- The launch of CS5001’s first-in-man clinical trial marks another milestone for CStone’s 2.0 pipeline
- Global development of CS5001 is being conducted as a multi-regional clinical trial, with sites initiated in the United States and Australiaand an IND request accepted by the NMPA in China
- As one of the most advanced ROR1 ADCs in clinical development, CS5001 has demonstrated therapeutic potential in multiple hematological and solid malignancies
SUZHOU, China, March 30, 2022 /PRNewswire/ — CStone Pharmaceuticals (“CStone”, HKEX:2616), a leading biopharmaceutical company focused on the research, development and commercialization of innovative immuno-oncology therapies and precision medicines, today announced the first patient has been enrolled in the US Phase 1 clinical trial for CS5001. This is a remarkable milestone for CStone’s Pipeline 2.0 strategy.
CS5001 is a potentially best-in-class antibody-drug conjugate (ADC) targeting the orphan receptor tyrosine kinase-like 1 (ROR1). As one of the three most advanced ROR1 ADCs in the world, CS5001 has been approved for initiation of a multi-regional clinical trial in the United States and Australia. The Chinese National Medical Products Administration (NMPA) has accepted the Investigational New Drug (IND) application of CS 5001. This first-in-man Phase 1 study aims to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of CS5001 in advanced B-cell lymphomas and solid tumors.
ROR1 is an oncofetal protein with low or no expression in adult tissues but high expression in a variety of cancers, including various forms of leukemia and non-Hodgkin’s lymphoma, breast, lung and ovarian cancers, making it an ideal ADC target. Results from preclinical studies showed that CS5001 exhibited potent and selective cytotoxicity against various ROR1-expressing cancer cell lines and demonstrated remarkable in vivo antitumor activity in solid and hematologic tumor xenograft models. The preclinical data was presented as a late-breaking abstract at the 33rd AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics 2021.
dr. Archie TseChief Scientific Officer of CStone, said, “We are very pleased to have the first patient enrolled in the first-in-man study of CS5001. This potentially best-in-class CDA ROR1 contains a number of differentiated features that may result in a broader therapeutic window against a variety of cancer types – a fully human antibody backbone, proprietary site-specific conjugation and a Tumor-cleavable prodrug and binding technology Results from preclinical studies of CS5001 have already shown its therapeutic potential in hematological treatments expressing ROR1 and solid malignancies. We will rapidly execute the global development program for CS5001, beginning with this Phase 1 study to characterize its safety and preliminary efficacy in the treatment of advanced B-cell lymphoma and certain solid tumors.
About CS5001（CAN ROR1）
CS5001 is a clinical-stage antibody-drug conjugate (ADC) targeting ROR1 (tyrosine kinase-like orphan receptor 1). CS5001 has a unique design and an LCB-exclusive tumor-cleavable linker and pyrrolobenzodiazepine (PBD) prodrug. Only after reaching the tumor are the linker and prodrug cleaved to release the PBD toxin, resulting in lethal DNA cross-linking in cancer cells. The use of the linker plus the PBD prodrug effectively helps address the toxicity issue associated with traditional PBD payloads, leading to a better safety profile. Additionally, CS5001 utilizes site-specific conjugation for an accurate drug antibody ratio of 2, enabling consistent production and large-scale manufacturing.
In October 2020CStone has signed a license agreement with LegoChem Biosciences, Inc. (LCB) for the development and commercialization of CS5001 which was initially generated by the collaboration of LCB and ABL Bio, both South Korealeading biotechnology companies. Under this agreement, CStone obtains the exclusive worldwide right to direct the development and commercialization of CS5001 outside of the Republic of Korea.
CStone Pharmaceuticals (HKEX: 2616) is a biopharmaceutical company focused on the research, development and commercialization of innovative immuno-oncology and precision medicines to address the unmet medical needs of cancer patients in China and around the world. Founded 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 focus on immuno-oncology combination therapies. Currently, CStone has received seven NDA approvals for four drugs. CStone’s vision is to be recognized globally as a world-renowned biopharmaceutical company by delivering innovative oncology therapies to cancer patients worldwide.
For more information about Cstone, please visit: www.cstonepharma.com.
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