US Valion Bio Initiates Safety Study of Entolimod for Radiation-Induced Gastrointestinal Injury

US biotechnology company Valion Bio announced on August 12 that the safety study of its investigational therapeutic candidate Entolimod for radiation-induced gastrointestinal injury is scheduled to commence this week. The study is being advanced by the Armed Forces Radiobiology Research Institute (AFRRI) under a contract with the National Institute of Allergy and Infectious Diseases (NIAID), as part of a government-funded research program.

According to the company's disclosure, Entolimod has been delivered to AFRRI, the study has received approval from the Institutional Animal Care and Use Committee (IACUC), and the experimental animals are currently in the pre-dosing acclimation phase. The safety study will confirm the tolerability of Entolimod in the animal strain used by AFRRI; if the safety study is successfully completed, the subsequent therapeutic study will commence immediately, with preliminary efficacy data expected to be released in early autumn.

The therapeutic study will evaluate whether administration of Entolimod after radiation exposure can support survival and gastrointestinal tissue recovery in mice following exposure to lethal doses of ionizing radiation. The study will employ a shielded mouse model to preserve as much bone marrow as possible, allowing researchers to more focusedly observe the drug's effect on gastrointestinal protection and reduce interference from bone marrow injury-related factors on the results.

Valion Bio CEO Michael K. Handley stated that Entolimod has previously been tested in more than 40 studies involving thousands of animals, including non-human primates, as well as approximately 300 human subjects. The company stated that the drug's development complies with the US Food and Drug Administration (FDA) Animal Rule, and it remains in the FDA Investigational New Drug (IND) application stage.

AFRRI has also expressed interest in conducting a potential prophylactic study to evaluate whether administration of Entolimod prior to radiation exposure can protect gastrointestinal tissue. However, Valion Bio stated that this study has not yet been finalized and still requires written confirmation.

Entolimod is a Toll-like receptor 5 (TLR5) agonist that activates the NF-κB signaling pathway. The drug has received FDA Fast Track designation and Orphan Drug designation for the treatment of acute radiation syndrome. Valion Bio stated that if relevant studies yield positive results, Entolimod has the potential to continue advancing as a candidate medical countermeasure for radiological and nuclear events.