Araris Biotech AG, a company advancing a differentiated pipeline of antibody-drug conjugates (“ADCs”) therapies, and Taiho Oncology, Inc., a company developing and commercializing novel treatments for hematologic malignancies and solid tumors, both members of the Taiho group, today announced that the first patient has been dosed in a Phase 1 clinical trial of ARC-02, a CD79b-targeted antibody-drug conjugate (ADC) for the treatment of non-Hodgkin lymphoma (NHL).
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ARC-02 selectively binds CD79b-positive B-cells and delivers monomethyl auristatin E (MMAE), a clinically validated anti-cancer payload, directly to tumor cells. It is the first clinical candidate generated using Araris’ proprietary AraLinQ® ADC technology and Arastatin™ linker-payload, designed for precise intracellular release and minimization of impact on healthy tissue.
“Dosing the first patient with ARC-02 marks a pivotal milestone for Araris as we enter the clinic and begin translating our innovative ADC platform into potential benefits for patients,” said Philipp Spycher, PhD, CSO and scientific founder of Araris.
“While ARC-02 is initially being developed for hematological malignancies, the differentiated safety profile observed in preclinical studies may also support its broader application across additional disease indications, including autoimmune diseases,” said Isabella Attinger-Toller, PhD, CTO and co-founder of Araris.
“This milestone represents the first human experience with the novel Araris platform and marks Taiho’s expansion into the clinical development of ADCs for oncology,” said Harold Keer, MD, PhD, Chief Medical Officer at Taiho Oncology. “We look forward to results from this trial and advancing other agents from Araris into the clinic.”
About AraLinQ®
AraLinQ® 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® 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 ArastatinTM
Arastatin™ is a novel linker-payload technology based on MMAE and an Araris proprietary hydrophilic peptide linker. Arastatin™ is designed specifically to be used with Araris’ site-specific ADC technology AraLinQ® which enables the direct conjugation of the MMAE linker-payload to Q295 of native, off-the-shelf antibodies in one step. In preclinical studies, Arastatin™ based ADCs were found to be highly potent, stable and well-tolerated among different antibodies compared to commercially available ADCs.
About Araris Biotech AG
Araris Biotech AG, a wholly owned subsidiary of Taiho Pharmaceutical Co., Ltd., is a leading biotech company pioneering the future of antibody-drug conjugates 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 anti-cancer agents that aim to 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/.
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.
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