Innovent Announces First Patient Dosed in A Phase 1 Clinical Trial of Anti-TIGIT Monoclonal Antibody in China

SUZHOU, China, May 26, 2020 /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, autoimmune, metabolic and other major diseases, today announced that the first patient has been successfully dosed in a Phase 1 clinical trial (CIBI939A101) of anti-T-cell immunoreceptor with Ig and ITIM domains (TIGIT) recombinant fully human monoclonal antibody drug candidate (IBI939) in China.

CIBI939A101 is a Phase 1 clinical study conducted in China to evaluate IBI939 in the treatment of patients with advanced malignancies. The primary objectives of the study are to evaluate the safety, tolerability, and initial anti-tumor efficacy of IBI939, either as monotherapy or in combination with TYVYT® (sintilimab injection), an anti-programmed cell death protein 1 (PD-1) antibody drug.

IBI939 can directly bind to TIGIT, disturb the interaction between CD155 and TIGIT, relieve the inhibition and depletion of T cells and NK cells, enhance the anti-tumor immune response of T cells and NK cells. We anticipate IBI939 to be a brand new clinical option to cancer patients. Furthermore, the combination of anti-TIGIT and anti-PD-1/PD-L1 may provide synergistic enhancement and improve the anti-tumor efficacy.

Professor Lin Shen, Vice President of Peking University Cancer Hospital, stated: "Although immune checkpoint inhibitors have made encouraging progress in the treatment of a variety of tumors, there are still some problems to be solved, such as potential drug resistance and initial treatment efficacy to be further improved. Therefore, it is of great significance to develop the next generation of tumor immune drugs. TIGIT is expected to be one of the most promising targets for a new generation of tumor immune drugs, and we are looking forward to the clinical results of IBI939."

Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent, stated: "TIGIT is an important immuno-inhibitory receptor, and currently there is a series of relevant clinical trials of anti-TIGIT antibodies ongoing abroad, but none of them received approval. The preliminary clinical results have shown certain safety and anti-tumor effectiveness of anti-TIGIT antibody in combination with anti-PD-1/PD-L1 antibody. Now, CIBI939A101 is the first clinical study of TIGIT-targeted drug in China. We hope to advance the evaluation of the potential clinical value of IBI939 and its combination therapy as soon as possible to benefit more patients in need."

About IBI939

IBI939 is an innovative recombinant fully human anti-TIGIT monoclonal antibody developed by Innovent. As class 1 innovative drug, IBI939 can directly bind to TIGIT, relieve the inhibition and depletion of T cells and NK cells, thus activate and enhance the anti-tumor immune response of T cells and NK cells. IBI939 may synergize with anti-PD-1/PD-L1 antibody to improve the anti-tumor efficacy, delay the drug resistance, which may provide more effective treatments for cancer patients.

About CIBI939A101

CIBI939A101 is a Phase 1 clinical study conducted in China to evaluate IBI939 in the treatment of patients with advanced malignancies. The primary objectives of the study are to evaluate the safety, tolerability, and initial anti-tumor efficacy of IBI939, either as monotherapy or in combination with TYVYT® (sintilimab injection), an anti-programmed cell death protein 1 (PD-1) antibody drug.

About TYVYT® (Sintilimab Injection)

TYVYT® (sintilimab injection), an innovative drug developed with global quality standards jointly developed by Innovent and Lilly in China, has been granted marketing approval by the NMPA for relapsed or refractory classic Hodgkin's lymphoma after second-line or later systemic chemotherapy, and included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies. TYVYT is the only PD-1 inhibitor that has been included in the new Catalogue of the National Reimbursement Drug List (NRDL), in November 2019. In April 2020, the NMPA accepted the supplemental new drug application for TYVYT in combination with ALIMTA® (pemetrexed) and platinum as first-line therapy in non-squamous non-small cell lung cancer (NSCLC). In May 2020, TYVYT combined with Gemzar® (gemcitabine for injection) and platinum chemotherapy met the predefined primary endpoint in the Phase 3 ORIENT-12 study as first-line therapy in patients with locally advanced or metastatic squamous NSCLC, TYVYT monotherapy met the primary endpoint in the ORIENT-2 study as second-line therapy in patients with advanced or metastatic esophageal squamous cell carcinoma as well.

TYVYT is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-Ligand 1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies with TYVYT to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registration or pivotal clinical trials.

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 oncology, 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 multifunctional 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 oncology, autoimmune, metabolic diseases and other major therapeutic areas, with 17 in clinical development, five in Phase 3 or pivotal clinical trials, four under NDA reviews by the NMPA (three under priority review status), while TYVYT® (sintilimab injection), officially approved for marketing in China in 2018, has been the only PD-1 inhibitor included in the NRDL, since 2019.

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, Hanmi, MD Anderson Cancer Center and other international parties. 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. For more information, please visit: www.innoventbio.com.

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http://www.innoventbio.com

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