CStone Pharmaceuticals announces initiation of CS1001 Phase I Study in U.S., patient enrollment under way

SUZHOU, China, Dec. 21, 2018 /PRNewswire/ — CStone Pharmaceuticals (“CStone”) today announced 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. 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.  

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.

About CStone

CStone Pharmaceuticals is a biopharma company focused on developing and commercializing innovative immuno-oncology and molecularly targeted drugs to address significant unmet medical needs for cancer patients in China and worldwide. Since company inception more than two years ago, CStone has assembled a world-class management team that has a full spectrum of complementary skillsets from preclinical research to clinical development and commercialization. Through a dual source of innovation, comprised of internal research and external partnership, the company has built a rich oncology pipeline of 14 drug candidates with significant mono- and combination-therapy potential and synergies, including 4 assets exclusively in-licensed from Agios and Blueprint Medicine. Among CStone’s portfolio, 4 late-stage drug candidates are at or near registrational trial. CStone’s business model has a clear focus on clinical development, while at the same time, the company is rapidly developing its commercial and manufacturing capabilities. The company is backed by prestigious VC and PE funds with record-breaking amounts of equity investment, raising a combined total of USD 412 million in two financing rounds to date. 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 biopharma company by bringing innovative and differentiated oncology therapies to cancer patients in China and worldwide.

For more information about CStone Pharmaceuticals, please visit: www.cstonepharma.com.

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