Author: Staff

A Phase 1/2 Study Evaluating the Safety and Efficacy of Autologous TAC-T Cells in Subjects with Claudin 18.2+ Advanced Solid Tumors

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INTRODUCTION

The T cell antigen coupler (TAC) is a novel, proprietary chimeric receptor that facilitates the re-direction of T cells to tumor cells and activates T cells by co-opting the endogenous T cell receptor complex, with the goal to elicit a safe and durable anti-tumor response. In preclinical models, TAC-engineered T cells effectively eradicate tumor cells in vitro and in vivo without toxicities typically associated with engineered T cell products. TAC01-CLDN18.2 is an autologous T cell product comprising T cells expressing the CLDN18.2 TAC, which specifically recognize CLDN18.2+ cells.

TACTIC-3 (NCT05862324) is an open-label, multicenter phase I/II study that aims to establish safety, maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), pharmacokinetic profile, and efficacy of TAC01-CLDN18.2 in patients with CLDN18.2 positive solid tumors by immunohistochemistry (i.e. gastric, GEJ, esophageal adenocarcinoma, PDAC, colorectal cancer, cholangiocarcinoma, ovarian mucinous cancer, gallbladder cancer and NSCLC) who have been exposed to at least 2 prior anti-cancer therapies.

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Triumvira Immunologics Presents Updated Clinical Data at the 2025 ASCO Gastrointestinal Cancers Symposium

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AUSTIN, Texas and HAMILTON, ON and SAN DIEGO — /PRNewswire/ — Triumvira 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, recently presented an abstract at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium, which was held in San Francisco, California,  from January 23-25, 2025. The company showcased updated clinical data from its ongoing Phase I/II TACTIC-3 study investigating the safety and efficacy of autologous TAC-T cells in subjects with Claudin 18.2+ advanced solid tumors (TACTIC-3 /NCT05862324).

The poster presentation, titled “A Phase 1/2 Study Evaluating the Safety and Efficacy of Autologous TAC-T Cells in Subjects with Claudin 18.2+ Advanced Solid Tumors”, provided an in-depth look at interim results from the Phase I study. Key highlights included:

Triumvira Immunologics’ Late-Breaking Abstract Selected for Oral Presentation at the 39th SITC Annual Meeting Demonstrates Preliminary Safety and Promising Clinical Activity of TAC01-CLDN18.2 Cell Therapy in Patients with Solid Tumors

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HOUSTON and SAN DIEGO – Nov. 11, 2024 /PRNewswire/ — Triumvira 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 preliminary results from its Phase I/II clinical trial TACTIC-3 (NCT05862324) investigating the safety and efficacy of autologous TAC01-CLDN18.2 in subjects with Claudin 18.2 positive solid tumors, were presented in a poster and an oral presentation at the 39th Society for Immunotherapy of Cancer Annual Meeting, held November 6-10 in Houston.

Ecaterina E. Dumbrava, MD, Assistant Professor in the Department of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center, presented promising preliminary clinical data from TACTIC-3 showing the positive safety profile and encouraging therapeutic potential of TAC01-CLDN18.2 at lower dosages, even among patients who have undergone multiple prior treatments. Dr. Dumbrava’s late-breaking abstract was selected for an oral presentation during the “Biotech Breakthroughs – Solid Tumor IO at the Tipping Point” session on Friday, November 8, and displayed during a Poster session on Saturday, November 9.

A Phase 1/2 Study Evaluating the Safety and Efficacy of Autologous TAC-T Cells in Subjects with Claudin 18.2+ Advanced Solid Tumors

Posted on by Staff

INTRODUCTION

The T cell antigen coupler (TAC) is a novel, proprietary chimeric receptor that facilitates the re-direction of T cells to tumor cells and activates T cells by co-opting the endogenous T cell receptor complex, with the goal to elicit a safe and durable anti-tumor response. In preclinical models, TAC-engineered T cells effectively eradicate tumor cells in vitro and in vivo without toxicities typically associated with engineered T cell products. TAC01-CLDN18.2 is an autologous T cell product comprising T cells expressing the CLDN18.2 TAC, which specifically recognize CLDN18.2+ cells.

TACTIC-3 (NCT05862324) is an open-label, multicenter phase I/II study that aims to establish safety, maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), pharmacokinetic profile, and efficacy of TAC01-CLDN18.2 in patients with CLDN18.2 positive solid tumors by immunohistochemistry (i.e. gastric, GEJ, esophageal adenocarcinoma, PDAC, colorectal cancer, cholangiocarcinoma, ovarian mucinous cancer, gallbladder cancer and NSCLC) who have been exposed to at least 2 prior anti-cancer therapies.

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Triumvira Claudin 18.2+ SITC 2024 poster image

Triumvira Immunologics to Present New Clinical Data from Ongoing Claudin 18.2 Phase 1 Study in Late-Breaking Oral Presentation at 39th SITC Annual Meeting

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SAN DIEGO and AUSTIN, TX and HAMILTON, ON – Oct 30, 2024 /PRNewswire/ — Triumvira 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 Dr. Ecaterina E. Dumbrava, Assistant Professor in the Department of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center,  will present a late-breaking abstract at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) 2024, being held from November 6-10, 2024, in Houston, Texas.

