Triumvira Begins Phase I/II Trial for TAC101-CLDN18.2 Cell Therapy in Solid Tumor Patients

Triumvira Immunologics, a firm in the clinical stage of development, has made a significant announcement regarding their TACTIC-3 trial, a Phase I/II study. The study is set to examine the safety and effectiveness of TAC101-CLDN18.2, a groundbreaking cell therapy for treating Claudin 18.2 positive solid tumors. This therapy is unique as it employs genetically modified autologous T cells that express a T-cell Antigen Coupler (TAC). The TAC is designed to utilize the natural signaling pathways of the T cell receptor complex to target Claudin 18.2, a protein that is overproduced in gastric cancer and other solid tumors.

The Chief Scientific Officer of Triumvira, Andreas Bader, Ph.D., has highlighted the potential of Claudin 18.2 as a target for cell therapy. He explains that while Claudin 18.2 is typically confined to the stomach and is shielded by neighboring cells in healthy tissues, it becomes more accessible and is highly expressed on the surface of tumor cells in gastric cancer and other solid tumors. This makes it an ideal target for a selective attack on cancer cells.

Deyaa Adib, M.D., Triumvira's Chief Medical Officer, expressed enthusiasm for the study, stating that it marks a critical juncture for the company as they progress with a clinical program intended to fill a significant gap in the treatment of solid tumors. TAC101-CLDN18.2 is set to be a novel therapy in their pipeline, offering a new solution for solid tumors that test positive for CLDN18.2, including those found in the stomach, lungs, ovaries, and pancreas. Currently, there are no approved treatments specifically targeting CLDN18.2. The development of new therapeutics like TAC101-CLDN18.2 brings hope to a substantial patient population, with approximately 40% of gastric cancer patients in the U.S. potentially benefiting. Triumvira's TAC technology aims to innovate in the field by providing therapeutic strategies that spare patients from chemotherapy.

The TACTIC-3 study is a pioneering human study that will assess the safety, recommended Phase II dose, pharmacokinetics, and efficacy of TAC101-CLDN18.2 in patients with CLDN18.2 positive solid tumors. These patients will have undergone a minimum of two prior treatment lines in Phase I and between two to four lines in Phase II. The study also includes patients with pancreatic ductal adenocarcinoma who may have received one prior line of antineoplastic therapy. Furthermore, patients currently undergoing treatment without demonstrated benefits may be eligible if no measurable disease was present at the study's start.

Triumvira Immunologics is renowned for developing first-in-class targeted autologous and allogeneic T cell therapies that leverage the natural biology of T cells to combat solid tumors. Their proprietary TAC technology platform is distinct from other cell therapies, such as CAR-T and engineered T cell receptor therapies, in that it activates T cell functions in a way that results in safe, effective, and reusable cell therapies. The company is also working on a pipeline of therapies targeting other promising tumor-associated antigens, including HER2, GUCY2C, and GPC3. With operations in San Diego, Austin, Texas, and Hamilton, Ontario, Triumvira is at the forefront of advancing cell therapy for solid tumors.