Innovent Announces the Preliminary Results of the Anti-PD-1/PD-L1 Bispecific Antibody IBI318 in a Phase 1 Clinical Study

SUZHOU, China, June 1, 2020 /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 announces 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 56^th American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract # 3062, Poster #126, 8:00 AM – 11:00 AM, U.S. Central Time, Friday, May 29, 2020).

The NCT03875157 study presented at the ASCO 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.

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, metabolic, autoimmune 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 multifunctional 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 23 valuable assets in the fields of cancer, metabolic, autoimmune diseases and other major therapeutic areas, with 17 in clinical development, five in Phase 3 or pivotal clinical trials, four under NDA reviews by the NMPA (three under priority review status), while TYVYT® (sintilimab injection), officially approved for marketing in China in 2018, has been the only PD-1 inhibitor included in the NRDL, since 2019.

Innovent has built an international team of advanced talents in high-end biological drug development and commercialization, including many overseas 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 all relevant parties to help advance China's biopharmaceutical industry, improve drug availability to ordinary people and enhance the quality of the patients' lives. For more information, please visit：www.innoventbio.com.

SOURCE Innovent Biologics, Inc.

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