Innovent Announces the First Patient Dosed in the Phase 1 Study of IBI319 (Anti-PD-1/CD137 Bispecific Antibody) in Patients with Advanced Malignant Tumors

SAN FRANCISCO and SUZHOU, China, July 15, 2021 /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 announced that the first patient has been dosed in a Phase 1a/1b study of IBI319, an anti-PD-1/CD137 bispecific antibody.

The objective of this open-label, multi-center Phase 1a/1b dose escalation and expansion study is to evaluate the safety, tolerability, potential optimal dosage and preliminary efficacy of IBI319 in patients with advanced malignant tumors whose cancer progressed on standard-of-care treatment. The trial is being conducted in China.

In preclinical studies, IBI319 has demonstrated synergistically targeting both PD-1 and CD137 to simultaneously achieve anti-tumor activity and enhance efficacy.

Professor Yilong Wu, Tenured Professor of Guangdong Provincial People's Hospital and Honorary Director of Guangdong Lung Cancer Research Institute, stated, "While immune checkpoint inhibitors have shown efficacy in treating a variety of tumor types, we still face challenges of primary and secondary drug resistance. The development of next-generation bispecific antibodies can have important clinical value implications. CD137 is a key co-stimulatory immune checkpoint molecule that plays a role in maintaining immune homeostasis and enhancing anti-tumor immune memory. With the innovative mechanism of a bispecific antibody that provides additional immune activation through CD137 axis in the suppressed tumor microenvironment, the preclinical research results of IBI319 are very promising."

Dr. Hui Zhou, Senior Vice President of Clinical Development, Innovent Biologics, stated: "Currently, there is no other bispecific antibody with the same target in clinical development in the world. Preclinical results have shown that IBI319 can further enhance the immune activation with improved convenience of administration, compared to the combination of two monoclonal antibodies. "

About IBI319 (anti-PD-1/CD137 bispecific antibody)

IBI319 was discovered through a collaboration between Innovent and Eli Lilly and Company and has been developed in China by Innovent. The IND for IBI319 has been approved by the NMPA in China, and clinical trial in China are actively being conducted.

About the Phase 1 Study of IBI319 (CIBI319A101)

Conducted by Innovent in China, this Phase 1a/1b study (CIBI319A101) will assess the efficacy and safety of IBI319 in patients with advanced malignant tumors. Phase 1a of the study will evaluate dosing and Phase 1b will further explore the efficacy of IBI319 in a variety of solid and hematological tumors (ClinicalTrials.gov, NCT04708210).

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 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 trials.

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.

Note:

Sintilimab is not an approved product in the United States.

BYVASDA^® (bevacizumab biosimilar injection), HALPRYZA^® (rituximab biosimilar injection), and SULINNO^® (adalimumab biosimilar injection) are not approved products in the United States.

TYVYT^® (sintilimab injection, Innovent)

BYVASDA^® (bevacizumab 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.

Innovent Biologics, Inc. Forward-Looking Statements

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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.

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SOURCE Innovent Biologics