^
    1year
    Preclinical characterization of an mRNA-encoded anti-Claudin 18.2 antibody. (PubMed, Oncoimmunology)
    IMAB362/Zolbetuximab, a first-in-class IgG1 antibody directed against the cancer-associated gastric-lineage marker CLDN18.2, has recently been reported to have met its primary endpoint in two phase 3 trials as a first-line treatment in combination with standard of care chemotherapy in CLDN18.2-positive Her2 negative advanced gastric cancer. BNT141 administration did not perpetrate mortality, clinical signs of toxicity, or gastric pathology in animal studies. A phase 1/2 clinical trial with BNT141 mRNA-LNP has been initiated in advanced CLDN18.2-expressing solid cancers (NCT04683939).
    Preclinical • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • CLDN18 (Claudin 18)
    |
    HER-2 positive • HER-2 negative • CLDN18.2 expression • CLDN18.2 positive
    |
    Vyloy (zolbetuximab-clzb) • BNT141
    1year
    Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT141 in Patients With Unresectable or Metastatic CLDN18.2-positive Gastric, Pancreatic, Ovarian and Biliary Tract Tumors (clinicaltrials.gov)
    P1/2, N=13, Terminated, BioNTech SE | N=96 --> 13 | Trial completion date: Sep 2024 --> Jul 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Sep 2024 --> Jul 2023; Sponsor decision
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Combination therapy • Metastases
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 expression • CLDN18.2 positive
    |
    gemcitabine • albumin-bound paclitaxel • BNT141
    over1year
    Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT141 in Patients With Unresectable or Metastatic CLDN18.2-positive Gastric, Pancreatic, Ovarian and Biliary Tract Tumors (clinicaltrials.gov)
    P1/2, N=96, Active, not recruiting, BioNTech SE | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Metastases
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 expression • CLDN18.2 positive
    |
    gemcitabine • albumin-bound paclitaxel • BNT141
    over1year
    A phase I/II dose escalation and expansion trial to evaluate safety and preliminary efficacy of BNT141 in patients with claudin-18.2-positive solid tumors. (ASCO 2023)
    The resulting antibody is sequence identical to IMAB362, a CLDN18.2-targeted antibody that provided clinical benefit as an add-on to chemotherapy in the Phase III SPOTLIGHT trial (Shitara et al.J Clin Oncol...The trial comprises 3 parts: dose escalation with BNT141 as monotherapy, dose escalation with BNT141 in combination with nab-paclitaxel and gemcitabine, and dose expansion...Sites in Spain, Portugal, Germany, Denmark, Netherlands and the UK will be opened in 2023. Clinical trial information: NCT04683939.
    Clinical • P1/2 data
    |
    CLDN18 (Claudin 18)
    |
    gemcitabine • albumin-bound paclitaxel • Vyloy (zolbetuximab-clzb) • BNT141
    almost2years
    A global study to evaluate preliminary efficacy of cancer drug BNT141 in patients with unresectable or metastatic CLDN18.2-positive solid tumors (clinicaltrialsregister.eu)
    P1/2, N=154, Ongoing, BioNTech SE
    New P1/2 trial • Combination therapy • Metastases
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 expression • CLDN18.2 positive
    |
    BNT141
    almost3years
    Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT141 (clinicaltrials.gov)
    P1/2, N=96, Recruiting, BioNTech SE | N=48 --> 96
    Enrollment change • Combination therapy
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 positive
    |
    gemcitabine • albumin-bound paclitaxel • BNT141
    3years
    Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT141 (clinicaltrials.gov)
    P1/2, N=48, Recruiting, BioNTech SE | Not yet recruiting --> Recruiting
    Clinical • Enrollment open • Combination therapy
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 positive
    |
    BNT141