On April 23, 2019 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines, reported that the first patient in China has been successfully dosed in a Phase I clinical trial of a recombinant fully human bispecific antibody targeting programmed cell death receptor-1 (PD-1) and programmed cell death ligand-1 (PD-L1) (IBI318), an innovative antibody developed in collaboration with Eli Lilly and Company (Press release, Innovent Biologics, APR 23, 2019, View Source [SID1234535334]).

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CIBI318A101 is a Phase I clinical study conducted in China to evaluate IBI318 in the treatment of patients with advanced malignancies. The primary objectives of the study are to evaluate the safety, tolerability, and initial efficacy of IBI318.

IBI318 is a recombinant fully human IgG1 bispecific antibody targeting PD-1 and PD-L1, and may offer a novel solution to patients’ unmet medical needs. IBI318 simultaneously binds to PD-1 and PD-L1, blocks PD-1 and PD-L1 signaling, bridges PD-1-expressing T cells to PD-L1-expressing tumor cells, and enhances the formation of immune synapses, thereby potentially enhancing anti-tumor activities and increased anti-tumor efficacy.

"Immunotherapies such as checkpoint-blocking antibodies targeting PD-1 and PD-L1 are playing increasingly important roles in oncology therapy. However, there are still many challenges in their clinical application. Particularly, for patients without predictive biomarkers, the clinical response rate is approximately 20%. Many patients also have primary or acquired resistance to anti-PD-1/PD-L1 antibodies. We still need to actively develop the next generation of immunotherapy. We are looking forward to seeing the clinical results of IBI318," said Professor Xu Ruihua, Director of Sun Yat-Sen University Cancer Center.

"IBI318 is the world’s first PD-1/PD-L1 bispecific antibody to enter clinical development. Therefore, the development of IBI318 has unique clinical value. We will evaluate the potential clinical value of this drug candidate and hope to provide a more effective treatment option and ultimately benefit more patients," said Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent.

About IBI318

IBI318, was discovered through the collaboration between Innovent and Eli Lilly and Company and has been developed in China by Innovent. IBI318 is a recombinant fully human immunoglobulin bispecific antibody that blocks both PD-1 binding to PD-L1 and PD-L2 and PD-L1 binding to CD80, which will restore T cell activation and generate anti-tumor activities. In preclinical studies, PD-1-expressing T cells and PD-L1-expressing tumor cells can be bridged by IBI318, which enhances immune synapse formation and anti-tumor activities. The cell bridging induced by IBI318 could further enhance the anti-tumor activities generated through modulating the PD-1/PD-L1 signaling pathway.

About CIBI318A101

CIBI318A101 is a Phase I clinical study conducted in China to evaluate IBI318 in the treatment of patients with advanced malignancies. The primary objectives of the study are to evaluate the safety, tolerability, and initial efficacy of IBI318.