On July 11, 2021 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, reported that the first patient has been dosed in a Phase 1 study of IBI323, an anti-LAG-3/PD-L1 bispecific antibody (Press release, Innovent Biologics, JUL 11, 2021, View Source [SID1234584772]).
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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).