TAC101-Claudin18.2 / Triumvira - LARVOL DELTA

A phase 1/2 study evaluating the safety and efficacy of autologous TAC T cells in subjects with claudin 18.2+ advanced solid tumors (SITC-SSC 2025) - No abstract available

Clinical • Metastases • P1/2 data • Oncology • Solid Tumor • CLDN18

Triumvira Immunologics to Present Updated Clinical Data at the 2025 SITC Spring Scientific, Cellular Therapy and Solid Tumors Conference (PRNewswire) - "The poster presentation, titled 'A Phase 1/2 Study on the Safety and Efficacy of Autologous TAC T Cells in Subjects with Claudin 18.2+ Advanced Solid Tumors,' will provide a detailed overview of interim findings from the Phase 1/2 study (TACTIC-3 /NCT05862324)."

P1/2 data • Oncology • Solid Tumor

TAC T-cells for the Treatment of Claudin 18.2 Positive Solid Tumors (TACTIC-3) (clinicaltrials.gov) - P1/2 | N=113 | Active, not recruiting | Sponsor: Triumvira Immunologics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Cholangiocarcinoma • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gallbladder Cancer • Gastric Cancer • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • ALK • BRAF • BRCA • CLDN18 • EGFR • HER-2

A phase 1/2 study evaluating the safety and efficacy of autologous TAC T cells in subjects with claudin 18.2+ advanced solid tumors. (ASCO-GI 2025) - P1/2 | "Treatment with the lower doses of TAC01-CLDN18.2 is safe and shows promising clinical activity in a heavily pre-treated cancer population. Treatment of cohort 3 has begun."

Clinical • IO biomarker • Metastases • P1/2 data • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CLDN18

Triumvira Immunologics Presents Updated Clinical Data at the 2025 ASCO Gastrointestinal Cancers Symposium (PRNewswire) - P1/2 | N=113 | TACTIC-3 (NCT05862324) | Sponsor: Triumvira Immunologics, Inc. | "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 study included subjects with multiple types of Claudin 18.2 positive advanced solid tumors, such as pancreatic, gastric, and esophageal cancers....Early clinical activity was observed, with a confirmed, ongoing partial response in a dose-level 1 (DL1) subject with stage IV pancreatic cancer, and an unconfirmed partial response in a heavily pretreated subject with esophageal adenocarcinoma (DL3). The disease control rate (DCR) was 70%, with an objective response rate (ORR) of 20% in a patient population that was not restricted based Claudin 18.2 expression levels, tumor burden, or location of metastatic disease."

P1/2 data • Esophageal Cancer • Gastric Cancer • Pancreatic Cancer • Solid Tumor

A phase 1/2 study evaluating the safety and efficacy of autologous TAC T cells in subjects with claudin 18.2+ advanced solid tumors (SITC 2024) - P1/2 | "TAC01-CLDN18.2 is an autologous T-cell product comprising T cells expressing CLDN18.2 TAC...This study was approved by University of Miami's Ethics Board; approval number 20231138. All subjects gave informed consent before participating."

Clinical • IO biomarker • Late-breaking abstract • Metastases • P1/2 data • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CLDN18

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 (PRNewswire) - P1/2 | N=113 | TACTIC-3 (NCT05862324) | Sponsor: Triumvira Immunologics, Inc. | "Triumvira Immunologics...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....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....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."

Late-breaking abstract • P1/2 data • Pancreatic Adenocarcinoma • Solid Tumor

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 (PRNewswire) - "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."

P1/2 data • Oncology • Solid Tumor

Preclinical development of T cells engineered to express a T cell antigen coupler (TAC) targeting Claudin 18.2-positive solid tumors. (PubMed, Cancer Immunol Res) - "CLDN18.2-TAC T cells effectively eradicated established tumor xenografts in mice in the absence of observed off-target or on-target/off-tumor effects, elicited durable efficacy in recursive killing and tumor rechallenge experiments, and remained unreactive in coculture with human cells representing vital organs. Thus, the data demonstrate that CLDN18.2-TAC T cells can induce a specific and long-lasting anti-tumor response in various CLDN18.2-positive solid tumor models without notable TAC-dependent toxicities, supporting the clinical development of TAC01-CLDN18.2."

IO biomarker • Journal • Preclinical • Gastrointestinal Cancer • Hematological Disorders • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

Triumvira Immunologics Announces Publication Demonstrating the Safety and Efficacy of TAC T Cells Targeting Claudin 18.2 in Solid Tumors (PRNewswire) - "Triumvira Immunologics...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....TAC01-CLDN18.2 T cells demonstrated high specificity and potent cytotoxicity against Claudin 18.2 positive tumor cells in both 2D cultures and 3D tumor spheroids, including models with low antigen expression....In a head-to-head comparison against CLDN18.2-directed 2nd-generation CAR T cells, CLDN18.2-TAC T cells exhibited greater proliferative capacity, lower levels and delayed onset of T cell exhaustion, and overall greater and longer-lasting cytotoxicity in a recursive tumor cell killing assay....In mouse models of gastric, gastroesophageal, and pancreatic cancers, TAC01-CLDN18.2 T cells effectively eradicated tumor xenografts, with durable..."

