NEWTOWN SQUARE, PA — ArriVent BioPharma (Nasdaq: AVBP) received U.S. Food and Drug Administration clearance to begin human testing of an experimental antibody-drug conjugate designed to improve targeting of ovarian and endometrial cancers, as drugmakers race to develop next-generation cancer therapies that address limitations of existing single-target treatments.
The company said the FDA cleared its investigational new drug application for ARR-002, a dual-target antibody-drug conjugate initially aimed at ovarian and endometrial cancers, with broader potential applications across solid tumors.
ArriVent expects to begin a Phase 1 trial and dose the first patient in the second half of 2026.
The experimental therapy targets both MUC16 and NaPi2b proteins, which are commonly expressed in ovarian and endometrial tumors but show limited expression in normal tissue. The company believes the dual-target approach could improve drug delivery to cancer cells while reducing off-target toxicity that has challenged some earlier antibody-drug conjugates.
At the American Association for Cancer Research annual meeting earlier this year, ArriVent and partner Aarvik Therapeutics presented preclinical data indicating ARR-002 demonstrated stronger tumor-targeting activity and improved internalization compared with single-target antibody controls.
The company also reported superior efficacy in OVCAR-3 xenograft models relative to single-target antibody-drug conjugates and cited animal data suggesting a potentially wider therapeutic window, including reversible hematologic effects observed in cynomolgus monkeys at higher tolerated doses.
President of Research and Development Stuart Lutzker stated that the therapy was designed to address several shortcomings associated with existing single-target approaches, including inconsistent target expression and inefficient payload delivery.
ARR-002, also identified as AV-P138-ADC, uses a tetravalent 2+2 antibody format and is linked to the chemotherapy payload vcMMAE with a drug-to-antibody ratio of four.
The program represents the second next-generation antibody-drug conjugate advanced by ArriVent into clinical development.
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