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    DRUG:

    BNT211

    i
    Other names: BNT211, BNT 211, CLDN6 CAR-T, CG001.2, CLDN6-CAR-T/CLDN6 RNA-LPX, CLDN6-CAR-T/CARVac, BNT-211, CG 001.2, CG-001.2
    Company:
    BioNTech
    Drug class:
    CLDN6-targeted CAR-T immunotherapy
    5ms
    Fetal gut cell-like differentiation in esophageal adenocarcinoma defines a rare tumor subtype with therapeutically relevant claudin-6 positivity and SWI/SNF gene alteration. (PubMed, Sci Rep)
    Furthermore, claudin-6 positive tumors have shown promising efficacy of CAR T cell therapy in the recently published BNT-211-01 trial (NCT04503278). This represents a personalized therapeutic option for this tumor subtype.
    Journal
    |
    CLDN6 (Claudin 6) • GPC3 (Glypican 3) • SALL4 (Spalt Like Transcription Factor 4)
    |
    BNT211
    9ms
    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
    11ms
    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
    12ms
    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
    1year
    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
    over1year
    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
    over1year
    CLDN6 CAR-T cell therapy of relapsed/refractory solid tumors ± a CLDN6-encoding mRNA vaccine: Dose escalation data from the BNT211-01 phase 1 trial using an automated product. (ASCO 2023)
    We intend to submit efficacy, safety and CAR T-cell pharmacokinetics data from 5 cohorts treated with 1x106, 1x107 or 1x108 CLDN6 CAR-T cells ± CARVac with a data cut-off of March 14th, 2023 from ≥17 treated patients as a late-breaking abstract. Clinical trial information: NCT04503278.
    P1 data • CAR T-Cell Therapy • IO biomarker
    |
    CLDN6 (Claudin 6)
    |
    CLDN6 expression
    |
    BNT211
    2years
    BNT211-01: A Trial to Evaluate the Safety and Efficacy of CLDN6 CAR-T +/- CLDN6 RNA-LPX (clinicaltrials.gov)
    P1/2, N=96, Recruiting, BioNTech Cell & Gene Therapies GmbH | Trial primary completion date: Sep 2022 --> Aug 2023
    Trial primary completion date • Metastases
    |
    AFP (Alpha-fetoprotein) • CLDN6 (Claudin 6) • IL2 (Interleukin 2)
    |
    CLDN6 expression • CLDN6 positive
    |
    BNT211
    over2years
    BNT211-01: A Trial to Evaluate the Safety and Efficacy of CLDN6 CAR-T +/- CLDN6 RNA-LPX (clinicaltrials.gov)
    P1/2; N=36 --> 96
    Enrollment change
    |
    IFNG (Interferon, gamma) • AFP (Alpha-fetoprotein) • CLDN6 (Claudin 6) • IL2RA (Interleukin 2 receptor, alpha) • IFNA1 (Interferon Alpha 1)
    |
    CLDN6 expression • CLDN6 positive
    |
    BNT211
    over2years
    BNT211: A Phase I trial to evaluate safety and efficacy of CLDN6 CAR-T cells and CARVac-mediated in vivo expansion in patients with CLDN6-positive advanced solid tumors (AACR 2022)
    CLDN6 CAR-T cells ± CARVac show an acceptable safety profile at doses tested and encouraging signs of clinical activity. Data from the completed dose escalation phase will be presented. Acknowledgements: BNT211-01 is funded by BioNTech Cell & Gene Therapies GmbH.Trial registration: Clinicaltrials.gov: NCT04503278.Ethics approval: Ethics & Institutional Review Board approvals were obtained from the respective participating countries prior to initiation of the trial.
    P1 data • Preclinical • CAR T-Cell Therapy
    |
    CLDN6 (Claudin 6)
    |
    CLDN6 positive
    |
    BNT211
    3years
    BNT211: A Phase I/II trial to evaluate safety and efficacy of CLDN6 CAR-T cells and CARVac-mediated in vivo expansion in patients with CLDN6+ advanced solid tumors (ESMO-IO 2021)
    Updated data from open cohorts will be presented. Clinical trial identification NCT04503278.
    P1/2 data • Preclinical • Late-breaking abstract • CAR T-Cell Therapy
    |
    IL6 (Interleukin 6) • CLDN6 (Claudin 6)
    |
    IL6 elevation • CLDN6 positive
    |
    BNT211
    3years
    BNT211: A phase I/II trial to evaluate safety and efficacy of CLDN6 CAR-T cells and vaccine-mediated in vivo expansion in patients with CLDN6-positive advanced solid tumors (SITC 2021)
    Manageable cytokine release syndrome (CRS, grade 1-2, the latter managed with Tocilizumab) without any signs of neurotoxicity have been observed in both patients of part 1 DL2. Updated data from open cohorts and especially for combination with CARVac will be presented. Clinicaltrials gov: NCT04503278
    P1/2 data • Preclinical • Late-breaking abstract • CAR T-Cell Therapy
    |
    IL6 (Interleukin 6) • CLDN6 (Claudin 6)
    |
    IL6 elevation • CLDN6 positive
    |
    Actemra IV (tocilizumab) • BNT211
    over3years
    [VIRTUAL] BNT211: A phase I/IIa trial to evaluate safety and efficacy of CLDN6 CAR-T and CARVac-based in vivo expansion to improve treatment of patients with CLDN6-positive advanced solid tumors. (CIMT 2021)
    "Robust engraftment of CLDN6 CAR-T cells and first signs of efficacy could already be observed in initial dose cohort. Enrollment into higher dose levels and cohorts for combination with CARVac is currently ongoing."
    P1/2 data • Preclinical
    |
    IL6 (Interleukin 6)
    |
    IL6 elevation
    |
    BNT211