On June 1, 2020 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 the preliminary results of the Phase 1a clinical study (NCT03875157) of the recombinant fully human anti-programmed bispecific antibody IBI318 against programmed death receptor 1 (PD-1) and programmed death ligand 1 (PD-L1) in patients with advanced tumors at the 56th American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Abstract # 3062, Poster #126, 8:00 AM – 11:00 AM, U.S. Central Time, Friday, May 29, 2020) (Press release, Innovent Biologics, JUN 1, 2020, View Source [SID1234560739]).
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The NCT03875157 study presented at the ASCO (Free ASCO Whitepaper) annual meeting was a Phase 1 clinical study conducted in China to evaluate the safety, tolerability and anti-tumor activity of IBI318 in subjects with advanced tumors. The main clinical data include:
As of January 10, 2020, a total of 15 subjects had enrolled in the 1a dose escalation phase, and the dose exploration phase of 600 mg Q2W is currently ongoing. A total of 11 subjects experienced treatment-related adverse events (TRAEs) and the most common TRAEs were pyrexia (20.0%, G1/2) and infusion reactions (20.0%, G1/2). There were no Grade 3 or higher TRAEs. One subject had a Grade 2 immune-related arthritis at a dose of 300 mg.
Twelve subjects had at least 1 tumor assessment, and 9 subjects received IBI318 treatment at doses of 10 mg and above, with 3 subjects experiencing an objective response.
Professor Ruihua Xu, the leader of the study and President of Zhongshan Cancer Prevention and Control Center, said: "Immunotherapy is entering into the era of bispecific antibodies from monoclonal antibodies. The preliminary results from NCT03875157 study show that IBI318, a first-in-class bispecific antibody, has an acceptable safety profile. We are hopeful to see positive results from the following studies to help more patients in need. "
About IBI318 (Anti-PD-1/PD-L1 Bispecific Antibody)
IBI318 is an innovative recombinant fully human IgG1 bispecific antibody that restores T cell activation and anti-tumor function by blocking PD-1 and PD-L1/PD-L2 signaling pathways, and blocking PD-L1 binding CD80 signaling pathway. IBI318 is expected to improve anti-tumor activity and efficacy by bridging PD-1-expressing T cells and PD-L1-expressing tumor cells through its bispecific ability to form an immune synapse between the two.