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    DRUG:

    vabametkib (ABN401)

    i
    Other names: ABN401, ABN 401, ABN-401
    Company:
    Abion
    Drug class:
    c-MET inhibitor
    Related drugs:
    2d
    c-MET Inhibitor in Advanced Solid Tumors With c-MET Gene Aberration (clinicaltrials.gov)
    P2, N=20, Recruiting, Yonsei University | Not yet recruiting --> Recruiting | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025
    Enrollment open • Trial completion date • Trial primary completion date • Pan tumor • Metastases
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET amplification • MET exon 14 mutation
    |
    vabametkib (ABN401)
    10ms
    To Evaluate the Safety, Pharmacokinetic and the Effect of Food After Administration of ABN401 in Healthy Adult Volunteers (clinicaltrials.gov)
    P1, N=25, Completed, Abion Inc | Recruiting --> Completed
    Trial completion
    |
    vabametkib (ABN401)
    10ms
    To Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of ABN401 in Patients With Advanced Solid Tumors and Non-Small Cell Lung Cancer Harboring c-MET Dysregulation (clinicaltrials.gov)
    P1, N=78, Recruiting, Abion Inc | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET amplification • MET exon 14 mutation • MET overexpression
    |
    vabametkib (ABN401)
    1year
    To Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of ABN401 in Patients With Advanced Solid Tumors and Non-Small Cell Lung Cancer Harboring c-MET Dysregulation (clinicaltrials.gov)
    P1, N=78, Recruiting, Abion Inc | Phase classification: P1/2 --> P1
    Phase classification • Metastases
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET amplification • MET exon 14 mutation • MET overexpression
    |
    vabametkib (ABN401)
    over1year
    Efficacy and Safety Outcomes of ABN401 in NSCLC Patients with MET Exon 14 Skipping: A Clinically Relevant Subgroup Analysis. (AACR-NCI-EORTC 2023)
    No abstract available
    Clinical
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET exon 14 mutation
    |
    vabametkib (ABN401)
    over1year
    A Phase II Study of ABN401 in Advanced Solid Tumors With c-MET Gene Aberration (clinicaltrials.gov)
    P2, N=20, Not yet recruiting, Yonsei University
    New P2 trial • Pan tumor • Metastases
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET amplification • MET exon 14 mutation
    |
    vabametkib (ABN401)
    over1year
    ABN401 in patients with NSCLC with MET exon 14 (METex14) skipping: Result from the pilot expansion study. (ASCO 2023)
    The ABN401 pilot expansion part of phase 1 demonstrated promising anti-tumor effects and safety in NSCLC pts with c-MET dysregulation, providing support for further evaluation of ABN401 in the METex14 skipping cohort (cohort-1) of the global phase 2 study (NCT05541822). Enrollment is currently ongoing. References National Comprehensive Cancer Network: Non-small cell lung cancer (version 2.2021).
    Clinical
    |
    EGFR (Epidermal growth factor receptor) • MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET amplification • MET exon 14 mutation • MET overexpression
    |
    vabametkib (ABN401)
    almost2years
    Synergistic anti-tumor effect of ABN401 in combination with KRAS inhibitor in a c-MET-altered KRASG12C non-small cell lung cancer model (AACR 2023)
    We have performed several in vitro and in vivo efficacy studies for the combination of ABN401, c-MET inhibitor, and sotorasib, KRASG12C variant inhibitor, including a PDX model of c-MET-altered KRASG12C NSCLC. Our results suggest that the combination of ABN401 and KRAS inhibitor could be an alternative treatment option for c-MET-altered KRASG12C NSCLC patients.
    Preclinical • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    KRAS mutation • EGFR mutation • KRAS G12C • BRAF mutation • MET expression
    |
    Lumakras (sotorasib) • vabametkib (ABN401)
    almost2years
    To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic Profile of ABN401 in Patients With Advanced Solid Tumors Harboring c-MET Dysregulation (clinicaltrials.gov)
    P2, N=40, Recruiting, Abion Inc | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET exon 14 mutation
    |
    vabametkib (ABN401)
    over2years
    To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic Profile of ABN401 in Patients With Advanced Solid Tumors Harboring c-MET Dysregulation (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, Abion Inc
    New P2 trial
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET exon 14 mutation
    |
    vabametkib (ABN401)
    over2years
    The MET inhibitor ABN401 in combination with the third-generation EGFR-TKI is effective MET-amplified and EGFR-mutant NSCLC with acquired resistance to third-generation EGFR-TKI in preclinical models (ESMO 2022)
    Methods The signal transduction inhibition and cytotoxic response of ABN401 in combination with Lazertinib were tested in vitro against Osimertinib-resistance NSCLC cell lines (HCC827-AR) and patient-derived organoid (YUO-010), analyzed by western blot and Cell Titer-Glo assay. Notably, in MET gene amplification (PDX model YHIM-1035, gefitinib/Osimertinib resistant), ABN401 alone showed a potent therapeutic effect. Conclusions Our findings suggest that the clinical application of ABN401 in combination with a third-generation EGFR-TKI to NSCLC patients with MET gene amplification can provide a promising therapeutic strategy for overcoming acquired resistance to EGFR-TKIs.
    Preclinical • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    EGFR mutation • EGFR exon 19 deletion • MET amplification • EGFR T790M • MET mutation • MET amplification + EGFR mutation
    |
    Tagrisso (osimertinib) • gefitinib • Lazcluze (lazertinib) • vabametkib (ABN401)
    over2years
    A phase I-II multicenter, open-label, dose-escalation study to evaluate the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of ABN401 in patients with advanced solid tumors and dose-expansion in patients with non-small cell lung cancer harboring c-MET dysregulation (ESMO 2022)
    We plan to open several cohorts to treat other types of cancers harboring MET alteration. In addition, combination therapies with different types of drugs are planned.
    Clinical • P1/2 data • PK/PD data
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET exon 14 mutation • MET overexpression • MET mutation • MET expression
    |
    vabametkib (ABN401)
    over4years
    Therapeutic Efficacy of ABN401, a Highly Potent and Selective MET Inhibitor, Based on Diagnostic Biomarker Test in MET-Addicted Cancer. (PubMed, Cancers (Basel))
    The results show that the efficacy of ABN401 is associated with MET status and they highlight the importance of determining the cut-off values. The results suggest that clinical trials need to establish the characteristics of each sample and their correlations with the efficacy of MET inhibitors.
    Clinical • Journal
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    vabametkib (ABN401)
    almost5years
    New Preclinical Development of a c-Met Inhibitor and Its Combined Anti-Tumor Effect in c-Met-Amplified NSCLC. (PubMed, Pharmaceutics)
    Unlike other c-Met inhibitors that fail clinically, ABN401 is a newly synthesized c-Met inhibitor that is not potentially degraded by aldehyde oxidase (AO) in human liver cytosol. The bioavailability is approximately 30% in dogs and it is highly efficient in the PDX model, achieving around 90% tumor growth inhibition in combination with erlotinib. These observations indicate that the compound is acceptable for the next phase of trials.
    Preclinical • Journal
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    erlotinib • vabametkib (ABN401)