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    1m
    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.
    Preclinical • Journal • IO biomarker
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    CLDN18 (Claudin 18)
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    CLDN18.2 expression • CLDN18.2 positive
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    TAC101-Claudin18.2
    11ms
    First-in-human phase 1/2 trial evaluating TAC01-CLDN18.2 autologous T cells in CLDN18.2-positive solid tumors. (ASCO-GI 2024)
    No data analysis is available as of the submission deadline. Clinical trial information: NCT05862324.
    P1/2 data • IO biomarker
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    HER-2 (Human epidermal growth factor receptor 2) • CLDN18 (Claudin 18)
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    HER-2 negative • CLDN18.2 expression • CLDN18.2 positive • CLDN18 fusion
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    TAC101-Claudin18.2
    1year
    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)
    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 • P1/2 data • IO biomarker • Metastases
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    HER-2 (Human epidermal growth factor receptor 2) • CLDN18 (Claudin 18)
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    HER-2 negative • CLDN18 fusion
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    TAC101-Claudin18.2
    1year
    TAC T-cells for the Treatment of Claudin 18.2 Positive Solid Tumors (TACTIC-3) (clinicaltrials.gov)
    P1/2, N=113, Recruiting, Triumvira Immunologics, Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
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    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • CLDN18 (Claudin 18) • BRCA (Breast cancer early onset)
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    EGFR mutation • BRAF mutation • HER-2 expression • CLDN18.2 positive • ALK translocation • BRCA mutation • CLDN18 fusion
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    albumin-bound paclitaxel • cyclophosphamide • TAC101-Claudin18.2
    over1year
    TAC T-cells for the Treatment of Claudin 18.2 Positive Solid Tumors (TACTIC-3) (clinicaltrials.gov)
    P1/2, N=113, Not yet recruiting, Triumvira Immunologics, Inc.
    New P1/2 trial • Metastases
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    CLDN18 (Claudin 18)
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    albumin-bound paclitaxel • cyclophosphamide • TAC101-Claudin18.2
    2years
    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).
    Preclinical • IO biomarker
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    HER-2 (Human epidermal growth factor receptor 2) • CLDN18 (Claudin 18)
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    HER-2 positive • CLDN18.2 expression • CLDN18.2 positive
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    TAC101-Claudin18.2
    over2years
    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.
    Preclinical • IO biomarker
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    HER-2 (Human epidermal growth factor receptor 2) • CLDN18 (Claudin 18) • IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha)
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    HER-2 positive • CLDN18.2 expression • CLDN18.2 positive
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    TAC100-HER2 • TAC101-Claudin18.2
    3years
    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
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    HER-2 (Human epidermal growth factor receptor 2) • CLDN18 (Claudin 18) • IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha)
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    HER-2 positive • CLDN18.2 expression • CLDN18.2 positive
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    TAC100-HER2 • TAC101-Claudin18.2