Innovent Biologics Announced the Results of the Phase 1b Clinical Study of TYVYT® (Sintilimab Injection) in Combination with IBI305 (Bevacizumab Biosimilar) in the Treatment of Advanced Hepatocellular Carcinoma

SUZHOU, China, May 31, 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, announced the Phase 1b preliminary clinical study (NCT04072679) data of TYVYT® (sintilimab injection) in combination with IBI305, a bevacizumab biosimilar independently developed by Innovent, in the treatment of advanced hepatocellular carcinoma at the 56^th Annual Meeting of the American Society of Clinical Oncology (ASCO)(Abstract # 3079, Poster # 143, 8:00 AM – 11:00 AM, U.S. Central Time, Friday, May 29, 2020).

The NCT04072679 study, presented at the ASCO annual meeting by poster, was conducted by Professor Aiping Zhou from the Cancer Hospital Chinese Academy of Medical Sciences, and is a Phase 1b study assessing the safety, tolerability and anti-tumor activity of TYVYT in combination with IBI305 in subjects with advanced hepatocellular carcinoma, the most common form of liver cancer. The study was divided into two parts, the first is a dose escalation phase and the second is a dose expansion phase. In the dose escalation phase, according to the enrollment sequence, subjects will receive either 7.5 mg/kg (low-dose group) or 15 mg/kg (high-dose group) of IBI305 in combination with a fixed dose of 200 mg of sintilimab, respectively, and then entered into the dose expansion phase after completing the dose escalation phase. The main clinical data include:

• As of January 7, 2020, a total of 50 subjects were enrolled, including 29 subjects in the low-dose group and 21 subjects in the high-dose group. 29 subjects in the low-dose group had at least two efficacy evaluations, of which 7 subjects had confirmed a partial response (PR), with objective response rate (ORR) of 24.1%; 18 subjects in the high-dose group had at least one efficacy evaluation, 6 subjects had a PR (1 unconfirmed, 5 confirmed), with an ORR of 33.3%.
• Treatment-related adverse events (TRAEs) were mostly Grade 1-2, with the most common TRAEs including hypertension (28%) and pyrexia (26%); a total of 6 (12%) subjects experienced Grade ≥ 3 TRAEs, with the most common Grade ≥ 3 TRAE being hypertension (2 subjects).

Professor Zhou Aiping from Cancer Hospital Chinese Academy of Medical Sciences said："Hepatocellular carcinoma is a common malignant tumor in China. Most patients with hepatocellular carcinoma have entered into the advanced stage at time of diagnosis and are beyond the point where surgery could effectively remove all of the cancer. There is a long-term lack of effective treatment for advanced hepatocellular carcinoma. In recent years, with the rise of immunotherapy, immunotherapy combined with anti-vascular targeted therapy has attracted more and more clinicians' attention, and multiple studies have shown outstanding clinical effects. This Phase 1b study preliminarily showed positive efficacy and good safety in patients with advanced liver cancer. Currently, there is a Phase 3 clinical trial of sintilimab in combination with IBI305 for first-line treatment of patients with advanced liver cancer ongoing, and we are hopeful to see positive results from this study to help more patients with liver cancer."

Dr. Zhou Hui, Vice President of Medical Science and Strategic Oncology of Innovent, said: "The combination of immunotherapy and anti-angiogenic therapy has a synergistic effect in the mechanism of action and is currently a hot spot for the clinical development of anti-tumor drugs. We are very pleased to see that sintilimab in combination with the bevacizumab biosimilar IBI305 has achieved preliminary positive efficacy in patients with advanced hepatocellular carcinoma and been showing the clinical application prospect of the combination of these two drugs in the treatment of liver cancer. We also hope that through our efforts, we can bring a new effective treatment option to patients in China with this type of cancer."

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 National Medical Products Administration (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® (sintilimab injection) is the only PD-1 inhibitor that has been included in the new Catalogue of the National Reimbursement Drug List (NRDL) in November 2019.

TYVYT® (sintilimab injection) 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® (sintilimab injection) to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registration or pivotal clinical trials.

About IBI305 (bevacizumab biosimilar)

IBI305 is a biosimilar of bevacizumab injection, which is a recombinant human anti-vascular endothelial growth factor (VEGF) monoclonal antibody injection, independently developed by Innovent. VEGF is an important factor in the angiogenic process and is overexpressed pathologically in the endothelial cells of most human tumors. Anti-VEGF antibody can selectively bind VEGF with high affinity, block the conduction of PI3K-Akt/PKB and Ras-Raf-MEK-ERK signaling pathways by blocking the binding of VEGF to receptors on the surface of vascular endothelial cells, thereby inhibiting the growth, proliferation and migration of vascular endothelial cells as well as angiogenesis, reducing vascular permeability, blocking the blood supply of tumor tissues, inhibiting the proliferation and metastasis of tumor cells, and inducing tumor cell apoptosis, so as to achieve anti-tumor therapeutic effect. On January 29, 2019, the NMPA accepted the New Drug Application (NDA) for IBI305 and was included in the priority review.

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, 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. For more information, please visit：www.innoventbio.com.

About Eli Lilly and Company

Lilly is a global healthcare leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com.

About Innovent Biologics' strategic cooperation with Eli Lilly and Company

Innovent entered into a strategic collaboration with Lilly focusing on biological medicine in March 2015 – a groundbreaking partnership between a Chinese pharmaceutical company and a multinational pharmaceutical company. Under the agreement, Innovent and Lilly are co-developing and commercializing oncology medicines, including TYVYT® (sintilimab injection) in China. In October 2015, the two companies announced the extension of their existing collaboration to include co-development of three additional antibodies targeting oncology indications. In August 2019, Innovent entered into an additional licensing agreement with Lilly to develop and commercialize a potentially global best-in-class diabetes medicine in China. Its collaboration with Lilly indicates that Innovent has established a comprehensive level of cooperation between China's innovative pharmaceuticals sector and the international pharmaceuticals sector in fields such as R&D, CMC, clinical development and commercialization.

SOURCE Innovent Biologics, Inc.

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