Synthetic Antibodies to Trump’s Rescue

Although clinical trials are still ongoing, the lab-made antibodies to treat COVID-19 already seem so promising that they have even convinced Donald Trump to receive an experimental treatment.

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Affected by the coronavirus, the 74-year-old American president was treated with a cocktail of several vitamins and drugs, including remdesivir, but he also received, at his request, an injection of synthetic antibodies developed by Regeneron. A strong dose of 8 grams.

“It was a blessing. It’s amazing how well it worked. I want you to be able to have what I got and I will organize myself so that it is free, ”he said, convinced that the antibodies allowed him to get back into shape.

As a sign of the level of confidence in this therapeutic approach, Regeneron received $ 600 million from the US government for its work, which is among the most advanced on the planet in this regard with the pharmaceutical giant Eli Lilly, which has partnered with Canadian biotech. AbCellera.

Preliminary results from trials on 275 patients, released by Regeneron, indicate that its monoclonal antibodies reduced viral load in outpatients and accelerated their recovery.

Too early to claim victory

The enormous potential of synthetic antibodies seems to be gaining more and more consensus in the scientific community. Nevertheless, several experts have been overthrown that an unapproved treatment is injected so quickly into the president, before phase 3 is completed, especially since there is no data on the possible interactions with other drugs. .

“It is always risky to embark on the use of a treatment which has not yet been fully proven”, observes the D^re Caroline Quach, epidemiologist at Sainte-Justine hospital, recalling the episode of the controversial chloroquine, the emergency use of which has been revoked by the American health authorities.

Benoit Barbeau, virologist and professor at UQAM, however, believes that the injection of antibodies involves less risk. “If you are in phase 2, there is already a series of analyzes which show that the safety of the treatment is not compromised. Donald Trump is probably the best followed patient on the planet, ”he puts into perspective.

Ammunition made in the lab

• The genetic sequence of several hundred antibodies must first be identified in blood samples from patients who have recovered from COVID-19.
• Only the best candidates – who have the ability to attack peaks in the virus’s outer layer to prevent it from replicating – are selected for large-scale replication in the laboratory using bioreactors.
• The advantage of this technique, compared to the transfusion of the plasma of a convalescent patient which also contains antibodies, is to “better control the quality and the quantity of antibodies that are injected”, according to the virologist. Benoit Barbeau.
• However, the lifespan of the injected antibodies would be limited and would provide “passive immunity”, compared to a possible vaccine which could allow the human body to make its own antibodies.

What Doctor Béliveau thinks

The exact state of health of the president at the time the antibodies were administered to him is not known, but it can be assumed that he was of sufficient concern to warrant the use of an experimental treatment. On the other hand, the preliminary data obtained with these antibodies are encouraging and suggest that this treatment can quickly decrease the viral load and prevent the development of severe forms of COVID-19. According to American experts like the D^rs Anthony Fauci and Eric Topol, it is likely that the cocktail of antibodies administered to the president is responsible for the rapid improvement in his health. However, it should be mentioned that these are difficult to produce and expensive, which limits their use.

Two emergency clearance requests to the FDA

Two pharmaceutical companies have filed in the last days a request to the American health authorities for the emergency use of their synthetic antibodies.

Since President Trump was given a cocktail of antibodies, things have moved at full speed in the United States regarding this potential “cure” aimed at building an immune response and slowing the progression of COVID-19.

In addition to Regeneron, whose product was administered to the president, the Indianapolis-based company Lilly has also asked the Food and Drug Administration (FDA) to authorize the immediate use of its antibody-based treatment, which is in phase 2 and 3 clinical trials.

Such an exceptional authorization can be granted by the FDA in the context of a health crisis in order to treat a disease that can lead to death such as COVID-19. The FDA had also authorized the emergency use of chloroquine and hydroxychloroquine in the spring before reversing its decision, ultimately considering that the results were inconclusive.

“Our teams have worked tirelessly for seven months. We believe that we have gathered enough evidence, so far, to demonstrate the effectiveness of our monotherapy and a combination of therapies to treat high-risk patients, ”argues the president of research laboratories at Lilly, Daniel Skovronsky.

Contribution of Canada

Lilly is working with Vancouver-based company AbCellera, which has been on the front lines since the start of the pandemic. The latter received $ 175 million in financial assistance from the Trudeau government several months ago to develop its platform, expand its facilities and hire more staff. Ottawa also relies heavily on this approach.

“Where monoclonal antibodies could also be of interest is in prevention. If it ever works and we are in the context of an outbreak in a CHSLD, for example, we can administer these antibodies to the population most at risk without having to wait for the response of a vaccine ”, explains the D^re Caroline Quach, epidemiologist at Sainte-Justine hospital.

“From a theoretical point of view, it looks very interesting at the level of phases 1 and 2 which went well, but you have to be careful before concluding in a rush without having the results of these studies. “