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    Home > Medical News > Medical Research Articles > Innovent Announces Preliminary Results of a Phase I Clinical Study of IBI322 (PD-L1/CD47 Bispecific Antibody) at the 2022 AACR Annual Meeting in Subjects with Advanced Malignancies who Failed Standard Therapy

    Innovent Announces Preliminary Results of a Phase I Clinical Study of IBI322 (PD-L1/CD47 Bispecific Antibody) at the 2022 AACR Annual Meeting in Subjects with Advanced Malignancies who Failed Standard Therapy

    • Last Update: 2022-05-24
    • Source: Internet
    • Author: User
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    SAN FRANCISCO, USA and SUZHOU, China , April 11, 2022 /PRNewswire/ -- Innovent Biopharmaceutical Group (SEHK: 01801), a company dedicated to the research and development, production and sales of drugs for the treatment of tumors, metabolic diseases, The biopharmaceutical company of innovative drugs for major diseases such as autoimmunity announced that preliminary results of a Phase I clinical study of IBI322 in subjects with advanced malignancies were presented in poster format at the 2022 American Association for Cancer Research Annual Meeting (AACR 2022) (No.
    : CT513)

    .
     

    This phase I clinical study aims to evaluate the safety, tolerability and preliminary efficacy of IBI322 monotherapy in subjects with advanced malignancies who have failed standard therapy, and is divided into dose escalation phase and dose expansion phase
    .
    A total of 58 patients with advanced malignant tumors who had previously failed standard therapy were enrolled in this study, of which 16 patients (27.
    6%) had received PD-1/L1 therapy in the past

    .
    research shows:

    • A total of 20 subjects with different types of advanced malignancies received an effective dose of IBI322 (≥10 mg/kg) and completed at least one tumor assessment, of which 4 subjects achieved partial responses with an objective response rate (ORR) of 20%
      .
    • A total of 9 subjects with advanced non-small cell lung cancer who failed standard therapy received an effective dose of IBI322, of which 3 subjects achieved partial response, the objective response rate (ORR) was 33.
      3%, and the disease control rate (DCR) was 88.
      9%

      .
    • In terms of safety, a total of 74.
      1% (43/58) of the subjects experienced drug-related adverse events, most of which were grade 1-2.
      The most common drug-related adverse events were anemia, thrombocytopenia and fever

      .
      It was generally well tolerated and no deaths related to the study drug occurred

      .

    The Phase Ia dose-expansion study of IBI322 monotherapy is still ongoing after the deadline for this data release, and initial disease responses and Control, more mature data are still under observation
    .

    In addition, given that IBI322 has shown preliminary efficacy signals and good safety and tolerability in patients with advanced malignant tumors who have failed standard therapy, the Phase Ib clinical study of IBI322 is continuing to advance to further explore the efficacy of IBI322 in multiple indications.
    Safety and efficacy

    .

    The principal investigator of this study, Professor Wang Jie of Cancer Hospital of the Chinese Academy of Sciences, said: "Immune checkpoint inhibitors have shown promising efficacy in the treatment of multiple tumor types, but there is room
    for further improvement in clinical practice.
    With the increasing popularity of checkpoint inhibitors in the first-line treatment of tumors, many clinically resistant patients have emerged, and some tumor types have poor response to immune checkpoint inhibitors

    .
    Therefore, the development of next-generation bispecific tumor immune Drugs have important clinical significance for solving drug resistance and improving response rates.

    CD47 is one of the promising and potential targets in tumor immunotherapy.
    IBI322 combines the innovative technology of bispecific antibodies to treat advanced malignant tumors that have failed previous standard treatments.
    The early study results in subjects showed good safety and preliminary efficacy, increasing our confidence in the follow-up expansion cohort study

    .
    "

    Dr.
    Hui Zhou, Senior Vice President of Innovent Bio,
    said: "IBI322 is a bispecific antibody that specifically targets recombinant anti-differentiation cluster 47 (CD47) and anti-programmed death ligand 1 (PD-L1), which was independently developed by Innovent Bio.
    And has global rights

    .
    We are very pleased to observe the preliminary efficacy signal and good safety and tolerability of IBI322 in patients with advanced malignant tumors who have failed standard therapy in the Phase Ia study, and we will continue to advance the Phase Ib expansion cohort study , to further explore the safety and efficacy of IBI322 in multiple indications.
    Innovent

    hopes to bring clinical benefits to more patients through a pipeline portfolio of next-generation tumor immunosuppressant targets with a complete layout and a leading progress
    .

