ARC-401 / Otsuka, Araris Biotech, Taiho - LARVOL DELTA

Pre-clinical characterization of ARC-401, a first-in-class anti-Nectin-4 triple payload ADC (EORTC-NCI-AACR 2026) - "Abstract will be available as of 4 November (with consent of the author)"

ADC • Preclinical • Oncology • NECTIN4

ARC-401 - a triple payload first-in-class ADC against Nectin-4 designed to overcome cancer resistance and tumor heterogeneity shows broad anti-tumor activity and high tolerability in rats and non-human primates (AACR 2026) - "Similarly, enfortumab-vedotin did not show any effect at 0.5mg/kg...Further, ARC-401 showed high anti-tumor activity in several mouse and rat PDX models with complete anti-tumor responses at very low doses, where EV and Sacituzumab govitecan, the FDA-approved ADC for TNBC, showed only limited to transient anti-tumor activity...Importantly, we confirm high tolerability in both rats and non-human primates suggesting a high therapeutic index. Further we show that combining multiple payloads within a single ADC can lead to improved anti-tumor activity compared to combination treatments."

ADC • Heterogeneity • Late-breaking abstract • Preclinical • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • NECTIN4 • TOP1

Taiho Pharmaceutical to Acquire Next-Generation ADC Drug Discovery Company Araris Biotech (GlobeNewswire) - "Taiho Pharmaceutical...and Araris Biotech AG...announced today that they have entered into a definitive agreement pursuant to which Taiho Pharmaceutical will fully acquire Araris (hereinafter 'the Acquisition'). Following necessary procedures, the Acquisition is expected to be completed in first half of 2025. The Acquisition follows a research collaboration between Taiho Pharmaceutical and Araris signed in November 2023. Under the terms of the agreement, Taiho Pharmaceutical will pay USD 400 million at closing, with the potential for additional milestone payments of up to USD 740 million....Araris is advancing three products for the treatment of hematological and solid tumors developed using its unique AraLinQ technology, which are currently in the preclinical stage. These products are anticipated to enter into clinical trials between 2025 and 2026."

M&A • New trial • Hematological Malignancies • Oncology • Solid Tumor

Novel peptide linker-based nectin-4 targeting ADC shows improved tolerability with long-lasting anti-tumor efficacy at low doses (AACR 2023) - "We generated an anti-Nectin-4 ADC that shows superior anti-tumor activity and tolerability compared to enfortumab-vedotin (EV) in head-to-head in vitro and in vivo studies. Our data impressively show that the Araris ADC has superior efficacy and durable anti-tumor response even at 3-fold lower payload dose compared to EV. The improved efficacy in mice and tolerability in rates resulted in a 8-fold better TI for the Araris ADC and offers the opportunity to develop a highly efficacious ADC having potentially lower dose-limiting toxicities such as peripheral neuropathy, rashes or neutropenia."

Clinical • Late-breaking abstract • Breast Cancer • Oncology • Solid Tumor • CTSB • NECTIN4

Araris Biotech AG Acquires ARS Pharmaceutical’s Nectin-4 Antibody (GlobeNewswire) - "Araris Biotech AG...announced the execution of an asset purchase agreement for the acquisition of ARS Pharmaceutical’s Nectin-4 antibody. The antibody was initially developed as part of an immune stimulating ADC by Silverback Therapeutics prior to its merger with ARS. Araris intends to use the antibody in the development of a differentiated Nectin-4 ADC using its proprietary linker technology to broaden its ADC pipeline....Under the terms of the agreement Araris will acquire ARS’ antibody against Nectin-4. The deal enables Araris to combine its proprietary linker technology with ARS’ GLP-tox ready Nectin-4 antibody, in order to develop targeted ADC therapeutics, with various linker-payloads, for the treatment of solid tumors of high unmet medical need."

Licensing / partnership • Oncology • Solid Tumor

Araris Biotech AG Presents Preclinical Data Highlighting Stable and Efficacious Low Drug-Load ADCs at American Association for Cancer Research (AACR) Annual Meeting 2023 (GlobeNewswire) - "The presentations will highlight late-breaking preclinical data on anti-Nectin-4 and anti-HER2 ADCs generated using the company’s proprietary linker technology. Both ADCs demonstrated improved anti-tumor activity compared to respective FDA approved ADCs in head-to-head in-vivo studies....Using a breast cancer model, Araris’ ADC demonstrated a complete tumor regression lasting for more than 100 days. EV administered at the same payload dose showed only a short and transient (20 day) tumor regression with no animal reaching a complete response."

Preclinical • Oncology

Araris Biotech AG to Present Preclinical Data at American Association for Cancer Research (AACR) Annual Meeting 2023 (GlobeNewswire) - "Araris Biotech AG...announced it will be presenting two late-breaking abstracts during the American Association for Cancer Research (AACR) Annual Meeting to be held April 14-19, 2023 at the Orange County Convention Center in Orlando, Florida."

Late-breaking abstract • Preclinical • Oncology

Inducing Complete and Long-Lasting Tumor Eradications of a Nectin-4 ADC Generated with a Novel Peptide Linker Technology (PEGS 2022) - No abstract available

Oncology • NECTIN4

Inducing complete and long-lasting tumor eradications at safe and well tolerated doses of a nectin-4 ADC generated with novel peptide linkers for payload conjugation (AACR 2022) - "Here, we generated an anti-Nectin-4 ADC that shows superior activity to enfortumab-vedotin (Padcev®, EV) in head-to-head in vitro and in vivo studies. Our data impressively show that the Araris ADC has superior efficacy even at least 3x lower payload dose compared to EV which are normally needed to achieve complete tumor remission. The very high efficacy even at low dose levels combined with the high plasma stability offer the opportunity to develop an ADC having potentially lower dose-limiting toxicities such as peripheral neuropathy, skin toxicity or neutropenia."

Late-breaking abstract • Breast Cancer • Oncology • Solid Tumor • CTSB • NECTIN4

Araris Biotech AG Presents Preclinical Data Highlighting Anti-CD79b ADC Program and Late-Breaking Data on Nectin-4 ADC at the American Association for Cancer Research (AACR) 2022 Annual Meeting (GlobeNewswire) - "Araris Biotech AG...announced the company will deliver a poster presentation and an oral presentation at this year’s American Association for Cancer Research (AACR) 2022 Annual Meeting, being held April 8-13, 2022, in New Orleans, Louisiana. The poster presentation highlights the company’s anti-CD79b antibody-drug conjugate (ADC) and the oral presentation, taking place during the conference’s minisymposium, will highlight late-breaking data on a Nectin-4 ADC generated using the company’s proprietary linker technology."

Late-breaking abstract • Preclinical • Oncology

Araris Biotech AG to Present Preclinical Data at American Association for Cancer Research (AACR) Annual Meeting 2022 (GlobeNewswire) - "Araris Biotech AG...announced the company will be presenting a scientific poster, as well as presenting preclinical data at the Minisymposium during the American Association for Cancer Research (AACR) Annual Meeting 2022....The poster will highlight preclinical data from Araris’ anti-CD79b antibody-drug conjugate (ADC) program, and the company will also present data on a Nectin-4 ADC."

Preclinical • Oncology