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    DRUG:

    Aibining (geptanolimab)

    i
    Other names: CBT 501, GB 226, APL-501, CBT-501, GB226
    Company:
    Apollomics, Walvax
    Drug class:
    PD1 inhibitor
    Related drugs:
    9ms
    Efficacy and safety of geptanolimab (GB226) for relapsed/refractory primary mediastinal large B-cell lymphoma: an open-label phase II study (Gxplore-003). (PubMed, Cancer Immunol Immunother)
    Geptanolimab (GB226) demonstrated promising efficacy and a manageable safety profile in Chinese patients with r/r PMBCL.
    P2 data • Clinical Trial,Phase II • Journal
    |
    Aibining (geptanolimab)
    9ms
    Genomic traits of therapeutic response to anti-PD-1 therapy in peripheral T cell lymphoma (ESMO 2023)
    Methods We enrolled 89 peripheral T cell lymphoma (PTCL) patients in phase II clinical trial of geptanolimab and performed targeted next-generation sequencing for 440 cancer-associated genes...Conclusions In this study we comprehensively depicted the pre-treatment mutation profiles of PTCL and identified genetic alterations with prognostic value for anti-PD-1 therapy. Notably, we found JAK3 mutations which are vital and prevalent in PTCL reduced PD-L1 levels in vivo and in vitro, which are of great clinical and biological sense.
    Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
    |
    TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden) • KMT2D (Lysine Methyltransferase 2D) • LRP1B (LDL Receptor Related Protein 1B) • KMT2C (Lysine Methyltransferase 2C) • SETD2 (SET Domain Containing 2, Histone Lysine Methyltransferase) • JAK3 (Janus Kinase 3) • PI3K (Phosphoinositide 3-kinases)
    |
    PD-L1 expression • TP53 mutation • TMB-H • JAK3 mutation • JAK3 M511I • SETD2 mutation
    |
    Aibining (geptanolimab)
    12ms
    CXD101 in Immunotherapy-related Liver Cancer (clinicaltrials.gov)
    P2, N=44, Not yet recruiting, Stephen Chan Lam
    New P2 trial • Checkpoint inhibition
    |
    sorafenib • Lenvima (lenvatinib) • Aibining (geptanolimab) • zabinostat (CXD101)
    1year
    A multicenter, open-label, single-arm, phase II trial to evaluate the efficacy and safety of geptanolimab (GB226) in the treatment of patients (pts) with programmed cell death ligand 1 (PD-L1)–positive recurrent or metastatic cervical cancer, for whom prior platinum-containing chemotherapy has failed. (ASCO 2023)
    Clinical benefit was observed across most patient subgroups, with a trend of higher ORR in pts with squamous cell carcinoma, no previous bevacizumab use and higher CPS. GB226 demonstrated durable antitumor activity and manageable safety profile in pts with recurrent or metastatic cervical cancer. Clinical trial information: NCT03808857.
