Entolasta™
Search documents
Tivic CEO To Present at the Upcoming Emerging Growth's April 2026 Virtual Conference
Accessnewswire· 2026-03-27 15:30
Core Viewpoint - Tivic Health Systems, Inc. will have its CEO, Michael K Handley, present at the Emerging Growth Virtual Conference on April 1-2, 2026, to discuss recent corporate milestones, including a significant agreement with NIAID for a preclinical study on Entolimod for gastrointestinal acute radiation syndrome [2][3]. Group 1: Corporate Milestones - The presentation will cover the recent agreement with the National Institute of Allergy and Infectious Diseases (NIAID) to sponsor a preclinical study evaluating Entolimod for gastrointestinal acute radiation syndrome (GI-ARS) [3]. - If the study data shows efficacy, NIAID may support future studies for GI-ARS using Entolimod [3]. Group 2: Conference Details - The conference will take place on April 1-2, 2026, with Michael K Handley presenting on April 1 from 2:55-3:05 PM Eastern Time [4]. - Attendees can register for the event and an archived webcast will be available for those unable to join live [4]. Group 3: Company Overview - Tivic Health is focused on developing biologics that activate innate immune pathways for cytoprotection and modulate immune responses in conditions driven by radiation, disease, and immune dysregulation [6]. - The lead candidate, Entolimod, has shown survival benefits and improved tissue recovery in animal models and has received Fast Track and Orphan Drug designations from the FDA [7]. - Tivic is also advancing Entolasta, a next-generation TLR5 agonist aimed at broader therapeutic applications, including oncology supportive care [8].
Tivic Secures NIAID Non-Clinical Evaluation Agreement for Entolimod, Targeting Gastrointestinal Acute Radiation Syndrome
Accessnewswire· 2026-03-26 12:30
Core Viewpoint - Tivic Health Systems Inc. has secured a non-clinical evaluation agreement with the National Institute of Allergy and Infectious Diseases (NIAID) to conduct preclinical studies on Entolimod for gastrointestinal acute radiation syndrome (GI-ARS) [2][4]. Group 1: Agreement and Study Details - The agreement allows NIAID to fund and conduct studies at the Armed Forces Radiobiology Research Institute (AFRRI) to evaluate Entolimod's efficacy in protecting GI tissue from radiation-induced damage [4][6]. - The initial studies will utilize mouse models, with potential advancement to non-human primate studies if initial results are promising [5]. Group 2: Strategic Importance - The development of Entolimod is seen as a critical advancement in addressing the treatment gap for acute radiation syndrome, particularly for gastrointestinal injuries, which are not effectively targeted by existing therapies [7][8]. - Currently approved therapies primarily focus on the hematopoietic system, leaving a significant unmet need for GI protection [8]. Group 3: Mechanism and Regulatory Pathway - Entolimod acts as a Toll-like receptor 5 (TLR5) agonist, activating NF-kB signaling pathways to potentially protect multiple tissue types from radiation damage [9][11]. - The studies are designed to support regulatory approval under the FDA's Animal Rule, facilitating an expedited Biologics License Application (BLA) submission [9][10]. Group 4: Company Overview - Tivic Health is focused on developing biologics that activate innate immune pathways for cytoprotection and modulate immune responses in various conditions, including radiation exposure [10]. - The company is also advancing Entolasta, a next-generation TLR5 agonist aimed at broader therapeutic applications, including oncology supportive care [12].