AB-101 / Arbutus - LARVOL DELTA

In a Phase 1a/1b clinical trial, AB-101, an oral PD-L1 inhibitor, has shown to be generally safe and well-tolerated with evidence of high receptor occupancy and no liver dysfunction in cHBV patients (GlobeNewswire) - P1 | N=164 | NCT05960240 | Sponsor: Arbutus Biopharma Corporation | "Also at EASL, Arbutus presented posters with pre-clinical and clinical data on AB-101, including Part 3 data from its Phase 1a/1b clinical trial, AB-101-001. Data from the first cohort of cHBV patients in Part 3 showed that once daily dosing of 10mg of AB-101 for 28 days was well tolerated, with PD-L1 receptor occupancy similar to that observed in healthy volunteers who received multiple doses of AB-101 10mg once daily. Importantly, there were no immune related adverse events reported in healthy volunteers or patients thus far, and no evidence of liver dysfunction."

P1 data • Hepatitis B

Preliminary safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of AB-101, a small-molecule PD-L1 inhibitor, in healthy and chronic hepatitis B subjects (EASL 2025) - P1 | "Single doses of AB-101 up to 40 mg and repeat doses up to 40 mg QD for 7 days were well tolerated in healthy subjects. Preliminary PD data shows AB-101 RO at doses ≥ 10 mg, with dose- related increases in RO observed. Dosing in Part 3 in CHB subjects is ongoing and available data, including RO and HBV virologic biomarkers, will be presented."

Clinical • IO biomarker • PK/PD data • Hepatitis B • Hepatitis C • Hepatology • Infectious Disease • Inflammation • PD-1

First-in-human pharmacokinetics and pharmacodynamics of oral small-molecule PD-L1 inhibitor AB-101 and correlation to preclinical models (EASL 2025) - "AB-101 was safe and well-tolerated in both single- and multiple-dose administrations in healthy subjects. Dose-responsive increases in RO were observed in peripheral blood cells, which correlated with dose-dependent increases in AB-101 plasma concentrations. The clinical plasma PK profile of AB-101 to date indicates rapid distribution into tissues, mirroring the plasma profiles seen in preclinical efficacy models, which exhibited high liver biodistribution and target engagement."

P1 data • PK/PD data • Preclinical • Hepatitis B • Hepatitis C • Hepatology • Infectious Disease • Oncology • PD-1

Arbutus to Present Imdusiran and AB-101 Data at EASL Congress 2025 (GlobeNewswire) - "Arbutus Biopharma Corporation...announced that five abstracts, including one late-breaker, have been accepted for presentation at the European Association for the Study of the Liver (EASL) Congress 2025 taking place May 7 - 10, 2025 in Amsterdam, Netherlands."

Clinical data • Hepatitis B

Safety, Tolerability, PK & PD of AB-101 Following Oral Administration in Healthy and CHB Subjects. (clinicaltrials.gov) - P1 | N=164 | Recruiting | Sponsor: Arbutus Biopharma Corporation | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Arbutus Announces Pipeline Updates and Dosing of the First Subject in the Phase 1a/1b Clinical Trial with AB-101; Cash Runway Extended (GlobeNewswire) - "The Company remains on track to report preliminary data in the fourth quarter of this year from the Phase 2a clinical trial with imdusiran and Vaccitech’s VTP-300 in patients with cHBV. In addition, the Company has dosed the first subject in its Phase 1a/1b clinical trial with its oral PD-L1 inhibitor, AB-101, for HBV and expects preliminary data in the first half of 2024."

P1 data • P2a data • Trial status • Hepatitis B

Safety, Tolerability, PK & PD of AB-101 Following Oral Administration in Healthy and CHB Subjects. (clinicaltrials.gov) - P1 | N=164 | Not yet recruiting | Sponsor: Arbutus Biopharma Corporation

New P1 trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Design and optimization of small molecules targeting the PD-1:PD-L1 immune checkpoint axis (ACS-Fall 2023) - "Compound A was profiled in vivo in a MC38 mouse tumor model and demonstrated comparable efficacy to the αPD-L1 antibody atezolizumab when dosed for 7 days at 10 mg/kg once daily. These preclinical results suggest that small-molecule inhibition of PD-L1 is a promising avenue to pursue for developing effective oncology and CHB immune therapies. Further optimization leading to the discovery of the clinical candidate AB-101 will be reported in due course."

