SUZHOU, China, Oct. 16, 2018 /PRNewswire/ — CStone Pharmaceuticals (“CStone”) today announced the recent approval of investigational new drug (IND) application from the United States Food and Drug Administration (FDA) for CS1001, a fully human anti-programmed death ligand 1 (PD-L1) monoclonal antibody independently developed by CStone. This marks CStone’s first drug to gain IND approval in the United States, and henceforth the company expects to make further IND filings with the FDA for other self-developed pipeline drug candidates.
“We are very happy to gain approval to begin clinical trials in the United States, which marks the entry of CS1001 into fully global development.” Dr. Frank Jiang, CStone’s Chairman and CEO, commented, “CStone already had three products entering Phase I clinical trials in Australia during the first half of 2018. CS1001’s IND approval further demonstrates our global clinical capabilities and aspiration. “
CS1001 is China’s first fully human and full-length anti-PD-L1 monoclonal antibody. The US clinical trial is a bridging Phase I dose-escalation study, designed to confirm CS1001’s recommended Phase II dosage (RP2D) in US patients with solid tumors.
Dr. Jason Yang, Chief Medical Officer at CStone, said, “CS1001 has already successfully completed a Phase I dose-escalation study in China. The safety and preliminary efficacy data set a solid foundation for starting clinical evaluation in the US. We aim to accelerate CS1001’s global development to provide patients with a new treatment option as soon as possible.”
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.
Currently, 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. In addition, 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.
CStone Pharmaceuticals is a clinical stage biopharmaceutical company devoted to the development of innovative drugs. With a broad pipeline, the company engages in the development of cancer therapeutics with a special focus on immuno-oncology based combination therapies. All members of the management team are seasoned executives from top multinational pharmaceutical companies. CStone has successfully built up its core competency in clinical development and translational medicine. The company is backed by prestigious VC/PE funds via two financing rounds to date, raising $150 million in a Series A round in July 2016, followed by $260 million in a Series B round in May 2018. With an experienced team, a rich pipeline, a robust R&D model, and substantial funding, CStone is well positioned as the partner of choice for multinational pharmaceutical / biotech companies to develop drugs in China and the Asia-Pacific region. For more information about CStone Pharmaceuticals, please visit: www.cstonepharma.com.
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