Valion Bio (NASDAQ: VBIO), based in San Antonio, has accepted the initial research protocol from the National Institute of Allergy and Infectious Diseases (NIAID) for its lead candidate Entolimod. The company entered a collaboration agreement that provides up to $700,000 for essential in vivo studies supporting a Biologics License Application (BLA).
NIAID Funds Critical Animal Studies Under FDA Animal Rule
NIAID plans to conduct these pivotal in vivo studies, generating rigorous data to bolster FDA approval under the Animal Rule. Officials expect the results to provide substantial evidence for Entolimod as a countermeasure against Acute Radiation Syndrome (ARS).
This protocol advances prior FDA-cleared designs tested at the Armed Forces Radiobiology Research Institute (AFRRI), where NIAID oversees funding and execution. Initial findings confirm Entolimod protects against Gastrointestinal ARS in partial-body irradiation models.
Filling a Key Gap in Radiation Countermeasures
No FDA-approved treatments currently stock the U.S. Strategic National Stockpile for GI ARS. Entolimod has undergone testing in 42 non-human primate studies and roughly 300 human subjects.
The development program has attracted over $140 million in total investment, including $35.6 million from government sources. The drug candidate carries FDA Fast Track and Orphan Drug designations for ARS, addressing a niche yet vital need through Animal Rule pathways.
CEO Highlights Strategic Impact
Michael K. Handley, CEO of Valion Bio, stated, “Having capital planned for this program now enables us to redirect it toward accelerating clinical development of the second-generation molecule Entolasta.”
The announcement triggered a sharp rise in Valion Bio shares, underscoring investor confidence in the biotech’s path forward amid ongoing challenges.
