Vir Biotechnology, Eli Lilly and GlaxoSmithKline struck a three-way collaborative deal to evaluate Vir’s investigational monoclonal antibody, VIR-7831, in combination with Lilly’s bamlanivimab in low-risk patients with mild to moderate COVID-19.
Eli Lilly expanded its ongoing BLAZE-4 study to include Vir’s monoclonal antibody in the trial. Eli Lilly’s bamlanivimab, a neutralizing antibody initially developed by AbCellera, was approved for emergency use authorization in November by the U.S. Food and Drug Administration to treat mild-to-moderate COVID-19 patients. Data published last week showed that bamlanivimab significantly reduced COVID-19 risk for nursing home residents in a Phase III trial.
Vir and GSK were already partnered on the development of VIR-7831, a dual-action monoclonal antibody that is currently being assessed in multiple Phase III studies. Pre-clinical data showed the antibody can neutralize the virus by binding to an epitope on SARS-CoV-2 shared with SARS-CoV-1. That ability indicates that the epitope is highly conserved, which may make it more difficult for escape mutants to develop, the companies said. It’s believed that Vir’s monoclonal antibody has the potential to both block viral entry into healthy cells and clear infected cells.
Eli Lilly’s bamlanivimab targets different sites on the SARS-CoV-2 spike protein. The belief of the companies is the combination of the two dual-action monoclonal antibodies has the potential to treat both current and future strains of novel coronavirus. This is the first time monoclonal antibodies from separate companies will be brought together to explore potential outcomes.
Vir Chief Executive Officer George Scangos said they believe VIR-7831 has significant potential as a single agent and noted the company is optimistic about pending interim data from two Phase III studies evaluating its potential for early treatment and in hospitalized patients.
“As the virus continues to evolve, we, along with Lilly and GSK, share the view that we should pursue all possibilities to help end the pandemic and maximize the number of lives that can be saved. This trial is a first step to assess whether the administration of VIR-7831, with its high barrier to resistance and potent effector function, alongside bamlanivimab, which has strong outcomes data in early treatment, can provide potential benefits beyond monotherapy,” Scangos said in a statement.
Daniel Skovronsky, Lilly’s chief scientific officer and president of Lilly Research Laboratories, said the emergence of new variants of the virus calls for new strategies even while vaccination is ongoing in many parts of the world.
“With a virus like SARS-CoV-2, it’s expected that variants could emerge that require new therapeutic options, which is why Lilly is studying bamlanivimab together with other neutralizing antibodies, including etesevimab. Adding VIR-7831 to our study is an important part of our commitment to develop therapies to treat current and future strains of COVID-19 until vaccines are widely available and utilized,” Skovronsky said in a statement.
VIR-7831 is also being evaluated in the global Phase II/III COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early) trial for the early treatment of COVID-19 in adults at high risk of hospitalization.
In addition to the COVID-19 partnership with Eli Lilly, this week Vir announced initial topline data from its ongoing Phase I trial of VIR-3434 in patients with chronic hepatitis B virus. Data from the first blinded cohort of eight patients, two of whom received placebo and six of whom received a single dose of 6 mg of VIR-3434, showed that six of eight patients achieved a mean reduction of 1.3 log10 IU/mL in serum hepatitis B virus surface antigen (HBsAg) by day eight, the day when nadir was achieved in most patients. VIR-3434 is an HBV-neutralizing monoclonal antibody designed to block entry of all 10 genotypes of HBV into hepatocytes and reduce the level of virions and subviral particles in the blood.
Phillip Pang, Vir’s chief medical officer, was pleased with the outcome and looks forward to seeing the continued capabilities of the monoclonal antibody.
“Extrapolating from our preclinical data, we expected it might require much higher doses of VIR-3434 to achieve this level of HBsAg knockdown. To have achieved it with a dose of 6 mg is unexpected. I am hopeful that we are seeing just the beginning of VIR-3434’s capabilities,” Pang said in a statement.
