Tivic Health delivers 200x scale-up in manufacturing for entolimod

Tivic Health (TIVC) 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.