Drug intelligence / Profile preview

mFOLFOXIRI + cadonilimab + fruquintinib

Development stage
Phase 2
Lead developer
Sun Yat-sen University
Modality
Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Small Molecules
Administration
Intravenous, Oral
01

Overview

mFOLFOXIRI + cadonilimab + fruquintinib is an investigational combination neoadjuvant therapy regimen being evaluated for the treatment of locally advanced colorectal cancer (LARC). The regimen integrates the intensive chemotherapy backbone mFOLFOXIRI (modified folinic acid, 5-fluorouracil, oxaliplatin, and irinotecan) with cadonilimab (AK104), a bispecific antibody targeting both PD-1 and CTLA-4, and fruquintinib, a highly selective small molecule inhibitor of VEGFR-1, -2, and -3. This multi-modal approach is designed to enhance anti-tumor activity through simultaneous cytotoxic action, dual checkpoint inhibition to overcome immune evasion, and inhibition of tumor angiogenesis. It is currently being studied in the Phase II OPTICAL-2 trial (NCT05571644) led by Sun Yat-sen University to improve pathological complete response rates and surgical outcomes in LARC patients.

Brand names
Kaitanni
Other names
mFOLFOXIRI + AK104 + fruquintinibmodified FOLFOXIRI plus cadonilimab and fruquintinib
02

Targets

CTLA-4 (Cytotoxic t-lymphocyte–associated protein 4)DNATOP1 (DNA Topoisomerase I)PDCD1 (Programmed cell death protein 1 receptor)TS (Thymidylate synthase)VEGFR-1 (Vascular endothelial growth factor receptor 1)VEGFR2 (Vascular endothelial growth factor receptor 2)VEGFR4 (Vascular endothelial growth factor Receptor-3)

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