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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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