Taiho Pharmaceutical and Araris Biotech AG advance ADC ARC-02 into phase 1 clinical development

CAR-T Digest - August 2020

28 April 2026: Taiho Pharmaceutical and Araris Biotech AG advance ADC ARC-02 into phase 1 clinical development

Taiho Oncology, Taiho Pharmaceutical, and Araris Biotech announced that the U.S. FDA has completed its Investigational New Drug review for ARC-02, enabling the initiation of a Phase 1 dose-escalation clinical trial for patients with non-Hodgkin lymphoma
The program marks the first clinical advancement of an ADC generated using the AraLinQ platform and reflects Taiho’s strategic expansion into ADC-based oncology following its acquisition of Araris Biotech in March 2025
The Phase 1 study will evaluate safety, tolerability, and early clinical activity of ARC-02 in patients, generating initial data to guide further development of both the asset and the broader ADC platform
ARC-02 is a CD79b-targeting antibody–drug conjugate developed using Araris’ proprietary AraLinQ technology, designed to enable stable, site-specific conjugation and selective delivery of a cytotoxic MMAE payload to B-cell malignancies
With ARC-02 entering clinical development, Taiho is strengthening its oncology pipeline and advancing its capabilities in next-generation biologics aimed at delivering more targeted and effective cancer therapies