Tivic Health Systems has received two investigational new drug applications (INDs) from Statera Biopharma for its lead immunotherapeutic candidate Entolimod, marking a significant regulatory milestone that advances the drug's development pathway for multiple indications.
The transferred INDs cover two distinct therapeutic areas: treatment of acute radiation syndrome, including both hematopoietic (ARS-H) and gastrointestinal (ARS-GI) sub-syndromes, and treatment of advanced cancers as an anti-tumor agent and for conditions resulting from cancer treatments.
Regulatory Pathway and Clinical Development Strategy
The IND transfer enables Tivic to formally engage with the FDA regarding Entolimod's regulatory pathway and pursue clinical trial programs in neutropenia, lymphocyte exhaustion, and other cancer-related conditions. According to Tivic CEO Jennifer Ernst, "While the IND for advanced cancers allows exploration of Entolimod's anti-tumor activity, building on prior developments, we remain focused in the near-term on Entolimod's first indication--acute radiation syndrome."
Mechanism of Action and Clinical Evidence
Entolimod functions as a novel TLR5 agonist that triggers NF-kB signaling, activating antiapoptotic and cell protective mechanisms. Under the FDA's Animal Rule, the drug has undergone extensive trials for acute radiation syndrome treatment, demonstrating robust survival benefits, enhanced gastrointestinal tract recovery, and improved hematopoiesis in animal models.
The compound has already received Fast Track designation from the FDA for acute radiation syndrome, reflecting the agency's recognition of its potential to address an unmet medical need in this critical indication.
Expanded Therapeutic Portfolio
Beyond acute radiation syndrome, Tivic holds exclusive rights for Entolimod in neutropenia treatment and maintains options to license additional indications including lymphocyte exhaustion, immunosenescence, and chronic radiation syndrome. This broad therapeutic potential positions the drug candidate across multiple areas of immune system dysfunction.
Company Platform Strategy
Tivic's dual platform strategy leverages both biopharmaceutical and bioelectronic systems to address unmet medical needs through immune system targeting. The company's biologics compounds are designed to activate innate immune pathways that prevent cell death in bone marrow and epithelial tissues across systems impacted by radiation and aging processes.
The IND transfers represent a crucial step in advancing Entolimod through late-stage development, with the company positioned to pursue multiple clinical pathways while maintaining strategic focus on its primary acute radiation syndrome indication.
