Valion Bio, Inc. reports company developments tied to its TLR5 agonist immunotherapeutic pipeline, including Entolimod™ for Acute Radiation Syndrome and oncology supportive care and Entolasta™ as a next-generation TLR5 agonist. Recurring updates include financial results, business updates, FDA pathway and designation references, government and biodefense engagement, and clinical-development positioning for supportive-care indications.
Valion Bio news also covers its completed rebranding from Tivic Health Systems, the Nasdaq ticker change to VBIO, leadership and legal-governance appointments, and activity at Velocity Bioworks, the company's wholly owned CDMO subsidiary in San Antonio.
Valion Bio (NASDAQ:VBIO) announced that Entolimod will advance into a government-funded animal study testing survival after radiation exposure. The Armed Forces Radiobiology Research Institute will evaluate treatment for gastrointestinal acute radiation syndrome, a form of radiation injury affecting the gut, following previously announced positive safety results.
The study is fully funded by NIAID's Radiation and Nuclear Countermeasures Program through an interagency agreement. Mice will receive Entolimod or saline 24 hours after radiation exposure and undergo 30 days of monitoring. The primary endpoint is survival compared between groups. Top-line results are anticipated in early December, the company said.
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.
Valion Bio (NASDAQ:VBIO) has received unsolicited acquisition inquiries from independent third parties for its wholly owned manufacturing subsidiary, Velocity Bioworks.
Valion has entered preliminary discussions and is evaluating strategic options, including a possible sale, while continuing to operate Velocity and pursue new customers. It has retained an investment banking firm to advise its board on a potential transaction. The review will consider valuation, terms, execution certainty and potential net proceeds.
Valion identifies retaining production rights and securing continued manufacturing capabilities for Entolimod, and potentially other pipeline assets, as a priority. Depending on its structure, a sale could provide capital for Entolimod development and other corporate priorities. Discussions remain preliminary, with no commitment to a sale or other specific transaction.
Valion Bio (NASDAQ:VBIO) outlined development priorities and a strategic review of Velocity Bioworks following its interim chief executive's first 30 days.
The agenda covers Entolimod development, customer acquisition for the wholly owned biologics manufacturer, and potential partnerships, co-investment, licensing or a sale of Velocity. No specific transaction has been committed to.
Entolimod has received approximately $35.6 million in non-dilutive U.S. government funding and holds FDA Fast Track and Orphan Drug designations for Acute Radiation Syndrome. Work includes an AFRRI evaluation of gastrointestinal radiation injury, preparations with Sheba Medical Center toward a cancer-patient trial, and an oral mucosal formulation with Shear Kershman Laboratories.
Valion also plans to advance Entolasta for potential therapeutic applications, including oncology supportive care, with program decisions guided by evidence, milestones and resource requirements.
Valion Bio (NASDAQ:VBIO) announced that its Velocity Bioworks subsidiary completed an initial feasibility evaluation of LarmorBio’s BioScan-NMR platform for biologics manufacturing. The evaluation found a correlation between the platform’s signal and OD600, an optical measurement used to estimate cell density in liquid cultures. The results indicate that nuclear magnetic resonance, or NMR, measurements have the potential to track microbial growth during fermentation.
The project remains an early-stage proof-of-concept, rather than an implemented continuous monitoring system. Velocity Bioworks intends to use the results to guide further development, including assessment of closed-system and continuous monitoring capabilities. Valion sees potential for greater visibility into fermentation without relying solely on invasive sampling, but reliable monitoring of additional critical process attributes remains subject to subsequent development work.
Valion Bio (VBIO) highlighted its wholly owned Velocity Bioworks subsidiary’s U.S. manufacturing capabilities for biologics programs in early clinical development.
The San Antonio facility offers process development, analytical services and drug substance manufacturing under good manufacturing practice (GMP) standards. Its microbial manufacturing capacity reaches 200 liters, and it also maintains mammalian manufacturing capabilities. Velocity supports Valion’s internal pipeline, including Entolimod, a potential treatment for Acute Radiation Syndrome. Valion is inviting discussions with potential external partners amid increased focus on domestic pharmaceutical manufacturing following the Section 232 tariff framework.
Valion Bio (VBIO) and Shear Kershman Laboratories have completed formulation work on an oral mucosal version of Entolimod for radiation emergencies. The formulation uses SKL's BioViscid platform and is designed for absorption through the lining of the mouth. It remains in development alongside injectable Entolimod for acute radiation syndrome (ARS), illness caused by high-dose radiation exposure.
Published animal studies of injected Entolimod demonstrated protection against lethal radiation before exposure, involving bone marrow and gastrointestinal tissues. Separate non-human-primate research reported improved survival and recovery of bone marrow and intestinal tissue after exposure. Valion believes a successfully developed and approved needle-free formulation could reduce reliance on personnel administering injections and support distribution across large populations.
Valion Bio (NASDAQ:VBIO) outlined new Board Chair Thomas H. Jensen’s priorities for advancing Entolimod, its investigational treatment for acute radiation syndrome.
Jensen has chaired the board since September 2026 and is working with management to align priorities with execution. He also serves as CEO and a director of Allarity Therapeutics. Entolimod’s development has received approximately $35.6 million in non-dilutive U.S. government funding and holds FDA Fast Track and Orphan Drug designations for acute radiation syndrome. Jensen sees a longer-term opportunity to explore Entolimod in cancer supportive care. Valion’s wholly owned Velocity Bioworks provides manufacturing support.
Valion Bio (NASDAQ:VBIO) and Shear Kershman Laboratories completed formulation work on oral mucosal Entolimod, advancing a potential alternative to injections. The investigational radiation-protection biologic was incorporated into SKL's BioViscid platform for delivery through the mouth lining. The next milestone is determining whether this route produces measurable exposure in the bloodstream and characterizing absorption.
Published studies of injected Entolimod showed protection in mice treated before radiation and improved survival in non-human primates treated 48 hours afterward. These results do not establish oral formulation performance. Valion estimates potential U.S. dose requirements could be approximately 10 to 40 times those of its injectable program if development and authorization or approval succeed. This is not a revenue forecast or committed demand; realization depends on performance, regulatory decisions, procurement priorities and funding.
Valion Bio (VBIO) appointed Board member Dean Zikria as Interim CEO and announced multiple Board leadership changes as it advances its Entolimod program.
Zikria will oversee strategic priorities that include accelerating clinical development of Entolimod and pursuing commercial and government partnerships. He brings experience spanning academic drug invention, seven years in strategy and business development roles within Pfizer’s U.S. cardiovascular business, and advisory work with UC Berkeley’s SkyDeck accelerator. Lisa Wolf remains President, COO and CFO, reporting to Zikria.
Thomas Jensen becomes Chair of the Board and Chair of the Compensation Committee, while Jared Malbin assumes the role of Audit Committee Chair. Former Board Chair Sheryle Bolton has stepped down from the Board and its committees.
Valion continues to develop Entolimod and next‑generation TLR5 agonist Entolasta, supported by in‑house CDMO subsidiary Velocity Bioworks.