ARC-02 / Otsuka, Araris Biotech, Taiho - LARVOL DELTA

Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Clinical Activity of the Antibody-Drug Conjugate ARC-02 as Monotherapy and in Combination With Rituximab in Adults With B-Cell Non-Hodgkin's Lymphoma (SOHO 2026) - "The anti-CD79b antibody-drug conjugate (ADC) polatuzumab vedotin is indicated for treatment of aggressive high-grade lymphomas but not other B-cell NHLs. These data will inform the recommended phase 2 dose of ARC-02 monotherapy or in combination with rituximab. CD: cluster of differentiation."

ADC • Clinical • Combination therapy • First-in-human • Monotherapy • P1 data • PK/PD data • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD79B

ABLATE-101: A Study of ARC-02 in B-cell NHL (clinicaltrials.gov) - P1 | N=140 | Recruiting | Sponsor: Taiho Oncology, Inc.

New P1 trial • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Araris Biotech AG and Taiho Oncology Announce Dosing of First Patient in Phase 1 Trial of ARC-02, a Novel ADC for the Treatment of Non-Hodgkin Lymphoma (Businesswire)

Trial status • Non-Hodgkin’s Lymphoma

Taiho Oncology, Taiho Pharmaceutical and Araris Biotech AG Advance ADC ARC-02 into Phase 1 Clinical Development (Businesswire) - "Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Araris Biotech AG...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....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."

IND • New P1 trial • Non-Hodgkin’s Lymphoma

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

Araris Biotech AG to Present at the 22nd Annual PepTalk: Protein Science and Production Week (GlobeNewswire) - "Araris Biotech AG...announced that Bernd Schlereth, Ph.D., chief development officer, will deliver an oral presentation at the 22nd annual PepTalk: Protein Science and Production Week being held January 16- 20, 2023 in San Diego....ARC-02 demonstrated potent cytotoxicity in three different non-Hodgkin Lymphoma (NHL) cell lines, with similar potency to Polivy^® despite ARC-02’s having a lower drug load; ARC-02 was more stable than Polivy^® in mouse, monkey and human sera and demonstrated no payload deconjugation or linker cleavage under physiological conditions during an incubation of 2 weeks; Single dose treatment of ARC-02 induced effective and long-lasting tumor responses at 3-4x lower payload dose compared to Polivy^® in NHL tumor models; In vivo pharmacokinetic studies in mice, rats and monkeys demonstrated an antibody-like exposure profile of the ADC with no premature toxin loss in circulation."

Preclinical • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology