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    DRUG:

    JIN-A02

    i
    Other names: JIN-A02
    Company:
    J Ints Bio
    Drug class:
    EGFR inhibitor
    Related drugs:
    5ms
    Overcoming triple mutant EGFR-tyrosine kinase barriers in the therapeutics of non-small cell lung cancer: a patent review on fourth-generation inhibitors (2017-2024). (PubMed, Expert Opin Ther Pat)
    This review highlights the significance of fourth-generation EGFR tyrosine kinase inhibitors (EGFR-TKIs) in addressing acquired resistance mechanisms, such as the C797S mutation, which compromises the efficacy of third-generation inhibitors like Osimertinib and explores their potential to revolutionize NSCLC treatment through enhanced molecular specificity. Preclinical trials highlight the potential of sulfonyl and phosphine oxide-based compounds for their potency, selectivity, and favorable pharmacokinetics. Promising clinical trials with inhibitors like BDTX-1535, JIN-A02, and HS-10504 could redefine NSCLC treatment, with future success likely relying on innovative strategies, such as combination therapies, to combat resistance and enhance efficacy.
    Review • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR T790M
    |
    Tagrisso (osimertinib) • JIN-A02 • silevertinib (BDTX-1535)
    7ms
    A Phase 1/2 Study to Evaluate the Safety, Tolerability and PK of JIN-A02 in Patients With EGFR Mutant Advanced NSCLC (clinicaltrials.gov)
    P1/2, N=150, Recruiting, J Ints Bio | Trial completion date: Nov 2025 --> Sep 2026 | Trial primary completion date: Jul 2024 --> Sep 2026
    Trial completion date • Trial primary completion date
    |
    EGFR mutation • EGFR positive
    |
    JIN-A02
    8ms
    A clinical review on third and fourth generation EGFR tyrosine kinase inhibitors for the treatment of non-small cell lung cancer. (PubMed, Bioorg Med Chem)
    This review delves into the current clinical status, efficacy, safety profiles, and regulatory approvals of third-generation EGFR TKIs, including Osimertinib, Lazertinib, Furmonertinib, Aumolertinib, Rezivertinib, Befotertinib, Sunvozertinib...Notable fourth-generation candidates such as TQB3804, BPI-361175, BDTX-1535, WJ13404, QLH11811, H002, HS-10375, BBT-207, JIN-A02, and HS-10504 are highlighted for their potential to overcome the C797S mutation...By evaluating the therapeutic potential and limitations of these EGFR TKIs, this review aims to guide future research in the management of EGFR-mutant NSCLC. This acts as guiding beacon for the strategic design and development of third and fourth generation EGFR-TK inhibitors to overcome the drug resistance hurdles in the development of EGFR-TK inhibitors.
    Review • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR T790M
    |
    Tagrisso (osimertinib) • Ameile (aumolertinib) • Ivesa (firmonertinib) • Lazcluze (lazertinib) • JIN-A02 • silevertinib (BDTX-1535) • Semena (befotertinib) • Zegfrovy (sunvozertinib) • Rui Bi Da (rezivertinib) • BPI-361175 • BBT-207 • HS-10375 • QLH11811 • TQB3804
    over2years
    A Phase 1, 2 Study to Evaluate the Safety and Anti-tumor Activity of JIN-A02 in Patients with EGFR Mutant Advanced NSCLC (IASLC-WCLC 2023)
    JIN-A02, a 4th generation EGFR TKI, selectively and reversibly binds to EGFR mutations, including C797S mutation that causes resistance to Osimertinib. Primary end points include dose limiting toxicity and AE/SAE for part A, RP2D for part B, and objective response rate for part C. Part A of JIN-A02 study has begun site activation in January 2023 in US, approved in Korea and is awaiting regulatory approval in Thailand. Clinical trial information: NCT05394831
    Clinical • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • EGFR C797S • EGFR positive
    |
    Tagrisso (osimertinib) • JIN-A02
    almost3years
    A Phase 1/2 Study to Evaluate the Safety, Tolerability and PK of JIN-A02 in Patients With EGFR Mutant Advanced NSCLC (clinicaltrials.gov)
    P1/2, N=150, Recruiting, J Ints Bio | Not yet recruiting --> Recruiting | N=95 --> 150 | Trial completion date: Dec 2024 --> Nov 2025 | Trial primary completion date: Dec 2023 --> Jul 2024
    Enrollment open • Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR C797S • EGFR positive
    |
    JIN-A02
    over3years
    A Phase 1/2 Study to Evaluate the Safety, Tolerability and PK of JIN-A02 in Patients With EGFR Mutant Advanced NSCLC (clinicaltrials.gov)
    P1/2, N=95, Not yet recruiting, J Ints Bio
    New P1/2 trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR T790M
    |
    JIN-A02