Suzhou, China, December 19, 2024--CStone Pharmaceuticals ("CStone", HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies, announced today the enrollment of the first patient in the global multicenter Phase 1b clinical trial of CS5001, an anti-ROR1 ADC and a key asset in company's Pipeline 2.0.
CS5001 has demonstrated encouraging safety and robust anti-tumor activity in the Phase 1a dose escalation trials across 10 dose levels. CS5001 was well tolerated in heavily pre-treated patients with advanced B-cell lymphomas and solid tumors, with no dose-limiting toxicity (DLT) observed up to dose level 10 (DL10). At the tentative recommended Phase 2 dose (RP2D) of DL8 (125 μg/kg), CS5001 achieved objective response rates (ORRs) of 70% in advanced B-cell lymphoma and 100% in Hodgkin lymphoma. Encouraging efficacy signals were also observed in advanced solid tumors, including non-small cell lung cancer and pancreatic cancer.
Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, commented, “The clinical data of CS5001 have been presented at multiple international academic meetings this year, raising widespread attention within the industry. Based on the latest data, CS5001 as a monotherapy has demonstrated a higher ORR in both aggressive and indolent advanced lymphomas compared to competitors, with consistent efficacy trends as patient numbers grow. This reinforces our confidence in its potential for faster-to-market registration and capacity for reshaping the frontline combination treatment landscape.
We are delighted to see CS5001 advance to the Phase 1b dose-optimization and expansion trial. This study also holds the potential to evolve into a Phase 2 single-arm registrational trial for relapsed/refractory diffuse large B-cell lymphoma (DLBCL). We will also explore the safety and efficacy of CS5001 as a monotherapy or in combination with the frontline standard of care (SOC) across multiple lymphomas and solid tumors. Our goal is to bring innovative treatments like CS5001 to global cancer patients, offering them improved survival benefits and new hope.”
About CS5001 (ROR1 ADC)
CS5001 is a clinical-stage antibody-drug conjugate ("ADC") targeting ROR1 (receptor tyrosine kinase-like orphan receptor 1). CS5001 has been uniquely designed with proprietary tumor-cleavable linker and pyrrolobenzodiazepine ("PBD") prodrug. Only after reaching the tumor, the linker and prodrug are cleaved to release the PBD toxin, resulting in lethal DNA cross-links in cancer cells. The use of the linker plus PBD prodrug effectively helps address the toxicity associated with traditional PBD payloads, leading to a better safety profile. CS5001 has demonstrated complete tumor suppression in several preclinical cancer models and demonstrated favorable serum half-life and pharmacokinetic characteristics. CS5001 is a promising candidate drug with precision treatment potential in both hematologic tumors and malignant solid tumors. Additionally, CS5001 utilizes site-specific conjugation for a precise drug antibody ratio of which enables homogeneous production and large-scale manufacturing.
In October 2020, CStone signed a licensing agreement with LigaChem Biosciences, Inc. (LCB) for the development and commercialization of CS5001 which was originally generated by collaboration of LCB and ABL Bio, both South Korea-based leading biotech companies. Under the agreement, CStone obtains the exclusive global right to develop and commercialize CS5001 outside the Republic of Korea.
The first-in-human data for CS5001 in patients with advanced solid tumors and lymphomas was presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Additionally, the latest clinical data on CS5001 as a monotherapy in patients with advanced lymphomas has recently been presented at the 66th American Society of Hematology (ASH) Annual Meeting.
About CStone
CStone (HKEX: 2616), established in late 2015, is an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies. Dedicated to addressing patients' unmet medical needs in China and globally, the Company has made significant strides since its inception. To date, the Company has successfully launched 4 innovative drugs and secured approvals for 16 new drug applications (NDAs) covering 9 indications. The company's pipeline is balanced by 17 promising candidates, featuring potentially first-in-class or best-in-class antibody-drug conjugates (ADCs), multispecific antibodies, immunotherapies and precision medicines. CStone also prides itself on a management team with comprehensive experiences and capabilities that span the entire drug development spectrum, from preclinical and translational research to clinical development, drug manufacturing, business development, and commercialization. For more information about CStone, please visit www.cstonepharma.com.
IR contact: ir@cstonepharma.com
PR contact: pr@cstonepharma.com
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