VIR/GILD addendum—I suspect the long delay in starting the phase-2 trial was procedural (i.e. not a lack of interest by the sponsors). Specifically, it may have taken some time to get the FDA’s buy-in on combining the four agents being tested in the trial.
In 2022, the Company expects data readouts from multiple trials evaluating VIR-2218 and VIR-3434:
• Initial data from the first cohorts of Phase 2 MARCH (Monoclonal Antibody siRNA Combination against Hepatitis B) trial of VIR-2218 in combination with VIR-3434, are expected in the first half of 2022.
• Additional data from the Phase 2 trial of VIR-2218 in combination with PEG-IFN-alpha are expected in the first half of 2022.
• Additional data from the Phase 1 monotherapy trial of VIR-3434 are expected in the first half of 2022.
• The Company’s collaborator, Brii Biosciences, continues to lead the Phase 2 trial evaluating VIR-2218 in combination with BRII-179, an investigational T cell vaccine, for the potential treatment of chronic HBV infection. Initial data are expected in the second half of 2022.
Evidently, there will not be a 2022 readout from the phase-2 trial testing combinations of VIR-2218, GILD’s GS-9688, Vemlidy (TAF), and Opdivo (#msg-167061759, #msg-160854272, #msg-167063133).