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    Home > Medical News > Latest Medical News > The multi-target inhibitor introduced by Zai Lab over US$350 million received clinical approval for the first time

    The multi-target inhibitor introduced by Zai Lab over US$350 million received clinical approval for the first time

    • Last Update: 2022-01-14
    • Source: Internet
    • Author: User
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    Article source: Medical Rubik's Cube Info

    Author: Sunshine

    On November 23, the CDE official website showed that Turning Point's TPX-0022 capsule clinical trial application was approved by the Food and Drug Administration for the treatment of locally advanced or metastatic non-small cell lung cancer, gastric cancer or solid tumors with MET gene mutations
    .

    TPX-0022 is an oral multi-target kinase inhibitor targeting MET and related cancer signaling pathways SRC and CSF1R
    .
    In January this year, Zai Lab reached a cooperation with Turning Point and obtained the exclusive authorization for the development and commercialization of TPX-0022 in Greater China
    .
    At the same time Turning Point is eligible to receive a cash advance of US$25 million, up to US$336 million in potential development, registration and sales milestone payments, and royalties
    .
    Previously, Zai Lab obtained the exclusive license to develop and commercialize repotrectinib in the Greater China region, with a total transaction amount of US$176 million
    .

    MET is a tyrosine kinase receptor for hepatocyte growth factor (HGF).
    Gene mutations (including point mutations, amplification, fusion, skipping and deletion of exon 14 and the formation of HGF-MET autocrine loops) Cancers such as non-small cell lung cancer and gastric cancer are present
    .
    SRC is a kinase involved in the MET signaling pathway.
    Inhibition of SRC can reduce or neutralize HGF, thereby preventing the activation of the signaling pathway
    .
    Targeting CSF1R can regulate tumor-associated macrophages (TAM), which is conducive to the immune response of anti-tumor T cells
    .

    TPX-0022 (elzovantinib) has a new three-dimensional macrocyclic structure that can inhibit MET, CSF1R (colony stimulating factor 1 receptor) and SRC kinase, and has the potential to regulate the tumor microenvironment to enhance its therapeutic effect
    .
    In June and August 2021, TPX-0022 was granted Fast Track and Orphan Drug Designation by the FDA for the treatment of gastric cancer
    .

    In October 2021, Turning Point announced the latest clinical data for the dose exploration part of the Phase I SHIELD-1 study
    .
    The results showed that the confirmed objective response rates of elzovantinib in MET TKI-naive non-small cell lung cancer and gastric and gastroesophageal junction cancer patients with MET gene abnormalities were 36% and 33%, respectively
    .

    In response to feedback from the FDA, Turning Point plans to initiate the phase II part of the SHIELD-1 study, and at the same time to initiate the phase Ib/II SHIELD-2 study in combination with epidermal growth factor receptor (EGFR) targeted therapy in mid-2022 (see The new drug clinical research application (IND) will be approved by the FDA depending on the time)
    .

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