TIVC News & Events

Tivic announced that a second, follow-up meeting with the Biomedical Advanced Research and Development Authority has been scheduled for March 10, to continue discussions focused on clinical data and the potential for funding and, ultimately, stockpiling Entolimod for Acute Radiation Syndrome. On January 26, Tivic attended an initial TechWatch meeting with BARDA and presented clinical data for Tivic's Toll-like Receptor 5 agonist, Entolimod, to potentially be used as a radiation countermeasure. The presentation discussed characteristics of Entolimod that are expected to distinguish it mechanistically from currently approved ARS therapies. Tivic also highlighted the company's manufacturing readiness, enabled through Tivic's newly formed biomanufacturing subsidiary Velocity Bioworks. Following this meeting, key government attendees recommended a follow-up meeting as soon as possible. "We see this invitation by the U.S. government to return for further discussions on the differentiated properties of Entolimod as a promising sign," said CEO Jennifer Ernst. "Our goal for this meeting is to explore potential government support for continued development of Entolimod, including activities necessary to pursue FDA approval and potentially incorporating Entolimod into the Strategic National Stockpile."

Tivic Health delivered an invited presentation at a TechWatch meeting with the Biomedical Advanced Research and Development Authority on January 26, with select members of the Department of Defense, Defense Threat Reduction Agency, National Institutes of Health (NIH) and National Institute of Allergy and Infectious Diseases. The company presented key clinical and manufacturing readiness data for Tivic's Toll-like Receptor 5 agonist, Entolimod, underscoring its potential use as a radiation countermeasure, as well as progress on manufacturing readiness that has been accelerated by newly formed subsidiary Velocity Bioworks.TechWatch meetings enable BARDA and other U.S. agencies to evaluate technology and manufacturing readiness and to identify potential pathways for funding and purchasing new technologies. Monday's meeting initiated Tivic's discussions with the agency regarding the potential for incorporating Entolimod into the Strategic National Stockpile, with key stakeholders requesting expedited follow-up. "We appreciate the U.S. government's interest in the differentiated properties of Entolimod compared to the other drugs already stockpiled for treating ARS," said Tivic CEO Jennifer Ernst. "We are fully committed to supporting BARDA and other agencies in their exploration of Entolimod through our upcoming engagements."

Tivic Health 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.