CS5006 / CStone Pharma - LARVOL DELTA

AACR 2026 Preview: CStone to Present Preclinical Data for Three Proprietary Pipeline Assets (CStone Pharma Press Release)

Preclinical • Neuroendocrine Tumor • Small Cell Lung Cancer

Preclinical efficacy and safety of CS5006, a novel integrin β4-targeting antibody-drug conjugate with a topoisomerase 1 inhibitor payload (AACR 2026) - "CS5006 demonstrates high potency, robust antitumor activity, a manageable safety profile, and excellent developability in preclinical studies, supporting its clinical translation. An IND application for CS5006 is planned for H2 2026 to support clinical development in patients with advanced solid tumors."

ADC • Preclinical • Breast Cancer • Colorectal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • ITGB4

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