Taiho Oncology and Araris start clinical phase 1

(CONNECT) The Baar-based European subsidiary Taiho Oncology of the Tokyo-based pharmaceutical group Taiho and the biotech company Araris from Au, which it acquired in March 2025, can start a Phase 1 clinical trial. As they have now announced, the Federal Drug Administration (FDA), the regulatory authority in the USA, has cleared the way for this. The antibody drug conjugate (ADC) with the study name ARC-02 is being tested for the treatment of non-Hodgkin's lymphoma. It is designed to selectively combat and kill these malignant B-cell malignancies.

This is the first clinical trial of a compound developed using Araris' AraLinQ platform and marks Taiho's entry into the clinical development of ADCs for oncology. According to Dr. Fabio Benedetti, Global Chief Medical Officer of Taiho Pharmaceutical, "The entry of the first antibody-drug conjugate into the clinical phase underscores the continued expansion of the Taiho Group's oncology development capabilities. This first clinical trial will allow us to evaluate ARC-02 in patients and generate data to support the further development of both ARC-02 and our ADC platform."

Araris' proprietary linker technology, which binds the antibody to the drug, is exceptionally stable. After uptake into a cancer cell, the linker can be easily cleaved to release the active substance. In addition, the Araris linkers are hydrophilic, so they do not clump together in aqueous solutions such as blood. They can also have unique branching structures. This enables the production of ADCs that can transport several different active ingredients.

According to Taiho, AraLinQ allows the one-step production of ADCs using commercially available native or genetically modified antibodies. The company describes the process as fast, cost-effective and easily scalable. ce/mm