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

“Transfer of these INDs to Tivic allows us to formally engage the FDA regarding Entolimod's regulatory pathway and enables clinical trials in neutropenia, lymphocyte exhaustion, and other cancer-related conditions,” stated 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.”