Tivic receives request from Ukraine for radiation syndrome treatment

Tivic Health Systems Inc. (NASDAQ: TIVC) received a formal Request for Information from the Ukrainian Ministry of Health regarding its Entolimod treatment for potential inclusion in Ukraine's national strategic reserves as a countermeasure against Acute Radiation Syndrome.

The Ukrainian Ministry of Health also requested to schedule a pre-submission meeting for Entolimod, according to the company's announcement. Entolimod is a late-stage Toll-like Receptor 5 agonist developed by the San Antonio-based clinical-stage immunotherapeutics company.

"We are working closely with the Ukrainian Ministry of Health to establish a pathway toward potential accelerated approval and a formal stockpiling agreement," said Michael K. Handley, chief executive officer of Tivic.

Entolimod functions differently from currently stockpiled treatments such as Neupogen, Neulasta, and Leukine by activating the NF-κB signaling pathway to prevent programmed cell death in both bone marrow and gastrointestinal epithelial tissues. Current approved therapies stimulate white blood cell recovery but do not address gastrointestinal tract damage at higher radiation doses.

The company has engaged with U.S. authorities, completing TechWatch meetings with the Biomedical Advanced Research and Development Authority on January 26 and March 10. These discussions focused on Entolimod's clinical data and domestic manufacturing capabilities.

Entolimod has received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration. The treatment has demonstrated survival benefits in animal models under the FDA's Animal Rule.

Tivic is also developing the treatment for oncology supportive care applications, targeting neutropenia in cancer patients undergoing chemotherapy and radiation. The company plans to advance this program into physician-sponsored clinical trials later this year.

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