- Eli Lilly, Vir Biotechnology and GlaxoSmithKline will team up in an unusual alliance to evaluate two of their COVID-19 antibody drugs together as a combination treatment.
- A planned trial will test Lilly's antibody drug bamlanivimab with Vir's medicine VIR-7831 in mild to moderate COVID-19 patients at "low risk" of disease progression. Though Lilly already has a two-drug regimen under review by the Food and Drug Administration, Vir's drug works differently. Lilly said it aims to develop drugs for "current and future strains of COVID-19."
- The alliance is part of a growing push by drugmakers to deal with new coronavirus variants emerging across the world. Antibody drug combinations, which bind to multiple different parts of the coronavirus, could be a key part of that effort. Regeneron said Wednesday, for instance, that its two-drug combination appeared effective in laboratory tests against variants that originated in the U.K., Brazil and South Africa.
When COVID-19 antibody therapies were first being developed last year, drugmakers faced an important strategic decision: should they make one antibody, or a cocktail of two or three?
There are advantages and drawbacks to each approach. A single antibody is easier to make in large quantities, and doses can be ramped up to higher levels. But a cocktail includes more ways to attack a pathogen, helping to account for potential viral mutations.
Fast forward nearly a year later and both a single antibody from Lilly and a two-drug cocktail from Regeneron are cleared for use in COVID-19 patients at "high risk" of becoming hospitalized. And both have shown an ability to prevent or treat the disease. But the combination approach has proven particularly important. New, more infectious coronavirus variants have emerged with mutations that could weaken antibody efficacy.
Lilly has already warned that a variant that originated in South Africa — which has several changes to the virus' spike protein — may evade bamlanivimab. And evidence suggesting that outcome emerged in a study from Columbia University and Regeneron scientists published this week on the pre-print server bioRxiv.
The experiment tested several antibody drugs against laboratory versions of the coronavirus that were engineered to have the mutations present in several variants. These "pseudoviruses" aren't the same as the naturally occurring coronavirus, but are designed to replicate it for testing purposes.
Against a pseudovirus containing mutations in the South African variant, bamlanivimab appeared ineffective. One of the two components of Regeneron's cocktail REGEN-COV was less effective, too, but still able to neutralize the manmade virus.
Lilly executives predicted etesevimab, the other component of a two-drug combination it's been developing, would be more effective. Nonetheless, "With a virus like SARS-CoV-2, it's expected that variants could emerge that require new therapeutic options," said Lilly chief scientific officer Daniel Skovronsky, in a statement on Wednesday.
That's cocern is behind the partnership between Lilly, Vir and GSK. Vir's single antibody, for instance, fared much better against the pseudovirus in the Columbia study than Lilly's.
Vir and GSK are already testing VIR-7831 as a single agent in Phase 3 studies in both early and later-stage COVID-19. Results are expected this quarter, and could lead the companies to file for emergency clearance. Nonetheless, Vir and GSK are preemptively looking to boost the drug's impact, while preparing for more elusive variants.
"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 Vir CEO George Scangos, in a statement.
Each antibody drug from Vir, Lilly and Regeneron, meanwhile, was found to effectively neutralize a pseudovirus of the strain that originated in the U.K. The strain found in Brazil — and, recently, in the U.S. — is similar to the one first found in South Africa.
Vir shares briefly skyrocketed nearly 80% on Wednesday, to $138 apiece, a day after shares climbed 60% on early data for an experimental hepatitis B drug. Late-morning trading, however, pared back those gains.