Innovent Announces the First Patient Dosed in the Phase 1 Study of IBI321 (Anti-PD-1/TIGIT Bispecific Antibody) in Patients with Advanced Malignant Tumors

Innovent Biologics, Inc., 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 IBI321, an anti-PD-1/TIGIT bispecific antibody.

The objective of this open-label, multi-center Phase 1a dose escalation and expansion study is to evaluate the safety, tolerability, potential optimal dosage and preliminary efficacy of IBI321 in patients with advanced malignant tumors whose cancer progressed on standard-of-care treatment. The trial is being conducted in China.

As a bispecific antibody, IBI321 has the potential to enhance efficacy by synergistically targeting both PD-1 and TIGIT. Preclinical studies of IBI321 have shown that the molecule retained the activity of a PD-1 inhibitor and simultaneously suppressed TIGIT to enhance the anti-cancer efficacy.

Professor Baohui Han, Chief of Respiration Department and GCP center of Shanghai Chest Hospital, stated: "Although immune checkpoint inhibitors have shown great efficacy in a variety of tumor types, we still face challenges of primary and secondary drug resistance. Meanwhile, the efficacy of immune checkpoint inhibitors needs to be further improved. Therefore, the development of the next generation of bispecific antibodies has important clinical value. TIGIT is an important immune checkpoint receptor which plays an important role in tumor immune surveillance. We look forward to the clinical research results of IBI321."

Professor Xiangdong Cheng, secretary of party committee of Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital) and Chief of Zhejiang Province Upper Gastrointestinal Tumor Diagnosis and Treatment Technology Research Center, stated: "The progress of immunotherapy in certain types of colorectal cancer and gastric cancer has not been satisfactory compared with the progress of anti-PD-1 monoclonal antibodies in melanoma, lung cancer and esophageal cancer, and this needs further exploration. TIGIT is highly expressed in gastric cancer. And pre-clinical experiments have proved that synergistically targeting PD-1 and TIGIT could significantly repress gastric tumor growth. We look forward to the clinical results of IBI321, particularly in GI tumors."

Dr. Hui Zhou, Senior Vice President of Clinical Development of Innovent, stated: "By specifically targeting both PD-1 and TIGIT, this type of bispecific antibody is designed to provide synergistic effects by blocking both the PD-1/PD-L1 and TIGIT/CD155 pathways – with the goal of improving the anti-cancer efficacy. Currently, there is no bispecific antibody that has same target as IBI321 in clinical-stage development worldwide. Preclinical studies of IBI321 have demonstrated that the combination of these two monoclonal antibodies further enhanced the immune activation with improved convenience of administration. Therefore, the development of an anti-PD-1/TIGIT bispecific antibody has the potential to provide patients with more effective and convenient treatment. We look forward to hope that IBI321 will benefit more patients."

About IBI321 (anti-PD-1/TIGIT bispecific antibody)

IBI321 was discovered through a collaboration between Innovent and Eli Lilly and Company and has been developed in China by Innovent. The IND for IBI321 has been approved by the NMPA in China, and clinical trials in China are actively being conducted.

About the Phase 1 Study of IBI321 (CIBI321A101)

Conducted by Innovent in China, the CIBI321A101 trial is a Phase 1a open-label, multi-center study of the safety, tolerability and primary efficacy of IBI321 in patients with advanced solid tumors. Phase 1a of the study will evaluate dosing of IBI321 in a variety of solid tumors (ClinicalTrials.gov, NCT04911894).

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality bio pharmaceutical 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, S.A.R., China 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 25 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, 1 asset's NDA under NMPA review, 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.