AUSTIN, TX, USA and HAMILTON, Canada and SOUTH SAN FRANCISCO, CA, USA I October 26, 2023 ITriumvira Immunologics, a clinical-stage company developing novel, targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid tumors, today announced that the first patient has been dosed in Phase II of its Phase I/II study TACTIC-2 (NCT04727151) investigating the safety and efficacy of autologous TAC-T cell lead asset, TAC01-HER2, in targeting HER2 in relapsed or refractory gastric and gastroesophageal junction (GEJ) tumors. TAC01-HER2 is a novel cell therapy based on genetically engineered autologous T cells expressing a T-cell Antigen Coupler (TAC) that recognizes human epidermal growth factor receptor 2 (HER2).

“This marks a significant milestone for our company, building upon the determination of the recommended Phase II dose, identifying gastric and gastroesophageal cancer patients as targets for the Phase II registration supporting study and the positive benefit we observed during the Phase I part of TACTIC-2,” said Deyaa Adib, M.D., Chief Medical Officer of Triumvira Immunologics. “Despite considerable advances in the oncology field, HER2-positive gastric and gastro-esophageal cancers remain difficult to treat, and new therapeutic options are urgently needed especially in later treatment lines in a growing patient segment. Our TAC technology offers a novel approach that works by leveraging the natural signaling pathways of endogenous TCRs and modifying T cells into TAC T cells with demonstrated success in the treatment of these tumors. We are committed to providing clinically meaningful therapeutic benefits to this patient population with high unmet medical needs.”

TACTIC-2 is an open-label, multicenter Phase I/II study that aims to establish safety, maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D), pharmacokinetic profile and efficacy of TAC01-HER2 as a monotherapy, and in combination with pembrolizumab, in subjects with HER2 positive gastric and gastroesophageal adenocarcinoma.

About Triumvira Immunologics

Triumvira Immunologics, Inc. (“Triumvira”) is a leading clinical-stage solid tumor cell therapy company developing unique, non-gene edited, first-in-class targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid tumors. The company’s proprietary T cell Antigen Coupler (TAC) technology is a robust and versatile platform that activates natural T cell functions differently from cell therapies such as CAR-T and engineered T cell receptor (TCR) therapies. Triumvira is developing a broad pipeline targeting promising tumor-associated antigens such as HER2, Claudin 18.2, GUCY2C and GPC3. Triumvira is headquartered in Austin, Texas, with research facilities in Hamilton, Ontario, and GMP manufacturing facilities in South San Francisco, California.

SOURCE: Triumvira Immunologics