    About IBI322

    IBI322 is a recombinant bispecific antibody specifically developed by Innovent Biopharmaceuticals against CD47/PD-L1 targets
    .
    This product candidate can target CD47 on the surface of tumor cells, block the SIRPα/CD47 signaling pathway, and activate the phagocytosis of tumor cells by macrophages; it can also bind to PD-L1 on the surface of tumor cells and block PD-1/PD-L1 signaling The pathway can relieve the tumor microenvironment's inhibition of T cells and activate the killing effect of T cells on tumor cells

    .
    IBI322 simultaneously activates the innate immune and adaptive immune pathways by simultaneously acting on the dual-specific functions of two immune checkpoints (CD47 and PD-L1), enhancing the targeted recognition of tumors by the immune system, and has an anti-tumor "synergistic effect"

    .
    In addition, through the targeting of PD-L1 antibody segment, IBI322 improves the selective binding ability to tumor cells, reduces the binding to human normal tissue cells expressing CD47, and reduces the toxic and side effects caused by CD47 therapeutic antibodies

    .
    IBI322 has obtained IND approvals from the National Medical Products Administration (NMPA) of China and the FDA of the United States, and is actively conducting clinical studies around the world

    .

    About Innovent

    "Begins with faith, achieves in action", and developing high-quality biological drugs affordable to the common people is the ideal and goal of Innovent
    .
    Founded in 2011, Innovent Bio is committed to the development, production and sales of innovative drugs for the treatment of major diseases such as tumors, autoimmunity, and metabolic diseases

    .
    On October 31, 2018, Innovent Biopharma was listed on the main board of The Stock Exchange of Hong Kong Limited, stock code: 01801

    .

    Since its establishment, the company has stood out among many biopharmaceutical companies with its innovative achievements and international operating model
    .
    A product chain including 32 new drug varieties has been established, covering tumor, metabolic diseases, autoimmunity and other disease fields, of which 7 varieties have been selected for the national "Major New Drug Creation" project

    .
    The company has 7 products (Sintilimab injection, trade name: Daboshu® , English trademark: TYVYT ®
    ; Bevacizumab biosimilar, trade name: Dayutong® , English trademark: BYVASDA ® ; Adalimumab biosimilar, trade name: Su Lixin® , English trademark: SULINNO® ; Rituximab biosimilar, trade name: Dabohua® , English trademark: HALPRYZA® ; Pemetinib Tablets, trade name: Dabotan® , English trademark: PEMAZYRE ® ; Orebatinib, trade name: Nerlik®; Ramucirumab, trade name: Ciranaze®, English trademark: CYRAMZA® ) has been approved for marketing, 1 product is under NMPA review, 5 products have entered Phase III or pivotal clinical research, and 19 products have entered clinical research .

    Innovent Bio has established a high-end biopharmaceutical development and industrialization talent team with international advanced level, including many returnee experts, and has cooperated with international partners such as Eli Lilly, Adimab, Incyte, MD Anderson Cancer Center and Hanmi in South Korea.
    reach a strategic cooperation

    .
    Innovent hopes to work together with everyone to improve the development level of China's biopharmaceutical industry to meet the availability of medicines and the pursuit of people's good wishes for life and health

    .
    For more information, please visit the company's website:
    or the company's LinkedIn account at .
     

    statement:

    1.
    The indication is the use of the drug under investigation and has not been approved in China;

    2.
    Innovent does not recommend the use of any unapproved drugs / indications
    .

    Innovent Forward-Looking Statements

    Information published in this press release may contain certain forward-looking statements
    .
    These statements are inherently subject to considerable risk and uncertainty

    .
    The use of words such as "anticipates," "believes," "forecasts," "expects," "intends," and other similar words in relation to the Company is intended to identify forward-looking statements

    .
    The Company undertakes no obligation to continually update these forward-looking statements

    .

    These forward-looking statements are based on the Company's management's current beliefs, assumptions, expectations, estimates, projections and understanding of future events at the time the statements are made
    .
    These statements are not guarantees for future development and are subject to risks, uncertainties and other factors, some of which are beyond the control of the company and are difficult to predict

    .
    Accordingly, actual results may differ materially from those contained in forward-looking statements as a result of future changes and developments in our business, competitive environment, political, economic, legal and social conditions

    .

    The Company, its directors and employee agents disclaim (a) any obligation to correct or update the forward-looking statements contained in this website; and (b) any responsibility
    .

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