Activating Innate Immunity.
Protecting & Extending Life.
Valion Bio is a clinical-stage immunotherapeutics company advancing Entolimod, a TLR5 agonist, being developed to protect against radiation injury and to support immune function in oncology settings.
Who We Are
Valion Bio (Nasdaq: VBIO) is developing Entolimod, a Toll-like Receptor 5 agonist that activates the innate immune system — the body’s first line of defense against radiation injury, infection, and cellular stress. More than $140 million has been invested in the program to date across institutional and U.S. government funding, and Entolimod has been administered to more than 300 humans in prior clinical studies.
The lead indication is Acute Radiation Syndrome (ARS), being developed under the FDA’s Animal Rule framework. Beyond ARS, the same molecule is being advanced into oncology supportive care for chemotherapy- and radiation-induced neutropenia, with immuno-oncology applications in earlier-stage development. Entolasta, a second-generation follow-on, is in IND-enabling work for chronic indications.
Valion Bio also owns Velocity Bioworks, a U.S.-based contract development and manufacturing organization (CDMO) in San Antonio, Texas. Velocity Bioworks is built to provide biomanufacturing capabilities that support secure supply and development needs, operating in alignment with applicable regulatory requirements, and generates independent commercial revenue serving outside clinical-stage biotech clients.
Three assets. One thesis.
Innate immunity is the body’s oldest and most fundamental defense system. We are building a platform around it.
Entolimod
A TLR5 agonist in clinical development.
Has received FDA Fast Track and Orphan Drug designations for Acute Radiation Syndrome. A single mechanism being investigated across indications — from biodefense, to cancer supportive care, to age-related immune function.
Velocity Bioworks
Domestic biomanufacturing, vertically integrated.
A wholly owned CDMO that supports Valion Bio’s own supply chain and generates independent commercial revenue from outside biotech clients. Operations are conducted in alignment with applicable regulatory requirements, are scalable, and strategically differentiated.
Government Pathway
An established framework for medical countermeasures.
Active engagement with BARDA, NIAID, DTRA, and the Department of War. Prior federal contracts totaling $35.6 million. Entolimod is being developed under the FDA’s Animal Rule framework for Acute Radiation Syndrome, a regulatory pathway established for medical countermeasures where human efficacy trials are not ethically feasible.
The Problem We Solve
In animal studies conducted under the FDA’s Animal Rule, Entolimod has been associated with an odds ratio of 7.9 in a post-hoc pooled analysis of the RS-23 study. A 25-hour post-exposure treatment window has been observed in nonclinical models. The program has the potential to address a $5.5B biodefense market, a $22.3B oncology supportive care market, and additional indications across a combined addressable market exceeding $330B.
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