Shanghai, China, April 4, 2019 – CStone Pharmaceuticals (“CStone”; HKEX:2616) delivered a poster of pre-clinical data of CS1003 at the 2019 American Association for Cancer Research (AACR) Annual Meeting.
CS1003 is a humanized IgG4 PD-1 monoclonal antibody designed to block the interaction of PD-1 with its ligands PD-L1 and PD-L2 for the immunotherapy of multiple tumor types. In contrast with other PD-1 antibodies, CS1003 recognizes both human and murine PD-1, providing a unique competitive advantage during efficacy testing in syngeneic mouse tumor models.
According to the pre-clinical result presented for the first time, CS1003 can specifically bind to human, mouse and cynomolgus monkey PD-1 and block the binding of PD-1 to PD-L1 and PD-L2; as a result, CS1003 promotes the proliferation and cytokine release of CD4+ T cells in vitro, and inhibites tumor progression in both CloudmanS91 mouse melanoma syngeneic model and MC38-huPD-L1 colon cancer engrafted in hu-PD-1 knock-in mouse model in vivo. The pharmacokinetic (PK) study in cynomolgus monkeys following single intravenous administration showed the exposure of CS1003 increased proportionally with dose levels and the PK properties were linear over 2-18 mg/kg. CS1003 demonstrated a favorable safety profile with the highest non-severely toxic dose (HNSTD) at 100 mg/kg.
CStone is currently conducting a Phase I clinical trial in China and Australia, and received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (‘FDA’) for CS1003 in October 2018.
"CS1003 is a differentiated anti-PD-1 monoclonal antibody which allows us to quickly evaluate efficacy for combination therapies in animal models at the preclinical stage, and better predict the safety and efficacy of clinical trials,” CStone Chief Science Officer Dr. Jon Wang noted. “As one of CStone’s immune-oncology backbone drug candidates, we will leverage this unique advantage to explore and develop combination therapies with CS1003 for various solid tumors and hematological malignancies, with the aim of providing better treatment options to patients in China and globally. "
Clinical Status of CS1003
CStone is currently conducting a Phase I clinical trial in Australia to assess the safety and anti-tumor effects of CS1003 as a monotherapy in patients with advanced solid tumors. CStone received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for CS1003 in October 2018 and will extend the Phase I study to the United States.
CS1003 was approved in June 2018 by the China National Medical Product Administration (NMPA) to start clinical research, and a Phase I bridging clinical study was initiated in November 2018 for patients to start clinical research with advanced solid tumors and lymphomas.
CStone Pharmaceuticals (HKEX:2616) is a biopharmaceutical company focused on developing and commercializing innovative immuno-oncology and precision medicine 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 with a strategic emphasis on immune-oncology combination therapies. Currently, 4 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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