Tivic Health Systems Scales Entolimod Manufacturing 200x, Achieves Reproducible Purity
Tivic Health Systems achieved a 200x scale-up in production of its lead TLR5 agonist candidate Entolimod, demonstrating reproducible yields, potency and purity via its CDMO Velocity Bioworks. The company will initiate cGMP manufacturing and pursue an FDA BLA filing ahead of its January 26 BARDA TechWatch meeting.
1. Tivic Achieves 200x Scale-Up in Entolimod Manufacturing
On January 12, 2026, Tivic Health Systems completed a 200-fold increase in manufacturing volume for its lead Toll-like Receptor 5 agonist, Entolimod, through its wholly-owned contract development and manufacturing organization, Velocity Bioworks. The company reported consistent yields, potency and purity across multiple production runs, validating its process controls and analytical methods. This commercial-scale demonstration precedes the transition to current Good Manufacturing Practice (cGMP) production, a prerequisite for filing a Biologics License Application (BLA) with the U.S. Food and Drug Administration. Management highlighted that the milestone positions Entolimod for Acute Radiation Syndrome and neutropenia indications, reinforcing Tivic’s late-stage immunotherapeutics profile.
2. Strategic Engagement with BARDA Ahead of TechWatch Meeting
Tivic noted that the manufacturing achievement comes ahead of a January 26 meeting with the Biomedical Advanced Research and Development Authority (BARDA) under the U.S. Department of Health and Human Services. The TechWatch session will review Entolimod’s federal strategic relevance for national defense and civilian use in acute radiation exposure scenarios. Company leadership emphasized that a favorable outcome could unlock continued cost-share arrangements or procurement commitments, potentially supporting scale-up funding and derisking the BLA pathway.