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, today announces that the first patient has been successfully dosed  in the phase 1, first-in-human clinical trial of its proprietary CD73 antibody (development code: IBI325) in patients with advanced solid tumor.

The open-label, dose escalation phase 1a/1b study (NCT05119998) will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of IBI325 as a single agent and in combination with sintilimab in patients with advanced solid tumors. The recommended dose for further clinical studies will also be determined.

CD73 is an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine. Adenosine binds adenosine A2A andA2B receptors on immune cells and inhibits immune responses directed against tumors. IBI325, as a differentiated, humanized antibody against CD73, is expected to relief the immunosuppressive tumor micro-environment and to work in combination with other cancer therapies such as PD-1 or PD-L1 antibodies. A complete inhibition to CD73 both soluble and on cell surface has been well demonstrated in preclinical studies. And the anti-tumor activities of IBI325 were observed in various tumor models.

Professor Jinming Yu, member of the Chinese Academy of Engineering and president of Shandong Cancer Hospital & Institute, stated, "CD73 is one of the most important targets in the adenosine pathway. Preclinical studies and preliminary clinical data from drugs in the same class has demonstrated the modulation effect of anti-CD73 in immune microenvironment. This new clinical trial will further evaluate the efficacy and safety profile of IBI325 alone and in combination with anti-PD-1 antibody and other immune checkpoint inhibitors in advanced tumors."

"Our preclinical data suggested that IBI325 could completely inhibit the activity of CD73 molecule with no 'hook effect' compared with the other candidates in the same class. An outstanding synergistic effect of combination with IBI325 and sintilimab was also demonstrated," said Dr. Zhou hui, senior VP of Innovent, "IBI325 has the potential to become the best-in-class molecule. The new combination therapy of IBI325 and sintilimab would potentially address the existing unmet medical needs left by current immunotherapies. We are excited that IBI325 has come to the clinical development stage, and are committed to develop new safe and efficacious treatment option for patients with advanced tumor."

About IBI325

IBI325 is a differentiated, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine. Adenosine binds adenosine A2A andA2B receptors on immune cells and inhibits immune responses directed against tumors. IBI325 is expected to relief the immunosuppressive tumor micro-environment and to work in combination with other cancer therapies such as PD-1 or PD-L1 antibodies. A complete inhibition to CD73 both soluble and on cell surface has been well demonstrated in preclinical studies. And the anti-tumor activities of IBI325 were observed in various tumor models.

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 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 29 valuable assets in the fields of cancer, metabolic, autoimmune disease and other major therapeutic areas, with 6 products approved for marketing in China – TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection) , Pemazyre® (pemigatinib oral inhibitor) and olverembatinib (BCR-ABL TKI), 5 assets in Phase 3 or pivotal clinical trials, and an additional 18 molecules in clinical studies.