On July 28, 2025 CStone Pharmaceuticals reported it will announce the latest clinical data from its 2.0 blockbuster product, CS2009 (a PD-1/VEGF/CTLA-4 trispecific antibody), as well as the design of the global, multicenter Phase Ib study for CS5001 (a ROR1 ADC) at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper), one of the world’s most influential oncology conferences, will be held in Berlin, Germany from October 17 to 21, 2025 (Press release, CStone Pharmaceauticals, JUL 28, 2025, View Source [SID1234656217]).
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CS2009 is a potential first-in-class/best-in-class trispecific antibody. Its global multicenter Phase I dose escalation and dose expansion study is actively recruiting patients in Australia and China, and plans to expand to the United States for Phase II enrollment. CStone Pharmaceuticals will announce the Phase Ia clinical study data of CS2009 at the ESMO (Free ESMO Whitepaper) Congress , which will also become the first globalClinical data report of PD-1/VEGF/CTLA-4 trispecific antibody.
CS5001 is the first known ROR1 ADC to demonstrate clinical efficacy in both lymphoma and solid tumors, and its clinical development progress ranks among the top two globally. Currently, a global, multicenter Phase Ib clinical trial of CS5001 is progressing simultaneously in the United States, Australia, and China. CStone Pharmaceuticals will unveil the design of the ongoing Phase Ib study at the ESMO (Free ESMO Whitepaper) Congress.
The following are the key messages presented by the company at the ESMO (Free ESMO Whitepaper) conference:
CS2009, a novel PD-1/VEGF/CTLA-4 trispecific antibody, in patients with advanced solid tumors: an open-label, multicenter, phase I first-in-human study
【Category】 Investigational immunotherapy
【Format】 Poster
【Exhibition Number】 1545P
A phase Ib trial of CS5001 (ROR1-ADC) as a single agent and in combination with systemic therapies in patients with advanced solid tumours and lymphomas
【Category】 Haematological malignancies
【Format】 Electronic poster
【Exhibition Number】 1316eTiP
About CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody)
CS2009 is a novel trispecific antibody targeting PD-1, VEGFA, and CTLA-4, independently developed by CStone Pharmaceuticals from the molecular design perspective. It achieves multi-dimensional anti-tumor effects through synergistic action and holds first-in-class/best-in-class potential. CS2009’s differentiated molecular design combines three clinically validated targets, enabling the reactivation of near-exhausted tumor-infiltrating T cells and demonstrating comparable VEGF neutralization to existing anti-VEGF antibodies. It targets a broad range of diseases, including but not limited to non-small cell lung cancer, liver cancer, gastric cancer, endometrial cancer, ovarian cancer, renal cell carcinoma, and cervical cancer.
About the CS5001 (ROR1 ADC)
CS5001 is an antibody-drug conjugate (ADC) targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1). The drug utilizes a unique design, combining a tumor-specifically activated pyrrolobenzodiazepine (PBD) protoxin payload and a linker. This "dual-control" mechanism of linker plus protoxin effectively mitigates the toxicity issues associated with traditional PBD payloads and significantly extends the safety window. CS5001 has demonstrated complete tumor inhibition in multiple preclinical cancer models and exhibited favorable serum half-life and pharmacokinetic properties, demonstrating its significant clinical development potential and broad application prospects in the treatment of various solid and hematological tumors. Furthermore, CS5001 utilizes targeted conjugation technology to achieve a precise drug-to-antibody ratio (DAR), ensuring homogeneous production and large-scale manufacturing.
In October 2020, CStone Pharmaceuticals and LigaChem Biosciences, Inc. (LCB) entered into a licensing agreement for the development and commercialization of CS5001. CS5001 was originally co-synthesized by LCB and ABL bio, two leading Korean biotech companies. Under the terms of the agreement, CStone Pharmaceuticals obtained exclusive development and commercialization rights for CS5001 worldwide, excluding Korea.