Tivic Delivers 200x Scale-up in Manufacturing for Lead Drug Candidate Entolimod(TM) And Achieves Reproducible Yields, Potency and Purity
Tivic Health SystemsTivic Health Systems(US:TIVC) Accessnewswire·2026-01-12 14:00

Core Insights - The company has successfully demonstrated commercial-scale production of its TLR5 agonist for Acute Radiation Syndrome (ARS) and Neutropenia through its wholly owned contract development manufacturing organization (CDMO) [1] - The next step for the company is to initiate production under current Good Manufacturing Practice (cGMP), which is a critical milestone towards filing a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) [1] - This milestone was achieved ahead of the January 26 TechWatch meeting with the Biomedical Advance Research and Development Authority (BARDA) to discuss federal strategic reliance on Entolimod for ARS [1] Company Developments - Tivic Health® Systems, Inc. has announced a 200x scale-up in manufacturing volume for its lead drug candidate Entolimod [1] - Entolimod is a TLR5 agonist being developed to treat ARS, Neutropenia, and other cancer-related conditions [1]