newsfilter
← Latest News
ACCESS Newswire·

Tivic Receives Formal Request for Information from Ukrainian Ministry of Health Regarding Strategic Stockpiling of Entolimod

  • Tivic Health Systems, Inc. (NASDAQ: TIVC) received a formal Request for Information (RFI) from the Ukrainian Ministry of Health on March 31, 2026, to evaluate Entolimod™ for Ukraine's national strategic reserves as a countermeasure against Acute Radiation Syndrome (ARS).
  • The Ukrainian Ministry of Health has requested a pre-submission meeting to discuss potential accelerated approval & a formal stockpiling agreement for Entolimod™.
  • Entolimod™ is a TLR5 agonist that activates the NF-κB signaling pathway to prevent apoptosis in both bone marrow & gastrointestinal (GI) tissues, offering dual-system protection that existing G-CSF therapies do not provide.
  • The company aims to advance its Entolimod™ program for neutropenia into physician-sponsored clinical trials later in 2026 to address chemotherapy-induced myelosuppression in cancer patients.
  • Tivic completed TechWatch meetings with BARDA & adjacent U.S. departments on January 26, 2026, & an expedited follow-up session on March 10, 2026, focusing on clinical data & domestic manufacturing readiness.
  • Entolimod™ holds Fast Track & Orphan Drug designations from the FDA, while Entolasta™, a next-generation TLR5 agonist, is being developed for broader oncology supportive care applications.
  • Tivic's subsidiary, Velocity Bioworks, operates as a CDMO to support the company's manufacturing needs & ensure supply chain security.