Valion Bio says AFRRI will evaluate Entolimod in fully funded therapeutic study
Valion Bio said AFRRI will conduct a therapeutic efficacy study of Entolimod after radiation exposure, with top-line results anticipated in early December.
Valion Bio, Inc. (NASDAQ:VBIO) said the Armed Forces Radiobiology Research Institute (AFRRI) will evaluate Entolimod in a therapeutic efficacy study involving gastrointestinal acute radiation syndrome (GI-ARS). The work will examine whether treatment given after radiation exposure can improve survival and support gastrointestinal tissue recovery.
The study is fully funded by the National Institute of Allergy and Infectious Diseases (NIAID) through its Radiation and Nuclear Countermeasures Program (RNCP). The funding is being provided under an Interagency Agreement with the Uniformed Services University and AFRRI.
Valion Bio said top-line results are anticipated in early December. The company described the study as the next development milestone for Entolimod after positive safety results announced just days earlier.
The research will use a partial-body irradiation model in mice, with roughly 2.5% of the animals' bone marrow shielded. Valion Bio said this design is intended to help researchers separate effects related to gastrointestinal injury mitigation from those linked to recovery.
Each mouse will receive a single administration of Entolimod or saline control 24 hours after radiation exposure. The animals will then be monitored for 30 days. Survival is the primary endpoint, and results will be compared between the treatment and control groups.
Valion Bio is developing Entolimod for both the hematopoietic, or bone marrow, and gastrointestinal forms of acute radiation syndrome. Interim Chief Executive Officer Dean Zikria said the study will address whether post-exposure treatment can improve survival in a model designed to isolate gastrointestinal injury.
Valion Bio describes Entolimod as a Toll-like Receptor 5 agonist designed to activate NF-κB signalling pathways associated with cellular protection, tissue recovery and immune response. The candidate is being developed as a potential medical countermeasure for acute radiation syndrome and has been assessed in animal models under the U.S. Food and Drug Administration's Animal Rule.
The FDA framework can allow new drugs and biological products to be approved using animal efficacy studies when human clinical trials are not ethical or feasible, including in cases involving acute radiation exposure. Entolimod has received Fast Track and Orphan Drug designations from the FDA.
Valion Bio holds an exclusive, worldwide licence from Statera Biopharma to develop and commercialise Entolimod for acute radiation syndrome, radiation-induced neutropenia and other indications. The company is also advancing Entolasta, a next-generation TLR5 agonist intended for potential broader applications including oncology supportive care. Its pipeline includes potential programmes in neutropenia and immune dysfunction.
Valion Bio's wholly owned subsidiary, Velocity Bioworks, provides biologics contract development and manufacturing services to support the company's internal pipeline. Valion Bio said the subsidiary's objectives include increasing manufacturing control, reducing costs, accelerating development timelines and strengthening domestic supply-chain security.
AFRRI will evaluate Entolimod in a therapeutic efficacy study for gastrointestinal acute radiation syndrome.
The study is fully funded by NIAID's Radiation and Nuclear Countermeasures Program under an agreement with the Uniformed Services University and AFRRI.
Mice will receive Entolimod or saline control 24 hours after radiation exposure and will be monitored for 30 days.
Survival is the primary endpoint, with roughly 2.5% of the animals' bone marrow shielded in the partial-body irradiation model.
Valion Bio said top-line results are anticipated in early December.
Valion Bio announced that the Armed Forces Radiobiology Research Institute (AFRRI) will evaluate Entolimod's therapeutic efficacy after radiation exposure. The study will assess whether post-exposure treatment improves survival in a model designed to evaluate gastrointestinal acute radiation syndrome (GI-ARS).
The announcement was made on October 30, 2026, and concerns the upcoming therapeutic efficacy study of Entolimod. Valion Bio said top-line results are anticipated in early December.
The study is fully funded by the National Institute of Allergy and Infectious Diseases (NIAID) and its Radiation and Nuclear Countermeasures Program (RNCP). The funding is provided under an Interagency Agreement with the Uniformed Services University and AFRRI.
The study will test whether Entolimod administered after radiation exposure improves survival in a model designed to assess gastrointestinal acute radiation syndrome. It will also evaluate gastrointestinal tissue recovery following radiation exposure.
Mice will receive a single administration of either Entolimod or saline control 24 hours after radiation exposure and will then be monitored for 30 days. The primary endpoint is survival, with outcomes compared between the treatment and control groups.
The model shields roughly 2.5% of the animals' bone marrow. Valion Bio said this will allow researchers to distinguish effects linked to the mitigation of gastrointestinal injury from those associated with recovery.
Valion Bio said the decision followed positive safety results announced just days earlier. The company described the AFRRI study as the next development milestone for Entolimod after those findings.
Valion Bio said top-line results are anticipated in early December. The company did not provide a more specific date in the announcement.
Interim Chief Executive Officer Dean Zikria said the central question is whether treatment after radiation exposure can improve survival in a model designed to isolate gastrointestinal injury. He said the fully funded study provides an opportunity to evaluate that potential while preserving Valion Bio's capital and generating efficacy data to guide Entolimod's next stage of development.
Valion Bio is developing Entolimod as a potential medical countermeasure for the haematopoietic, or bone marrow, and gastrointestinal forms of acute radiation syndrome. The company holds an exclusive, worldwide licence from Statera Biopharma to develop and commercialise Entolimod for acute radiation syndrome, radiation-induced neutropenia and other indications.
Valion Bio describes Entolimod as a novel Toll-like Receptor 5 agonist designed to activate NF-κB signalling pathways associated with cellular protection, tissue recovery and immune response. The company is developing biologics that activate innate immune pathways for cytoprotection and immune modulation.
Entolimod has received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration. Valion Bio said the candidate has been evaluated in animal models under the FDA's Animal Rule, which allows approval based on animal efficacy studies when human clinical trials are not ethical or feasible, such as in acute radiation exposure.
Valion Bio is advancing Entolasta, a next-generation TLR5 agonist designed for potential broader therapeutic applications, including oncology supportive care. Its pipeline also includes potential programmes in neutropenia and immune dysfunction, while its wholly owned subsidiary Velocity Bioworks provides biologics contract development and manufacturing services to support the internal pipeline.
Valion Bio's shares trade on the Nasdaq Capital Market under the ticker symbol NASDAQ:VBIO.