Covid-19 drugmakers are looking for new antibodies after warning that some treatments may be ineffective against rapidly spreading variants of the coronavirus.
Antibody treatments – like the one given to Donald Trump when he contracted the virus in October – are used to boost the immune systems of patients who are struggling to mount their own response. Data from the trials suggest that the drugs, also known as monoclonal or “conception” antibody therapy, could also be used as a preventative measure in high-risk settings such as nursing homes.
But new studies show that their effectiveness could be “severely” reduced by mutated strains of the virus, warned Anthony Fauci, chief medical adviser at the White House, this week.
A paper by scientists at Columbia University, which has not yet been peer reviewed, said that the treatment from US drug maker Eli Lilly failed to neutralize the variant of the coronavirus 501.V2 which first emerged in South Africa. The drug is one of two antibody treatments with emergency US approval and government contracts for hundreds of thousands of doses.
Unlike vaccines, some of which could be reformulated in a matter of weeks, companies producing such treatments would have to start the process over from scratch if new variants escape the chosen antibodies, which can take months to develop. They are also expected to obtain new authorizations from regulators.
Eli Lilly has already selected a potential 501. V2 treatment and said this week he is preparing to enter clinical trials in humans.
The company believes its development may be faster than the six months it takes to create the original Covid-19 treatments. But he warned it could still take that long to reach significant production levels.
“That’s why we need to start working on variants as quickly as possible so that manufacturing can be scaled up,” said Dan Skovronsky, Scientific Director.
Antibody therapy is one of the fastest growing areas of biomedical research and is widely used in the treatment of cancer and autoimmune diseases such as rheumatoid arthritis and Crohn’s disease.
It was scientifically successful in a process that found some good drugs for Covid-19. However, the treatments can be expensive and difficult to administer because it is an infusion and not a pill.
The median price in the United States for one-year antibody treatment for diseases such as cancer ranges from $ 15,000 to $ 200,000, according to the Wellcome Trust, a British charity. As a result, 80% of these therapies are sold in the United States, Europe and Canada.
In the United States, government contracts mean the drugs are free for now, although patients may have to pay bills for the hospitals that administer them.
The Columbia article revealed that the two-monoclonal antibody combination of Regeneron, which also has emergency use clearance in the United States, is active against the 501. V2 variant, even though the potency of one antibody level was reduced.
If it has to adapt in the future, Regeneron said it already had a number of antibodies pending in the wings that were not used in the final cocktail.
Eli Lilly is working with British company GlaxoSmithKline and San Francisco-based Vir Biotechnology in an unusual collaboration to launch a trial of a cocktail of all their antibodies.
George Scangos, chief executive of Vir, said that “every company that makes antibodies predicted escape mutations would occur,” and warned that the virus could now begin to mutate at a faster rate.
“This is the tip of the iceberg, they are the first,” he said. “As more and more people get vaccinated and recover, the virus is under selective pressure.”
Dr Scangos said his team is testing hundreds of different antibodies to identify which ones work against the new variants.
Seattle-based Adaptive Biotechnologies, which is also developing antibody treatments, is in discussions with regulators about what would be needed to deliver promising therapies without having to undergo the same expensive studies.
“Once you’ve developed that manufacturing capability, you go into it, and it’s very difficult to pivot without having a big impact on delivery,” said Lance Baldo, Chief Medical Officer of Adaptive.
The UK regulator has yet to approve any antibody therapy for emergency use, but the government has reached an agreement in principle to ensure access to 1m doses of an antibody cocktail produced by AstraZeneca, pending test results.
In the United States, Dr Fauci said he plans to work with companies to develop alternatives or boosters for antibody treatments that would use the same platforms rather than completely replacing products.
“We’ll always want to be a step or two ahead of what might be a problem in the future,” he said.