CS5006 / CStone Pharma - LARVOL DELTA

CStone Presents Preclinical Results of…CS5006 (ITGB4 ADC) at 2025 AACR (PRNewswire) - "Key Highlights:...CS5006 preclinical proof-of-concept models using ITGB4-vedotin and ITGB4-DXd showed potent antitumor activity in both in vitro and in vivo studies, along with favorable pharmacokinetic (PK) profiles. (i) ITGB4-vedotin exhibited strong antigen-dependent cytotoxicity in ITGB4-positive tumor cell lines in vitro and demonstrated potent antigen-dependent tumor inhibition in CDX models in vivo; (ii) ITGB4-DXd also exhibited potent antigen-dependent cytotoxicity in vitro and strong tumor-inhibitory effects in vivo CDX tumor models; (iii) Both ITGB4-vedotin and ITGB4-DXd exhibited favorable PK characteristics."

Preclinical • Solid Tumor

CS5006: A novel integrin β4-targeted antibody-drug conjugate (ADC) with robust antitumor activity in preclinical studies (AACR 2025) - "CS5006 is a novel ITGB4-targeted ADC with robust preclinical efficacy and a favorable safety and PK profile. These findings support further IND-enabling and clinical evaluation of CS5006 as a promising ADC therapy for various advanced solid tumors."

Preclinical • Colorectal Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • HER-2 • ITGA6 • ITGB4 • MET

CS5006: A novel integrin β4-targeted antibody-drug conjugate (ADC) with robust antitumor activity in preclinical studies (PRNewswire) - "CStone to showcase...latest research achievements at AACR 2025....Abstract Number: 2953....Key Findings: CS5006 (ITGB4 ADC) demonstrated promising therapeutic potential by effectively killing tumor cells in both in vivo and in vitro studies, while maintaining a PK profile comparable to those of monoclonal antibodies."

Preclinical • Oncology

CStone Announces Patent Publication for First-in-Class ADC CS5006 (CStone Pharma Press Release) - "CStone Pharmaceuticals...announced the patent (WO/2024/208354) for its internally developed antibody-drug conjugate (ADC) CS5006 was published on October 10, 2024....In vitro studies showed that both CS5006-GGFG-DXd and CS5006-VC-MMAE ADCs efficiently released cytotoxins upon internalization in tumor cells, rapidly inducing cell death. In vivo data further confirmed the potent anti-tumor activity and favorable tolerability of these two ADCs, providing robust support for the next phase of clinical development."

Patent • Preclinical • Solid Tumor

CStone Reports 2024 Interim Results and Recent Corporate Updates (PRNewswire) - "Anticipated near-term catalysts include:...(i) CS2009: IND submissions expected in 2024/2025; (ii) CS5006: IND submission expected in 2025; (iii) CS5005: IND submission expected in 2025; (iv) CS2011/CS5007: IND submission expected in 2025."

IND • Solid Tumor

CStone Pharmaceuticals Reports 2023 Annual Results and Business Updates (CStone Pharma Press Release) - "(i) CS2009: submit clinical trial notification ('CTN') to Australian Human Research Ethics Committee ('HREC') by the end of 2024, and apply for China IND in the first quarter of 2025; (ii) CS5006: nominate PCC in the first half of 2024, and expect to file IND in 2025; (iii) CS5005: nominate PCC in 2024, and expect to file IND in 2025."

IND • New molecule • New trial • Solid Tumor