Valion Bio (NASDAQ: VBIO) has announced that the Armed Forces Radiobiology Research Institute (AFRRI), under its contract with the National Institute of Allergy and Infectious Diseases, is conducting a U.S. Department of War government-funded program evaluating Entolimod for radiation-induced gastrointestinal (GI) injury.
Valion expects the program to advance through a safety study this week and, upon its successful completion, a therapeutic study in rapid sequence. The therapeutic study will evaluate whether Entolimod, administered after radiation exposure, can support survival and GI tissue recovery following lethal doses of ionizing radiation. Top-line therapeutic data are anticipated in early fall.
In a statement, Michael K. Handley, CEO of Valion, commented, “We have completed the operational milestones needed to keep the program on schedule: Entolimod is at AFRRI, animals are being acclimated, and IACUC approval is in hand. Entolimod has generated an extensive safety database across thousands of animals in more than 40 studies, including non-human primates, and in 300 human subjects. It was developed in accordance with the FDA’s Animal Rule and remains under an open Investigational New Drug application with the FDA. That history gives us confidence as AFRRI prepares to initiate the safety study in this new mouse strain.”
Mr. Handley continued, “AFRRI’s plan to conduct these studies in rapid sequence underscores the importance and urgency we believe the government places on advancing medical countermeasures for lethal radiation injury. The therapeutic study is designed to isolate Entolimod’s GI-specific effect in a challenging model using lethal doses of ionizing radiation while preserving bone marrow.”
“To our knowledge, no drug has previously demonstrated efficacy in this model. A positive result could therefore represent an important first for a U.S. government-tested radiation countermeasure. Evaluating Entolimod across multiple radiation scenarios reflects the potential breadth of this program. We look forward to reporting progress and sharing top-line therapeutic data when available,” Mr. Handley added.
Radiation-induced GI injury is a major potential cause of mortality following high-dose radiation exposure and remains a key focus of U.S. medical-countermeasure development. Successful development could support Entolimod’s potential role in government preparedness for radiological and nuclear mass-casualty scenarios.
The therapeutic study uses a shielded-mouse model designed to preserve the majority of the animals’ bone marrow. This should allow investigators to evaluate survival and tissue-recovery effects attributable specifically to GI protection, rather than confounding results with bone-marrow outcomes. The company believes Entolimod’s ability to support survival while promoting GI recovery in this model would represent a result not previously demonstrated by a U.S. government-tested countermeasure.
