Triumvira Immunologics Initiates Phase I/II Trial for TAC101-CLDN18.2 in Claudin 18.2+ Solid Tumors

6 February 2024

Triumvira Immunologics, a clinical-stage biotech company focusing on developing innovative autologous and allogeneic T cell therapies for solid tumors, has announced the initiation of dosing for the first patient in its TACTIC-3 trial. This Phase I/II study (NCT05862324) aims to assess the safety and efficacy of their autologous TAC-T cell therapy, TAC101-CLDN18.2, targeting Claudin 18.2-positive solid tumors.

TAC101-CLDN18.2 is a novel cell therapy that involves modifying autologous T cells to express a T-cell Antigen Coupler (TAC), enabling them to utilize the natural signaling pathways of the native T cell receptor complex and target Claudin 18.2, a protein overexpressed in gastric cancer and various other solid tumors.

Triumvira Immunologics, highlighted the potential of Claudin 18.2 as a promising target for cell therapy due to its abundant expression on tumor cell surfaces in certain solid tumors, while being relatively restricted in normal tissues.

Triumvira Immunologics, emphasized the significance of this clinical program in addressing the therapeutic gap for solid tumors. TAC101-CLDN18.2 offers a unique therapeutic approach for Claudin 18.2-positive solid tumors, including gastric, lung, ovarian, and pancreatic cancers, for which there are currently no approved treatment options. With approximately 40% of the gastric cancer population in the U.S. alone classified as Claudin 18.2 positive, novel therapeutics like TAC101-CLDN18.2 offer hope for patients.

The TACTIC-3 trial aims to evaluate the safety, recommended Phase II dose, pharmacokinetic profile, and efficacy of TAC101-CLDN18.2 in patients with CLDN18.2-positive solid tumors who have undergone prior therapy. Eligible patients include those who have received at least 2 lines of prior therapy in Phase I and between 2-4 lines of prior therapy in Phase II, with the possibility of inclusion for patients with pancreatic ductal adenocarcinoma who have undergone 1 line of prior antineoplastic therapy. Additionally, patients currently undergoing therapy without demonstrated benefit may also be eligible, provided no measurable disease was reported at baseline.

 

Source: prnewswire.com