Innovent Announces the First Patient Dosed in the Phase 1 Study of IBI323 (Anti-LAG-3/PD-L1 Bispecific Antibody) in Patients with Advanced Malignant Tumors
Innovent Biologics has announced the first patient dosing in a Phase 1 study of IBI323, an anti-LAG-3/PD-L1 bispecific antibody. The trial aims to evaluate its safety, tolerability, dosage, and preliminary efficacy in patients with advanced malignant tumors who have progressed on standard treatments. IBI323 is designed to enhance T lymphocyte activation more effectively than existing treatments by blocking both PD-1/PD-L1 and LAG-3 pathways. Innovent plans to submit an IND application for IBI323 to the FDA soon.
- Initiation of Phase 1 clinical trial for IBI323.
- IBI323 shows potential for improved efficacy compared to current treatments.
- Positive preclinical results indicating better T lymphocyte activation.
- Current market exposure limited to China for the trial.
- Uncertainty in future regulatory approvals outside China.
SAN FRANCISCO and SUZHOU, China, July 11, 2021 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, today announced that the first patient has been dosed in a Phase 1 study of IBI323, an anti-LAG-3/PD-L1 bispecific antibody.
The objective of this open-label, multi-center Phase 1 dose escalation and expansion study is to evaluate the safety, tolerability, potential optimal dosage and preliminary efficacy of IBI323 in patients with advanced malignant tumors whose cancer progressed on standard-of-care treatment. The trial is being conducted in China.
IBI323 is a recombinant LAG-3/PD-L1 bispecific antibody. Preclinical studies showed that IBI323 effectively blocks both the PD-1/PD-L1 and LAG-3 pathways and can generate more effective and durable activation of T lymphocyte activation than the combination of anti-PD-L1 monoclonal antibody and anti-LAG monoclonal antibody. Besides, through the bridging effect of bispecific antibody, tumor cells expressing PD-L1 can be drawn closer to T lymphocyte expressing LAG-3, thus forming stable TCR: MHC immune synapses and enhancing T lymphocyte activation. Therefore, IBI323 shows advantages compared with two drugs combination according to the mechanism. Recently, an article about IBI323's bispecific antibody enhances tumor-specific immunity was published on Oncolmmunology.
Professor Caicun Zhou, Chief of Oncology Department of Shanghai Pulmonary Hospital Affiliated to Tongji University and Director of Cancer Institute of Tongji University Medical School, stated: "Although immune checkpoint inhibitors have shown promising results in the treatment of a wide range of tumors, there still remains many new challenges. Many patients inevitably develop drugs resistance and the efficacy of immune checkpoint inhibitors needs to be further enhanced. Therefore, it is of great value to develop the next generation of bispecific antibodies. LAG-3 is one of the most promising targets among cancer immunotherapy, combining innovative techniques for bispecific monoclonal antibody, we look forward to the results of IBI323 clinical trials. "
Dr. Hui Zhou, Senior Vice President of Clinical Development of Innovent, stated: "The LAG-3/PD-L1 bispecific antibody can specifically target both LAG-3 and PD-L1, block both the PD-1/PD-L1 and LAG-3 pathways, synergically enhance the activity of T lymphocyte and close the distance between tumor cells with high PD-L1 expression and T cells expressing LAG-3. The preclinical results have shown that compared with two monoclonal antibodies, IBI323 can further enhance the immune activation with improved convenience of administration. Therefore, the development of LAG-3/PD-L1 bispecific antibody will provide patients with a novel, comprehensive, effective and cost-saving treatment regimen. We hope that IBI323 will benefit more patients. "
About IBI323 (anti-LAG-3/PD-L1 bispecific antibody)
IBI323 is a recombinant LAG-3/PD-L1 bispecific antibody developed by Innovent Biologic. The IND of IBI323 has been approved by NMPA and we are actively conducting the clinical trial in China. We also plan to prepare an IND application with the U.S. Food and Drug Administration (FDA).
About the Phase 1 Study of IBI323 (CIBI323A101)
Conducted by Innovent in China, the CIBI323A101 trial is a Phase 1 open-label, multi-center study of the safety, tolerability and primary efficacy of IBI323 in patients with advanced solid tumors (ClinicalTrials.gov, NCT04916119).
About Innovent
Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune, metabolic and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.
Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 24 valuable assets in the fields of cancer, metabolic, autoimmune disease and other major therapeutic areas, with 5 products – TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection) and Pemazyre® (pemigatinib oral inhibitor) – officially approved for marketing, sintilimab's Biologics License Application (BLA) acceptance in the U.S., 5 assets in Phase 3 or pivotal clinical trials, and an additional 14 molecules in clinical studies.
Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, MD Anderson Cancer Center, Hanmi and other international partners. Innovent strives to work with many collaborators to help advance China's biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives. For more information, please visit: www.innoventbio.com.
Forward-Looking Statements
This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly.
These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions.
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