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    Home > Medical News > Medical Research Articles > Biotech terminates clinical development of PD-1 monoclonal antibody and Trop2 antibody conjugate drug project

    Biotech terminates clinical development of PD-1 monoclonal antibody and Trop2 antibody conjugate drug project

    • Last Update: 2021-07-21
    • Source: Internet
    • Author: User
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    On the 4th, Biotech announced that its BAT800 (recombinant humanized anti-Trop2 monoclonal antibody-maytansine conjugate for injection) and BAT1306 (recombinant humanized anti-PD-1 monoclonal antibody) Antibody injection) is in the clinical research stage

    .
    But recently, the company has carefully considered the subsequent development risks of the drug and decided to terminate the clinical trial of the project

    .


    Reason for project termination


    About BAT8003:


    BAT8003 is an innovative drug independently developed by the company.
    It is an ADC drug targeting Trop2.
    It is formed by covalently linking a glycosylated recombinant humanized anti-Trop2 monoclonal antibody to Batansine through site-directed coupling technology

    .
    The clinical indication of BAT8003 is Trop2-positive advanced epithelial carcinoma

    .
    BAT8003 was launched in March 2019 in a phase I clinical trial for patients with Trop2-positive advanced epithelial cancer.
    In the preclinical evaluation, BAT8003 has proven good tolerability, PK characteristics and good efficacy in preclinical studies

    .
    Taking into account the changes in the market structure in the field of Trop 2 ADC today, and considering that BAT8003 and BAT8001 have similar technical features (although 8003 is fixed-point coupled, batansine technology is also used), there is a high clinical development and market risk

    .


       About BAT1306:


    BAT1306 is a monoclonal antibody against immune suppression checkpoint PD-1 developed by the company.
    The single-agent indication is EBV-related gastric cancer.
    Currently, BAT1306 combined with XELOX has been launched in the first-line treatment of EBV-related gastric cancer clinical trials and BAT8001 combined with BAT1306 in the second-line treatment of HER2-positive advanced Clinical trials of solid tumors

    .
    The company has terminated the advancement of the BAT8001 project, and the clinical trial of BAT8001 combined with BAT1306 for the second-line treatment of HER2-positive advanced solid tumors has also been terminated due to the termination of the above-mentioned project

    .
    At the same time, judging from the clinical data of various PD-1 monoclonal antibodies, it is estimated that in the next 2-3 years, there will be more than 20 PD-1 products on the market globally, and the market competition will become increasingly fierce

    .
    China is the region with the most intense PD-1 competition.
    There are 154 PD-1s in the world, 85 of which are developed or jointly developed by Chinese companies, accounting for 55%

    .
    PD-1 The global and domestic PD-1 monoclonal antibody research and development track has become crowded, and a large number of research and development competing products have also intensified the competition with CRO companies, which further intensified the development cost

    .


    Combining the above reasons, given that BAT8003 and BAT1306 are currently in clinical phase I and phase II respectively, both are relatively early stages, subsequent clinical trials will require a lot of human and financial resources for the company

    .
    In order to rationally allocate the company's R&D resources and focus on advantageous projects in the R&D pipeline, after careful consideration by the company, the company decided to terminate the clinical trials of the above-mentioned projects

    .


    Regarding the company’s losses from terminating the above-mentioned projects, Biotech frankly, in addition to the BAT8003 project’s cumulative R&D investment of 61.
    65 million yuan (as of December 2020), and the BAT1306 project’s cumulative R&D investment of 51.
    974 million yuan (as of December 2020), it may also cause The company lost its competitive position in the aforementioned markets

    .


    Biotech announced on February 8 that it had terminated the clinical development of the HER2 ADC project BAT8001 for breast cancer.
    The previous research and development investment totaled 226 million yuan

    .
    In addition to the two projects terminated this time, the cumulative R&D investment loss is 340 million yuan

    .

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