Arbutus Announces FDA Clinical Hold is Lifted on IND Application for AB-101, an Oral PD-L1 Inhibitor

WARMINSTER, Pa., Oct. 22, 2026 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS) (“Arbutus” or the “Company”), a clinical-stage biopharmaceutical company focused on infectious disease, today announced that the Company was notified by the U.S. Food and Drug Administration (“FDA”) that the clinical hold on the Investigational New Drug (“IND”) application for AB-101 has been removed and that the Company may engage in additional clinical development for AB-101 in the United States. Arbutus is evaluating next steps for the continued development of AB-101.

AB-101 is a proprietary oral PD-L1 inhibitor that has the potential to activate patients’ hepatitis B virus (“HBV”)-specific immune response by inhibiting PD-L1. AB-101 has completed a Phase 1a/1b clinical trial (AB-101-001) evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of single- and multiple-ascending oral doses in healthy subjects and patients with chronic HBV (“cHBV”) infection. The data from healthy subjects in Parts 1 and 2 and cHBV patients in Part 3 of this clinical trial have shown that AB-101 was generally well-tolerated with evidence of high receptor occupancy in seven cHBV patients and hepatitis B surface antigen decline in two cHBV patients at the 30mg dose.