MINNEAPOLIS--(BUSINESS WIRE)--Humanetics Corporation (Humanetics) announced today that it was awarded an additional $5 million from the Department of Defense (DOD) to be added to its Other Transaction Authority (OTA) for Prototype Agreement that was received in Fall 2023. The Company aims to develop its drug, BIO 300, as a medical countermeasure to reduce bodily harm caused by acute exposure to radiation. The Company is advancing BIO 300 toward a New Drug Application (NDA) submission with pre-approval for emergency use authorization (pre-EUA) application as an early access point in the event a radiological/nuclear emergency occurs prior to full approval.
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 is a need to improve the standard of care for ARS with a U.S. Food and Drug Administration (FDA)-approved MCM that can be administered prior to radiation exposure. Radiation exposure remains a global health concern, especially with the unprecedented challenges the world is facing. These range from nuclear accidents to potential acts of terrorism or the use of nuclear weapons, all making the need for effective radioprotectants like BIO 300 an urgent priority. A prophylactic radioprotectant such as BIO 300 would be a valuable asset in emergency situations, supporting a range of individuals including the military, first responders, and civilians faced with a radiological emergency.
This crucial additional funding will be used to accomplish additional manufacturing activities for both the BIO 300 drug substance and BIO 300 drug product. These activities will strengthen manufacturing capabilities, which are currently all within the United States. Second, the funding will support clinical and nonclinical studies of BIO 300. Data collected from these studies will accelerate BIO 300’s development toward FDA approval.
“Our team is committed to developing safe and reliable solutions for those at increasing risk of radiation exposure, and we are thankful to receive this additional funding to advance our work,” said Ronald J. Zenk, Chief Executive Officer at Humanetics. “This support is not only a testament to the potential of BIO 300 as a prophylactic radioprotectant but also a vital step toward making this protective option widely available.”
The radioprotective effects of BIO 300 were discovered by researchers at the DOD and the National Institutes of Health and subsequently exclusively licensed to Humanetics for advanced development and FDA licensing. The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) is managing the Company’s OTA contract and the Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical) will continue to oversee BIO 300’s development, including the utilization of the additional funding.
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 Corporation is a clinical-stage 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, radiation modulators for oncology and inflammatory lung diseases. For more information, visit www.humaneticscorp.com.
Contacts
Michael Kaytor
VP – Research and Development
mkaytor@humaneticscorp.com
