Antibodies and COVID-19: Everything You Need to Know with Biopharmaceutical Expert Carsten Thiel

When it comes to the novel coronavirus pandemic, broaching the topic of antibodies can quickly see it spinning into a million different questions. What exactly are antibodies? Does everybody infected with the virus produce them? If so, how long do they last? Can those antibodies be used to treat those suffering from severe symptoms of COVID-19? How long would it take for such treatments to be widely available?

Thankfully, scientists and pharmaceutical companies have been working around the clock, collaborating at unprecedented levels on a global scale to address these questions. As president of European commercialization efforts for the global biopharmaceutical company EUSA Pharma, Carsten Thiel has been in close collaboration with his researchers to ensure that no stone is left unturned in the search for treatments. Below, we explore some of the many ways antibodies play a role in the coronavirus pandemic.

Antibodies

Generally, antibodies are proteins the body produces are able to fight infections. While there have recently been worries as to whether those who are asymptomatic may be producing antibodies, recent studies have shown that those who have been infected by the coronavirus do produce antibodies designed to fight it, whether they were symptomatic or not. Antibodies to other coronaviruses such as those that cause SARS and MERS are thought to last around one year, but while scientists hope that antibodies to the new virus will last at least as long, there is not currently any data confirming or denying this. This is why developing treatments and vaccines to supplement natural infections remains a high priority, as it cannot be relied on alone to achieve herd immunity. The intention of a vaccine is to instruct your body on creating its own immune response through antibodies, allowing it to fight off the coronavirus before it can create severe disease in the body, but for those who have already been infected by the deadly virus, antibody treatments can be developed to introduce antibodies that have already been created to the body, either through convalescent plasma or monoclonal antibodies.

Convalescent plasma

One of the earliest ways antibodies have been introduced to the body from an external source is through convalescent plasma or serum, or the antibody-filled blood plasma from patients who have already covered from the disease. This essentially gives the infected patient a massive boost to their adaptive immune system, and has been used to treat diseases since the 1800s. In the past, doctors have even used the blood of infected animals to create serums of convalescent plasma, such as using horses to treat tetanus until the 1970s. More recently, convalescent plasma from previously infected patients was successfully used to treat Ebola virus, but this does not mean it is always successful. With the virus that causes dengue fever, receiving convalescent plasma actually causes the virus to replicate, making the patient worse as a result. So far, convalescent plasma treatments for COVID-19 have shown promising results, but poor testing conditions mean the studies were far from conclusive. Regardless, the Food and Drug Administration (FDA) has already authorized the use of convalescent plasma in patients with serious or life-threatening cases of COVID-19, which could make it difficult for more accurate trials to be conducted in the future, as patients may be less likely to accept the randomized nature of a placebo-controlled study.

Monoclonal Antibodies

Where convalescent plasma is limited, monoclonal antibodies can provide solutions. Monoclonal antibodies are lab-made antibodies created specifically to target an infection. Many labs have begun analyzing convalescent plasma of Covid-19 patients to identify which antibodies it contains can attack the coronavirus effectively and which can’t. Ideally, these antibodies could then be reproduced synthetically in a lab and manufactured in bulk, providing a bumper for society by reducing the morbidity of the virus until an effective vaccine can be developed. Drug companies Regeneron, and Eli Lilly have begun clinical trials on such antibody treatments, and some companies have formed partnerships to work together on monoclonal antibodies such as Amgen and Adaptive Biotechnologies and Vir Biotechnology and GlaxoSmithKline.

In an effort to quickly find effective treatments for seriously ill Covid-19 patients, other researchers have instead turned to previously developed monoclonal antibodies originally produced to treat other diseases. Regeneron ran a study to determine the efficacy of their monoclonal antibody treatment for rheumatoid arthritis Kevzara, but recently determined it had failed to help patients critically ill with Covid-19. However, Carsten Thiel’s company EUSA Pharma has just announced the FDA has approved a Phase 3 clinical trial for their monoclonal antibody treatment Siltuximab, previously authorized to treat multicentric Castleman disease.

Cytokine Inhibitors

The two aforementioned drugs do have one other commonality besides the fact that they are monoclonal antibodies: both were originally produced to halt cytokine storms. Cytokines are molecules the body creates to fight off diseases, but when the body begins to overproduce them it can trigger an extreme overreaction in the immune system, also known as a cytokine storm. Since the start of the pandemic, a growing body of evidence has shown that the Acute Respiratory Distress Syndrome (ARDS) associated with Covid-19 may actually be a result of systemic hyperinflammation, meaning drugs previously used to treat inflammatory disorders such as arthritis could prove to be effective.

Carsten Thiel has been close to EUSA Pharma’s recently concluded study of Siltuximab in March at Papa Giovanni XXIII hospital in Bergamo, northern Italy while the virus was ravaging the country. Studying 30 severely ill COVID-19 patients, who were treated with the drug versus a matched control cohort of 188 patients, revealed a survival benefit of 54% (p=0.0399) in favour of siltuximab.

FDA Approval

Because of these results, the FDA has approved EUSA Pharma to move forward with a randomized, double-blind, placebo-controlled Phase 3 clinical trial of siltuximab in viral ARDS. Through a placebo-controlled trial, the FDA can evaluate the safety and efficacy of the drug versus standard of care in hospitalized patients with Covid-19. Growing their patient base to roughly 550 patients and extending the trial to 28 days, it will also involve multiple centers in the United States, and should favorable results be found move forward in FDA approval.

Approximately 25% — 30% of drugs that undergo a Phase 3 clinical trial move to the next phase, and EUSA Pharma would need adequate data from two large scale clinical trials under their belt to end the clinical trials phase of Siltuximab and file for a marketing application. The drug approval process for the FDA is an arduous one, with it typically taking around two years for a drug to be approved, but the urgency the coronavirus demands means that there is a possibility some treatments may be able to advance faster than average. However, even after a treatment is approved there are still many potential complications involving production and distribution that monoclonal antibody treatment producers will have to deal with.

When it comes to treating those whose health was put in serious jeopardy by Covid-19, monoclonal antibodies that target cytokine storms show serious promise, but they still have many hurdles to overcome. Thankfully, the scientific community has been working closely together worldwide to tackle the coronavirus problem. Where there was previously secrecy and division, scientists are foregoing the lengthy process of publishing new discoveries in scientific journals and instead choosing to share the information immediately with their peers and colleagues. Carsten Thiel has previously said that biotech is the future of the world, the opportunity and promise of this century, and with the global health crisis at the forefront of everybody’s mind, this is more true than ever.

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Originally published at https://www.sciencetimes.com on August 4, 2020.