Tivic Completes Verification of Entolimod™ Cell Line: First Step in Establishing CGMP Manufacturing for BLA Filing

FREMONT, Calif.--(BUSINESS WIRE)--Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified immunotherapeutics company, today announced that it has completed verification of its Entolimod™ cell line, the first step in establishing Current Good Manufacturing Practices (CGMP) in preparation for a Biologics License Application, or BLA.

Cell line verification in recombinant protein production is required because it ensures the processes used to grow cells and activate protein expression do not compromise the structural integrity of the protein or cause unwanted modifications that might adversely affect a protein’s function.

As part of the verification process, Tivic successfully produced new Entolimod proteins with its partner, Scorpius Biomanufacturing. In vitro testing then verified that the resulting protein structure and yields are suitable to move into larger batch production.

“The successful verification of our Entolimod protein production is a significant milestone towards commercialization of Entolimod,” stated Tivic CEO, Jennifer Ernst.

About Entolimod

Entolimod is a novel Toll-like Receptor 5 (TLR5) agonist that triggers NF-kB signaling, activating antiapoptotic and cell protective mechanisms. Under the FDA’s Animal Rule, Entolimod has been the subject of extensive trials for the treatment of acute radiation syndrome (ARS), and has demonstrated robust survival, enhanced GI tract recovery and improved hematopoiesis in animal models. Entolimod has been granted Fast Track Designation for ARS.

Tivic also holds the exclusive rights for Entolimod for the treatment of neutropenia, and has the option to license additional indications, including lymphocyte exhaustion, immunosenescence, and chronic radiation syndrome.

About Tivic Health Systems, Inc.

Tivic’s dual platform utilizes the body’s biopharmaceutical and bioelectronic systems to treat unmet medical needs through targeting the immune system.

Tivic’s biologics compounds activate an innate immune pathway to prevent cell death in the bone marrow and epithelial tissues across systems impacted by radiation and age. The company’s lead drug candidate, Entolimod™ for acute radiation syndrome, is a novel TLR5 agonist that has been granted Fast Track and Orphan Drug designations and is in late-stage development.

Tivic’s bioelectronic program is developing a novel, non-invasive medical device designed to target the neural pathways implicated in many prevalent and debilitating diseases. Early trials show promising signals that Tivic’s approach may regulate specific biologic responses, and the company believes its early-stage vagus nerve stimulation device has the potential to deliver clinical outcomes similar to or better than those of surgically implanted devices. To learn more about Tivic, visit: https://ir.tivichealth.com

Forward-Looking Statements

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