Arbutus Announces 2024 Corporate Objectives and Provides Financial Update

Additional data from two on-going Phase 2a clinical trials evaluating imdusiran, our RNAi therapeutic, as a cornerstone therapy in combination with other compounds expected in 2024

Initiation of a third Phase 2a clinical trial evaluating imdusiran and an approved PD-L1 monoclonal antibody expected in 1H 2024

Preliminary data from a Phase 1a/1b clinical trial with AB-101, our oral PD-L1 inhibitor, expected in 1H 2024

Claim construction hearing for Moderna LNP litigation scheduled for February 8, 2024

Strong financial position; cash runway into Q1 2026

WARMINSTER, Pa., Jan. 08, 2024 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS) (“Arbutus” or the “Company”), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop a cure for people with chronic hepatitis B virus (cHBV) infection, today announced its 2024 business outlook including its clinical development milestones to advance its HBV pipeline and a financial update.

“As we enter 2024, our strong balance sheet and anticipated clinical trial readouts position us well towards achieving our mission of developing a functional cure for patients with cHBV,” said Michael J. McElhaugh, Interim President and Chief Executive Officer of Arbutus Biopharma. “Our Phase 2a program for imdusiran, our RNAi therapeutic, consisting of three separate trials, reinforces the potential role of imdusiran as a cornerstone in a treatment regimen to functionally cure patients with cHBV. Additionally, AB-101, our oral PD-L1 inhibitor, continues to progress and we look forward to preliminary data from the ongoing Phase 1a/1b clinical trial. We remain committed to continuing discovery research in HBV and we are confident that we have the talent and resources to execute our mission.”

2024 Clinical Development Milestones

Imdusiran (AB-729, RNAi Therapeutic)    

• AB-729-201 is a Phase 2a clinical trial that is evaluating the safety, tolerability and antiviral activity of the combination of imdusiran, nucleos(t)ide analogue (NA) therapy and pegylated interferon alfa-2a (IFN) in patients with cHBV. Preliminary data presented at the EASL Congress in June 2023 suggest that the addition of IFN to imdusiran was generally well-tolerated and appears to result in continued HBsAg declines in some patients. Arbutus plans to announce end-of-treatment data from this trial in the first half of 2024. 
• AB-729-202 is a Phase 2a clinical trial that is evaluating the safety and immunogenicity of imdusiran, NA therapy and Barinthus Bio’s (formerly Vaccitech plc) VTP-300, an HBV antigen-specific immunotherapy.  Preliminary data presented at AASLD – The Liver Meeting in November 2023 showed that the combination of imdusiran and VTP-300 provided a meaningful reduction of HBsAg levels that are maintained well below baseline. In addition, a subset of patients given imdusiran and then VTP-300 showed early signs of immune activation. Arbutus plans to announce end-of-treatment data from this portion of the trial in the first half of 2024.
• AB-729-202 was amended to include an additional cohort of 20 patients who will receive imdusiran plus NA therapy for 24 weeks followed by VTP-300 plus up to two low doses of nivolumab, an approved anti-PD-1 monoclonal antibody. Enrollment is complete in this additional cohort with preliminary data expected in the second half of 2024.   
• AB-729-203 is a Phase 2a clinical trial that will initiate in the first half of 2024 and will evaluate the safety, tolerability and antiviral activity of intermittent low doses of durvalumab, an approved PD-L1 monoclonal antibody in combination with imdusiran and NA therapy.

AB-101 (Oral PD-L1 Inhibitor)