COVID-19 has been a real leveler in competitor terms; once warring Big Pharmas have joined forces for the greater good on vaccines, both in R&D and more recently on production, and now on treatments.
Today, Lilly penned a deal with GlaxoSmithKline and biotech partner Vir for its emergency-cleared COVID-19 antibody bamlanivimab 700 mg to be tested in a trial with GSK/Vir’s experimental therapy VIR-7831 (aka GSK4182136) 500 mg.
This isn't however, a combo trial: GSK told Fierce Biotech that the two drugs are being given to patients together in one of the arms, but as 2 separate infusions.
The hope is that in the so-called Blaze-4 trial, which has been expanded to accommodate the second med, will see the two neutralizing antibodies that bind to different epitopes of the SARS-CoV-2 spike protein create better potency and make the virus less likely to evade, especially with new variants.
This is the first time that monoclonal antibodies from separate companies will be brought together in this way.
Bamlanivimab is a neutralizing antibody directed against the spike protein of SARS-CoV-2 designed to block viral attachment and entry into human cells, thus neutralizing the virus. Late last year, it nabbed an FDA emergency authorization in mild to moderate COVID-19 in patients who are at high risk for progressing to severe COVID-19 and/or hospitalization.
It has, like rival Regeneron which has its own cocktail antibody therapy authorized, struggled to get this therapy to patients across the U.S., and with vaccines now coming in full force, its already limited use will likely further diminish. It’s also contending with new viral variants that could also lessen the impact of the antibody.
This is one reason for tapping VIR-7831, which works as a dual-action monoclonal antibody that was “selected for clinical development based on its potential to both block viral entry into healthy cells and clear infected cells, as well as its potential to provide a high barrier to resistance,” Lilly said in a joint statement.
In early preclinical trials, it showed it could bind to an epitope on SARS-CoV-2 shared with SARS-CoV-1, indicating that the epitope is highly conserved, which may make it more difficult for escape mutants to develop.
If it can work alongside Lilly’s med and work against new variants with all involved, including the federal government, able to help get patients to these infused therapies better, it could help lower deaths and severe disease. The Blaze-4 trial will run to tell us exactly that.
Just this week, Lilly said in a release (and with thin details) that its internal antibody cocktail bamlanivimab-etesevimab slashes deaths and hospitalizations in high-risk 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,” said George Scangos, Ph.D., CEO of Fierce 15 winner Vir.
“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.”