Valion Bio (NASDAQ: VBIO) and closely held Shear Kershman Laboratories (SKL) announced the successful completion of formulation work under the companies’ ongoing program to develop a novel oral mucosal formulation of Entolimod*, Valion’s investigational biologic aimed at protecting cells from severe damage or death from radiation exposure, using SKL’s proprietary BioViscid drug-delivery platform.
The milestone advances a potential second delivery pathway for Entolimod, which has historically been administered by injection. The BioViscid-Entolimod formulation is designed to deliver Entolimod through the lining of the mouth. If further studies demonstrate effective delivery and the product receives appropriate authorization or approval, a needle-free formulation could significantly expand how and where Entolimod is deployed during radiological or nuclear emergencies.
In a statement, Dean Zikria, Interim CEO of Valion, commented, “The opportunity we are investigating goes beyond changing how Entolimod is administered. 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.”
In published animal studies of injected Entolimod given before lethal radiation, mice were protected from both the gastrointestinal and hematopoietic forms of acute radiation syndrome (ARS). In a separate study, non-human primates given injected Entolimod 48 hours after exposure showed improved survival, with faster recovery of the bone marrow and the lining of the gut.
The distinction matters for preparedness. All current FDA-approved products address only the hematopoietic, or bone marrow, form of ARS in patients who have already been exposed to myelosuppressive doses of radiation. No treatment is currently approved for the gastrointestinal indication. A product demonstrated to work for both forms, before and/or after exposure, and suitable for distribution to personnel in advance, could serve an additional use case.
Valion believes successful development could support evaluation of:
- Distributed readiness: Supplying Entolimod doses to designated military or emergency-response personnel in advance of potential exposure.
- Needle-free administration: Reducing reliance on injections and the personnel and supplies needed to give them.
- Simpler storage and transport: Testing whether the formulation can achieve stability that eases storage and deployment, potentially including eliminating or reducing refrigeration needs.
If oral mucosal Entolimod is successfully developed and authorized or approved, the number of doses potentially required in the U.S. could be approximately 10 to 40 times that of Valion’s injectable program. The estimate assumes that 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 is supplied. Valion noted that is an estimate of a possible addressable opportunity, not a revenue forecast, an estimate of committed purchases, or a measure of demonstrated demand. Its realization depends on product performance, regulatory decisions, procurement priorities and funding.
“Our injectable program remains a priority,” added Mr. Zikria. “The oral mucosal program allows us to investigate whether Entolimod could eventually serve additional preparedness needs. We look forward to additional stability, systemic-delivery, safety and efficacy data, which will help us determine the full potential of this program.”
Oral mucosal delivery is being investigated because it is designed to enable absorption across the oral mucosa and into systemic circulation, potentially avoiding gastrointestinal degradation and first-pass metabolism associated with conventional oral delivery of biologic molecules, such as swallowing tablets or capsules.
Dr. Blake Hawley, principal of SKL, remarked, “Successfully incorporating Entolimod into BioViscid and completing this stage of formulation work represents an important technical milestone. We can now move toward answering the next key question: whether oral mucosal administration produces measurable systemic exposure to Entolimod and, if so, characterizing the pharmacokinetic profile of that absorption.”
Demonstration of systemic exposure would represent the next key development milestone for the needle-free program and would inform subsequent formulation optimization, dosing and development activities.
*Valion holds an exclusive worldwide license from Statera Biopharma to develop and commercialize Entolimod for acute radiation syndrome, radiation-induced neutropenia with an exclusive option for other indications.
