Valion Bio, Inc. (NASDAQ: VBIO) announced on October 28, 2026, that it has received final data from a safety study of its lead biologic candidate, Entolimod. The study was conducted by the Armed Forces Radiobiology Research Institute (AFRRI) under a partnership with the National Institute of Allergy and Infectious Diseases (NIAID) and the Radiation and Nuclear Countermeasures Program (RNCP).
The research evaluated a single subcutaneous injection of Entolimod in 20 male C57BL/6 mice. The study followed a 14-day observation period to assess potential treatment-related toxicity. Results indicated no evidence of treatment-related toxicity across multiple clinical measures.
- Body Weight: Treated animals maintained stable body weights. While a minor statistical difference was noted on day 7, follow-up comparisons confirmed no significant differences between the Entolimod and saline control groups on days 3, 11, and 14.
- Hematologic Profiles: Complete blood count (CBC) evaluations showed no disruptions to hematologic parameters, with all values remaining within normal reference ranges.
- Organ Function: End-of-study serum chemistry panels, which measured blood urea nitrogen (BUN), creatinine, total protein, glucose, AST, ALT, and ALP, confirmed normal metabolic and organ function with no statistically significant differences between groups.
Valion Bio stated that these findings represent a de-risking milestone in the development of Entolimod as a potential medical countermeasure for Acute Radiation Syndrome (ARS). The company noted that the program is now positioned to move into a fully funded therapeutic study focused on survival and gastrointestinal tissue recovery following radiation exposure.
Entolimod is a Toll-like Receptor 5 agonist designed to activate NF-kappa B signaling pathways. The candidate has received Fast Track and Orphan Drug designations from the FDA and is being developed under the FDA’s Animal Rule.
