Taiho Oncology and Araris launch ARC-02 Phase 1 ADC trial in Tokyo; First AraLinQ ADC clinical trial ARC-02.

Taiho Oncology and Araris launch Phase 1 clinical trial

Tokyo - Araris and Taiho are set to conduct the first clinical trial for an antibody-drug conjugate developed using the AraLinQ platform from Araris. This has been designed for the selective destruction of B-cell malignancies, one of the most common cancers of the lymphatic system.

(CONNECT)Taiho Oncology, the European subsidiary based in Baar in the Swiss canton of Zug of the pharma groupTaihofrom Tokyo, andAraris, a biotech company from Au in the canton of Zurich that was acquired by the latter in March 2025, have been given the green light to launch a Phase 1 clinical trial. As they have now announced, the Federal Drug Administration (FDA), as the regulatory approval authority for the USA, paved the way for this happen. The antibody-drug conjugate (ADC) with the study name ARC-02 is being tested in relation to the treatment of non-Hodgkin lymphoma. It is intended to selectively combat and kill these cancerous B-cell malignancies.

This is the first clinical trial of a drug developed using the AraLinQ platform from Araris and marks Taiho’s entry into the clinical development of ADCs for oncology. The start of clinical development activities for this first ADC underscores, according to Dr. Fabio Benedetti, Global Chief Medical Officer at Taiho Pharmaceutical, the “continued expansion of Taiho group’s oncology development capabilities. 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.

The proprietary linker technology developed by Araris, which binds the antibody to the drug, is exceptionally stable. Once inside a cancer cell, the linker can be easily broken to release the drug. Moreover, Araris linkers are hydrophilic, meaning they do not clump in water-based solutions such as blood. They can also exhibit unique branching structures, facilitating the creation of ADCs capable of delivering multiple different drugs.

According to Taiho, AraLinQ allows for one-step production of ADCs on the basis of off-the-shelf antibodies that are native or engineered. The company describes the process as fast, cost-effective and easily scalable. ce

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