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TAC01-CLDN18.2 was well tolerated, with no dose-limiting toxicities and a favorable safety profile in the first two cohorts of the ongoing trial

A pancreatic cancer patient treated with the lowest dose has demonstrated clinical benefit for nearly eight months and achieved a confirmed partial response in the target lesion as well as an unconfirmed complete response in the non-target lesion

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 39^th 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.

"As an emerging biomarker, Claudin 18.2 offers a promising target for cellular therapies due to its selective expression in certain advanced solid tumors, including, but not limited to, gastric and pancreatic cancers," said Dr. Dumbrava. "These initial data on TAC01-CLDN18.2, a new T-cell therapy approach designed to address the needs of patients with solid tumors expressing Claudin 18.2 are promising. Because this is a patient population with limited treatment choices, I look forward to the full results of the clinical trial TAC01-CLDN18.2's potential to improve patient outcomes."

Key Preliminary Findings

• The first two dose cohorts of Phase I have been completed, with no reported dose-limiting toxicities (DLT), showing a favorable safety profile.
  
  
• All TAC-related adverse events were low-grade, and no cytokine release syndrome was reported. One subject in cohort 2 experienced a grade 1 neurotoxicity, which resolved the same day without intervention. Six subjects reported a total of 6 serious adverse events, none related to TAC01-CLDN18.2.
  
  
• An 83% disease control rate was observed at first tumor assessment in the six eligible subjects for efficacy assessment.
  
  
• One subject in cohort 1 with heavily pre-treated pancreatic adenocarcinoma with high Claudin 18.2 expression has an ongoing, confirmed partial response in the target lesion. The subject received a second dose approximately five months after the initial dose and has remained on treatment for nearly eight months with ongoing therapy. An efficacy assessment was conducted in early November 2024, three months after the second dose was administered, and in addition to an ongoing partial response in the target lesion, revealed a complete response in the patient's non-target lesion. The incremental response observed following the administration of a second dose highlights the potential benefits of re-treating patients with Claudin 18.2 positive solid tumors with TAC01-CLDN18.2.

Oral Presentation Details:

Title: A phase 1/2 study evaluating the safety and efficacy of autologous TAC T cells in subjects with claudin 18.2+ advanced solid tumors

Authors: Ecaterina E. Dumbrava, Syma Iqbal, Simon Turcotte, Gregory Botta, Benjamin Schlechter, Geoffrey Ku, Peter Hosein, Sam Saibil, Miriam Gavriliuc, Maria Apostolopoulou, Mobolaji Giwa, Kara Moss, Swaminathan Murugappan, Davendra Sohal

Session: Biotech Breakthroughs - Solid Tumor IO at the Tipping Point

Oral Presentation Date: Friday, November 8, 2024, between 1:45 p.m. and 3:20 p.m. CDT

Abstract Number: 1472

Abstract Type: Late-Breaking Abstract

Abstracts are currently available on the SITC website.

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 platform activates natural T cell functions differently from other cell therapies such as CAR-T and engineered T cell receptor (TCR) therapies, resulting in clinically safe, effective, and re-dosable cell therapies. Triumvira is developing a pipeline targeting promising tumor-associated antigens such as Claudin 18.2, HER2, GUCY2C and GPC3. Triumvira has operations in San Diego, CA, Austin, Texas, and Hamilton, Ontario.

For more information, visit us at www.triumvira.com or follow us on LinkedIn and X.

Media Contact
David Schull or Ignacio Guerrero-Ros, Ph.D.
Russo Partners
858-717-2310
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ignacio.guerrero-ros@russopartnersllc.com

SOURCE Triumvira Immunologics