Regeneron opens antibody trial with UTHSC, Regional One

By , Daily Memphian Updated: September 25, 2020 8:20 AM CT | Published: September 24, 2020 6:40 PM CT

Regeneron Pharmaceuticals is opening a clinical trial in Memphis to see how well a cocktail of two synthetic antibodies performs against the coronavirus, both in people recently diagnosed and those who have been in close contact.

The trial, which will be conducted at Regional One Health, will be done in two stages beginning with people who received a COVID-19 diagnosis within four days of applying.

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The second phase is for people who live or have close contact with a newly diagnosed person but are negative themselves.

Both groups will receive one intravenous infusion of the synthetic antibody cocktail, REGN-COV2, which will take about an hour. The participants will be monitored for several hours afterward at Regional One, where the infusion will be given.

They may return to the hospital for follow-up blood work over the next five to six weeks. Regeneron will also send a home health care worker to participants’ homes if that is more convenient.

Regeneron is also partnering with University of Tennessee Health Science Center. Memphis is one of dozens of sites in the Regeneron trial in the U.S., Mexico, Brazil and Chile.

Regeneron developed antibodies in the REGN-COV2 therapy to bind to the SARS-CoV2 “spike” protein and prevent it from attaching to cells in the human body.

The cocktail is expected to neutralize the coronavirus, potentially shortening the duration of illness in sick people, and enhancing the immunity of people who have been in close contact with a COVID-positive person.

<strong>John Jeffries</strong>

John Jeffries

“Regeneron is really putting the word out and helping us to recruit patients. One of the biggest downfalls for most clinical trials is that you don’t get enough people that meet your inclusion criteria. But that’s usually because you’re just word of mouth,” said Dr. John L. Jefferies, who holds the Jay M. Sullivan Endowed Chair in Cardiovascular Medicine and is chief of cardiology at UTHSC.

If enrollment is successful, he said, Regeneron would consider Memphis for further investigation, “which I think is important.”

Jefferies and Dr. Amber Thacker, assistant professor of medicine and pediatrics at UTHSC and medical director of Hospital Medicine Service at Regional One, are leading the trials.

“Memphis is a hard-hit area,” Thacker said. “Many of our patients have comorbidities that put them at higher risk, so we see patients who are very sick. Treating people before they need to be in the hospital, or giving them better outcomes if they are hospitalized, is an amazing thing.”

The infusion is similar to what people on convalescent plasma therapy receive. That treatment is also in clinical trials for COVID-19, but has a long history of positive results in other diseases.

“What Regeneron did is make two antibodies specifically for the spike protein, which is the protein that the virus has on its surface that it uses to attach to a human receptor and enter the cell,” Thacker said.

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The antibodies attach to different spots on the spike protein and interfere with bonding and entering the human cells so it can’t replicate and can’t cause infection, she said.

Because Regeneron is paying for follow-up lab work to be done in people’s homes, Jefferies says it is possible for people living across the tri-state area to participate.

<strong>Amber Thacker</strong>

Amber Thacker

“That’s a huge advantage and it increases the compliance and follow-up,” he said. “When you look at these trials, one of the problems is that people fail to come back and meet with their providers to provide the clinical endpoints.”

People could have a reaction to the treatment itself, Jeffries said, but not related to COVID-19.

Pfizer has a Phase 3 trial in Memphis for is COVID-19 vaccine. Its partner is CNS Healthcare.

Regional One is working on other COVID-19 trials, including one with its patients. It is in the process of setting up one for critically ill patients.

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To participate in the Regeneron treatment trial, people must be at least 18, have a laboratory-confirmed COVID-19 diagnosis or be experiencing symptoms and have not been hospitalized for COVID.

To participate in the Regeneron prevention trial, participants must be at least 18, test negative for COVID-19, and live with or are close to someone who recently tested positive.

People who meet the qualifications and are interested should call (901) 448-2499 for details.

More information, including enrollment data, is here.

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Regional One Health REGN-COV2 Dr. John L. Jefferies Dr. Amber Thacker Regeneron Pharmaceuticals UTHSC
Jane Roberts

Jane Roberts

Longtime journalist Jane Roberts is a Minnesotan by birth and a Memphian by choice. She's lived and reported in the city more than two decades. She covers healthcare and higher education for The Daily Memphian.


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