Preclinical • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer

A phase 1/2 study investigating the safety and efficacy of autologous TAC T cells in subjects with unresectable, locally advanced, or metastatic claudin 18.2+ solid tumors (AACR 2024) - P1/2 | "TAC01-CLDN18.2 is an autologous T-cell product comprising T cells expressing CLDN18.2 TAC. This is a first-in-human study (NCT05862324) to investigate the safety and preliminary anti-tumor activity of TAC01-CLDN18.2 in CLDN18.2+/HER2- solid tumors...A Simon 2-stage design will be used to enroll ≤57 subjects in Group A and ≤22 subjects in Group C. Group B will be exploratory and will enroll ≤10 subjects with an opportunity of cohort enrichment based on clinical efficacy data. The first patient was enrolled in December and continues to participate in the trial."

Clinical • IO biomarker • Metastases • P1/2 data • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CLDN18 • HER-2

First-in-human phase 1/2 trial evaluating TAC01-CLDN18.2 autologous T cells in CLDN18.2-positive solid tumors. (ASCO-GI 2024) - P1/2 | "No data analysis is available as of the submission deadline. Clinical trial information: NCT05862324."

IO biomarker • P1/2 data • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CLDN18 • HER-2

A phase 1/2 study investigating the safety and efficacy of autologous TAC T cells in subjects with unresectable, locally advanced or metastatic claudin 18.2+ solid tumors (SITC 2023) - P1/2 | "2 expression levels will be based on retrospective analysis of data from Phase 1 in association with clinical efficacy. A Simon 2-stage design will be used to enroll ≤57 subjects in Group A and ≤22 subjects in Group C. Group B will be exploratory and will enroll ≤10 subjects with an opportunity of cohort enrichment based on clinical efficacy data."

Clinical • IO biomarker • Metastases • P1/2 data • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CLDN18 • HER-2

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 (PRNewswire) - "Triumvira Immunologics...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....TACTIC-3 is a first-in-human study investigating TAC101-CLDN18.2 to evaluate the safety, recommended Phase II dose (RP2D), pharmacokinetic profile, and efficacy in subjects with CLDN18.2+ solid tumors who have been treated with at least 2 lines of prior therapy in Phase I and between 2-4 lines of prior therapy in Phase II."

Trial status • Solid Tumor

Triumvira Immunologics to Present Clinical Data at the 2024 ASCO Gastrointestinal Cancers Symposium (PRNewswire) - "Triumvira Immunologics...today announced that it will present two abstracts at the 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in San Francisco, California, from January 18-20, 2024. The company will showcase clinical data from its ongoing Phase I/II studies investigating the safety and efficacy of autologous TAC-T cells targeting human epidermal growth factor receptor 2 (HER2) and Claudin 18.2 (CLDN 18.2), respectively, in relapsed or refractory solid tumors (TACTIC-2 /NCT04727151, TACTIC-3 /NCT05862324)."

P1/2 data • Oncology • Solid Tumor

TAC T-cells for the Treatment of Claudin 18.2 Positive Solid Tumors (TACTIC-3) (clinicaltrials.gov) - P1/2 | N=113 | Recruiting | Sponsor: Triumvira Immunologics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Cholangiocarcinoma • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gallbladder Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • ALK • BRAF • BRCA • CLDN18 • EGFR • HER-2

TAC T-cells for the Treatment of Claudin 18.2 Positive Solid Tumors (TACTIC-3) (clinicaltrials.gov) - P1/2 | N=113 | Not yet recruiting | Sponsor: Triumvira Immunologics, Inc.

Metastases • New P1/2 trial • Oncology • Solid Tumor • CLDN18

Preclinical studies of TAC01-CLDN18.2, an autologous Claudin 18.2-directed TAC T cell therapy, in the treatment of gastric cancer (SITC 2022) - "In gastric cancer cells, CLDN18.2 expression can go awry, is no longer confined to tight junctions and, thus, targetable by CLDN18.2-TAC T cells...Conclusions The in vitro and in vivo data confirm strong and specific activity of CLDN18.2-targeted TAC T cells against CLDN18.2-expressing solid tumor models and highlight the versatility of the TAC platform for therapeutic applications in solid tumors. Ethics Approval The animal study was approved by McMaster University’s Animal Research Ethics Board (AUP 20-10-37)."

