USFDAMay 7, 2026, 08:03 AM
ArriVent gets FDA IND clearance for ARR-002; Phase 1 H2 2026
AI Summary
ArriVent BioPharma, Inc. announced that the FDA has cleared its Investigational New Drug (IND) application for ARR-002, a potential first-in-class MUC16/NaPi2b targeting tetravalent antibody-drug conjugate (ADC). The company plans to initially focus ARR-002 on ovarian and endometrial cancers, with broader therapeutic potential across solid tumors. Preclinical data presented at AACR demonstrated superior efficacy and favorable tolerability compared to single-target approaches. ArriVent anticipates initiating a Phase 1 trial and dosing the first patient in the second half of 2026.
Key Highlights
- ArriVent received FDA Investigational New Drug (IND) clearance for ARR-002.
- ARR-002 is a potential first-in-class MUC16/NaPi2b targeting tetravalent antibody-drug conjugate (ADC).
- Initial focus for ARR-002 is in ovarian and endometrial cancers, with broader potential across solid tumors.
- Preclinical data showed superior in vivo efficacy vs. single-target ADCs in the OVCAR-3 xenograft model.
- Preclinical data indicated a wider therapeutic window with favorable tolerability in cynomolgus monkeys.
- ArriVent expects to initiate a Phase 1 trial and dose the first patient in the second half of 2026.
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