On April 27, 2026 Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Araris Biotech AG ("Araris") reported 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.
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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 AraLinQTM 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.
"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, MD, Global Chief Medical Officer, 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."
About AraLinQ
AraLinQTM is Araris’ ADC technology, which enables site-specific payload attachment to a privileged attachment site on a specific amino acid residue (Q295) within the native antibody Fc framework. Preclinical data demonstrate that when a payload is attached to this site using Araris’ proprietary linkers, the antibody maintains nearly identical performance (e.g. pharmacokinetics and effector functions) to the unconjugated, original antibody. Furthermore, the linker-payload is connected to the antibody through a very strong isopeptide bond resulting in exceptional stability. Once entering a cancer cell via antibody-mediated internalization, the linker can be easily broken to release the payload. All three of these properties are key factors to enable efficient payload delivery and maximize ADC efficacy. AraLinQTM linkers are hydrophilic, rendering them soluble and avoiding their clumping in water-based solutions like blood. In addition, this linker can have unique branching structures that make it possible to create ADCs that carry multiple payloads of different types. AraLinQ allows for the generation of ADCs in one step using "off-the-shelf," antibodies that are native or engineered. The process is fast, cost-efficient and can be easily upscaled without the need for custom antibody synthesis.
(Press release, Taiho, APR 27, 2026, View Source [SID1234664817])