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    BIOMARKER:

    CLDN6 positive

    i
    Other names: CLDN6, Claudin 6, Claudin-6, Skullin
    Entrez ID:
    9074
    Related biomarkers:
    Expression
    1year
    SAIL66, a next generation CLDN6-targeting T-cell engager, demonstrates potent antitumor efficacy through dual binding to CD3/CD137. (PubMed, J Immunother Cancer)
    Our data demonstrate that SAIL66, designed to engage CLDN6, CD3, and CD137, has the potential to enhance antitumor activity and provide a potent therapeutic option for patients with ovarian and other solid tumors expressing CLDN6. Clinical trials are currently underway to evaluate the safety and efficacy of SAIL66.
    Journal • IO biomarker
    |
    CD8 (cluster of differentiation 8) • CLDN6 (Claudin 6) • CD4 (CD4 Molecule) • TNFRSF9 (TNF Receptor Superfamily Member 9)
    |
    CLDN6 expression • CLDN6 positive
    |
    SAIL66
    over1year
    Preclinical efficacy and pharmacokinetics of an RNA-encoded T cell-engaging bispecific antibody targeting human claudin 6. (PubMed, Sci Transl Med)
    No signs of adverse effects from BNT142 RNA-LNP administration were observed in mice or cynomolgus monkeys. On the basis of these and other findings, a phase 1/2 first-in-human clinical trial has been initiated to assess the safety and preliminary efficacy of BNT142 RNA-LNP in patients with CLDN6-positive advanced solid tumors (NCT05262530).
    PK/PD data • Preclinical • Journal
    |
    CLDN6 (Claudin 6)
    |
    CLDN6 positive
    |
    BNT142
    over1year
    NK-92MI Cells Engineered with Anti-claudin-6 Chimeric Antigen Receptors in Immunotherapy for Ovarian Cancer. (PubMed, Int J Biol Sci)
    More importantly, CAR-NK cells combined with immune checkpoint inhibitors, anti-PD-L1, could synergistically enhance the antitumor efficacy of CLDN6-targeted CAR-NK cells. These results indicate that CLDN6-CAR NK cells possess strong antitumor activity and represent a promising immunotherapeutic modality for ovarian cancer.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CLDN6 (Claudin 6) • NKG2D (killer cell lectin like receptor K1)
    |
    CLDN6 expression • CLDN6 positive
    |
    CLDN6-CAR-NK cell therapy
    almost2years
    CARVac: A Clinical Study of the Safety and Effectiveness of an Investigational Cell Therapy Given With and Without an Investigational RNA-based Vaccine in Patients With Organ Tumors (clinicaltrials.gov)
    P1, N=145, Recruiting, BioNTech Cell & Gene Therapies GmbH | Phase classification: P1/2 --> P1 | Trial completion date: Sep 2037 --> Jan 2040 | Trial primary completion date: Aug 2024 --> Jan 2027
    Phase classification • Trial completion date • Trial primary completion date • Metastases
    |
    AFP (Alpha-fetoprotein) • CLDN6 (Claudin 6)
    |
    CLDN6 expression • CLDN6 positive
    |
    BNT211
    almost2years
    CLDN6/GPC3/Mesothelin/AXL-CAR-NK Cell Therapy for Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=200, Recruiting, Second Affiliated Hospital of Guangzhou Medical University | Phase classification: P1/2 --> P1 | N=40 --> 200
    Phase classification • Enrollment change • Metastases
    |
    AXL (AXL Receptor Tyrosine Kinase) • MSLN (Mesothelin) • CLDN6 (Claudin 6) • GPC3 (Glypican 3)
    |
    CLDN6 expression • CLDN6 positive
    almost2years
    CARVac: A Trial to Evaluate the Safety and Efficacy of CLDN6 CAR-T +/- CLDN6 RNA-LPX (clinicaltrials.gov)
    P1/2, N=114, Recruiting, BioNTech Cell & Gene Therapies GmbH
    Trial completion date • Trial primary completion date • Metastases
    |
    AFP (Alpha-fetoprotein) • CLDN6 (Claudin 6)
    |
    CLDN6 expression • CLDN6 positive
    |
    BNT211
    almost2years
    Safety and Preliminary Efficacy Trial of BNT142 in Patients With CLDN6-positive Solid Tumors (clinicaltrials.gov)
    P1/2, N=288, Recruiting, BioNTech SE
    Trial completion date • Trial primary completion date • Metastases
    |
    CLDN6 (Claudin 6)
    |
    CLDN6 positive
    |
    BNT142
    2years
    CLDN6-specific CAR-T cells plus amplifying RNA vaccine in relapsed or refractory solid tumors: the phase 1 BNT211-01 trial. (PubMed, Nat Med)
    A repeat of the dose escalation is ongoing and will identify a RP2D for pivotal trials. ClinicalTrials.gov Identifier: NCT04503278 .
    P1 data • Journal • CAR T-Cell Therapy
    |
    CLDN6 (Claudin 6)
    |
    CLDN6 positive
    |
    BNT211
    2years
    CARVac: A Trial to Evaluate the Safety and Efficacy of CLDN6 CAR-T +/- CLDN6 RNA-LPX (clinicaltrials.gov)
    P1/2, N=114, Recruiting, BioNTech Cell & Gene Therapies GmbH | Trial completion date: Sep 2036 --> Sep 2037 | Trial primary completion date: Aug 2023 --> Aug 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    AFP (Alpha-fetoprotein) • CLDN6 (Claudin 6)
    |
    CLDN6 expression • CLDN6 positive
    |
    BNT211
    over2years
    The tight junction protein claudin 6 is a potential target for patient-individualized treatment in esophageal and gastric adenocarcinoma and is associated with poor prognosis. (PubMed, J Transl Med)
    High expression of CLDN6 mRNA is associated with the dysregulation of distinct biological pathways regulating cell growth, proliferation, and cell-matrix interactions. Clinically, the expression of CLDN6 protein is a valuable adverse prognostic marker in EAC and GAC.
    Journal
    |
    CLDN6 (Claudin 6)
    |
    CLDN6 expression • CLDN6 positive
    over2years
    BNT211-01: Interim results from a repeat dose escalation study of CLDN6 CAR-T cells manufactured with an automated process ± a CLDN6-encoding CAR-T cell-Amplifying RNA Vaccine (CARVac) (ESMO 2023)
    The safety profile in terms of CRS, ICANS and DLTs observed is in line with previously reported observations. We intend to present data on up to 42 pts, with a data cut-off of 10.09.2023.
    Late-breaking abstract • CAR T-Cell Therapy
    |
    CLDN6 (Claudin 6)
    |
    CLDN6 positive
    |
    BNT211
    over2years
    Preclinical Efficacy of the Antibody-Drug-Conjugate CLDN6-23-ADC for the Treatment of CLDN6 Positive Solid Tumors. (PubMed, Clin Cancer Res)
    We report the development of a novel antibody-drug conjugate, CLDN6-23-ADC, that selectively targets CLDN6, a potential onco-fetal-antigen which is highly expressed in ovarian and endometrial cancers. CLDN6-23-ADC exhibits robust tumor regressions in mouse models of human ovarian and endometrial cancers and is currently undergoing Phase I study.
    Preclinical • Journal
    |
    CLDN6 (Claudin 6)
    |
    CLDN6 expression • CLDN6 positive