Tivic Secures NIAID Non-Clinical Evaluation Agreement for Entolimod, Targeting Gastrointestinal Acute Radiation Syndrome

Armed Forces Radiobiology Research Institute (AFRRI) Will Conduct the Gastrointestinal Acute Radiation Syndrome (GI-ARS) Study

Mar. 27, 2026 at 3:03am

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Tivic Health Systems Inc. (Nasdaq:TIVC), a clinical-stage immunotherapeutics company, has entered into an agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, to sponsor and conduct a series of preclinical studies evaluating Entolimod™ for gastrointestinal acute radiation syndrome (GI-ARS). The program is expected to support Tivic's development strategy for Entolimod™ as a medical countermeasure for acute radiation syndrome (ARS).

Why it matters

Currently approved ARS therapies primarily target the hematopoietic system, while damage to the gastrointestinal tract is a key determinant of survival at higher radiation doses and is not directly addressed by these agents. Entolimod's differentiated mechanism of activating innate immune pathways may enable a broader cytoprotective effect across multiple organ systems, including the GI tract, potentially addressing a major unmet need.

The details

Under the agreement, NIAID will fund and conduct GI-ARS studies, the first of which will be performed at the Armed Forces Radiobiology Research Institute (AFRRI). The study is designed to evaluate Entolimod's ability to protect GI tissue and mitigate radiation-induced mucosal necrosis following exposure to lethal radiation doses. The research will begin with mouse models and may advance to non-human primate studies provided the initial studies demonstrate efficacy. These preclinical studies are typically required to support regulatory approval under the FDA's Animal Rule.

  • The program is expected to support Tivic's development strategy for Entolimod™ as a medical countermeasure for acute radiation syndrome (ARS).
  • The research will begin with mouse models and may advance to non-human primate studies provided the initial studies demonstrate efficacy.

The players

Tivic Health Systems Inc.

A clinical-stage immunotherapeutics company developing biologics that activate innate immune pathways for cytoprotection and modulate immune responses.

National Institute of Allergy and Infectious Diseases (NIAID)

Part of the National Institutes of Health, NIAID will fund and conduct the GI-ARS studies.

Armed Forces Radiobiology Research Institute (AFRRI)

The institute that will conduct the first GI-ARS study under the agreement with NIAID.

Michael K. Handley

Chief executive officer of Tivic Health.

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What they’re saying

“Government-sponsored development of Entolimod represents an important step forward in addressing a critical gap in the treatment of acute radiation syndrome.”

— Michael K. Handley, Chief executive officer of Tivic Health

What’s next

The initial mouse model studies will determine if the research can advance to non-human primate studies, which would further support Tivic's efforts to seek regulatory approval for Entolimod under the FDA's Animal Rule.

The takeaway

Tivic's partnership with NIAID to evaluate Entolimod for gastrointestinal acute radiation syndrome represents a strategic move to address a significant unmet need in the treatment of acute radiation syndrome, which is not directly addressed by currently approved therapies.