Innovent Announces First Patient Dosed with CD73 Antibody in Phase 1a/1b Clinical Trial for Advanced Solid Tumor

SAN FRANCISCO and SUZHOU, China, Feb. 23, 2022 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), 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.

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. For more information, please visit: www.innoventbio.com. and www.linkedin.com/company/innovent-biologics/.

Note:

TYVYT® (sintilimab injection) is not an approved product in the United States.
BYVASDA® (bevacizumab biosimilar injection), SULINNO®, and HALPRYZA® (rituximab biosimilar injection) are not approved products in the United States.

TYVYT® (sintilimab injection, Innovent)
BYVASDA® (bevacizumab biosimilar injection, Innovent)
HALPRYZA® (rituximab biosimilar injection, Innovent)
SULINNO® (adalimumab biosimilar injection, Innovent)
Pemazyre® (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan.

Disclaimer:

1. This indication is still under clinical study, which hasn't been approved in China.
2. Innovent does not recommend any off-label usage.
3. For medical and healthcare professionals only.

Forward-Looking Statements

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions.

Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect.

SOURCE Innovent Biologics