SUZHOU, China, Sept. 30, 2019 /PRNewswire/ -- CStone Pharmaceuticals ("CStone" or the "Company", HKEX: 2616) released pooled safety data from the Phase Ib (GEMSTONE-101) study of the Company's anti-PD-L1 antibody CS1001 in a poster presentation at the European Society of Medical Oncology 2019 Congress (ESMO 2019), demonstrating the promising safety and tolerability profile
Dr. Frank Jiang, Chairman and CEO of CStone, commented: "CS1001 is an investigational anti-PD-L1 monoclonal antibody developed by CStone, and one of our three backbone immunotherapy drug candidates. I am pleased that following the data release at CSCO 2019. We have presented additional promising trial data at ESMO 2019. CS1001 is currently being investigated in multiple tumor types in China. We hope CS1001 will deliver more encouraging results in future studies."
CStone's Chief Medical Officer, Dr. Jason Yang, noted: "Being a fully human, full-length anti-PD-L1 monoclonal antibody, CS1001 has the potential to reduce the risk of immunogenicity and associated toxicity in patients. In the pooled safety data from the Phase Ib study released at ESMO 2019, CS1001 was shown to be safe and well tolerated, without any unexpected adverse event reported. Based on the benign safety profile and promising efficacy data, we will continue to explore CS1001's potential in both monotherapy and combination therapies, thereby to benefit more cancer patients as soon as possible."
Overview of the GEMSTONE-101 Study
The GEMSTONE-101 study is a Phase Ia/Ib, open-label, multi-dose, dose-escalation and dose-expansion study designed to evaluate the safety, tolerability, pharmacokinetics, and antitumor efficacy of CS1001 in advanced solid tumors or lymphoma in China.
Pooled safety data from the GEMSTONE-101 Ib study
Promising antitumor activities that were demonstrated in the four cohorts of the GEMSTONE-101 Ib study
CS1001 is an investigational monoclonal antibody directed against PD-L1 being developed by CStone. 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, potentially representing a unique advantage over similar drugs.
CS1001 has completed a Phase I dose-escalation study in China, in which CS1001 showed good tolerability and produced sustained clinical benefits during the Phase Ia stage of the study.
CS1001 is being investigated in a number of ongoing clinical trials, including one Phase I bridging study in the U.S. In China, its clinical program includes one multi-arm Phase Ib study, two pivotal Phase II studies, and three Phase III studies for several tumor types.
CStone Pharmaceuticals (HKEX: 2616) is a biopharmaceutical company focused on developing and commercializing innovative immuno-oncology and molecularly-targeted drugs to address unmet medical needs for cancer patients in China and worldwide. Since the Company's inception in 2015, CStone has assembled a world-class management team that has a full spectrum of complementary skillsets from preclinical research to clinical development and commercialization. With combination therapies as a core strategy, the Company has built a rich oncology pipeline of 15 oncology drug candidates. Currently five late-stage drug candidates are at or near pivotal trials. With an experienced team, a rich pipeline, a robust clinical development-driven business model, and substantial funding, CStone's vision is to become globally recognized as a leading Chinese biopharmaceutical company by bringing innovative and differentiated oncology therapies to cancer patients worldwide.
For more information about CStone Pharmaceuticals, please visit: www.cstonepharma.com
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SOURCE CStone Pharmaceuticals