Valion Bio reports clean safety data for Entolimod from AFRRI radiation study

Valion Bio, Inc. announced on October 27, 2026 final data from a safety study of its lead biologic candidate, Entolimod, funded by the National Institute of Allergy and Infectious Diseases Radiation and Nuclear Countermeasures Program. The study found no evidence of treatment-related toxicity after a single dose of Entolimod and is meant to support moving toward a fully funded therapeutic study looking at survival and gastrointestinal recovery after radiation exposure.¹

The Armed Forces Radiobiology Research Institute ran the study under an interagency agreement between NIAID/RNCP and the Uniformed Services University/AFRRI, testing a single subcutaneous injection of Entolimod followed by 14 days of observation in male C57BL/6 mice.¹ Twenty mice were weighed and split into groups, including an untreated control, and each animal got either a single subcutaneous dose of Entolimod at 0.72 mg/kg or a saline control at a fixed 0.2 mL volume.¹

Body weights stayed stable across groups, with no statistically significant overall difference in mean body weight between Entolimod-treated and control animals across all time points (p = 0.1424)¹. Blood counts showed no disruption from Entolimod, with all values staying within normal ranges and no significant group differences.¹ End-of-study serum chemistry panels covering BUN, creatinine, total protein, glucose, AST, ALT and ALP also showed normal organ and metabolic function with no significant differences between groups.¹

With the safety phase done, AFRRI is planning a fully funded therapeutic study in a specialized GI-ARS mouse model to test whether Entolimod, given after radiation exposure, can improve survival and support GI tissue recovery.¹

Valion has licensed Entolimod from Statera Biopharma. The company holds an exclusive, worldwide license from Statera Biopharma covering Entolimod's development and commercialization for acute radiation syndrome, radiation-induced neutropenia, and other indications.¹ Entolimod is being developed under the FDA's Animal Rule and has received Fast Track and Orphan Drug designations from the agency.¹