Drug intelligence / Profile preview

ciltistotug

Development stage
Phase 2
Lead developer
Eucure Biopharma
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intratumoral, Intravenous
01

Overview

Ciltistotug (formerly YH003) is an investigational humanized IgG2 monoclonal antibody designed to target and activate CD40 (tumor necrosis factor receptor superfamily member 5, TNFRSF5), a key co-stimulatory receptor expressed on antigen-presenting cells (APCs) such as dendritic cells, macrophages, and B cells. Developed by Eucure Biopharma (a subsidiary of Biocytogen), ciltistotug acts as a CD40 agonist, triggering downstream signaling cascades that promote APC maturation, antigen presentation, and the activation of tumor-specific T cells. The antibody is engineered with an IgG2 isotype to minimize Fc-mediated antibody-dependent cellular cytotoxicity (ADCC) effector functions, thereby extending its half-life and improving its safety profile by reducing systemic toxicity. Ciltistotug is currently being evaluated in Phase II clinical trials for advanced solid tumors, including unresectable/metastatic melanoma and pancreatic ductal adenocarcinoma (PDAC), both as a monotherapy and in combination with PD-1 inhibitors and chemotherapy. Additionally, ciltistotug is licensed to Syncromune as a key component of SV-102, an intratumoral multi-target immunotherapy combination being evaluated in Phase II trials for metastatic castration-resistant prostate cancer.

Other names
anti-CD40 agonist antibody YH003anti-CD-40 agonist antibody YH003anti-CD 40 agonist antibody YH003
02

Targets

FcγR (Low affinity immunoglobulin gamma Fc region receptor II-c)CD40 (Cluster of differentiation 40 receptor)

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