Valion Bio, Inc. (Nasdaq: VBIO) announced on September 30, 2026, the completion of formulation work to develop a novel oral mucosal version of its investigational biologic Entolimod. The company partnered with Shear Kershman Laboratories (SKL) to utilize SKL’s proprietary BioViscid drug-delivery platform. This platform is designed to apply bio-adhesive mucosal technologies to oral tissues.
The new formulation aims to create a needle-free administration pathway for Entolimod, which is currently developed for injection. The goal is to deliver Entolimod through the lining of the mouth. The next step in the program will involve testing whether the formulation delivers measurable amounts of Entolimod into the bloodstream.
Valion Bio holds an exclusive worldwide license from Statera Biopharma to develop and commercialize Entolimod for acute radiation syndrome. In published animal studies, injected Entolimod has shown the ability to protect mice from both gastrointestinal and hematopoietic forms of acute radiation syndrome. It has also improved survival in non-human primates given the drug 48 hours after exposure.
The company notes that current U.S. Food and Drug Administration (FDA)-approved products address only the hematopoietic form of radiation injury in patients who have already been exposed. No treatment is currently approved for the gastrointestinal indication. Valion believes a successful oral mucosal version could support distributed readiness, needle-free administration, and simpler storage and transport.
Regarding the potential market opportunity, Valion estimates that if an oral mucosal version were authorized or approved, the number of doses potentially required in the United States could be approximately 10 to 40 times that of the injectable program. This estimate assumes supplying every one of about 2.0 million active-duty and Selected Reserve service members, 1.0 million firefighters, and 790,000 full-time sworn law enforcement officers. The company emphasizes this is an estimate of a possible addressable opportunity, not a revenue forecast.
Shear Kershman Laboratories is headquartered in Chesterfield, Missouri. The company develops proprietary drug-delivery technologies designed to address formulation and delivery challenges across a range of therapeutic compounds.
