Wednesday, 12 August 2026 09:29 AM
Company Update
AFRRI/NIAID Program to Advance Safety and Therapeutic Studies in Rapid Sequence; Top-Line Therapeutic Data Expected in Early Fall
Study drug delivered • IACUC approval secured • Safety study planned to start this week
Near-Term Program Milestones
Study readiness: Entolimod has been delivered to AFRRI, IACUC approval has been obtained, and study animals are being acclimated ahead of dosing. Dosing will begin this week.
Safety study: Planned to start this week to confirm Entolimod's tolerability in the animal strain AFRRI is using.
Therapeutic study: Expected to follow promptly upon successful completion of the safety study, with top-line data anticipated in early fall.
Broader program: The two government-funded studies form part of a broader Entolimod program AFRRI/NIAID is advancing. If the studies are successful, Entolimod would be the first drug to our knowledge that provides hematopoietic protection as well as GI protection.
SAN ANTONIO, TX / ACCESS Newswire / August 12, 2026 / Valion Bio, Inc. (Nasdaq:VBIO), a late-stage innate immunotherapeutics company, today announced that the Armed Forces Radiobiology Research Institute (AFRRI), under its contract with the National Institute of Allergy and Infectious Diseases (NIAID), is conducting a U.S. Department of War (DoW) government-funded program evaluating Entolimod for radiation-induced gastrointestinal (GI) injury.
The program is expected to advance through a safety study and, upon its successful completion, a therapeutic study in rapid sequence. The safety study is planned to start this week. The therapeutic study will evaluate whether Entolimod, administered after radiation exposure, can support survival and GI tissue recovery following lethal doses of ionizing radiation. Top-line therapeutic data are anticipated in early fall.
Why the Therapeutic Study Matters
Radiation-induced GI injury is a major potential cause of mortality following high-dose radiation exposure and remains a key focus of U.S. medical-countermeasure development. Successful development could support Entolimod's potential role in government preparedness for radiological and nuclear mass-casualty scenarios.
The therapeutic study uses a shielded-mouse model designed to preserve the majority of the animals' bone marrow. This should allow investigators to evaluate survival and tissue-recovery effects attributable specifically to GI protection, rather than confounding results with bone-marrow outcomes. The Company believes Entolimod's ability to support survival while promoting GI recovery in this model would represent a result not previously demonstrated by a U.S. government-tested countermeasure.
AFRRI/NIAID Entolimod Study Program
AFRRI is conducting the following studies under the government-funded program:
Safety study - To confirm Entolimod's tolerability in the animal strain AFRRI is using; planned to start this week ahead of the therapeutic study.
Therapeutic study - Evaluates whether Entolimod supports survival and GI tissue recovery when administered after radiation exposure; expected to initiate upon successful completion of the safety study, with top-line data anticipated in early fall.
Potential prophylactic study - Determine if Entolimod can protect GI tissue when administered before radiation exposure. While the Company has received an indication of interest, the study has not yet been confirmed and remains subject to written confirmation from AFRRI. Valion Bio expects to provide further information if and when it is confirmed.
Management Commentary
"We have completed the operational milestones needed to keep the program on schedule: Entolimod is at AFRRI, animals are being acclimated, and IACUC approval is in hand," said Michael K. Handley, Chief Executive Officer of Valion Bio. "Entolimod has generated an extensive safety database across thousands of animals in more than 40 studies, including non-human primates, and in 300 human subjects. It was developed in accordance with the FDA's Animal Rule and remains under an open Investigational New Drug application with the FDA.² That history gives us confidence as AFRRI prepares to initiate the safety study in this new mouse strain."
"AFRRI's plan to conduct these studies in rapid sequence underscores the importance and urgency we believe the government places on advancing medical countermeasures for lethal radiation injury," Handley continued. "The therapeutic study is designed to isolate Entolimod's GI-specific effect in a challenging model using lethal doses of ionizing radiation while preserving bone marrow. To our knowledge, no drug has previously demonstrated efficacy in this model. A positive result could therefore represent an important first for a U.S. government-tested radiation countermeasure."