The oral presentation will highlight interim data from Triumvira’s ongoing Phase 1/2 study, TACTIC-3 clinical trial, which is investigating the safety and efficacy of TAC101-CLDN18.2, a novel T cell therapy targeting Claudin 18.2+ advanced solid tumors. The therapy leverages Triumvira’s proprietary T cell Antigen Coupler (TAC) technology, a unique platform that activates natural T cell functions to combat solid tumors effectively and safely.

Triumvira Immunologics Announces Publication Demonstrating the Safety and Efficacy of TAC T Cells Targeting Claudin 18.2 in Solid Tumors

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SAN DIEGO and AUSTIN, TX and HAMILTON, ON – Feb. 5, 2024 /PRNewswire/ — Triumvira 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 the publication of a peer-reviewed article titled “Preclinical development of T cells engineered to express a T cell antigen coupler (TAC) targeting Claudin 18.2-positive solid tumors” in Cancer Immunology Research, a journal of the American Association for Cancer Research. The article, authored by a team of scientists led by Dr. Andreas Bader, Triumvira’s Consulting Chief Scientific Officer, details the preclinical pharmacology and safety of TAC01-CLDN18.2, a novel autologous T cell therapy targeting Claudin 18.2 for the treatment of solid tumors. TAC01-CLDN18.2 is currently the subject of a clinical Phase I/II study (TACTIC-3, NCT05862324).

“Our findings highlight the unique advantages of TAC01-CLDN18.2, which is designed to target and eliminate tumors with high specificity while minimizing the risk of adverse events that are commonly associated with T cell and other therapies,” said Andreas Bader, Ph.D., Consulting Chief Scientific Officer of Triumvira Immunologics. “This research underscores our commitment to developing next-generation T cell therapies that are both effective and safe, and we are excited to continue exploring the clinical potential of TAC01-CLDN18.2 in treating patients with Claudin 18.2 positive solid tumors.”

Triumvira Immunologics Pivots to Claudin 18.2-Targeted Cell Therapy, Pauses HER2 Program

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Article by Catherine Shaffer @ Precision Medicine Online

NEW YORK – Triumvira Immunologics on Monday said it began dosing patients in a Phase I/II trial or an autologous T-cell antigen coupler (TAC) therapy, TAC101-CLDN18.2, targeting claudin 18.2 (CLDN18.2)-positive solid tumors.

At the same time, in an effort to optimize finite resources, the Austin, Texas-based company has paused clinical development of its HER2-targeted TAC agent, TAC 100-HER1 (formerly TAC01-HER2), and is focusing instead on the CLDN18.2 program, said Robert Williamson, Triumvira’s president and chief operating officer.

Triumvira Immunologics Announces First Patient Dosed in Phase I/II Cell Therapy Trial of TAC101-CLDN18.2 for the Treatment of Claudin 18.2+ Solid Tumors

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SAN DIEGO and AUSTIN, TX and HAMILTON, ON – Feb. 5, 2024 /PRNewswire/ — Triumvira 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 its TACTIC-3 trial, a Phase I/II study, (NCT05862324) investigating the safety and efficacy of autologous TAC-T cell asset, TAC101-CLDN18.2, targeting Claudin 18.2+ solid tumors. TAC101-CLDN18.2 is a novel cell therapy based on genetically engineered autologous T cells expressing a T-cell Antigen Coupler (TAC) that harnesses the inherent signaling pathways of the native T cell receptor complex and targets Claudin 18.2, an epithelial transmembrane protein overexpressed in gastric cancer and several other solid tumor types.

“Claudin 18.2 is a promising target for cell therapy,” said Andreas Bader, Ph.D., Chief Scientific Officer of Triumvira Immunologics. “Among normal tissues, it is restricted to the stomach and hidden between neighboring cells. In gastric cancer and a few other solid tumors, however, it is accessible and abundantly expressed on tumor cell surfaces and, therefore, it represents a significant tumor selective opportunity to address these types of cancers.”

JPM2024: On the Ground in San Francisco

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BioSpace News Editor Greg Slabodkin gives his takeaways from this year’s J.P. Morgan Healthcare Conference. After a challenging 2023, the biopharma industry appears to be turning a corner, with excitement about an improved outlook for the sector. Certain areas in particular stood out, including cell and gene therapy, artificial intelligence (AI), neuroscience and GLP1. At the same time, attendees acknowledged several challenges that lay ahead, including policy considerations such as the ramifications of the Inflation Reduction Act on drug development.

“It’s not all downhill from here—significant hurdles still face the biopharma industry—but the sector feels invigorated to take on the challenge,” Slabodkin wrote. “Let the journey begin!”

Takeda Touts Promise of Latest Narcolepsy Candidate

Saftey issues may have quashed the development of Takeda’s earlier orexin candidate, but Elena Koundourakis says the company “bounced back big time.” Koundourakis, who leads the company’s orexin franchise, told BioSpace that the company quickly shifted its focus from the previous orexin candidate, TAK-994, to its latest orexin product, TAK-816, and will soon have results to share from an ongoing Phase II trial. “It has the potential to serve [an] unmet need in several indications,” Koundourakis said.