Valion Bio reports completed formulation work on potential needle-free Entolimod option
Valion Bio says it has completed formulation work with Shear Kershman Laboratories on an oral mucosal version of Entolimod, which remains an investigational candidate for acute radiation syndrome.
Valion Bio, Inc. (Nasdaq:VBIO) has reported completed formulation work with Shear Kershman Laboratories (SKL) on an oral mucosal version of its investigational biologic Entolimod. The BioViscid™-Entolimod formulation is designed to be absorbed through the oral mucosa and could potentially offer a needle-free way to administer the candidate in the company’s acute radiation syndrome (ARS) programme.
The work was conducted under an ongoing collaboration using SKL’s BioViscid™ drug-delivery platform. Entolimod has historically been administered by intramuscular injection, while the new formulation is being developed as an additional route rather than a replacement for the injectable programme.
The oral mucosal candidate has not been approved. Valion says its possible use in radiation emergencies would depend on successful development and approval, as well as factors including pharmacokinetics, stability, dosing, regulatory status and procurement requirements.
Valion is positioning the programme within discussions about emergency planning as nuclear power capacity is considered alongside rising electricity demand from artificial intelligence, data centres and other digital infrastructure. The company said possible expansion of nuclear infrastructure, including on-site small modular reactors, increases the importance of preparing medical countermeasures for radiological or nuclear incidents.
Interim Chief Executive Officer Dean Zikria said the changing nuclear landscape raises questions about how communities and emergency systems would prepare for radiation events. His comments concerned preparedness for events described by the company as low-probability and high-consequence.
Valion is developing Entolimod as a potential countermeasure for ARS. The company describes the biologic as being investigated for use both before and after radiation exposure, with the aim of protecting cells from severe damage or death.
Valion cites published animal research involving injected Entolimod before exposure and non-human-primate research involving administration after exposure. According to the company, the studies reported effects involving survival, bone marrow and intestinal tissue. These findings are being used as part of the scientific rationale for continued investigation; they do not establish that the oral mucosal formulation is effective in people.
#Hematopoietic and gastrointestinal effects under investigation
The company said current FDA-approved ARS countermeasures address the hematopoietic, or bone-marrow, component of radiation injury. Valion also stated that no treatment is currently approved for the gastrointestinal component of ARS.
Entolimod’s development programme is investigating whether the candidate could provide cytoprotection involving both tissue areas. The potential gastrointestinal and hematopoietic applications remain part of the investigational programme.
Valion said an oral mucosal formulation, if successfully developed and approved, could alter how Entolimod is distributed and administered during a mass-casualty radiological or nuclear event. The company believes a needle-free option could reduce reliance on trained personnel for injections and support different approaches to administering countermeasures across large populations.
Valion also said injectable and oral mucosal formulations could eventually serve different preparedness requirements. Their suitability would depend on factors such as absorption characteristics, product stability, dosing, regulatory status and procurement needs.
Valion Bio is a clinical-stage biopharmaceutical company developing biologics that activate innate immune pathways for cytoprotection and modulate immune responses in conditions involving radiation, disease and immune dysregulation.
In addition to Entolimod, the company is advancing Entolasta, a next-generation TLR5 agonist being investigated for broader applications including oncology supportive care. Its pipeline also includes potential programmes in neutropenia and immune dysfunction. The company’s wholly owned subsidiary, Velocity Bioworks, provides biologics contract development and manufacturing services to support Valion’s internal pipeline.
Valion cautioned that the development and regulatory progress of Entolimod, the ability of the oral formulation to produce measurable systemic exposure, its pharmacokinetic profile, potential uses before or after radiation exposure, product portability and stability, and possible government interest in stockpiling remain subject to risks and uncertainties. The company also identified uncertainties involving Entolasta, additional capital and the continued listing of its common stock on the Nasdaq Capital Market.
Valion Bio announced that it and Shear Kershman Laboratories had recently completed formulation work under their ongoing programme to develop an oral mucosal formulation of Entolimod. The resulting BioViscid™-Entolimod formulation is designed to enable absorption through the oral mucosa and could potentially provide a needle-free alternative to injectable administration.
Valion Bio’s announcement was published on October 9, 2026, and describes recently completed formulation work under its ongoing oral mucosal Entolimod programme. It also discusses the potential relevance of the programme to future radiological or nuclear emergencies as nuclear-energy and data-centre infrastructure develops.
Valion Bio says the BioViscid™-Entolimod formulation is designed to enable absorption through the oral mucosa. The company says this could potentially provide a needle-free administration option for Entolimod, which has historically been administered by intramuscular injection.
Valion Bio’s oral mucosal Entolimod formulation remains a development programme rather than an approved product. The company says a needle-free formulation could have these uses if it is successfully developed and approved.
Valion Bio is developing Entolimod as a potential medical countermeasure for acute radiation syndrome, or ARS. The company describes Entolimod as an investigational biologic designed to potentially protect cells from severe damage or death both before radiation exposure and after exposure.
Valion Bio cites published animal studies in which injected Entolimod demonstrated protection against lethal radiation when administered before exposure, including protection involving haematopoietic and gastrointestinal tissues. The company also cites non-human-primate research reporting improved survival and recovery of bone marrow and intestinal tissue when Entolimod was administered after radiation exposure.
Valion Bio says its development programme is investigating whether Entolimod could provide cytoprotection involving both haematopoietic and gastrointestinal tissues. The company notes that current FDA-approved ARS countermeasures address the haematopoietic, or bone-marrow, component, while no treatment is currently approved for the gastrointestinal component of ARS.
Valion Bio says a successfully developed oral mucosal formulation could potentially reduce dependence on trained personnel to administer injections and create new models for rapid distribution and administration across large populations. The company says this may be relevant in a mass-casualty radiological or nuclear event, where demand for medical countermeasures could exceed conventional healthcare-delivery capacity.
Valion Bio says the oral mucosal programme is intended to create an additional development and deployment pathway alongside its injectable Entolimod programme. The company says different formulations could ultimately serve different preparedness requirements depending on pharmacokinetics, stability, dosing, regulatory status and procurement needs.
Valion Bio says rising electricity demand from artificial intelligence, data centres and other digital infrastructure is driving plans to expand nuclear-power capacity, possibly including on-site small modular reactors. Interim Chief Executive Officer Dean Zikria said the changing nuclear landscape also raises questions about how communities and emergency systems prepare for low-probability, high-consequence radiation events.
Valion Bio is a clinical-stage biopharmaceutical company developing biologics that activate innate immune pathways for cytoprotection and modulate immune responses in conditions driven by radiation, disease and immune dysregulation. Its pipeline includes Entolimod, Entolasta, potential programmes in neutropenia and immune dysfunction, and services provided through its wholly owned biologics contract development and manufacturing subsidiary, Velocity Bioworks.
The announcement identifies Valion Bio on Nasdaq under the ticker Nasdaq:VBIO and later identifies the company as NASDAQ:VBIO. The release also refers to the continued listing of the company’s common stock on the Nasdaq Capital Market as a forward-looking matter.
Valion Bio cautions that the development and regulatory advancement of Entolimod, regulatory or government interactions, measurable systemic exposure and the pharmacokinetic profile of oral mucosal absorption remain subject to risks and uncertainties. It also identifies uncertainties concerning use before or after radiation exposure, potential gastrointestinal or haematopoietic benefits, portability and stability, government interest in stockpiling or prophylactic administration, investigator-sponsored studies, Entolasta and other applications, additional capital and the continued listing of its common stock on the Nasdaq Capital Market.