Tivic Health Signs Validation Agreement with Scorpius for FDA Submission of Entolimod

Reuters
14 May
Tivic Health Signs Validation Agreement with Scorpius for FDA Submission of Entolimod

Tivic Health Systems Inc. (Nasdaq: TIVC), a diversified therapeutics company based in Fremont, California, has announced a definitive agreement with Scorpius BioManufacturing. This agreement aims to complete the GMP manufacturing validation of Tivic's lead candidate, Entolimod™, which is intended for the treatment of Acute Radiation Syndrome $(ARS.UK)$. The validation process is a crucial step in preparing for the submission of a Biological Licensing Application $(BLA.AU)$ to the U.S. Food & Drug Administration. Scorpius BioManufacturing, a subsidiary of Scorpius Holdings Inc. (OTC:SCPX) and an experienced contract development and manufacturing organization, will leverage its facility in San Antonio, Texas, for the process. The GMP Validation Program, valued at approximately $4.1 million, includes comprehensive activities to ensure a complete chemistry, manufacturing, and control $(CMC)$ package is submitted to the FDA. The partnership highlights Scorpius' expertise in biomanufacturing and its strategic advantage in manufacturing the product domestically, aiming for streamlined commercial success.

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