    Clinical • P2 data • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Avastin (bevacizumab) • Aibining (geptanolimab) • GB222 (bevacizumab biosimilar)
    almost2years
    APL-501 Study for Select Advanced or Relapsed/Recurrent Solid Tumors (clinicaltrials.gov)
    P1, N=30, Completed, Apollomics (Australia) Pty. Ltd. | Active, not recruiting --> Completed | Trial completion date: Jun 2022 --> Feb 2022
    Trial completion • Trial completion date
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    Aibining (geptanolimab)
    over2years
    Phase I Clinical Trial in Chinese Patients of Advanced and (or) Recurrent Solid Tumor/Lymphoma (clinicaltrials.gov)
    P1, N=72, Recruiting, Genor Biopharma Co., Ltd. | Trial primary completion date: Jun 2021 --> Jun 2022
    Clinical • Trial primary completion date
    |
    IFNG (Interferon, gamma)
    |
    Aibining (geptanolimab)
    almost3years
    APL-501 Study for Select Advanced or Relapsed/Recurrent Solid Tumors (clinicaltrials.gov)
    P1, N=30, Active, not recruiting, Apollomics (Australia) Pty. Ltd. | Recruiting --> Active, not recruiting | N=45 --> 30 | Trial completion date: Dec 2021 --> Jun 2022 | Trial primary completion date: Jun 2021 --> Dec 2021
    Clinical • Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    Aibining (geptanolimab)
    3years
    Phase I Clinical Trial in Chinese Patients of Advanced and (or) Recurrent Solid Tumor/Lymphoma (clinicaltrials.gov)
    P1, N=72, Recruiting, Genor Biopharma Co., Ltd. | Trial completion date: Aug 2020 --> Aug 2022 | Trial primary completion date: Jun 2020 --> Jun 2021
    Clinical • Trial completion date • Trial primary completion date
    |
    PD-1 (Programmed cell death 1) • IFNG (Interferon, gamma)
    |
    Aibining (geptanolimab)
    3years
    A Study in Recurrent or Metastatic Cervical Cancer Patients With PD-L1 Positive (clinicaltrials.gov)
    P2, N=80, Recruiting, Genor Biopharma Co., Ltd. | Trial completion date: Jul 2021 --> Jul 2022 | Trial primary completion date: Dec 2020 --> Dec 2021
    Clinical • Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 negative
    |
    Aibining (geptanolimab)
    over3years
    Efficacy and safety of geptanolimab (GB226) for relapsed or refractory peripheral T cell lymphoma: an open-label phase 2 study (Gxplore-002). (PubMed, J Hematol Oncol)
    In this study, geptanolimab showed promising activity and manageable safety profile in patients with r/r PTCL. Anti-PD-1 antibody could be a new treatment approach for this patient population.
    Clinical • P2 data • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Aibining (geptanolimab)
    over3years
    A Study in Recurrent or Metastatic Cervical Cancer Patients With PD-L1 Positive (clinicaltrials.gov)
    P2, N=80, Recruiting, Genor Biopharma Co., Ltd. | Trial completion date: Jul 2020 --> Jul 2021 | Trial primary completion date: Jun 2020 --> Dec 2020
    Clinical • Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 negative
    |
    Aibining (geptanolimab)
    almost4years
    A Study in Recurrent or Metastatic Cervical Cancer Patients With PD-L1 Positive (clinicaltrials.gov)
    P2, N=80, Recruiting, Genor Biopharma Co., Ltd. | Trial primary completion date: Mar 2020 --> Jun 2020
    Clinical • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 negative
    |
    Aibining (geptanolimab)
    4years
    [VIRTUAL] The efficacy and safety of Geptanolimab (GB226) in patients with relapsed/refractory peripheral T cell lymphoma (PTCL): A multicenter, open-label, single-arm, phase 2 trial (AACR-I 2020)
    Patients could benefit from Geptanolimab after failure of Chidamide (an oral histone deacetylase [HDAC] inhibitor) treatment with an ORR of 33.3% (8/24). Geptanolimab (GB226), an anti-PD-1 antibody, can be an effective treatment for R/R PTCL, with an acceptable safety profile.
    Clinical • P2 data
    |
    ALK (Anaplastic lymphoma kinase)
    |
    Epidaza (chidamide) • Aibining (geptanolimab)
    4years
    [VIRTUAL] The efficacy and safety of Geptanolimab (GB226) in patients with recurrent/metastatic/unresectable alveolar soft part sarcoma (ASPS): A multicenter, open-label, single-arm, phase 2 trial (AACR-I 2020)
    The ORR was 33.3% (95%CI: 7.5%-70.1%) in patients with prior anlotinib therapy (n=9). Geptanolimab shows promising efficacy and acceptable safety profile for recurrent/metastatic/unresectable ASPS.
    Clinical • P2 data
    |
    PD-L1 (Programmed death ligand 1)
    |
    Focus V (anlotinib) • Aibining (geptanolimab)
    over5years
    APL-501 Study for Select Advanced or Relapsed/Recurrent Solid Tumors (clinicaltrials.gov)
    P1, N=50, Not yet recruiting, CBT Pharmaceuticals, Inc.
    Clinical • New P1 trial
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    Aibining (geptanolimab)