Humanetics Corporation has been awarded an additional $5 million from the Department of Defense (DOD) to advance the development of BIO 300, a drug designed to prevent radiation injury. This funding supplements an existing Other Transaction Authority (OTA) agreement received in Fall 2023 and aims to accelerate BIO 300 towards a New Drug Application (NDA) submission with a pre-approval for emergency use authorization (pre-EUA). The goal is to provide early access to the drug in the event of a radiological/nuclear emergency before full approval is granted.
Addressing Acute Radiation Syndrome
Exposure to radiation, whether accidental or intentional, can lead to acute radiation syndrome (ARS), a condition characterized by severe and life-threatening injuries. Currently, there is an unmet need for improved standards of care for ARS, specifically with a U.S. Food and Drug Administration (FDA)-approved medical countermeasure (MCM) that can be administered prior to radiation exposure. Given the ongoing global health concerns related to nuclear accidents, potential terrorism, and the use of nuclear weapons, the development of effective radioprotectants like BIO 300 is a high priority.
A prophylactic radioprotectant such as BIO 300 would be a valuable asset in emergency situations, offering protection to a range of individuals, including military personnel, first responders, and civilians facing radiological emergencies.
Strengthening Manufacturing and Clinical Development
The additional funding will be allocated to enhance manufacturing activities for both the BIO 300 drug substance and the final drug product. These activities are intended to bolster manufacturing capabilities, which are currently based within the United States. Furthermore, the funding will support clinical and nonclinical studies of BIO 300, with the data collected from these studies aimed at expediting the drug's development and eventual 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 initially 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, while the Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical) will oversee BIO 300’s development, including the utilization of the new funding.
