On May 7, 2026 ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, reported clearance of an investigational new drug (IND) application by the United States Food and Drug Administration (FDA) for ARR-002, a potential first-in-class MUC16/NaPi2b targeting tetravalent antibody-drug conjugate (ADC) with an initial focus in ovarian and endometrial cancers and broader therapeutic potential across solid tumors.
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"We are pleased to advance ARR-002 into the clinic as the second next-generation ADC from our portfolio," said Stuart Lutzker, MD, Ph.D., President of Research and Development of ArriVent. "At AACR (Free AACR Whitepaper), compelling preclinical data was presented demonstrating ARR-002’s potential to improve safety and efficacy over conventional single-target and bivalent bispecific ADCs in ovarian and endometrial cancers. ARR-002’s dual-target approach is designed to improve delivery and reduce off-tumor toxicity to overcome key limitations of single-target ADCs, including limited internalization, suboptimal payload delivery, and heterogeneous target expression. We expect to initiate a Phase 1 trial and dose the first patient in the second half of the year."
MUC16 and NaPi2b are highly expressed on ovarian and endometrial cancers with limited expression in normal tissues, making them strong co-targets. Select preclinical data included in the IND submission of ARR-002 was presented at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in a joint presentation with Aarvik Therapeutics demonstrating:
Effective binding to individual targets, simultaneous engagement of both targets, and enhanced internalization vs. single-target antibody controls
Superior in vivo efficacy vs. single-target ADCs in the OVCAR-3 xenograft model
The potential for a wider therapeutic window based on a favorable tolerability profile in cynomolgus monkeys, consisting of reversible hematologic findings at a higher maximum tolerated single dose vs. other approaches in development
(Press release, ArriVent Biopharma, MAY 7, 2026, View Source [SID1234665365])