On December 21, 2018 CStone Pharmaceuticals ("CStone") reported the successful enrollment and dosing of the first three patients in a Phase I clinical trial in the United States for CS1001, China’s first fully human and full-length anti-PD-L1 monoclonal antibody (Press release, CStone Pharmaceauticals, DEC 21, 2018, View Source [SID1234532227]). The multi-center, dose-escalation bridging trial will investigate the safety, tolerability, preliminary efficacy of CS1001 in patients with advanced solid tumors. Study results will support CS1001’s future clinical trials in the U.S., and serve to accelerate this candidate drug’s global development.
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Dr. Frank Jiang, chairman and CEO of CStone, commented: "CStone is committed to providing patients around the world with innovative and differentiated oncology therapies. We have now successfully initiated over ten clinical trials on multiple drug candidates in Australia, the United States and China, demonstrating CStone’s growing ability to carry out global drug development."
"CS1001 has unique advantages and potential, and is one of the company’s backbone IO drug candidates", noted Dr. Jason Yang, Chief Medical Officer at CStone. "We currently have several registrational clinical trials as monotherapy and in combination under way for CS1001 in China. We will continue to explore CS1001’s full value in order to provide new treatment options for cancer patients as soon as possible."
About CS1001
CS1001 is an investigational monoclonal antibody directed against PD-L1 being developed by CStone Pharmaceuticals. Authorized by the U.S.-based Ligand Corporation, CS1001 is developed by the OMT transgenic animal platform, which can generate fully human antibodies in one step. As a fully human, full-length anti-PD-L1 monoclonal antibody, CS1001 mirrors natural G-type immune globulin 4 (IgG4) human antibody, which can reduce the risk of immunogenicity and potential toxicities in patients, a unique advantage over similar drugs.
CS1001 has completed a Phase I dose-escalation study in China, which showed the drug to be well-tolerated and produced sustained clinical benefit during the Phase Ia stage of development. Currently, two pivotal Phase II studies have been initiated in China: for natural killer cell/T-cell lymphoma (CS1001-201) and classical Hodgkin’s lymphoma (CS1001-202). Meanwhile, Phase III studies are under way or being prepared both in China and globally for various serious tumor indications.