A message from our CEO

Valion Bio has entered an important phase of its development. Our lead asset, Entolimod, is a TLR5 agonist in clinical development, supported by more than $140 million of prior institutional and U.S. government funding, and has been administered to more than 300 participants in clinical studies. The program is being developed under the FDA Animal Rule, a regulatory framework designed for situations where human efficacy studies are not feasible or ethical.

Beyond our lead indication, the same molecule is being investigated in oncology supportive care, where currently approved therapies focus on bone marrow support. Entolimod is being evaluated for its potential to activate innate immune pathways and support tissue responses to injury.

Our second-generation follow-on, Entolasta, extends the platform into chronic indications with IND-enabling work underway. Entolasta is expected to be treated by FDA as a new molecular entity and will require its own development program.

We have also built a biomanufacturing capability that most clinical-stage companies do not have. Velocity Bioworks, based in San Antonio, provides biomanufacturing capabilities that support secure supply and development needs, operating in alignment with applicable regulatory requirements, and generates independent commercial revenue from outside clients.
We are executing against a defined development roadmap — BARDA engagement, Neutropenia trial initiation, Entolasta IND-enabling work, and advancing regulatory interactions across the next 18 to 24 months.

— Michael K. Handley, Chief Executive Officer