- Tivic Health Systems (TIVC, Financial) partners with Scorpius BioManufacturing for GMP manufacturing validation.
- The validation focuses on Tivic's lead candidate, Entolimod™, for addressing Acute Radiation Syndrome (ARS).
- The program is valued at approximately $4.1 million, setting the stage for a BLA submission to the FDA.
Tivic Health Systems, Inc. (TIVC), a prominent therapeutics company, has formalized a definitive agreement with Scorpius BioManufacturing to execute the Good Manufacturing Practice (GMP) manufacturing validation of its lead candidate Entolimod™. This critical development is aimed at treating Acute Radiation Syndrome (ARS) and is part of Tivic's strategic preparation for filing a Biological Licensing Application (BLA) with the U.S. Food & Drug Administration (FDA).
Headquartered in San Antonio, Texas, Scorpius BioManufacturing, Inc., a subsidiary of Scorpius Holdings Inc. (SCPX), will serve as the primary U.S. manufacturer for Entolimod™. The GMP validation program, valued at approximately $4.1 million, will encompass a comprehensive suite of activities, including cell line verification, legacy process verification, GMP scale-up production, drug product fill and finish, analytical development and qualification, as well as upstream and downstream process optimization.
Jennifer Ernst, CEO of Tivic, expressed confidence in Scorpius' specialized focus on biologicals manufacturing and its extensive experience with Department of Defense programs. She emphasized that these capabilities make Scorpius the ideal partner for completing the GMP manufacturing validation for the BLA submission. The utilization of Scorpius' domestic facility is expected to streamline the supply chain and accelerate the path toward commercial success.
Tivic believes that Entolimod™ holds a unique position in the treatment of ARS, potentially serving as the sole therapy to prevent and treat radiation-induced damage to human hematopoietic and gastrointestinal cells. With FDA Fast Track and Orphan Drug designations in place, Tivic is poised to advance their bioelectronic and biopharma innovations, aiming to enhance patient outcomes in critical care settings.
