Valion Bio Reports No Treatment-Related Toxicity in Entolimod Mouse Safety Study
Valion Bio said a government-funded safety study of Entolimod found no evidence of treatment-related toxicity in 20 male mice. AFRRI is planning a fully funded therapeutic study focused on survival and gastrointestinal recovery after radiation exposure.
Valion Bio, Inc. (NASDAQ:VBIO) has reported final findings from a government-funded safety study of Entolimod, its lead biologic candidate for acute radiation syndrome. The study, conducted by the Armed Forces Radiobiology Research Institute (AFRRI), found no evidence of treatment-related toxicity after a single dose in male mice, according to the company.
The findings come ahead of a planned therapeutic study that AFRRI is expected to conduct with funding from the National Institute of Allergy and Infectious Diseases’ Radiation and Nuclear Countermeasures Program. That study is intended to examine survival and gastrointestinal recovery after radiation exposure, but no therapeutic efficacy results have been reported.
The study involved 20 male C57BL/6 mice, which were assigned to experimental groups including an untreated control group. Each animal received either one subcutaneous injection of Entolimod at 0.72 mg/kg or a saline control administered at 0.2 mL.
Researchers observed the animals during the first hour and four hours after dosing, then continued monitoring for a 14-day period. The assessment included body weight, clinical observations, complete blood counts and serum chemistry.
Valion Bio said the Entolimod-treated mice maintained stable body weights. Across the study’s time points, the overall difference in mean body weight between the treatment and control groups was not statistically significant, with p = 0.1424.
A group-by-time effect was recorded at p < 0.0001. The company said follow-up comparisons found no significant differences between the Entolimod and saline groups before dosing or on days 3, 11 and 14. A difference recorded on day 7, at p = 0.0199, reflected a temporary increase in the saline group rather than weight loss in the Entolimod group, according to Valion Bio.
Serial complete blood count testing showed no disruption in the measured blood parameters. Valion Bio said all recorded values remained within normal reference ranges and that there were no statistically significant differences between the groups.
End-of-study serum chemistry testing assessed blood urea nitrogen, creatinine, total protein, glucose, AST, ALT and ALP. The company reported no statistically significant differences between the Entolimod-treated mice and the saline control group across those measures, describing the results as consistent with normal metabolic and organ function.
Following completion of the safety phase, AFRRI is planning a fully funded therapeutic study using a specialised gastrointestinal acute radiation syndrome mouse model. Entolimod would be administered after radiation exposure, with the study designed to evaluate survival and gastrointestinal tissue recovery.
Valion Bio described the planned work as the next stage of its AFRRI research programme. The company also cautioned that statements concerning the timing and outcome of studies, regulatory progress and future development remain subject to substantial risks and uncertainties.
Valion Bio is developing Entolimod as a potential medical countermeasure for the haematopoietic and gastrointestinal forms of acute radiation syndrome. The company describes the candidate as a Toll-like Receptor 5 agonist intended to activate NF-κB signalling pathways associated with cellular protection, tissue recovery and immune response.
Entolimod has received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration, according to Valion Bio. The company holds an exclusive, worldwide licence from Statera Biopharma to develop and commercialise the candidate for acute radiation syndrome, radiation-induced neutropenia and other indications.
Valion Bio reported final results from an AFRRI safety study of Entolimod in 20 male C57BL/6 mice.
The animals received a single subcutaneous dose of 0.72 mg/kg or a saline control at 0.2 mL, followed by 14 days of observation.
The company reported no evidence of treatment-related toxicity, with no statistically significant differences in measured blood or serum chemistry parameters.
AFRRI is planning a fully funded therapeutic study focused on survival and gastrointestinal tissue recovery after radiation exposure.
Valion Bio announced final data from a National Institute of Allergy and Infectious Diseases/Radiation and Nuclear Countermeasures Program-funded safety study of Entolimod. The study, conducted by the Armed Forces Radiobiology Research Institute, evaluated a single subcutaneous injection followed by a 14-day observation period in male C57BL/6 mice.
The study found no evidence of treatment-related toxicity following a single dose of Entolimod, according to Valion Bio. The company said the findings support continued evaluation in the next phase of the AFRRI research programme.
The study included a total of 20 male C57BL/6 mice, which were weighed and randomised into experimental groups including an untreated control group. The animals received either Entolimod or a saline vehicle control.
The study tested a single subcutaneous injection of Entolimod at 0.72 mg/kg. The saline vehicle control was administered at a fixed volume of 0.2 mL.
Investigators assessed clinical observations, body weight, complete blood counts and serum chemistry during the study. The observation period lasted 14 days after administration, with clinical observations recorded during the first hour and four hours after dosing and throughout the subsequent period.
Valion Bio reported that Entolimod-treated animals maintained stable body weights and that there was no statistically significant overall difference in mean body weight compared with control groups across all time points, with p = 0.1424. A group-by-time effect was recorded at p < 0.0001, while a day 7 difference at p = 0.0199 reflected a transient weight increase in the saline control group, according to the company.
Serial complete blood count evaluations found no disruptions to the measured haematologic parameters, Valion Bio said. All measured values remained within normal reference ranges, with no statistically significant differences between the groups.
End-of-study serum chemistry panels showed normal organ and metabolic function, according to Valion Bio. The panels evaluated blood urea nitrogen, creatinine, total protein, glucose, AST, ALT and ALP, with no statistically significant differences between the Entolimod-treated group and the saline control across the measured parameters.
Valion Bio is developing Entolimod as a potential medical countermeasure for acute radiation syndrome, including its haematopoietic and gastrointestinal forms. The company 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.
AFRRI is planning a fully funded therapeutic study using a specialised GI-ARS mouse model, according to Valion Bio. The study is designed to evaluate whether Entolimod administered after radiation exposure can improve survival and support gastrointestinal tissue recovery.
Valion Bio said the next AFRRI therapeutic study is expected to be fully funded. Interim Chief Executive Officer Dean Zikria said the programme is positioned to move into this study after completion of the safety phase, but the release also cautions that forward-looking statements about study timing and outcomes are subject to substantial risks and uncertainties.
Valion Bio's common stock trades on the Nasdaq Capital Market under the ticker symbol NASDAQ:VBIO.
Valion Bio said it is also advancing Entolasta, a next-generation TLR5 agonist designed for potential broader therapeutic applications including oncology supportive care, alongside potential programmes in neutropenia and immune dysfunction. Its wholly owned subsidiary, Velocity Bioworks, provides biologics contract development and manufacturing services to support Valion Bio's internal pipeline.