First-in-Human – T-Cell Therapy Clinical Trial.

TACTIC-2 marks first in-human use of TAC-T cell therapy.

T-cell-therapy Clinical Trial

Triumvira Immunologics Inc. today announced that the first patient has been dosed as part of the TACTIC-2 trial evaluating the company’s lead candidate, TAC01-HER2, an autologous T cell therapy for the treatment of human epidermal growth factor receptor 2 (HER2) positive solid tumors. Triumvira, a clinical-stage company, is developing novel, targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid and liquid tumors. The company’s proprietary T cell Antigen Coupler (TAC) platform technology activates natural T cell functions differently from other cell therapies such as Chimeric Antigen Receptor T cell (CAR-T) and engineered T cell receptor therapies.

“Despite advances with CAR-T cell therapies in hematological malignancies, there remains a substantial patient population within solid tumors in need of treatments that can demonstrate prolonged safety and efficacy,” said Paul Lammers, M.D., M.Sc., President and CEO of Triumvira. “The initiation of our TACTIC-2 trial represents a significant milestone for Triumvira and an opportunity to establish clinical proof of concept for our TAC technology. We look forward to sharing our progress with this program as we build out a pipeline of candidates targeting solid tumors.”

Triumvira’s TAC technology has the potential to empower T cells to locate and destroy tumor cells by activating the natural T cell receptor for maximal and controlled anti-tumor responses. Triumvira’s HER2-TAC engineered T cells have demonstrated superior anti-cancer properties and more favorable safety profiles in preclinical studies when compared to both CAR-T cell and standard-of-care therapies.

TACTIC-2 is a Phase 1/2 multicenter, open-label trial designed to evaluate the safety, tolerability and efficacy of TAC01-HER2 in people with HER2-positive metastatic, advanced, unresectable solid tumors such as breast, gastric and many other cancers. The clinical trial is actively enrolling participants at MD Anderson Cancer Center in Houston, Texas, and Dana Farber Cancer Institute in Boston, Mass., and University of Chicago, Ill. and plans to enroll approximately 70 participants.

In addition to TAC01-HER2, Triumvira intends to bring multiple TAC programs directed at other promising targets in solid and liquid cancers into clinical development in the coming years.



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