Vir Biotechnology, Inc. ( VIR Quick Quote VIR - Free Report) along with its partner GlaxoSmithKline ( GSK Quick Quote GSK - Free Report) announced that NHS-supported clinical study on their second coronavirus therapeutic candidate, VIR-7832, is expected to begin in the first quarter of 2021. The companies inked an agreement with U.K.-based AGILE initiative to evaluate the candidate in a phase Ib/IIa AGILE study.
Please note that Vir Biotech and Glaxo are developing another monoclonal antibody candidate, VIR-7831 as a potential treatment of COVID-19 in late-stage studies. Pre-clinical data suggest that both candidates may function as a therapeutic and/or prophylactic T cell vaccine.
Shares of Vir Biotech were up 13.4% on Jan 12 following the announcement. In fact, the stock has gained 120.3% in the past year compared with the
industry’s increase of 8.5%.
The AGILE study will evaluate VIR-7832 and VIR-7831 in adult outpatients with mild-to- moderate COVID-19 infection. The phase Ib part of the study will evaluate a single administration of VIR-7832 and determine the dose for evaluation in the phase IIa part. The three-arm phase II part will evaluate VIR-7832, VIR-7831, and placebo for co-primary endpoints of safety and virologic activity and T cell responses to SARS-CoV-2.
We note that VIR-7831 is being developed as an early treatment for COVID-19 patients who are at a high risk of hospitalization in the phase II/III COMET study and for the treatment of hospitalized adults with COVID-19 in the National Institutes of Health-led phase III ACTIV-3 study. Top-line data from the COMET study is expected later this quarter.
The companies also have plans to develop VIR-7831 as the prophylaxis or prevention of symptomatic COVID-19 infection. A study is expected to start in the first quarter.
Vir Biotech in collaboration with
Alnylam Pharmaceuticals ( ALNY Quick Quote ALNY - Free Report) is developing a pre-clinical candidate, VIR-2703, as an inhaled SARS-CoV-2-targeting therapeutic.
In a separate press release, Vir Biotech announced that it has entered into a collaboration agreement with
Gilead Sciences ( GILD Quick Quote GILD - Free Report) to evaluate a novel immunomodulation and antigen suppression combination regimen for treating chronic hepatitis B virus. The companies are planning to start a phase II study to evaluate a combination of Vir Biotech’s VIR-2218, Gilead’s selgantolimod and a PD-1 antagonist in previously-treated as well as treatment-naïve HBV patients. The primary endpoint of the study will be proportion of patients achieving function cure as measured by off-therapy loss of hepatitis B surface antigen (HBsAg) and HBV DNA from the serum.
Future development path for this combination regimen will be based on data readout from this study. Meanwhile, both companies will retain rights to their individual candidates.
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