PRINCETON, N.J.– Taiho Oncology Inc., Taiho Pharmaceutical Co. Ltd., and Araris Biotech AG have advanced their experimental cancer therapy ARC-02 into clinical testing after the U.S. Food and Drug Administration completed its review of the company’s investigational new drug application.
The clearance allows Taiho to begin a Phase 1 dose-escalation trial evaluating ARC-02, an antibody-drug conjugate designed to treat non-Hodgkin lymphoma by targeting and killing malignant B cells.
The study marks the first clinical trial of a therapy developed using Araris’ proprietary AraLinQ™ technology, which is designed to create stable, site-specific antibody-drug conjugates using standard antibodies and scalable manufacturing methods.
Taiho Pharmaceutical acquired Araris Biotech in March 2025, expanding its capabilities in biologics and antibody-drug conjugate research and development. Araris, a Swiss biotech spin-off from the Paul Scherrer Institute and ETH Zurich, focuses on advancing next-generation ADC platforms.
ARC-02 targets the CD79b protein and uses monomethyl auristatin E as its cytotoxic payload, a combination intended to selectively attack cancerous B cells while limiting damage to healthy tissue.
“Advancing our first ADC into the clinic represents an important milestone for our pipeline and reflects the continued expansion of Taiho group’s oncology development capabilities,” said Fabio Benedetti, M.D., Global Chief Medical Officer of Taiho Pharmaceutical. “This initial clinical study will allow us to evaluate ARC-02 in patients and generate data to inform both the continued development of ARC-02 and our ADC platform. We look forward to advancing this program as part of our broader efforts to deliver innovative therapies to people living with cancer.”
The trial represents a broader push by Taiho to expand its oncology portfolio and develop targeted therapies using advanced drug delivery technologies.
