ArriVent Secures FDA Clearance for ARR-002 IND, Phase 1 Trial Slated H2 2026
AVBP•ArriVent BioPharma’s IND application for ARR-002 targeting MUC16/NaPi2b dual-ADC received FDA clearance, enabling a Phase 1 trial in H2 2026 for ovarian and endometrial cancers. Preclinical data showed superior in vivo efficacy in OVCAR-3 xenografts and tolerability at higher doses in cynomolgus monkeys.
1. IND Clearance and Clinical Timeline
ArriVent secured FDA clearance of its IND application for ARR-002, enabling initiation of a Phase 1 trial in the second half of 2026 targeting ovarian and endometrial cancers.
2. Dual-Target ADC Design
ARR-002 is a first-in-class tetravalent ADC with a 2+2 format and drug-to-antibody ratio of 4, designed to concurrently engage MUC16 and NaPi2b to enhance internalization and minimize off-tumor toxicity.
3. Preclinical Efficacy and Tolerability
Preclinical results demonstrated superior in vivo efficacy in an OVCAR-3 xenograft model compared with single-target ADCs, and tolerability studies in cynomolgus monkeys showed reversible hematologic effects at doses higher than existing approaches.
