Valion Bio Announces Positive Safety Results From U.S. Government-Funded Entolimod Study, Paving Way For Therapeutic Efficacy Evaluation
Key Highlights
- ➤Entolimod safety study found no significant body-weight, hematologic, metabolic, or organ-function concerns
- ➤AFRRI plans fully funded therapeutic study testing survival and GI tissue recovery after radiation exposure
- ➤Study evaluated single 0.72 mg/kg subcutaneous Entolimod dose in 20 male C57BL/6 mice
- ➤Valion Bio (VBIO) says Entolimod program is positioned to advance after safety phase
Expert Statements
Dean Zikria, Interim Chief Executive Officer of Valion Bio
“These positive safety findings represent an important de-risking milestone in the ongoing development of Entolimod as a potential medical countermeasure for ARS, a life-threatening condition with severe unmet medical needs,”
Dean Zikria, Interim Chief Executive Officer of Valion Bio
“With this phase complete, the program is positioned to move into a fully funded AFRRI therapeutic study focused on survival and GI tissue recovery following radiation exposure.”
Dean Zikria, Interim Chief Executive Officer of Valion Bio
“Moving into the therapeutic phase is a significant step forward because it shifts the focus from single-dose safety characterization to the outcomes that matter most in ARS: survival and recovery of the gastrointestinal system,”
Dean Zikria, Interim Chief Executive Officer of Valion Bio
“With the safety study completed and the next study expected to be fully funded, we should have a clear path toward generating important data to guide Entolimod's future development. We look forward to this next phase of research and its potential to advance a much-needed medical countermeasure for severe radiation injury.”
SAN ANTONIO, TX / ACCESS Newswire / October 28, 2026 / Valion Bio, Inc. (NASDAQ:VBIO) ("Valion" or the "Company"), a clinical-stage biopharmaceutical company developing biologics that activate innate immune pathways for cytoprotection and immune modulation, today announced final data from a National Institute of Allergy and Infectious Diseases ("NIAID")/Radiation and Nuclear Countermeasures Program ("RNCP")-funded safety study of its lead biologic drug candidate, Entolimod, which is designed to protect and mitigate both hematopoietic (bone marrow) and gastrointestinal ("GI") forms of acute radiation syndrome ("ARS").
Conducted by the Armed Forces Radiobiology Research Institute ("AFRRI"), under an Interagency Agreement between NIAID/RNCP and the Uniformed Services University (USU)/AFRRI, the safety study evaluated a single subcutaneous ("SC") injection of Entolimod followed by a 14-day observation period in male C57BL/6 mice.
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