DENVER, Colo. (247marketnews.com) -- Valion Bio (NASDAQ:VBIO) is adding a potentially significant new dimension to its Entolimod program, announcing that it and Shear Kershman Laboratories have successfully formulated an oral mucosal version of the investigational biologic using SKL’s BioViscid delivery platform. The milestone creates a potential second development pathway alongside Valion’s injectable Entolimod program and moves the company toward testing whether the needle-free formulation can produce measurable systemic exposure in the bloodstream.
The potential opportunity is tied to the unique challenges of acute radiation syndrome (ARS), where rapid deployment and practical administration could be important considerations during a radiological or nuclear emergency. The FDA says ARS can result from high-dose whole-body radiation exposure and identifies medical countermeasures for hematopoietic ARS as an important preparedness need. Existing FDA-approved countermeasures include products intended to help patients recover from radiation-induced bone-marrow damage.
Valion’s Entolimod is being developed under the FDA’s Animal Rule framework, which allows efficacy evaluation through appropriate animal studies when human efficacy trials are not ethical or feasible.
The underlying Entolimod science provides an additional reason investors may be watching the formulation milestone. Published non-human-primate research reported that a single Entolimod injection administered as late as 48 hours following lethal total-body irradiation improved survival and accelerated recovery of hematopoietic and gastrointestinal tissues.
Valion now wants to determine whether those established injectable properties can ultimately be paired with a simpler mucosal delivery method. “The opportunity we are investigating goes beyond changing how Entolimod is administered,” said Valion Interim CEO Dean Zikria. “An oral gel formulation with demonstrated systemic delivery, appropriate stability and an approved or authorized use could allow us to explore deployment models that are difficult to achieve with an injectable product.”
Important Editorial Note: 247 highlights companies approaching significant catalysts and inflection points. This report reflects information available at the time of publication. Since developments can occur rapidly, readers should independently verify current information and review all company filings and disclosures.