Valion Bio receives first study protocol under agreement with NIAID

Valion Bio (VBIO) announced it has received the first study protocol under its previously announced non-clinical evaluation agreement with the National Institute of Allergy and Infectious Diseases, a component of the National Institutes of Health. Under the agreement, valued at up to $7M, NIAID will fully fund the in vivo studies required to support the company’s Biologics License Application for Entolimod under the FDA’s Animal Rule pathway, with the agency further committed to co-navigate the FDA submission process alongside Valion Bio upon favorable study outcomes. The protocol provided to Valion Bio is identical to a study design previously used and accepted by the FDA in support of a prior ARS medical countermeasure approval. This regulatory precedent meaningfully de-risks the design phase of the company’s BLA-enabling work, as the agency has already accepted the structure as evidentiary under the Animal Rule. The studies will be conducted at the Armed Forces Radiobiology Research Institute, the U.S. government’s primary radiological research facility for ARS countermeasure evaluation, with NIAID serving as the contracting and funding agency.