Chipscreen Biosciences Announces a Collaboration with Innovent to Evaluate Chidamide and the Combination of Sintilimab, Anti-VEGF Monoclonal Antibody IBI305 in Colorectal Cancer patients
SHENZHEN, China, Feb. 17, 2019 /PRNewswire/ -- Chipscreen Biosciences, a leading integrated Chinese biotech company specialized in discovery and development of novel small molecule pharmaceuticals with a primary focus in oncology, metabolic disease, and autoimmune diseases, announce the signing of a collaboration agreement with Innovent Biologics, Inc. (Innovent) to evaluate the safety and tolerability of Chipscreen's Chidamide and Innovent's Sintilimab in combination with an anti-VEGF monoclonal antibody IBI305 in patients with advanced colorectal carcinoma.
Under the terms of the agreement, Chipscreen Biosciences and Innovent will jointly explore potential applications of this combination in colorectal carcinoma with unmet medical needs through development efforts to establish the safety and efficacy in China.
"There are significant unmet medical needs for patients with advanced colorectal carcinoma, and the combination treatment with different targeted therapy may prove to be an important solution", said Chipscreen's executive vice president, Dr. Zhiqiang Ning. "We look forward to partnering with Innovent to explore a potential clinical application with the combination regimen of immune check-point inhibitor, angiogenesis inhibitor and epigenetic modulator in this indication."
"Epigenetic aberrations appear to be one of the major causes of resistance to immune-oncological therapies. Chidamide, a novel epigenetic modulating agent discovered in China, seems to reverse patient resistance to immune therapy in early clinical studies," said Innovent's Chief Scientific Officer, Dr. Kerry Blanchard. "We are pleased to be partnering with Chipscreen Biosciences to explore combination therapy with Sintilimab, IBI305, and Chidamide in colorectal carcinoma. We hope this collaboration will bring clinical benefits to patients in need."
Chidamide, a benzamide-based, selective inhibitor of class I (subtypes 1, 2, 3) and IIb (subtype 10) HDACs, reverses epigenetic abnormalities related to tumorigenesis. Chidamide induces chromatin remodeling by inhibiting specific subtypes of HDACs which leads to increased acetylation of histones (i.e., epigenetic changes), thereby modifying gene expression in multiple signal transduction pathways. Chidamide directly inhibits the cell cycle and induces apoptosis of tumor cells from the blood and lymphatic system. It can induce and activate tumor killing by natural killer cells (NK) and antigen-specific cytotoxic T-cells (CTL), and modulates the anti-tumor cellular immunity of the body. Chidamide also induces the differentiation of tumor stem cells and reverses epithelial mesenchymal phenotype transformation (EMT) of tumor cells through epigenetic regulation mechanisms, thereby playing a potential role in restoring the drug sensitivity of drug-resistant tumor cells, and inhibiting tumor metastasis and recurrence. It is a new molecular entity with global patent protection developed by Chipscreen Biosciences, China's first international-recognized subtype selective histone deacetylation enzyme (HDAC) oral inhibitor, and a national class 1.1 drug. In December 2014, it was approved for marketing by the China Food and Drug Administration (CFDA). Its first indication is relapsed and refractory peripheral T-cell lymphoma. Meanwhile, clinical studies on other blood tumors, solid tumors and HIV with either a single drug or combined with other drugs are being carried out simultaneously in the United States, Japan, Mainland China and Taiwan, as well as in other countries and regions.
Sintilimab (IBI308) is a fully human anti-PD-1 antibody. It binds to the PD-1 receptor on T cells, blocking the PD-1 ligand from interacting with PD-1 to help restore T-cell response and immune response, thus destroying the tumor cells. Sintilimab is jointly developed by Innovent and Eli Lilly and Company in China. National Medical Products Administration (NMPA, successor to 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.
Innovent's IBI305 is a biosimilar of bevacizumab, a recombinant humanized anti-VEGF monoclonal antibody for injection. Vascular endothelial growth factor (VEGF) is an important factor in angiogenesis that is highly expressed by the endothelial cells in most human tumors. An anti-VEGF antibody binds VEGF selectively with high affinity and blocks its binding to VEGF receptors on the surface of vascular endothelial cells, thereby inhibiting signaling pathways such as PI3K-Akt/PKB and Ras-Raf-MEK-ERK. Bevacizumab ultimately produces anti-tumor effects by inhibiting the growth, proliferation and migration of vascular endothelial cells, blocking angiogenesis, reducing vascular permeability, blocking the blood supply to tumor tissues, inhibiting the proliferation and metastasis of tumor cells and inducing apoptosis in tumor cells.
About Chipscreen Biosciences
In 2001, Chipscreen Biosciences was founded in Shenzhen, specializing in the research and development of original small molecule drugs. With the self-created "integrated drug discovery and early evaluation platform based on chemical genetics" as its core competitiveness, Chipscreen Biosciences has now become one of China's leading innovative drug enterprises, forming a modern biomedicine group company in Shenzhen, as its headquarters / research and development center / GMP production base, Chengdu, as a regional headquarter / research and development center / GMP production base, Beijing clinical research center and Shanghai commercial center. At present, the company has developed a number of original new drug product lines for tumors, diabetes, and endocrine and autoimmune diseases. In December 2014, the original anti-tumor new drug Chidamide was approved by the China Food and Drug Administration for listing
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Innovent was established in 2011. Since it was founded, Innovent has developed a fully-integrated platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. These capabilities have enabled us to build a robust pipeline of innovative and commercially promising monoclonal antibodies and other biologics in the fields of oncology, ophthalmology, autoimmune, and cardiovascular diseases. Leveraging our platform, we have built up a pipeline of 17 antibody drug candidates in the last seven years, led by our four core products that are in late-stage clinical development in China. In addition, out of our pipeline of 17 antibody drug candidates, ten have entered in clinical development, four have entered Phase III clinical trials and two that have New Drug Applications (NDA) accepted by the NMPA including one with priority review status for sintilimab.
Innovent has built a biopharmaceutical production facility that operates under global standards. The design and operation of our clinical and commercial facilities are in compliance with the cGMP standards of NMPA, FDA and EMA. The existing production lines have already passed GMP audits by an international pharmaceutical company. The company has also entered into various key strategic alliances with Eli Lilly and Company, Adimab and other biopharmaceutical companies. On October 31, 2018, Innovent was successfully listed on the main board of the Hong Kong Stock Exchange and the stock code is 01801.
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. Innovent wishes to work with all relevant parties helping the advancement of China's biopharmaceutical industry, improving the drug availability to ordinary people and enhancing the quality of the patients' life.
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SOURCE Shenzhen Chipscreen Biosciences, Ltd.