SUZHOU, China, Aug. 19, 2019 /PRNewswire/ -- CStone Pharmaceuticals ("CStone", HKEX: 2616) today announced that an abstract on the company's ongoing CS1001-101 Phase Ib clinical study has been accepted for poster presentation at the upcoming European Society for Medical Oncology (ESMO) 2019 Annual Congress.
CS1001 is an investigational anti-PD-L1 monoclonal antibody developed by CStone, and one of the company's three backbone immunotherapy assets. CS1001 is currently being evaluated in a number of clinical trials in China, including one multi-arm Phase I study, two registrational Phase II studies, and three Phase III clinical studies.
CS1001-101 is a Phase Ia/Ib open-label, multiple-dose, dose-escalation and expansion study assessing the safety, tolerability, pharmacokinetics and anti-tumor efficacy of CS1001 in patients with advanced solid tumors or lymphomas. The study has already completed its dose-escalations. According to data released at the ASCO 2019 Annual Meeting, as of the data cut-off of November 30, 2018, 7 of the 29 enrolled patients showed partial response, with an overall response rate (ORR) of 24% (6 patients are still on treatment). This data demonstrates CS1001's durable anti-tumor activities in a variety of solid tumors and lymphomas.
The updated data to be presented at the ESMO 2019 Annual Congress includes the safety data from the CS1001 Phase Ia/Ib study, and efficacy data of CS1001 in gastric cancer, esophageal cancer, MSI-H cancer and cholangiocarcinoma from the Phase Ib study. It is worth mentioning that, based on previously released data, CS1001 has shown good overall safety and tolerability, and durable anti-tumor activities across different tumor types.
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 precision medicines to address the unmet medical needs of cancer patients in China and worldwide. Established in 2015, CStone has assembled a world-class management team with extensive experience in innovative drug development, clinical research, and commercialization. The company has built an oncology-focused pipeline of 15 drug candidates with a strategic emphasis on immuno-oncology combination therapies. Currently, five late-stage 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 oncology therapies to cancer patients worldwide.
For more information about CStone Pharmaceuticals, please visit: www.cstonepharma.com.
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SOURCE CStone Pharmaceuticals