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    Home > Active Ingredient News > Drugs Articles > Clinical advantages of Lepu Bio's differential PD-1 monoclonal antibody

    Clinical advantages of Lepu Bio's differential PD-1 monoclonal antibody

    • Last Update: 2021-06-16
    • Source: Internet
    • Author: User
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    At the beginning of April 2021, Lepu Bio announced the completion of 261 million yuan in Series C financing, with a pre-investment valuation of 10 billion yuan
    .


    At the end of April, Lepu Bio's Hong Kong stock IPO prospectus was public, and the research and development pipeline was fully disclosed, including PD-1 putlizumab (HX008), 5 ADC drugs (targeting EGFR, HER2, CD20, TF and Claudin 18.


    Putrizumab (HX008) is a differentially designed PD-1 antibody.


    The S254T/V308P/N434A mutation was introduced into the Fc of IgG4 to extend the half-life


    Based on the unique molecular design, preclinical model test mouse monoclonal antibody was found Pute Li (HX008) O drug exhibits superior antitumor activity K drugs
    .

    At the ASCO meeting in 2021, Lepu Biotech reported on the progress of two clinical studies of Putrizumab (HX008)
    .


    The first study is the second-line and above treatment of advanced melanoma


    The overall response rate ORR of Putrizumab (HX008) for second-line and above treatment of advanced melanoma was 18.


    49%, the disease control rate DCR was 44.
    54%, the median progression-free survival mPFS was 3.
    25 months, and the median overall survival mOS 17.


    The second clinical trial is the second-line clinical trial of Putrizumab (HX008) for the treatment of MSI-H/dMMR advanced solid tumors
    .

    The overall response rate ORR of Putrizumab (HX008) in the treatment of dMMR solid tumors is 47.


    67%, the disease control rate DCR is 75.
    58%, the median progression-free survival mPFS has not yet reached, and the 12-month progression-free survival rate is 52.


    Although there is a lack of head-to-head comparison, the efficacy data of Pratrizumab (HX008) is better than the historical data of O drugs and K drugs
    .


    Furthermore, the total response rate of Pratizumab (HX008) is close to the data of Opdivo+Yervoy combination therapy


    to sum up

    Lepu Biotech has achieved rapid development in the past 3 years since its establishment, and has established a rich R&D pipeline, including a variety of monoclonal antibodies, double antibodies, ADCs, oncolytic viruses and other macromolecular new drugs
    .


    Putrizumab (HX008) has a unique and differentiated design, and its preclinical research shows its advantages.
    The Phase II clinical data of MSI-H/dMMR solid tumors show that it has the potential to become a Bio better


    At the beginning of April 2021, Lepu Bio announced the completion of 261 million yuan in Series C financing, with a pre-investment valuation of 10 billion yuan
    .


    At the end of April, Lepu Bio's Hong Kong stock IPO prospectus was public, and the research and development pipeline was fully disclosed, including PD-1 putlizumab (HX008), 5 ADC drugs (targeting EGFR, HER2, CD20, TF and Claudin 18.
    2), PD-L1 monoclonal antibody LP002, CD47 monoclonal antibody, TIGIT monoclonal antibody, PD-L1/TGFβ double antibody and oncolytic virus CG0070


    Putrizumab (HX008) is a differentially designed PD-1 antibody.
    The S254T/V308P/N434A mutation was introduced into the Fc of IgG4 to extend the half-life
    .
    In the first-phase clinical trial, the half-life of a single administration is 17-24 days, and the half-life after stabilization is 18-38 days
    .

    Based on the unique molecular design, preclinical model test mouse monoclonal antibody was found Pute Li (HX008) O drug exhibits superior antitumor activity K drugs
    .

    At the ASCO meeting in 2021, Lepu Biotech reported on the progress of two clinical studies of Putrizumab (HX008)
    .
    The first study is the second-line and above treatment of advanced melanoma
    .

    The overall response rate ORR of Putrizumab (HX008) for second-line and above treatment of advanced melanoma was 18.
    49%, the disease control rate DCR was 44.
    54%, the median progression-free survival mPFS was 3.
    25 months, and the median overall survival mOS 17.
    91 months
    .

    The second clinical trial is the second-line clinical trial of Putrizumab (HX008) for the treatment of MSI-H/dMMR advanced solid tumors
    .

    The overall response rate ORR of Putrizumab (HX008) in the treatment of dMMR solid tumors is 47.
    67%, the disease control rate DCR is 75.
    58%, the median progression-free survival mPFS has not yet reached, and the 12-month progression-free survival rate is 52.
    70%
    .

    Although there is a lack of head-to-head comparison, the efficacy data of Pratrizumab (HX008) is better than the historical data of O drugs and K drugs
    .
    Furthermore, the total response rate of Pratizumab (HX008) is close to the data of Opdivo+Yervoy combination therapy
    .
    The data shows that the differentiated design and preclinical advantages of Putrizumab (HX008) may be transformed into clinical superiority
    .

    to sum up

    Lepu Biotech has achieved rapid development in the past 3 years since its establishment, and has established a rich R&D pipeline, including a variety of monoclonal antibodies, double antibodies, ADCs, oncolytic viruses and other macromolecular new drugs
    .
    Putrizumab (HX008) has a unique and differentiated design, and its preclinical research shows its advantages.
    The Phase II clinical data of MSI-H/dMMR solid tumors show that it has the potential to become a Bio better
    .
    It is hoped that Putrizumab (HX008) will pass the follow-up clinical test and be available for the benefit of patients as soon as possible
    .
    (Sina Pharmaceutical News)

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