Taiho Oncology, Taiho Pharmaceutical and Araris Biotech AG Advance ADC ARC-02 into Phase 1 Clinical Development

Phase 1 dose-escalation trial represents the first clinical trial of a product developed using the AraLinQ™ ADC technology and marks Taiho’s expansion into the clinical development of ADCs for oncology

Excerpt from the Press Release:

PRINCETON, N.J. & TOKYO & ZURICH–(BUSINESS WIRE)–Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Araris Biotech AG (“Araris”) today announced that the U.S. Food and Drug Administration (FDA) has completed its Investigational New Drug (IND) review period for ARC-02, an antibody-drug conjugate (ADC) being developed for the treatment of non-Hodgkin lymphoma, enabling Taiho Oncology to initiate a Phase 1 dose-escalation clinical trial of ARC-02.

Taiho Pharmaceutical acquired Araris Biotech in March 2025, expanding Taiho group’s capabilities in biologics and ADC research and development. Araris is a spin-off of the Paul Scherrer Institute and ETH in Switzerland focused on the development of antibody-drug conjugates (ADCs). Central to Araris’ approach is its proprietary AraLinQ™ ADC technology, which enables the creation of stable and site-specific ADCs using standard antibodies with scalable manufacturing processes. ARC-02 is a CD79b-protein-targeting ADC based on Araris’ proprietary AraLinQ^TM technology using monomethyl auristatin E (MMAE) as payload, designed for selective targeting and killing of B-cell malignancies.

The trial represents the first clinical trial of a product candidate developed using the AraLinQ™ ADC technology and marks Taiho’s expansion into the clinical development of ADCs for oncology.

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