Although not in the Limelight like Vaccines, COVID-19 Investigational Antibody Pipeline is Critically Important

Jun 26, 2020 | Antibodies, Coronavirus, COVID-19, Cytokine Storm, Monoclonal Antibodies, News

Although not in the Limelight like Vaccines, COVID-19 Investigational Antibody Pipeline is Critically Important

A major push right now to battle COVID-19 concerns not only vaccines, but also antibodies, because these treatments could be available sooner than a vaccine and hence mitigate serious risk. Antibodies are proteins the body produces to help fight infection and have been a topic of discussion among doctors since the Victorian era. And more recently, the development of convalescent plasma was used to treat severe flu, not to mention MERS and SARS. Now, there are FDA approved emergency use initiatives for convalescent plasma targeting COVID-19 patients. Scientists are working on making monoclonal antibodies (lab-made antibodies) purpose-designed to target SARS-CoV-2.

CNN recently reported that the production of antibody-based drugs could be just as important as vaccines with the COVID-19 pandemic raging on. While vaccines can last much longer, antibodies could last a month or two, then wear off, reports CNN. However, they represent powerful temporary treatments to protect vulnerable populations such as frontline health care workers, nursing home residents, and other at-risk populations.

Essential in the Fight Against COVID-19

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and a White House coronavirus task force member, touts the use of the therapies as essential in the war on COVID-19. He reported in a JAMA Interview on June 8, “Right now we have a major push on a program to develop monoclonal antibodies, convalescent plasma, and hyperimmune globulin, all of which are founded on the same principle of using an antibody that is directed against the virus for either prophylaxis or treatment.”

Antibody Pipeline

At least 102 COVID-19 antibody treatments are in the various stages of the clinical trials pipeline reports David Thomas, vice present of Industry Research at BIO, the biotech industry trade association. Mr. Thomas’ research contributes to BIO’s COVID-19 therapeutic development tracker. It’s hard to keep up with the rapid pace of change.

Breakdown of Pipeline Therapies

Some of the drugs and therapies under development help patients deal with secondary effects of SARS-CoV-2 (e.g., inflammation), while others are designed to destroy the virus itself.

Monoclonal Antibodies

CNN reports that four monoclonal antibody treatments to either treat or even prevent the novel coronavirus moved into clinical trials by June, including two sponsored by Eli Lilly, including LY-CoV555, an antibody Lilly developed with Canadian biotech AbCellera, now in Phase 2 clinical trials of non-hospitalized patients, and another antibody co-developed with Junshi Biosciences.

Meanwhile, Regeneron sponsors an antibody mix in patients in an American clinical trial. This particular trial enrolls hospitalized and ambulatory patients with COVID-19 In the initial safety/virology phase of the study, reports Alexandra BowieCNN reports that Regeneron may have preliminary study data over the next couple of months. Exhibiting absolute confidence, Regeneron scales up manufacturing production capacity.

Finally, Singapore-based Tychan initiated a Phase 1 clinical trial targeting hospitalized patients. The study should be conducted in about a month and a half.

Additionally, companies are repurposing monoclonal antibodies to target COVID-19: some examples include the following:

Novartis’ Canakinumab, an FDA approved interleukin-1 blocker, has been moved into a Phase 3 clinical trial targeting COVID-19. It is currently used to treat rare types of periodic fever syndromes known as auto-inflammatory syndromes. Novartis hopes the therapy can target the potentially deadly cytokine storm associated with COVID-19.

I-Mab, based in China, sponsored a clinical trial targeting its antibody therapy for use against patients experiencing the cytokine storm. The company hopes to have data available in August.

Humanigen sponsors lenzilumab may be working against cytokine storms based on a small study at the Mayo Clinic. This Phase 3 clinical trial continues.

CNN reports on several other therapies still in the lab.

Source: CNN

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