In-Depth: FDA weighs new COVID antibody drug that could be 'holy grail' for immunocompromised

AZD7442 showed 77% efficacy, AstraZeneca said
Posted at 7:08 PM, Nov 02, 2021
and last updated 2021-11-02 22:21:04-04

SAN DIEGO (KGTV) -- The Food and Drug Administration is reviewing a new antibody drug for COVID-19 that could significantly improve protection for people at the highest risk: those with compromised immune systems.

Dr. Brian Koffman calls it the “holy grail.”

The retired physician from the Los Angeles area is one of about 200,000 Americans living with chronic lymphocytic leukemia, a type of blood cancer that seriously weakens his ability to make antibodies and fight infections.

For him, even three doses of a vaccine might not be enough. About 40 percent of all breakthrough infections have occurred in the immunocompromised. They represent just 3 percent of the population.

But a new monoclonal antibody drug from AstraZeneca called AZD7442 appears to bolster protection significantly. The company applied for emergency use authorization last month.

The drug mimics the body’s natural defenses using laboratory-made antibodies cloned from donors.

It’s similar to ones already available in clinics from Eli Lilly and Regeneron, but AstraZeneca’s long-lasting antibodies could be the first authorized for purely preventative purposes -- what doctors call “pre-exposure prophylaxis.” No infection or exposure necessary.

“The Holy Grail for us immunocompromised, vulnerable people is pre-exposure prophylaxis,” Koffman said.

“If somebody is a Type 1 diabetic and can’t make insulin, we can give them insulin,” he said. For those who can’t make antibodies, monoclonals could act as a stand-in.

A study by AstraZeneca showed its antibodies were 77 percent effective in reducing the risk of symptomatic infection. The study included a large number of people at high risk, including people with compromised immune systems.

Based on the half-life of the antibodies, protection could last up to one year.

Instead of current antibodies that have to be infused via IV, AstraZeneca’s antibodies are administered with a standard shot.

“One shot and you’re done, and you have protection that’s in the similar range as the protection of people who are vaccinated,” Koffman said. (It’s actually two shots, Koffman notes, both given during the same visit in the gluteus maximus.)

Monoclonal antibodies have surged in popularity since they were first introduced, but most clinics focus on patients who are infected, said Family Health Centers of San Diego infectious disease specialist Dr. Christian Ramers.

Ramers, who runs FHCSD's antibody clinic, said he was aware of only one location in San Diego County that administers antibodies to people with a suspected exposure. Accommodating people who have not yet been infected or exposed will pose some logistical challenges, he said.

“If we are going to bring in highly immunocompromised people to get a treatment, it’s going to have to be done very carefully,” he said.

Clinics will have to operate separate facilities or on different days to keep infected patients away from uninfected ones, he said.

Still, immunocompromised people are pinning their hopes on the investigational treatment. Dr. Koffman took part in AstraZeneca’s clinical trial.

Koffman, the co-founder of the CLL Society, said he’s often asked by fellow patients when they’ll be able to visit restaurants, board airplanes or hug their kids again.

“I think with these antibodies, the answer might be ‘soon,’” he said. “That’s going to be a huge psychological lift for our community."

He’s hopeful the FDA will issue an emergency authorization before the year, potentially this month.