Innovent Announces First Patient Dosed in a Phase I Clinical Trial of Anti-CTLA-4 Monoclonal Antibody

Thursday, October 18, 2018 General News
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SUZHOU, China, Oct. 18, 2018 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent), a world-class China-based

biopharmaceutical company that develops and commercializes high quality drugs, announces that the first patient has been dosed in a phase I clinical trial of anti-CTLA-4 (Cytotoxic T Lymphocyte-associated Antigen-4) monoclonal antibody (IBI310) for patients
with advanced solid tumors. IBI310 is a fully human monoclonal antibody that blocks CTLA-4.

This phase I clinical study in China, is a two phase study that in phase 1a evaluates the tolerability and safety of IBI310 as a monotherapy for patients with advanced malignancies and in phase 1b evaluates IBI310 in combination with sintilimab, our anti-PD-1 monoclonal antibody, for patients with advanced melanoma.

"Melanoma has been instrumental in understanding the science of immunotherapy. From interferon-gamma to IL-2 to checkpoint inhibitors melanoma has been the sentinel cancer for demonstrating the power of immunotherapy. Melanoma in Chinese patients is quite different from that in Western patients. In Western populations melanoma is largely cutaneous, while in China melanoma is mainly acral and mucosal. The disease is severe and the treatment options are limited. There is an urgent unmet medical need for better, more affordable drugs to prolong the survival for patients," said Professor Jun Guo, from the Beijing Cancer Hospital, Peking University.

"Combination immunotherapy is an emerging trend for novel treatment of cancers. With sintilimab as the foundation, Innovent will combine different antibodies from its rich product pipeline for cancer immunotherapy, and provide affordable, high-quality biopharmaceuticals for even more patients," said Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent.

About Malignant Melanoma

Malignant melanoma is a neoplasm that develops from melanocytes. Melanoma is one of the fastest-growing malignant tumors and increases with an annual growth rate of 3%-5%. The incidence of melanoma in China is relatively low, however recently the number of new cases has increased about 20,000 each year. Patients with distant metastasis have a five-year survival rate of less than 10%.

In China melanoma is unique in that it is mainly acral (49.4%) and mucosal (22.6%), and liver metastasis is more common. Given the severity of the disease, it is urgent to explore appropriate new treatments for Chinese melanoma patients.

About IBI310

IBI310, a fully human monoclonal antibody blocking CTLA-4 (Cytotoxic T Lymphocyte-associated Antigen-4). When CTLA-4 binds to its ligands, T cell activation is negatively regulated. IBI310 binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands leading to augmented T-cell activation and proliferation including the activation and proliferation of tumor infiltrating T-effector cells.

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 Combination Therapy

The combination of IBI310 and sintilimab takes advantage of distinct and complementary mechanisms to enhance the anti-tumor activity of T cells. The combination of an anti-PD-1 monoclonal antibody with an anti-CTLA-4 monoclonal antibody has been successfully applied in the treatment of multiple types of cancers, such as melanoma, lung cancer and kidney cancer.

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.

For inquiries, please contact:Innovent Biologics, Inc.Email: Tel: 86 512 6956 6088

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SOURCE Innovent Biologics, Inc.

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