On February 17, 2019 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality innovative medicines for the treatment of oncology, autoimmune and other major diseases, reported the signing of a collaboration agreement with Shenzhen Chipscreen Biosciences Co., Ltd. (Chipscreen Biosciences) to evaluate the safety and tolerability of the combination therapy of Innovent’s Tyvyt (generic name: sintilimab injection), a fully human anti-programmed cell death protein 1 (anti-PD-1) monoclonal antibody and IBI305, a biosimilar product candidate of bevacizumab and a recombinant humanized anti-vascular endothelial growth factor (anti-VEGF) monoclonal antibody, with Chipscreen Biosciences’ Chidamide, a benzamide-based selective inhibitor of class I (subtypes 1, 2, 3) and IIb (subtype 10) histone deacetylases (HDACs), in patients with advanced colorectal cancer (Press release, Innovent Biologics, FEB 17, 2019, View Source [SID1234533367]).
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Under the terms of the agreement, Chipscreen Biosciences and Innovent will jointly in China to explore potential applications of this combination on colorectal cancer and to evaluate its safety and tolerability.
"There are significant unmet medical needs for patients with advanced colorectal cancer, and the combination treatment with different targeted therapies may serve as an additional solution to these patients", said Chipscreen Biosciences’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 cancer. We hope this collaboration will eventually benefit those patients in need."
About Chidamide
Chidamide, a benzamide-based selective inhibitor of class I (subtypes 1, 2, 3) and IIb (subtype 10) histone deacetylases (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), therefore 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 bodies. 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.
About Tyvyt (sintilimab injection)
Tyvyt (sintilimab injection) is an innovative drug jointly developed in China by Innovent and Eli Lilly and Company. Innovent is currently conducting the clinical studies of sintilimab injection in the United States. 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-1 Ligand-1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Tyvyt (sintilimab injection) is the only PD-1 antibody in China branded by both a local biopharmaceutical company and a global pharmaceutical company. Tyvyt (sintilimab injection) has been granted marketing approval by the National Medical Products Administration (NMPA) for relapsed or refractory classical Hodgkin’s lymphoma (r/r cHL). There are currently more than twenty clinical studies of sintilimab injection, including seven registration studies, are ongoing to evaluate the efficacy of sintilimab injection on other solid tumors.
About IBI305 (bevacizumab biosimilar)
IBI305 is a biosimilar product candidate of bevacizumab and 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 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, therefore inhibiting signaling pathways such as PI3K-Akt/PKB and Ras-Raf-MEK-ERK. Bevacizumab produces anti-tumor effects by inhibiting the growth, proliferation and migration of vascular endothelial cells, blocking angiogenesis, reducing vascular permeability, blocking blood supply to tumor tissues, inhibiting the proliferation and metastasis of tumor cells and inducing apoptosis in tumor cells. The new drug application (NDA) of IBI305 was accepted by the NMPA on 29 January 2019.