Innovent Receives IND Approval to Initiate Clinical Trials in China with Sintilimab in Combination with its Biosimilar to Bevacizumab

SUZHOU, China, Oct. 15, 2018 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent), a world-class China-based biopharmaceutical company that develops and commercializes high quality drugs, today announced that its IND application for a combination therapy of IBI308 (Sintilimab, an anti-PD-1 monoclonal antibody) and IBI305 (a biosimilar to the recombinant humanized anti-VEGF monoclonal antibody bevacizumab), has been approved by the National Medical Products Administration (NMPA, formerly known as CFDA) for clinical development. Innovent will initiate clinical trials based on this combination to assess its safety and efficacy in patients with Non-Small Cell Lung Cancer (NSCLC) and hepatocellular carcinoma (HCC).

"China has the highest burden of cancer patients of all countries in the world. Lung cancer and liver cancer account for about one third of all incident cases of cancers in China. At Innovent, an innovative biopharmaceutical company in China, we are dedicated to take advantage of the latest technological advances in science to develop and commercialize new medicines for cancer patients," said Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent, "Sintilimab's New Drug Application (NDA) is currently under priority regulatory review and IBI305 has completed its phase 3 program. We believe the combination of IBI308 and IBI305 will provide more effective treatment for both lung cancer and liver cancer patients. We intend to capitalize on our company's rich pipeline to explore new directions in combination therapy and to create even more innovative breakthroughs."

"Recent studies have shown there is a strong relationship between tumor induced angiogenesis driven by VEGFA and ANGPT2 and tumor induced immunosuppression driven by PD-1/PD-L1. Abnormal tumor-induced angiogenesis appears to limit the therapeutic effect of anti-PD-1/PD-L1 antibodies and other immunotherapy drugs. We believe the combination of sintilimab and bevacizumab biosimilar will be better able to control tumor growth through a two-pronged approach involving stimulation of the immune system with an anti-PD-1 antibody and blocking angiogenesis with an anti-VEGF antibody," said Dr. Kerry Blanchard, Chief Scientific Officer of Innovent.

About Non-Small Cell Lung Cancer

Lung cancer is the most common malignant tumor in China with the highest morbidity (781,000 new cases annually) and mortality (626,000 deaths annually). Non-small cell lung cancer (NSCLC) accounts for approximately 80% to 85% of all lung cancer cases. Seventy percent of NSCLC patients have non-squamous NSCLC and 40% of these patients harbor EGFR mutations. Treatment with a tyrosine kinase inhibitor (TKI: gefitinib, erlotinib or icotinib) is recommended for patients with advanced NSCLC who have EGFR mutations. After progression on TKI treatment, some patients acquire a T790M mutation and can be treated with osimertinib. In the absence of the T790M mutation or after treatment progression on osimertinib, the choice of systemic treatment is platinum-containing dual-agent chemotherapy. For such patients, new and more effective treatment options are urgently needed.

About Hepatocellular Carcinoma (HCC)

Liver cancer is the second leading cause of cancer-related death in China according to National Central Cancer Registry of China (NCCRC), with about 365,000 new cases and 319,000 deaths annually. Liver cancer with about 841,000 new cases and 782,000 deaths annually is the fourth leading cause of cancer-related death worldwide in 2018. Most primary liver cancers (70%-90%) are hepatocellular carcinoma (HCC) and most patients have locally advanced or metastatic disease at the time of diagnosis and are not eligible for radical treatment. With current therapy the global median survival time is only 7.9 months. However, for HCC patients in the Asia-Pacific region the median survival time is only 4.2 months. Hence, there is an urgent need for effective treatments for patients with advanced HCC in China and around the world.

About Sintilimab

Sintilimab is a fully human anti-PD-1 antibody. It binds to the PD-1 receptor on T cells, blocking the PD-L1 ligand from interacting with PD-1 to help restore T-cell response and immune response, thus destroying the tumor cells. Sintilimab is an anti-PD-1 monoclonal antibody jointly developed by Innovent and Eli Lilly and Company in China. National Medical Products Administration (NMPA, formerly known as CFDA) accepted the New Drug Application (NDA) submitted by Innovent for sintilimab on April 16, 2018, and granted it priority review status on April 23, 2018. The indication for the first new drug application is relapsed/refractory classical Hodgkin's Lymphoma.

About IBI305

IBI305, a biosimilar of bevacizumab, one of worldwide best-selling drugs, is currently in Phase III clinical trials. IBI305 specifically binds to vascular endothelial growth factors (VEGF), blocks the binding of VEGF to VEGF receptors and inhibits VEGF-induced angiogenesis and vascular permeability, thus limiting the growth of malignant tumors. Innovent has completed bioequivalence studies in healthy subjects and a randomized, double-blind, multicenter, phase III study in non-small cell lung cancer comparing IBI305 with Avastin.

About Combination Therapy

Combination strategies have become a key area of clinical research and may unlock the potential of immuno-oncology therapies by combining two anti-cancer agents that could have a synergistic mechanism of action. In IMpower150, a Phase III study, patients with non-squamous NSCLC and EGFR mutation who failed EGFR TKI treatment benefited from treatment with an anti-PD-L1 monoclonal antibody in combination with bevacizumab and chemotherapy . A Phase Ib trial (NCT02715531) of Atezolizumab combined with bevacizumab in the first-line treatment of advanced liver cancer showed that the combination was safe and effective with an objective response rate as high as 65%.

Sintilimab is a foundational agent for cancer therapies and Innovent will combine sintilimab with its rich development pipeline of innovative antibodies to form a diversity of tumor immunotherapies in our quest to provide affordable high quality biopharmaceuticals for even more patients.

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action", Innovent's mission is to develop and commercialize high quality biopharmaceutical products that are affordable to ordinary people. Since its establishment from 2011, Innovent has developed a fully-integrated platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities, and a pipeline of innovative and commercially promising monoclonal antibodies and other biologics in the fields of oncology, ophthalmology, autoimmune and metabolic diseases. Innovent has built up a pipeline of 17 antibody drug candidates, with four core products in late-stage clinical development in China and one that has a New Drug Application (NDA) accepted by the NMPA with priority review status.

Innovent has a highly talented international team, including many expert returnees with experience in innovative biopharmaceutical drug discovery, development, production and commercialization. The company has also entered into various key strategic alliances with Eli Lilly and Company, Adimab, and other biopharmaceutical companies. Innovent wishes to work with all relevant parties helping the advancement of China's biopharmaceutical industry, so as to improve drug availability to people and address their aspiration for a healthy, happy life.

About the partnership between Innovent Biologics and Eli Lilly and Company

Eli Lilly and Company (Lilly) and Innovent Biologics (Innovent) in March 2015 announced one of the largest biotech drug development collaborations in China to date between a multi-national and domestic company. Under the terms of the agreement, Lilly and Innovent shall collaborate to provide support to the development and potential commercialization of at least three cancer treatments over the next decade. In October 2015, they announced an expansion of their drug development collaboration. These collaborations represent that Innovent has struck one of the most comprehensive strategic partnerships of any Chinese company with a multinational partner in terms of the scope and breadth ranging from discovery to commercialization and involving up to six therapeutic antibodies for cancers.

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