Tivic Health receives IND approvals from Statera Biopharma for Entolimod treatment of acute radiation syndrome and advanced cancers.

Tivic Health has received two investigational new drug applications from Statera Biopharma for its lead candidate, Entolimod. The INDs cover the use of Entolimod to treat acute radiation syndrome and advanced cancers, including as an anti-tumor agent and for conditions resulting from cancer treatments.

Tivic Health Systems, Inc. (Nasdaq: TIVC) has received two investigational new drug applications (INDs) from Statera Biopharma for its lead candidate, Entolimod. The INDs cover the use of Entolimod to treat acute radiation syndrome (ARS), including both hematopoietic (ARS-H) and gastrointestinal (ARS-GI) sub-syndromes, as well as advanced cancers, including as an anti-tumor agent and for conditions resulting from cancer treatments [1].

The transfer of these INDs to Tivic allows the company to formally engage the FDA regarding Entolimod's regulatory pathway and enables clinical trials in neutropenia, lymphocyte exhaustion, and other cancer-related conditions. While the IND for advanced cancers allows exploration of Entolimod's anti-tumor activity, Tivic remains focused on Entolimod's first indication—acute radiation syndrome [2].

Entolimod is a novel TLR5 agonist that triggers NF-kB signaling, activating antiapoptotic and cell protective mechanisms. Under the FDA’s Animal Rule, Entolimod 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 [1].

Tivic's dual platform strategy utilizes the body’s biopharmaceutical and bioelectronic systems to treat unmet medical needs through targeting the immune system. The company'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. Tivic’s lead drug candidate, Entolimod™ for acute radiation syndrome, is in late-stage development [2].

The INDs received by Tivic represent a significant milestone in the company's efforts to develop Entolimod as a treatment for acute radiation syndrome and advanced cancers. The success of these INDs could pave the way for clinical trials and potential regulatory approvals, enhancing Tivic's portfolio and market position.

References:
[1] https://www.businesswire.com/news/home/20250820053049/en/Tivic-Receives-Two-Investigational-New-Drug-Applications-for-Entolimod-for-the-Treatment-of-Acute-Radiation-Syndrome-ARS-and-Advanced-Cancers
[2] https://www.nasdaq.com/press-release/tivic-receives-two-investigational-new-drug-applications-entolimodtm-treatment-acute