GS-4774 / GlobeImmune - LARVOL DELTA

[VIRTUAL] CLONAL AMPLIFICATION OF PERIPHERAL B AND T CELLS IS ASSOCIATED WITH CLINICAL RESPONSE TO CHECKPOINT BLOCKADE IN CHRONIC HEPATITIS B (AASLD 2020) - " CHB subjects were treated with a single dose of the PD-1 inhibitor nivolumab with or without the vaccine GS-4774. These results suggest a pronounced peripheral baseline Tn and Tscm signal may be associated with clinical response to checkpoint blockade in CHB. On-treatment expansion of peripheral B and T cell clones may also inform treatment outcome."

Checkpoint inhibition • Clinical • IO biomarker • Hepatitis B • Hepatology • Infectious Disease • CD8

[VIRTUAL] Characterization of the HBV-specific T cell pool reveals shared epitope usage but different phenotypes of HBV-reactive T cells across patients (EASL-ILC-I 2020) - " Baseline and on-treatment PBMC samples from GS-US-330-1401, a study designed to evaluate the safety and efficacy of the T-cell vaccine GS-4774 in combination with Tenofovir Disoproxil Fumarate (TDF) in patients with chronic HBV infection were investigated by high-dimensional immune profiling. The sensitivity and robustness of our antigen-specific T cell identification methodology enabled us to detect and profile rare HBV-specific CD8+ T cells in a pilot trial cohort. The donor- dependent epitope reactivity and HBV-specific T cell phenotype provide insight into patient clinical history and/or outcome and may be leveraged as a biomarker to guide future HBV treatment strategies."

Clinical • IO Biomarker • Hepatitis B • Infectious Disease • CD8

Long Term Follow-up Registry Study of Individuals Treated in A Gilead-Sponsored Trial With Chronic Hepatitis B Infection (clinicaltrials.gov) - P=N/A; N=500; Not yet recruiting; Sponsor: Gilead Sciences

New trial • Biosimilar • Immunology • Oncology

Combined GS-4774 and Tenofovir Therapy can Improve HBV-Specific T-Cell Responses in Patients with Chronic Hepatitis. (PubMed, Gastroenterology) - P2; "In a phase 2 study of patients with chronic HBV infection given TDF with or without GS-4774, we found that vaccination can increase production of IFNG, TNF, and IL2 by CD8+ T cells exposed to antigenic peptides, with little effect on CD4+ T cells. Although GS-4774 did not reduce levels of HBsAg in patients, its strong immune stimulatory effect on CD8+ T cells might be used in combination with other antiviral agents to boost the anti-virus immune response. Clinicaltrials.gov no: NCT02174276."

Clinical • Journal

Anti-PD-1 Blockade with Nivolumab with and without Therapeutic Vaccination for Virally Suppressed Chronic Hepatitis B: A Pilot Study. (PubMed, J Hepatol) - "In virally suppressed HBeAg-negative patients, checkpoint blockade was well-tolerated and led to HBsAg decline in most patients and sustained HBsAg loss in one patient. Australian New Zealand Clinical Trials Registry (http://www.anzctr.org.au/) number: ACTRN12615001133527."

Clinical • Journal