IO biomarker • Preclinical • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18 • HER-2

Triumvira Immunologics Demonstrates Strength of Preclinical Research Pipeline for Gastric and Colorectal Cancers in Three Posters at SITC 2022 (Businesswire) - "Triumvira Immunologics...announced preclinical data for its investigational TAC-T cell therapies...at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting....The data continue to demonstrate that CLDN18.2-TAC T effectively eliminates CLDN18.2-expressing gastric cancer cells in vitro and in vivo. The study also demonstrated that the activation of CLDN18.2-TAC T cells was specific to target cells that expressed CLDN18.2. In vitro data show strong and persistent anti-tumor activity and in vivo treatment led to complete and sustained tumor clearance with no signs of toxicity."

Preclinical • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18

Triumvira Immunologics to Present Clinical and Preclinical Updates at Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting (Businesswire) - "Triumvira Immunologics...announced that it will present data from its ongoing clinical and preclinical programs at the upcoming Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting, being held Nov. 10-12, 2022, in Boston and virtually. The presentations will include updated clinical data from its Phase 1/2 trial of TAC01-HER2 in patients with solid tumors and preclinical data on T cell therapy candidates TAC01-CLDN18.2 and GUCY2C-TAC T....Building on the proof-of-concept of its clinical-stage autologous TAC01-HER2 program, Triumvira is continuing to develop and advance its gamma delta allogeneic pipeline with IND filings anticipated over the next three years."

P1/2 data • Preclinical • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Triumvira Immunologics Announces Expansion of Cell Therapy Manufacturing Capabilities to Facility in South San Francisco (Businesswire) - "Triumvira Immunologics...announced a multi-year agreement with AmplifyBio to use its facilities in South San Francisco, Calif. for Triumvira to manufacture its own cell therapy candidates within the company’s pipeline.... Triumvira expects the facility to be fully operational in 2023....Once operational, the South San Francisco facility will manufacture TAC01-HER2, which is currently in a Phase 1/2 trial for solid tumors, and manufacture additional candidates for subsequent clinical studies. Manufacturing of Triumvira’s second most advanced candidate, TAC-Claudin 18.2 – in preclinical development for the treatment of gastric cancer – will start at C3i in 2023."

Commercial • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Pre-clinical evaluation of Claudin 18.2 TAC T cells for the treatment of gastric cancer (AACR 2022) - "Based on this preclinical pharmacology and toxicology data, TAC01-HER2, a first-in-class TAC T product targeting HER2 (ERBB2), has entered a phase I/II clinical trial in patients with HER2-positive solid tumors. The in vitro and in vivo data confirm strong and specific activity of CLDN18.2-targeted TAC T cells against CLDN18.2-expressing solid tumor models and highlight the versatility of the TAC platform for therapeutic applications in solid tumors."

IO biomarker • Preclinical • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18 • HER-2 • IFNG • TNFA

Triumvira Immunologics to Present Two Posters Covering Ongoing Phase 1/2 Solid Tumor Trial and New Preclinical Gastric Cancer Data at AACR Annual Meeting 2022 (Businesswire) - "Triumvira Immunologics...today announced it will present two posters at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 8-13, 2022 in New Orleans. The company will present an update from its ongoing TACTIC-2 clinical trial evaluating TAC01-HER2 in patients with HER2-positive solid tumors and new preclinical proof-of-concept data for its gastric cancer candidate, TAC-Claudin 18.2 (CLDN18.2)...In the preclinical study of CLDN18.2, strong and specific activity of TAC-T cells targeted against CLDN18.2 was shown through a variety of in vitro assays, including demonstrated TAC-T cell activation in target cells expressing CLDN18.2."

P1/2 data • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Development of Claudin 18.2 TAC T cells for the treatment of gastric cancer (SITC 2021) - "TAC01-HER2, a first-in-class TAC T product targeting HER2 (ERBB2), has recently entered a phase I/II clinical trial in patients with HER2-positive solid tumors. Intravenous administration of CLDN18.2-TAC T cells in mice carrying CLDN18.2-positive tumor xenografts led to a sustained anti-tumor response. Conclusions The in vitro and in vivo data confirm strong and specific activity of CLDN18.2-targeted TAC T cells against CLDN18.2-expressing cancer cells and highlight the versatility of the TAC platform for therapeutic applications in solid tumors."

IO biomarker • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18 • HER-2 • IFNG • TNFA

Triumvira Announces Data from Gastric Cancer Preclinical Study to be Presented at SITC Annual Meeting (Businesswire) - "Triumvira Immunologics...announced the presentation of preclinical data from its proof-of-concept study in gastric cancer. These new data demonstrate that Triumvira’s novel T cell antigen coupler (TAC)-T cell candidate targeting Claudin 18.2 (CLDN18.2) effectively eradicates CLDN18.2-expressing gastric tumor cells in vitro and in vivo....the study demonstrated that the activation of CLDN18.2-TAC T cells was specific to target cells that expressed CLDN18.2. "

Preclinical • Gastric Cancer • Oncology • Solid Tumor