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A great deal of publicity has centered on monoclonal antibody use for those suffering from COVID-19. Weeks after the U.S. president received this therapy, the FDA approved its use for emergency purposes in select individuals. For many, this may have been the first time they had heard of monoclonal antibody therapies at all. But believe it or not, these treatments have been rapidly increasing in popularity for at least a decade. In fact, it’s hard to tune into any media today without seeing advertisements for drugs that end in “-mab.” This suffix is the telltale sign the medication belongs to the larger group of monoclonal antibody treatments.

Today, monoclonal antibody use extends well beyond the management of COVID-19. These drugs are commonly employed in a variety of cancer therapies. Likewise, monoclonal antibody therapies are routinely administered in some immune disorders. But now, these protein-based infusions may hold promise for a much more elusive disorder…Alzheimer’s disease. If subsequent trials support what preliminary results suggest, monoclonal antibody treatments may well be a wonder drug. For a disorder that has no highly effective therapies, this would indeed be a huge breakthrough.

“Monoclonal antibodies, like small molecules, are tools for a specific job. They are an incredibly flexible platform and very good at what they do. It is hard to imagine anything that has the same advantages.” – Janice Reichert, PhD, Executive Director of The Antibody Society

A Little History of Monoclonal Antibody Therapies

Though its start was pretty rough, some scientists began researching immune proteins as potential treatments a century ago. In the late 19th century, efforts to infuse blood containing suspected antibodies for specific conditions existed. But the results were miserable. The technologies and insights were simply not present at the time. But by the mid-1980s, things had changed with immune therapy pioneers emerging. The FDA approved the first monoclonal antibody therapies for those suffering from transplant rejection. Monoclonal antibody use then escalated further with the development of gene-editing techniques. As of 2020, there are now roughly 100 monoclonal antibody treatments approved by the FDA for cancer and non-cancer conditions.

A medical professional about to administer a monoclonal antibody shot
Monoclonal antibody use extends beyond just the treatment of COVID-19.

Monoclonal antibodies are essentially very specific proteins that target specific antigens in the body. Depending on what researchers want a drug to do, they design a monoclonal antibody for that intended purpose. Sometimes, monoclonal antibody therapies attach to a specific protein antigen in the body to boost an immune response against it. Other times, they are designed to block specific activities when they attach to an antigen. And others actually carry additional drugs to a specific site to exert a specific effect. Though monoclonal antibody use has been primarily for cancers in the past, this is changing quickly. Today, a host of non-cancer conditions are being managed with monoclonal antibody treatments.

“The greatest challenge now is to understand the biology, not to generate the antibodies. The whole biology of ligands, receptors, redundancies, antagonists, and so on is much more complicated than it appears.” – Andreas Plückthun, PhD, Professor of Biochemistry, University of Zurich.

The Potential for Monoclonal Antibody Use in Alzheimer’s

Recent reports suggest that monoclonal antibody therapies may play a role in Alzheimer’s dementia as well. Researchers at Eli Lilly are currently conducting clinical trials for a drug named donanemab. In essence, this monoclonal antibody is designed to target amyloid plaque proteins in the brain. In Alzheimer’s patients, these are believed to interfere with brain functioning, leading to progressive declines. Thus, if monoclonal antibody use could eliminate these plaques by augmenting an immune response against them, patients would improve. Based on early results, researchers suggest donanemab removes amyloid plaques and slows decline by roughly a third compared to placebo.

These results are far from definitive at this point, and additional research is being planned. However, monoclonal antibody use in this manner demonstrated how targeted and precision medicine in Alzheimer’s is advancing. In this instance, monoclonal antibody therapies allow the immune system to better attack these destructive amyloid plaques. Assumedly, this could lead to better cognitive function and slower decline. Also, no significant side effects were reported among patients during the four weeks of infusion. These are indeed potentially exciting results that could completely change the management of dementia.

“Monoclonal antibody products are a godsend to those patients who are eligible and are seen by us early in the course of illness. The earlier, the better.” –  Michael Saag, MD, Infectious Disease, University of Alabama at Birmingham

Challenges with Monoclonal Antibody Use in COVID

As you might imagine, COVID has been a catalyst for healthcare advances. In terms of monoclonal antibody therapies in COVID, the mechanism of action is different from other monoclonal antibody treatments. Two drugs, used in combination, have been approved by the FDA in select patients. For those over 65 years of age or who have chronic disease, they may qualify. They are required to have a positive COVID test, not be hospitalized, and not require oxygen. Ideally, they should also be within 3 days of symptoms or a positive test. In this population, monoclonal antibody use significantly reduces the chance of hospitalization or emergency room care.

The two drugs are called casirivimab and imdevimab, and these are provided by an intravenous infusion. These monoclonal antibodies therapies work by attaching themselves to the spike protein on the coronavirus molecule. But rather than stimulating an immune attack at that point, they essentially prevent the virus from attaching to human cells. Regeneron Pharmaceuticals and Eli Lilly manufacture these substances, but unfortunately, they are being underutilized. Too few providers as well as patients appreciate the impact these wonder drugs might offer.

Much More to Come for Monoclonal Antibody Therapies

According to many researchers, we are just beginning to scratch the surface when it comes to monoclonal antibody use. Much more must be learned about how our immune system functions before we can really tap into their potential. However, it’s clear already that this approach to treatment holds tremendous promise. From COVID, to cancer, to Alzheimer’s, monoclonal antibody therapies will play a major role in ongoing care.

 

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