Hepatitis B • Hepatology • Immune Modulation • Infectious Disease • Oncology • Solid Tumor • PD-1

Artiva Biotherapeutics Presents Initial Data from First-in-Human Phase 1/2 Clinical Trial of AB-101 at the 2023 ASCO Annual Meeting (Businesswire) - P1/2 | N=93 | NCT04673617 | Sponsor: Artiva Biotherapeutics, Inc. | "Initial activity observed in combination therapy of one billion cells per dose with rituximab; majority of responses were observed in patients who had previously failed autologous CAR-T cell therapy; AB-101 was well tolerated at up to four billion cells per dose as a monotherapy; up to 16 doses of AB-101 at one billion cells per dose were successfully administered in combination with rituximab in an outpatient setting; No observations of ICANS or GvHD; two patients (8%) had AEs of CRS, based on Grade 1 fevers which resolved within five to 24 hours without the usage of steroids and/or tocilizumab; Enrollment at highest dose level of four billion cells per dose in combination with rituximab to begin in June."

P1/2 data • Trial status • Oncology

Artiva Announces Abstract Accepted for Presentation at the 64th American Society of Hematology Annual Meeting & Exposition (Businesswire) - "Artiva Biotherapeutics, Inc...announced today the presentation of preclinical efficacy data combining anti-CD38 antibodies with AB-101, the Company’s clinical-stage ADCC-enhancer product candidate, in multiple myeloma models....The data to be presented highlight the naturally low expression of CD38 and high and consistent expression of CD16 on AB-101, enabling its use with anti-CD38 antibodies for enhanced ADCC activity without the requirement for CD38 editing."

Preclinical • Hematological Malignancies • Multiple Myeloma • Oncology

Arbutus Announces 2022 Corporate Objectives and Provides Financial Update (GlobeNewswire) - "Summary of 2022 Anticipated Key Milestones:...Announce preliminary AB-729 data in the second half of 2022 from the following three on-going Phase 2a proof-of-concept clinical trials in patients with chronic hepatitis B (HBV) infection:...Initiate a triple combination Phase 2a proof-of-concept clinical trial in the first half of 2022 to evaluate AB-729, combined with VTP-300, Vaccitech’s therapeutic vaccine, and a NA. Present at a medical conference the long-term on- and off-treatment follow-up data from our Phase 1a/1b clinical trial evaluating multiple doses and dosing schedules of AB-729. Announce data from our Phase 1a/1b clinical trial evaluating AB-836 in patients with chronic HBV in the first half of 2022. Complete IND-enabling studies with our oral PD-L1 inhibitor compound, AB-101, in the second half of 2022. Complete IND-enabling studies for AB-161, our next-generation oral HBV specific RNA destabilizer, in the second half of 2022."

New P2a trial • P1 data • P2a data • Preclinical • Hepatitis B • Infectious Disease

Novel Immunotherapy Combos Target TIM-3 and PD-1/PD-L1 Networks (OncLive) - "'The theory here is that you can overcome I/O [immuno-oncology] resistance with a combination of a TIM-3 antibody with a PD-1/PD-L1 antibody,' Fred R. Hirsch, MD, PhD, said during the program....Findings from a meta-analysis published in Frontiers in Oncology in August 2020 illustrate the prognostic impact of TIM-3 expression, according to Hirsch....Paul A. Bunn Jr, MD, who served as moderator for the OncLive program, wondered about the rationale for not testing the combination in upfront settings, where the regimen might be more effective. He also questioned whether a patient who progressed on ICI therapy would respond to repeat administration of an ICI with an added therapy."

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