Healthcare
AFRRI/NIAID Designs Proprietary PBI-BM2.5 Protocol to Evaluate Valion Bio's (NASDAQ: VBIO) Entolimod as the First and Only Treatment for GI-ARS
Valion Bio, Inc. (Nasdaq: VBIO) ("Valion Bio" or the "Company") today announced that the Armed Forces Radiobiology Research Institute ("AFRRI"), a division of the U.S. Department of War ("DoW"), in partnership with the National Institute of Allergy and Infectious Diseases ("NIAID"), has completed design of the survival efficacy protocol that will be used to evaluate the Company's lead candidate, Entolimod™, for the treatment of Gastrointestinal Acute Radiation Syndrome ("GI-ARS").
About this update from Valion Bio, Inc.
AFRRI/NIAID partnership and validated animal models significantly derisk regulatory and commercial advancement of Company's lead candidate Positive momentum further positions Entolimod as a potential first and only treatment for GI-ARS, representing a multi-billion-dollar commercial opportunity SAN ANTONIO, June 25, 2026 /PRNewswire/ -- Valion Bio, Inc. (Nasdaq: VBIO) ("Valion Bio" or the "Company") today announced that the Armed Forces Radiobiology Research Institute ("AFRRI"), a division of the U.S. Department of War ("DoW"), in partnership with the National Institute of Allergy and Infectious Diseases ("NIAID"), has completed design of the survival efficacy protocol that will be used to evaluate the Company's lead candidate, Entolimod™, for the treatment of Gastrointestinal Acute Radiation Syndrome ("GI-ARS"). The final AFRRI/NIAID protocol design for Entolimod emanates from the Company's previously announced non-clinical evaluation agreement with NIAID, and closely follows the U.S. House Armed Services Committee's direction to the DoW to develop a resources and fielding plan for prioritizing radiation/nuclear countermeasures that, like Entolimod, are both prophylactic (pre-exposure) and therapeutic (post-exposure). Currently, no U.S. Food and Drug Administration ("FDA")-approved medical countermeasures exist to mitigate GI-ARS; representing a critical therapeutic and commercial gap in a market driven by U.S. government emergency preparedness requirements. The AFRRI/NIAID-selected partial body irradiation with 2.5% bone marrow sparing/shielding ("PBI-BM2.5") at lethal radiation dose (LD50/30 of 14.6 Gy) murine model to evaluate Entolimod is scientifically rigorous and meets the FDA's Animal Rule criteria, which allows the Agency to approve new drugs and biological products based on animal efficacy studies when human clinical trials are unethical or not feasible, such as in the case of internal radioactive contamination.1,2,3 Entolimod is a recombinant deletion variant of Salmonella FliC flagellin engineered to activate TLR5 selectively. Upon engagement, Entolimod triggers specific pathways that ultimately promote multi-tissue cytoprotection and inhibit apoptosis in radiosensitive hematopoietic and gastrointestinal tissues. By utilizing a proprietary murine model that spares only 2.5% of bone marrow (one hind leg and tail) from a lethal radiation dose, the study will isolate GI pathophysiology from overwhelming hematopoietic failure — creating a cleaner efficacy signal for a mechanism targeting intestinal epithelial recovery and immune restoration.