon as possible after exposure by subcutaneous injection. A significant limitation of these drugs is the requirement for special cold storage, which makes their use challenging in austere military settings.

"We are tremendously honored to collaborate with the DOD to provide this important capability,” said Ronald J. Zenk, Chief Executive Officer at Humanetics. “Given the current geopolitical climate, the need for prophylactic prevention of acute radiation injury is more urgent than ever for our military, first responders, and at-risk civilian populations around the globe.”

The radioprotective effects of BIO 300 were discovered by researchers at the DOD and the National Institutes of Health. This congressionally funded agreement will be executed by the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense’s (JPEO-CBRND) Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical). The JPEO-CBRND will manage the OTA agreement, overseeing the development of BIO 300, exclusively licensed to Humanetics for advanced development and FDA licensing. BIO 300 is also in clinical development for oncology applications to protect cancer patients from unintentional side effects caused by radiation therapy. Humanetics recently completed a phase 1b/2a clinical trial in lung cancer patients (NCT02567799). In addition, a phase 2b trial is currently in progress evaluating BIO 300 to protect lung tissues against the long-term effects of COVID-19 (NCT04482595).

“It is exciting to take something that showed promise with its initial research, and then license it to a third party such as Humanetics, who is equally excited to work toward FDA approval of this potential new tool as a radioprotectant,” said COL Matthew Clark, Joint Project Manager for CBRN Medical. “We look forward to collaborating with Humanetics on this effort.”

The views expressed herein are those of Humanetics Corporation and do not reflect the official policy or position of the U.S. Department of the Army, U.S. Department of Defense, or the U.S. government.

About Humanetics Corporation

Humanetics is a clinical-stage specialty pharmaceutical company engaged in the accelerated discovery, development, and commercialization of proprietary drugs in markets with urgent and unmet needs, with a focus on medical countermeasures to prevent harm caused by exposure to radiation, for protective use in cancer radiation therapy, and to guard against the long-term damaging effects of COVID-19. For more information, visit humaneticscorp.com.