Valion Bio Announces Positive Safety Results From U.S. Government-Funded Entolimod Study, Paving Way For Therapeutic Efficacy Evaluation

The next planned mouse study will test survival and gastrointestinal recovery after radiation exposure.

Rhea-AI Summary

Valion Bio (NASDAQ:VBIO) announced final safety data for Entolimod from a government-funded mouse study supporting further evaluation for acute radiation syndrome.

The AFRRI study involved 20 male mice and assessed a single injection at 0.72 mg/kg over 14 days. Treated animals maintained stable body weights, with no statistically significant overall difference versus controls. Blood counts remained within normal ranges, and serum chemistry showed no significant differences versus saline controls.

AFRRI plans a fully funded therapeutic study to test whether Entolimod given after radiation exposure improves survival and gastrointestinal tissue recovery. The completed study assessed safety, not therapeutic efficacy.

Positive

• Minor pointEntolimod-treated mice maintained stable body weights, with no significant overall difference versus controls over 14 days.
• Minor pointBlood counts remained within normal reference ranges, with no statistically significant differences between groups.
• Minor pointSerum chemistry showed normal organ and metabolic function, without significant differences versus saline controls.
• Minor point. Forward-looking: it has not happened yet and may not happen.AFRRI plans a fully funded therapeutic study testing post-exposure survival and gastrointestinal tissue recovery.

Negative

• None.

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Key Figures

Study animals: 20 male mice Entolimod dose: 0.72 mg/kg Observation period: 14 days +3 more

Study animals

20 male mice

AFRRI safety study

Entolimod dose

0.72 mg/kg

Single subcutaneous injection

Observation period

14 days

After administration

Mean body weight comparison

p = 0.1424

No statistically significant overall difference versus controls

Group-by-time effect

p < 0.0001

Body-weight analysis; follow-up comparisons found no significant group differences on specified days

Day 7 weight difference

p = 0.0199

Transient weight increase in saline controls

Key Terms

acute radiation syndrome, subcutaneous, complete blood counts, animal rule, +2 more

6 terms

acute radiation syndrome medical

"forms of acute radiation syndrome (&quot;ARS&quot;)"

Acute radiation syndrome is the sudden illness that happens after a person absorbs a large dose of ionizing radiation in a short time, damaging blood cells, the gut, skin, and other organs. Think of it like a severe, internal burn that can impair a person’s ability to heal and fight infection. Investors watch it because outbreaks, accidents, or tests can trigger urgent regulatory action, reshape demand for medical treatments and protective equipment, create liability risks, and affect the operations and stock prices of companies in healthcare, energy, insurance, and related supply chains.

subcutaneous medical

"a single subcutaneous (&quot;SC&quot;) injection of Entolimod"

Subcutaneous means situated or applied just beneath the skin. In finance, the term can describe processes or investments that are hidden or not immediately visible, much like something placed under the skin that isn't easily seen from the outside. Recognizing subcutaneous activities helps investors understand underlying factors that may influence markets or asset values over time.

complete blood counts medical

"body weight, complete blood counts (&quot;CBC&quot;), and serum chemistry"

A complete blood count (CBC) is a routine laboratory test that measures the main components of blood: red blood cells (including hemoglobin and hematocrit), white blood cells (total count and often a differential showing types such as neutrophils and lymphocytes), and platelets, plus red cell size and hemoglobin content indices. It is performed on a small blood sample using automated analyzers and gives objective numbers used to detect or monitor anemia, infection, bleeding risk, bone marrow function and other hematologic changes. Limitation: a CBC provides quantitative signals about blood cell levels but usually cannot by itself determine the exact cause of an abnormal result—further clinical assessment or specialized tests are often needed.

animal rule regulatory

"evaluated in animal models under the U.S. Food and Drug Administration's (&quot;FDA&quot;) Animal Rule"

A regulatory pathway that allows safety and effectiveness of drugs or vaccines to be judged primarily from well-controlled animal studies when human trials would be unethical or impossible, such as for treatments against rare, lethal exposures. It matters to investors because approval via this route can speed a product to market for urgent or niche needs but carries extra scientific and regulatory risk—think of it as accepting a high-quality dress rehearsal instead of a live show, with requirements for strong animal models and often additional post-approval obligations.

fast track regulatory

"received Fast Track and Orphan Drug designations from the FDA"

A fast track designation is a regulatory label that speeds up the review and communication between a drug developer and regulators for treatments addressing serious illnesses or unmet medical needs. For investors, it matters because it can shorten development time and reduce regulatory delays—like getting a VIP lane at the airport—raising the chance of earlier market access and potential revenue, though it does not guarantee approval.

