CS5005 / CStone Pharma - LARVOL DELTA

Preclinical efficacy and safety of CS5008, a novel SSTR2×DLL3 bispecific antibody-drug conjugate (ADC) with topoisomerase 1 inhibitor payload for small cell lung cancer and neuroendocrine tumors (AACR 2026) - "DLL3 is a clinically validated target in SCLC, serving as the target of tarlatamab, a T-cell engager...A single treatment with 10 mg/kg CS5008 achieved significant tumor growth inhibition in all 5 tested SCLC CDX models with different expression level of DLL3 and SSTR2 assessed by FACS, indicating the designated character of CS5005 to overcome the heterogeneity of SCLC... CS5008 demonstrated potent antitumor activity against SCLC by dual targeting of SSTR2 and DLL3, effectively addressing heterogeneity. Its favorable preclinical safety and robust PK support further clinical development. An IND application is expected by the end of 2026."

ADC • Bispecific • Preclinical • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3 • SSTR2

CS5005: A novel SSTR2-targeted antibody-drug conjugate (ADC) with robust antitumor activity in preclinical studies (AACR 2025) - "In SCLC, SSTR2-targeted therapies, including RAZ101 (225Ac bearing RDC), PEN221 (peptide drug conjugate) etc., have shown encouraging clinical results. CS5005 represents a promising SSTR2-targeted ADC for the treatment of advanced solid tumors. The preclinical findings support further IND-enabling studies and clinical investigations of CS5005 as a novel therapeutical option."

ADC • Preclinical • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • SSTR • SSTR2

CStone Presents Preclinical Results of…CS5005 (SSTR2 ADC)…at 2025 AACR (PRNewswire) - "Key Highlights:...CS5005 demonstrated potent antigen-dependent cytotoxic activity against tumor cells in vitro and robust tumor-growth inhibition in CDX tumor model. The antitumor activity of CS5005 (SSTR2-DXd) is not compromised by concomitant ligand-derived treatments (e.g., octreotide, Lutathera), thereby avoiding drug-drug interference commonly observed with current anti-SSTR2 therapies. CS5005 demonstrated superior in vitro stability due to its proprietary linker, outperforming ADCs conjugated with well-validated dipeptide and tetrapeptide linkers."

Preclinical • Solid Tumor

CS5005: A novel SSTR2-targeted antibody-drug conjugate (ADC) with robust antitumor activity in preclinical studies (PRNewswire) - "CStone to showcase...latest research achievements at AACR 2025....Abstract Number: 4751....Key Findings: CS5005 (SSTR2 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. Additionally, a dual-target ADC against DLL3 and SSTR2 also exhibited potential as a therapeutic agent."

Preclinical • Oncology

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