Innovent Biologics, Inc., a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, announces that the first patient outside China has been successfully dosed in a Phase 1 clinical trial of the potentially first-in-class recombinant anti-CD47/PD-L1 bispecific antibody (IBI322).

This is a Phase 1a clinical study conducted in the United States to evaluate IBI322 in the treatment of patients with advanced malignancies. The primary objective of the study is to evaluate the safety, tolerability, and initial anti-tumor efficacy of IBI322 in patients with advanced malignancies who have failed standard therapy.

IBI322 is a recombinant anti-CD47/PD-L1 bispecific antibody that blocks both the PD-1/PD-L1 and CD47/ SIRP-α pathways. Pre-clinical studies showed that IBI322 can effectively block CD47–SIRP-α interactions and induce macrophages to phagocytize CD47 expressed tumor cells, which is equivalent to anti-CD47 monoclonal antibody. IBI322, on the other way, effectively blocks the binding of PD-1 to PD-L1 and activates CD4+T lymphocyte, which is comparable to anti-PD-L1 monoclonal antibody. Because of PD-L1 expression on tumor cells, IBI322 can selectively binds to tumor cells more potent than anti-CD47 monoclonal antibody, thus reducing the possibility of bind to CD47 on red blood cells, which could ultimately reduce the toxicity associated with anti-CD47 antibodies. Therefore, IBI322 has better antitumor activity and higher safety profile.

Although immune checkpoint inhibitors have shown promising results in the treatment of a wide range of tumors, there still remains many new challenges. A part of patients has developed 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 anti-tumor immune bispecific antibodies. CD47 is one of the most promising targets among cancer immunotherapy, combining innovative techniques for bispecific monoclonal antibody, we look forward to the results of IBI322 clinical trials.

Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent, stated: " By targeting effector cells directly to tumor cells, bispecific monoclonal antibody enhances cytotoxicity, antibody selectivity and functional affinity. The preliminary results showed that IBI322 had higher efficacy in vivo, tumor-rich distribution and better safety than the single-specific anti-CD47 antibody. Bispecific monoclonal antibody could bring a lower-cost solution to patients compared with a combination of monoclonal antibody therapies. Therefore, the development of the anti-CD47/PD-L1 bispecific antibody will provide patients with a novel, comprehensive, effective and cost-saving treatment regimen. We hope IBI322 could potentially benefit more patients in need."          

About IBI322

IBI322 is a recombinant anti-CD47/PD-L1 bispecific antibody developed by Innovent. As a class 1 innovative drug and a potentially first-in-class molecule, IBI322 can effectively induce the phagocytosis of tumor cells and stimulate the activation of T lymphocytes to exert anti-tumor activity. IBI322 is of more affinity to tumor cells, thus reducing the toxicity to normal tissue, providing more effective treatment to cancer patients. IBI322 has received an IND approval from both the NMPA and the U.S. FDA. Innovent is actively preparing to develop it globally.

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, 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 23 valuable assets in the fields of cancer, metabolic, autoimmune diseases and other major therapeutic areas, with 4 products - TYVYT? (sintilimab injection), BYVASDA? (bevacizumab biosimilar injection), SULINNO? (adalimumab biosimilar injection) and HALPRYZA? (rituximab biosimilar injection) - officially approved for marketing in China, four assets in Phase 3 or pivotal clinical trials, and additional 15 molecules in clinical trials. TYVYT? was included in the National Reimbursement Drug List (NRDL) in 2019 as the historically first PD-1 inhibitor entering in NRDL and the only PD-1 included in the list in that year.

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.