SUZHOU, China, Sept. 20, 2018 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent), a world-class China-based biopharmaceutical company that develops and commercializes high quality drugs, today presented clinical trial data from a phase Ib clinical trial (NCT02937116) that treated patients with neuroendocrine tumors (NET) who have failed of standard therapy with single agent sintilimab, a fully human anti-programmed cell death 1 (PD-1) monoclonal antibody (mAb), at the 2018 Annual Meeting of Chinese Society of Clinical Oncology (CSCO).
To our best knowledge, this is one of the largest clinical studies of anti-PD-1 antibody for the treatment of NET. Based on data from 22 patients with at least one radiological assessment, the objective response rate (ORR) is 22.7%. Furthermore, in 19 patients with poorly differentiated neuroendocrine carcinoma, the ORR was 26.3%. As of the data analysis cutoff on June 28, 2018, median duration of response (DOR) is 5.8 months and progression free survival (PFS) is 2.2 months, median overall survival has not been reached. The safety profile of sintilimab in this trial is consistent with safety profile in trials with other tumors.
"The efficacy of current treatments available for poorly differentiated NET is very limited. We are excited to see the solid evidence of significant clinical activity with sintilimab in the patients with difficult-to-treat cancers. We are delighted to see that sintilimab may give such patients a new option as an effective therapy," said Professor Jianming Xu, from the 307 Hospital of PLA, and study data presenter.
"At present, the overall prognosis of neuroendocrine tumor is still unfavorable, with limited therapeutic approaches," said Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent, "We are encouraged by the initial study results and we anticipate a new therapy will be developed for this patient population. Hopefully, it can help to extend the overall survival and quality of life for NET patients."
About Neuroendocrine Tumor (NET)
Arising from neuroendocrine cells, neuroendocrine tumor is one kind of neoplasm which can develop in any part of the body, but most commonly occur in the digestive system such as stomach, intestine and pancreas. Medical treatment aims at controlling tumor growth and relieving symptoms caused by functioning NET. Biotherapy and target therapy are considered for well differentiated NET. Cytotoxic medication remains the first-line treatment for poorly differentiated NET, the overall survival of which is approximately 10 months.
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.
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 has raised 580 million USD in private financing from numerous world-renowned VC or PE firms, including Eight Roads and F-Prime Capital (which form part of the proprietary investment business of Fidelity), Lilly Asia Ventures, Capital Group, Legend Capital, Temasek, Rock Springs Capital, Cormorant Private Healthcare, Hillhouse Capital, China Life, Ally Bridge, Taikang Insurance Group, and State Development & Investment Corporation.
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.
For inquiries, please contact:
Tel: 86 512 6956 6088
SOURCE Innovent Biologics, Inc.