Valion Bio, a late-stage innate immunotherapeutics company, has announced that it presented Entolimod for acute radiation syndrome (ARS) to senior officials from the US Department of War and the Biomedical Advanced Research and Development Authority (BARDA) in a joint briefing held on 14 May.
The session was Valion Bio’s second engagement with senior Department of War officials, following the company’s April Pentagon briefing on Entolimod.
‘We believe the cross-agency engagement reflects continued US government interest in Entolimod as a differentiated medical countermeasure for radiological threats. Agency discussion included a specific interest in an oral formulation of the company’s lead candidate, which would offer operational advantages over injectable agents in mass-casualty scenarios and support broader field deployment for the warfighter and national stockpile integration.
Entolimod is a novel toll-like receptor 5 (TLR5) agonist that activates NF-κB signalling to stimulate bone marrow and protect gastrointestinal tissues following ionizing radiation exposure — a dual-tissue mechanism not available in currently stockpiled countermeasures. Unlike Neupogen® (filgrastim), Neulasta® (pegfilgrastim) and Leukine® (sargramostim), which target hematopoietic recovery alone, Entolimod addresses the gastrointestinal damage that is often the limiting factor for survival at higher radiation doses. Valion Bio is working to advance both injectable and oral transmucosal formulations of Entolimod to support a broad range of deployment scenarios.
The May briefing follows prior Valion Bio engagements with BARDA, the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agency (DTRA) and the company’s selection for the Department of War’s tech watch programme.
To date, over $140 million has been invested in the Entolimod program, including approximately $35.6 million in non-dilutive US government funding. The compound has been evaluated in 42 non-human primate studies and administered to approximately 300 human subjects, demonstrating a well-characterised safety and efficacy profile.
The company has received FDA fast track and orphan drug designations for Entolimod in acute radiation syndrome and is advancing the programme toward a biologics license application under the FDA’s animal rule.
