Company demonstrates commercial-scale production of its Toll-like Receptor 5 (TLR5) agonist for Acute Radiation Syndrome (ARS) and Neutropenia through wholly owned contract development manufacturing organization (CDMO), Velocity Bioworks
Company's next step is to initiate production under current Good Manufacturing Practice (cGMP), a critical milestone moving towards filing a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA)
Milestone achieved in advance of January 26 TechWatch meeting with the Biomedical Advance Research and Development Authority (BARDA) to discuss federal strategic relevance of Entolimod for ARS
FREMONT, CA AND SAN ANTONIO, TX / ACCESS Newswire / January 12, 2026 / Tivic Health Systems, Inc. (Nasdaq:TIVC), a late-stage immunotherapeutics company, today announced it has delivered a 200x scale-up in manufacturing volume for Tivic's lead drug candidate Entolimod. Entolimod is a TLR5 agonist in development to treat ARS, as well as Neutropenia and other cancer-related conditions. This scale-up was completed by Tivic's wholly owned CDMO, Velocity Bioworks, the acquisition of which has enabled Tivic to quickly advance towards cGMP manufacturing, a requirement for filing a BLA for Entolimod for ARS with the FDA.
As part of the verification and validation process, Tivic successfully demonstrated Entolimod at a 50-liter production volume, equivalent to approximately 1.3 million human doses, with purity and potency meeting all drug release requirements. In addition, yields were consistent with historical batches produced.
"In less than one year, Tivic has accomplished extraordinary acceleration in the potential commercialization of Entolimod -- from initial licensing through completion of cell validation, and now verification of a scale-up batch that represents a 200-fold increase in volume without compromising the drug substance or yields," said Tivic CEO Jennifer Ernst.
"Last month," she added, "Tivic acquired, at a favorable valuation, certain CDMO assets that are now branded as Velocity Bioworks. This acquisition has immediately enhanced our operational and cost efficiencies for manufacturing Entolimod. We anticipate rapidly advancing to commercial-scale production at 200?liters under cGMP conditions, the next step in our path to a BLA filing, and ultimately commercialization."
Ernst concluded, "As we prepare for our meeting with BARDA later this month, we have demonstrated large-scale manufacturing readiness, with the capability to produce millions of doses of Entolimod for ARS. We will also present robust clinical evidence supporting Entolimod's differentiated potential versus existing ARS countermeasures, including its ability to mitigate and prevent both gastrointestinal and hematopoietic injury, reinforcing our strategy to advance Entolimod as a priority therapeutic asset for government partnership or potential acquisition."
About BARDA TechWatch Meetings
BARDA is part of the Administration for Strategic Preparedness and Response and operates within the U.S. Department of Health and Human Services agency to develop, procure, and stockpile medical countermeasures that address chemical, biologic, radiologic, and nuclear public health threats. The TechWatch format enables BARDA and other US agencies to evaluate technology and manufacturing readiness, and potential pathways to funding and purchasing of new technologies. Tivic anticipates exchanging technical information with BARDA, presenting potential development pathways for Entolimod for ARS as a potential mitigant and/or therapeutic in mass-casualty or field deployment situations, and as part of the strategic national stockpile.
About Entolimod
Entolimod is a novel Toll-like Receptor 5 (TLR5) agonist that triggers NF-kappaB pathway signaling, activating anti-apoptotic and cell protective mechanisms. Entolimod for Acute Radiation Syndrome (ARS) has been the subject of extensive trials under the FDA's Animal Rule and in animal models has demonstrated robust survival rates, enhanced gastrointestinal tract recovery, and improved hematopoiesis. To see the complete Tivic pipeline visit: https://tivichealth.com/pipeline/
About Tivic
Tivic is a late-stage immunotherapeutics company whose lead drug candidate, Entolimod to treat ARS, is in late-stage development. Entolimod is a TLR5 agonist that activates an innate immune pathway to prevent cell death in the bone marrow and epithelial tissues across systems impacted by radiation and age. The pipeline includes Entolimod to treat Neutropenia, and lymphocyte exhaustion, as well as Entolasta, an immunologically optimized variant of Entolimod for chronic applications.
Tivic's wholly owned subsidiary, Velocity Bioworks, is a full-service CDMO based in San Antonio, Texas. Tivic also leverages Velocity Bioworks' manufacturing capabilities to advance its own drug pipeline with the expected benefits of lower costs, accelerated manufacturing outcomes and supply chain security. To learn more about Tivic, visit: https://tivichealth.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 Tivic Health Systems Inc.'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, including as a result of the company's interactions with and guidance from the FDA and other regulatory authorities; the ability of the company to achieve the expected benefits from the acquisition of development and manufacturing assets within expected time frames or at all; changes to the company's relationship with its partners; failure to obtain FDA or similar clearances or approvals and noncompliance with FDA or similar regulations; the company's future development of its ncVNS treatment, Entolimod and Entolasta; changes to the company's business strategy; timing and success of clinical trials and study results; regulatory requirements and pathways for approval; the company's ability to successfully commercialize its product candidates in the future; changes in the markets and industries in which the company does business; consummation of any strategic transactions; the company's need for, and ability to secure when needed, additional working capital; the company's ability to maintain its Nasdaq listing; and changes in tariffs, inflation, legal, regulatory, political and economic risks. Accordingly, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of risks and uncertainties relevant to the company, and other important factors, see Tivic Health's filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 21, 2025, 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 the company undertakes no duty to update such information except as required by applicable law.
Investor Contact:
Hanover International, Inc.
ir@tivichealth.com
Media Contact:
DJ Freyman
DJ@fastrackPR.com
SOURCE: Tivic Health Systems
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/tivic-delivers-200x-scale-up-in-manufacturing-for-lead-drug-candidate-1126283