"Evaluating Entolimod across multiple radiation scenarios reflects the potential breadth of this program. We look forward to reporting progress and sharing top-line therapeutic data when available," Handley added.
Notes and Sources
1. Casualty and mortality context for acute radiation syndrome, including radiological and nuclear mass-casualty scenarios, is described in the Entolimod program documentation (Entolimod Summary Document, 10 October 2022) and the underlying published literature cited therein.
2. Entolimod safety-database figures, FDA Animal Rule development (21 CFR 601.90), and open Investigational New Drug status are as described in the Entolimod Investigator's Brochure, Version 9 (12 August 2019). The clinical safety database comprises approximately 300 human subjects, including 150 healthy subjects in the Phase I safety studies (HU-7014 and HU-9001) and additional subjects dosed in Company-sponsored oncology studies, including a neoadjuvant colorectal cancer study (ClinicalTrials.gov NCT02715882, 40 subjects enrolled, 30 dosed with Entolimod); nonclinical evaluation includes non-human primate and other animal studies conducted across the Entolimod development program.
About Valion Bio, Inc.
Valion Bio, Inc. (Nasdaq:VBIO) is developing biologics that activate innate immune pathways for cytoprotection and modulate immune responses in conditions driven by radiation, disease, and immune dysregulation. The Company's lead candidate, Entolimod, for acute radiation syndrome (ARS), has been extensively studied and has demonstrated survival benefits and improved tissue recovery in animal models under the FDA's Animal Rule. Entolimod is a novel Toll-like receptor 5 (TLR5) agonist that activates NF-κB signaling pathways to protect cells from damage and stimulate immune responses and has received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration.
Valion Bio is also advancing Entolasta, a next-generation TLR5 agonist designed for potential broader therapeutic applications, including oncology supportive care. Valion Bio's wholly owned subsidiary, Velocity Bioworks®, is a full-service CDMO offering biomanufacturing services to third-party biotech companies, which Valion Bio also leverages to advance its own pipeline with the expected benefits of lower costs, accelerated manufacturing outcomes, and supply-chain security. For more information, visit valionbio.com.
Forward-Looking Statements
This press release may contain "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements may be identified by words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," or similar expressions, although not all forward-looking statements contain these words.
Forward-looking statements are based on Valion Bio, Inc.'s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. These include the Company's interactions with and guidance from the FDA and other regulatory authorities; continued interest of BARDA, NIAID, and other U.S. government agencies in Entolimod; the timing and success of preclinical and clinical trials and study results, including the AFRRI/NIAID studies described herein; the risk that the safety study may not be completed successfully or on the anticipated timeline, which could delay or prevent initiation of the therapeutic study; the risk that the therapeutic study may not be completed successfully or on the anticipated timeline; the risk that U.S. government funding or authorization for studies described herein, including any potential prophylactic study, may not be formalized, confirmed, may be reduced, or may be withdrawn; the Company's ability to achieve expected benefits from acquisitions; changes in partner relationships; failure to obtain regulatory approvals or comply with applicable regulations, including the Animal Rule; future development of Entolimod or Entolasta; commercialization risks; strategic-transaction risks; working-capital needs; Nasdaq-listing risks; and changes in tariffs, inflation, legal, regulatory, political, and economic conditions.
Readers are cautioned not to place undue reliance on forward-looking statements. For a discussion of relevant risks and uncertainties, see Valion Bio's filings with the SEC, including its Annual Report on Form 10-K for the year ended December 31, 2025, filed March 30, 2026, under "Risk Factors," and subsequent SEC filings. Forward-looking statements are made as of the date of this release, and the Company undertakes no duty to update them except as required by applicable law.
Investor and Media Contact
Rich Cockrell
CG Capital
[email protected]
404.736.3838
Valion Bio, Inc. | Nasdaq: VBIO
SOURCE: Valion Bio, Inc.