DewDiligence
2 years ago
VIR -14% on amended Sotrovimab EUA due to Omicron BA.2 variant:
https://finance.yahoo.com/news/us-food-drug-administration-revises-200400156.html GlaxoSmithKline plc and Vir Biotechnology…today announced that the US Food and Drug Administration has amended the Emergency Use Authorization (EUA) Fact Sheet for sotrovimab, an investigational monoclonal antibody. The FDA has determined that, based on the totality of available evidence, including new live virus data generated by Vir, it is unlikely that the sotrovimab 500 mg dose will be effective against the Omicron BA.2 variant.
GSK and Vir are preparing a package of data in support of a higher dose of sotrovimab for the Omicron BA.2 subvariant and will be sharing these data with regulatory and health authorities around the world for discussion. This PR was issued after the close, but the market apparently got wind of the FDA decision about 3:45pm ET.
DewDiligence
2 years ago
VIR 4Q21 results:
https://www.globenewswire.com/news-release/2022/02/24/2391890/0/en/Vir-Biotechnology-Provides-Corporate-Update-and-Reports-Fourth-Quarter-and-Full-Year-2021-Financial-Results.html As of December 31, 2021, excluding restricted cash, the Company had approximately $909.5 million in cash, cash equivalents, and investments. Excluding restricted cash and its equity investment in Brii Biosciences, the Company had approximately $766.4 million in cash, cash equivalents and investments.
DewDiligence
2 years ago
VIR’s 2022 HBV newsflow:
https://www.globenewswire.com/news-release/2022/02/24/2391890/0/en/Vir-Biotechnology-Provides-Corporate-Update-and-Reports-Fourth-Quarter-and-Full-Year-2021-Financial-Results.html 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).
DewDiligence
3 years ago
VIR starts HBV_combination_trial_of_ VIR-2218 and VIR-3434:
https://finance.yahoo.com/news/vir-biotechnology-initiates-phase-2-123000780.html The multi-center, open-label Phase 2 trial is designed to evaluate the safety, tolerability and efficacy of the combination of VIR-2218 and VIR-3434 in approximately 90 adult patients (ages 18 to 65) with chronic HBV infection receiving nucleot(s)ide reverse transcriptase inhibitor therapy. Both VIR-2218 and VIR-3434 will be administered via subcutaneous injection at varying dose levels over the course of the trial for a treatment period ranging from four to 20 weeks, and a follow-up period of up to 116 weeks, depending on the dosing cohort.
…VIR-2218 is an investigational small interfering ribonucleic acid (siRNA) designed to inhibit the production of all HBV proteins (X, polymerase, S and core), which may be acting as immune tolerogens. VIR-3434 is an investigational HBV-neutralizing monoclonal antibody designed to block entry of all 10 genotypes of HBV into hepatocytes, as well as reduce the level of virions and subviral particles in the blood. It has also been Fc engineered to include the XX2 “vaccinal mutation,” allowing it to potentially function as a therapeutic T cell vaccine against HBV. See #msg-164593550, #msg-161217289, and #msg-164599741 for related info.
DewDiligence
3 years ago
GILD, VIR collaborate on phase-2 HBV trial:
https://www.businesswire.com/news/home/20210112005578/en The companies plan to initiate a Phase 2 trial evaluating combination therapy for both treatment-experienced and treatment-naïve people living with HBV. The multi-arm trial will evaluate different combinations of selgantolimod, Gilead’s investigational TLR-8 agonist; VIR-2218, Vir’s investigational small interfering ribonucleic acid (siRNA); and a commercially-sourced, marketed PD-1 antagonist. People in the trial with HBV treatment experience may also receive Gilead’s Vemlidy (tenofovir alafenamide fumarate, TAF). The primary outcome of the study will be the proportion of patients achieving a functional cure, defined as an off-therapy loss of hepatitis B surface antigen (HBsAg) and HBV DNA from the serum.
Both companies retain full rights to their individual product candidates and will discuss the potential path forward for any future combination studies based on the outcome of the Phase 2 trial. I.e., no cash is changing hands between the two companies.
DewDiligence
4 years ago
VIR reports interim phase-2 data in HBV:
https://finance.yahoo.com/news/vir-2218-demonstrates-dose-dependent-200110652.html Vir Biotechnology today announced additional interim data from the ongoing Phase 2 trial… of VIR-2218, an investigational small interfering ribonucleic acid (siRNA) that mediates RNA interference (RNAi) for the treatment of chronic hepatitis B virus (HBV) infection.
…In the ongoing Phase 2 trial, virally suppressed patients on nucleos(t)ide reverse transcriptase inhibitor therapy (n=24) received two subcutaneous 20, 50, 100, or 200 mg doses of VIR-2218 on Day 1 and Day 29. At Week 24, the mean change in HBsAg observed with 20, 50, 100, and 200 mg was -0.76 log10, -0.93 log10, -1.23 log10, and -1.43 log10, respectively [a nice dose response].
Of note, all patients who received the 200 mg dose level achieved a >=1 log10 reduction in HBsAg, with HBeAg- and HBeAg+ patients achieving similar mean declines. There has been no dose-related trend in the frequency of AEs observed during the trial, with the most common AE being headache (n=6; 25%). No patients discontinued the trial due to an AE.
…“Our next step will be to demonstrate whether knockdown of HbsAg can result in high rates of functional cure when VIR-2218 is given in combination with other agents, which is the goal of our next set of trials. We expect the first of those combination trials—combining VIR-2218 with a shortened course of pegylated interferon—to begin dosing patients in the second half of this year.” VIR-2218 incorporates ALNY’s ESC+ siRNA technology, which VIR claims is a differentiating factor for VIR-2218 compared to other RNAi-based programs in HBV.
CC slides for the above data:
https://investors.vir.bio/static-files/48b8fe3c-79cb-4a80-85e9-ba1f14682abd
VIR is flattish in AH trading, but this doesn’t mean much vis-à-vis the HBV data presented above; lately, VIR has been trading as a COVID-19 play.