orphan drug designation regulatory

"received Fast Track and Orphan Drug designations from the FDA"

Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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SAN ANTONIO, TX / ACCESS Newswire / October 28, 2026 / Valion Bio, Inc. (NASDAQ:VBIO) ("Valion" or the "Company"), a clinical-stage biopharmaceutical company developing biologics that activate innate immune pathways for cytoprotection and immune modulation, today announced final data from a National Institute of Allergy and Infectious Diseases ("NIAID")/Radiation and Nuclear Countermeasures Program ("RNCP")-funded safety study of its lead biologic drug candidate, Entolimod, which is designed to protect 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.

"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," said Dean Zikria, Interim Chief Executive Officer of Valion Bio. "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."

Safety Study Demonstrates Favorable Findings Across Multiple Measures

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 3, 11, and 14. A minor divergence on day 7 (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 (BUN), 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.

Next Milestone: Therapeutic Efficacy Study Targeting Survival and GI Recovery in ARS

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.

"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," added Mr. Zikria. "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."

About Valion Bio, Inc.

Valion Bio, Inc. (NASDAQ:VBIO) is developing biologics that activate innate immune pathways for cytoprotection and modulate immune responses in conditions driven by radiation, disease and immune dysregulation.

The Company's lead candidate, Entolimod, is being developed as a potential medical countermeasure for Acute Radiation Syndrome ("ARS") and has been evaluated in animal models under the U.S. Food and Drug Administration's ("FDA") Animal Rule, which allows the Agency to approve new drugs and biological products based on animal efficacy studies when human clinical trials are not ethical or feasible, such as in the case of acute radiation exposure. Entolimod is a novel Toll-like Receptor 5 agonist designed to activate NF-κB signaling pathways associated with cellular protection, tissue recovery and immune response. The product candidate has received Fast Track and Orphan Drug designations from the FDA. Valion holds an exclusive, worldwide license from Statera Biopharma to develop and commercialize Entolimod for ARS, radiation-induced neutropenia, and other indications.

Valion is also advancing Entolasta, a next-generation TLR5 agonist designed for potential use in broader therapeutic applications, including oncology supportive care. The Company's pipeline includes potential programs in neutropenia and immune dysfunction.

Valion's wholly owned subsidiary, Velocity Bioworks, is a biologics contract development and manufacturing organization providing development and manufacturing services to Valion to support its internal pipeline, with the objective of increasing manufacturing control, reducing costs, accelerating development timelines and strengthening domestic supply-chain security.

For more information, visit www.valionbio.com.

Forward-Looking Statements

This press release may contain "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Valion's current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Forward-looking statements in this press release include, among others, statements regarding: the timing and success of preclinical and clinical trials and study results, including the AFRRI/NIAID studies described herein; the development and regulatory advancement of Entolimod under the FDA Animal Rule; the timing and outcome of regulatory or government interactions; the initiation, design, timing and outcome of investigator-sponsored studies in neutropenia; the development and potential applications of Entolasta; the ability of the Company to expand the TLR5 platform into oncology supportive care or other indications; and the Company's ability to obtain additional capital and the continued listing of the Company's common stock on the Nasdaq Capital Market. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Valion's actual results to differ from those contained in the forward-looking statements, see Valion's filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 30, 2026, under the heading "Risk Factors"; as well as the Company's subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and Valion undertakes no duty to update such information except as required by applicable law.

Investor and Media Contact
Stephen Kilmer
(646) 274-3580
stephen.kilmer@valionbio.com

SOURCE: Valion Bio, Inc.

View the original press release on ACCESS Newswire

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Valion Bio's Entolimod safety study show?

Entolimod-treated mice maintained stable body weights, normal blood counts and normal serum chemistry during the safety study. The study involved 20 male mice and evaluated a single subcutaneous injection at 0.72 mg/kg followed by a 14-day observation period.

What is the next study planned for Valion Bio's Entolimod?

AFRRI plans a fully funded therapeutic study using a mouse model of gastrointestinal acute radiation syndrome. It will evaluate whether Entolimod administered after radiation exposure can improve survival and support gastrointestinal tissue recovery.

Did mice lose weight in Valion Bio's Entolimod safety study?

Entolimod-treated mice maintained stable body weights throughout the study. A difference on day 7 reflected a transient weight increase in the saline control group rather than weight loss or toxicity in the Entolimod group; comparisons before dosing and on days 3, 11 and 14 showed no significant differences between those groups.