Valion Bio (NASDAQ: VBIO) has announced final data from a safety study funded by the National Institute of Allergy and Infectious Diseases (NIAID)/Radiation and Nuclear Countermeasures Program (RNCP) that evaluated its lead biologic drug candidate, Entolimod, which is designed to protect against 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.
In a statement, Dean Zikria, interim CEO of Valion, commented, “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. 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.”
In the AFRRI study, a total of 20 male C57BL/6 mice were weighed and randomized into experimental groups, including an untreated control group, to establish baseline growth parameters. Each animals received either a single SC injection of Entolimod at 0.72 mg/kg or a saline vehicle control administered at a fixed volume of 0.2 mL. Investigators documented clinical observations during the first hour and four hours after administration and throughout the subsequent 14-day observation period.
The study evaluated body weight, complete blood counts (CBC), and serum chemistry to assess potential treatment-related effects. Key statistical and clinical outcomes include:
- Stable body weight and clinical observations: Entolimod-treated animals maintained stable body weights throughout the study, with no statistically significant overall difference in mean body weight compared to control groups across all time points (p = 0.1424). While a group-by-time effect was noted (p < 0.0001), follow-up comparisons confirmed no significant differences between the Entolimod and saline groups before dosing or on days three, 11, and 14. A minor divergence on day seven (p = 0.0199) reflected a transient weight increase in the saline control group rather than weight loss or toxicity in the Entolimod cohort.
- Unchanged hematologic profiles: Serial CBC evaluations confirmed that Entolimod administration caused no disruptions to measured hematologic parameters. All measured values remained within normal reference ranges with no statistically significant differences between groups.
- Normal metabolic and organ function: End-of-study serum chemistry panels evaluating blood urea nitrogen, creatinine, total protein, glucose, AST, ALT, and ALP confirmed normal organ and metabolic function. No statistically significant differences were observed between the Entolimod-treated group and the saline control across any measured parameters.
Taken together, the findings provide encouraging preclinical safety data across multiple assessment measures and support continued evaluation of Entolimod in the next phase of AFRRI’s research program.
Following the successful completion of the safety phase, AFRRI is planning to advance a fully funded therapeutic study using a specialized GI-ARS mouse model. The study is designed to evaluate whether Entolimod, when administered after radiation exposure, can improve survival and support GI tissue recovery.
Mr. Zikria added, “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. 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.”
