CStone files MEK inhibitor CS3006 for clinical trial approval in Australia
SUZHOU, China, December 27, 2017
CStone Pharmaceuticals (Suzhou) Co., Ltd, announced today that a formal application for clinical trial approval has been submitted to Human Research Ethics Committees of Linear Clinical Research Center in Australia for CS3006, a small-molecule inhibitor of mitogen-activated protein kinase kinase (MEK). CS3006 is CStone’s second independently-developed novel oncology drug candidate soon to reach the clinical development stage, following the anti-programmed death ligand-1 (PD-L1) antibody CS1001.
“The successful clinical trial application for CS3006 in Australia is CStone’s first overseas filing for an innovative drug, and an important step for the company’s global R&D strategy. Concurrent with this, we plan to make regulatory filings to initiate international studies for a number of novel drug candidates in our pipeline in the near future.” Noted by Dr. Frank Jiang, Chief Executive Officer (CEO) of CStone, “CS3006 is a strategically important program for CStone’s development of combination therapies. We are very much looking forward to the initiation of clinical trials in Australia, which will provide a wealth of clinical data as we begin to explore the most effective combinations for treating cancer.”
CS3006 is an independently developed, highly selective small molecule kinase inhibitor, designed to inhibit the growth of cancer cells by binding to key enzymes, MEK 1/2, in the MAPK signaling pathway (RAS-RAF-MEK-ERK). Preliminary studies have shown that CS3006 demonstrated good pharmacokinetic properties, and has produced promising synergistic activity when combined with an anti-PD-1 antibody in animal models.
“Evidence from early clinical trials for competitor drugs in the same class indicates that MEK inhibitors in combination with immunotherapy can produce breakthrough antitumor activities in indications that are typically insensitive to PD-1 or PD-L1 monotherapy.” Commented Dr. Jason Yang, Chief Medical Officer (CMO) of CStone, “As a highly specific MEK inhibitor, CS3006 can combine both with the company’s immunotherapy backbone products and with other targeted therapies in our pipeline. We hope these combination therapies will lead to more effective treatments for multiple tumor types with severe unmet medical needs”.
CStone Pharmaceuticals focuses on the development of therapeutic drugs for oncology, and has independently developed CS1001, China’s first full-length, fully human anti-PD-L1 monoclonal antibody candidate. CS1001 has received clinical trial approval by the China Food and Drug Administration (CFDA) in June 2017 and is currently in Phase I clinical trial in patients with advanced solid tumor and lymphoma.
About CStone Pharmaceuticals
CStone Pharmaceuticals is a biopharmaceutical company devoted to the development of a new generation of innovative drugs. With its broad immuno-oncology pipeline, CStone is pursuing a development strategy focusing on combination therapy.