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

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.

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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 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.

“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™

AraLinQ^TM 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. AraLinQ^TM 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.

About Taiho Oncology, Inc.

The mission of Taiho Oncology, Inc. is to improve the lives of patients with cancer, their families and their caregivers. The company specializes in the development and commercialization of orally administered anti-cancer agents for various tumor types. Taiho Oncology has a robust pipeline of small-molecule clinical candidates targeting solid-tumor and hematological malignancies, with additional candidates in pre-clinical development. Taiho Oncology is a subsidiary of Taiho Pharmaceutical Co., Ltd. which is part of Otsuka Holdings Co., Ltd. Taiho Oncology is headquartered in Princeton, New Jersey and oversees its parent company’s European and Canadian operations, which are located in Baar, Switzerland and Oakville, Ontario, Canada.

For more information, visit https://www.taihooncology.com/, and follow us on LinkedIn and X.

Taiho Oncology and the Taiho Oncology logo are registered trademarks of Taiho Pharmaceutical Co., Ltd. Araris and AraLinQ are trademarks of Araris Biotech AG.

About Taiho Pharmaceutical Co., Ltd. (Japan)

Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co., Ltd. (https://www.otsuka.com/en/), is an R&D-driven specialty pharma focusing on the fields of oncology and immune-related diseases. Its corporate philosophy takes the form of a pledge: “We strive to improve human health and contribute to a society enriched by smiles.” In the field of oncology, in particular, Taiho Pharmaceutical is known as a leading company in Japan for developing innovative medicines for the treatment of cancer, a reputation that is rapidly expanding through their extensive global R&D efforts. In areas other than oncology, as well, the company creates and markets quality products that effectively treat medical conditions and can help improve people’s quality of life. Always putting customers first, Taiho Pharmaceutical also aims to offer consumer healthcare products that support people’s efforts to lead fulfilling and rewarding lives. For more information about Taiho Pharmaceutical, please visit https://www.taiho.co.jp/en.

About Araris Biotech AG

Araris Biotech AG, a wholly owned subsidiary of Taiho Pharmaceutical Co., Ltd. ("Taiho"), is a leading biotech company pioneering the future of antibody-drug conjugates (ADCs) and redefining the entire paradigm of targeted cancer therapy and beyond. Araris’ vision is a world without chemotherapy and its proprietary conjugation and groundbreaking multi-payload technology represents a quantum leap forward in ADC design, enabling the transformation of any antibody into an ADC with the goal of better safety and efficacy. By enabling the attachment of multiple, synergistic cancer-fighting payloads to a single antibody in an efficient one-step process, Araris is creating a new generation of smart missiles that deliver the potency of combination chemotherapy in a targeted fashion in order to tackle the persistent challenges of cancer resistance. For more information about our science and pipeline, please visit https://www.ararisbiotech.com/.

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