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Early data shows promising results from Regeneron's antibody cocktail for coronavirus

Biotechnology company Regeneron released some early results of tests using its antibody cocktail in coronavirus patients Tuesday, and said it seemed to reduc...

Posted: Sep 29, 2020 4:44 PM
Updated: Sep 29, 2020 8:00 PM

Biotechnology company Regeneron released some early results of tests using its antibody cocktail in coronavirus patients Tuesday, and said it seemed to reduce levels of the virus and improve symptoms in patients.

The greatest improvements were seen in patients who hadn't already mounted a natural response to the infection, the company said.

The results only involve 275 patients of the 1,000 they have enrolled in this particular trial, but appear 'very promising,' Dr. Jeanne Marrazzo, the director of the division of infectious diseases at University of Alabama at Birmingham, told CNN.

The treatment also showed positive trends at reducing medical visits for the patients, none of whom were sick enough to be hospitalized at the start of the trial, the company said. The numbers in this early release of information were small and the data has not been peer reviewed yet. Only topline data was available in a news release from the company.

A company spokesperson said the data validates the treatment as a therapeutic substitute for a natural response to the virus.

Marrazzo said what stood out to her is that the study characterized patients by their immune responses prior to treatment and determined who did and did not benefit.

'What I think is fascinating is that it shows that antibodies really matter and the antibody to the spike protein was really helpful, particularly when people made the antibodies themselves,' said Marrazzo. 'Whether it's antibody therapy or vaccine that target these proteins, it sounds like we are on the right track. I think that's really encouraging.'

She was also encouraged by the reduction in the amount of virus in people's throats, which could in theory reduce the risk of infecting others. 'If it plays out and you could treat people early and actually reduce the viral load in the nasopharynx, and they might be less infectious, that would be hugely helpful,' said Marrazzo.

Because the company released the information in a news release and not as a scientific report, it's unclear who was enrolled in the study and how reflective they were of the population. The treatment would have to be tested in many more people to know for sure how well it works. Scientists will also want to know more about how many patients who got the treatment needed to be hospitalized.

'We don't have that information today, but we will,' Dr. Leonard Schleifer, co-founder of Regeneron, told CNN. 'We have already learned that hospitalized patients have even higher viral load, suggesting they're not attempting an adequate immune response. So we would hope we'd be able to see the same thing with those patients.'

Schleifer is 'very encouraged' by these early results.

'It came in exactly the way we expected it to work,' Schleifer said.

Dr. Claudia Hoyen, an infectious disease specialist with University Hospitals Cleveland Medical Center, also sees the results as 'promising.' The data doesn't show any safety concerns, she said, and the preliminary data looks good so far.

'It seems safe, and it seems to be headed in the right direction in terms of decreasing the virologic load and, looks like there's some preliminary correlation with fewer symptoms and less hospitalizations,' Hoyen said. 'But again, they still have a lot of patients to get through to know for sure.'

Jennifer Gommerman, a professor of immunology at the University of Toronto, also used the phrase 'really promising.'

She said that, along with Regeneron's earlier work published in a peer-reviewed journal in August, the additional key takeaway is that the 'cocktail' approach is effective.

A cocktail antibody therapy uses two or more lab-engineered antibodies. Regeneron's cocktail includes a monoclonal antibody that targets the spike protein the virus uses to drill into healthy cells, and another antibody that targets a different part of the novel coronavirus. With two, the hope is is to trap and shut down viral replication.

'It appears that they've got positive results and that this antibody cocktail doses reduce the amount of time that the patients are sick, especially the patients that weren't able to mount their own antibody response,' Gommerman said. 'They're obviously going to have to do much more human experiments and bigger trials to really make sure.'

Dr. Richard Besser, a former acting CDC director who now heads the Robert Wood Johnson Foundation, said it makes sense that a treatment that gives a patient antibodies would help the immune system, but he said peer review will find any holes or pitfalls.

'I would withhold judgment on this until we see the data,' said Besser. 'You know these early results that keep coming out from companies in press releases strike me as being about much more, much more about the stock price than they are about science.'

Gommerman, Marrazzo and Hoyen think antibody treatments could be a real help in patient populations that don't generate a real robust immune response to a vaccine, like patients in nursing homes or other elderly people. The treatment may also be helpful in the transition period, before everyone can get vaccinated.

Regeneron isn't the only company working on an antibody treatment. Eli Lilly is also in late stage trials with its antibody treatment. There are at least 70 different antibody treatments under investigation according to BIO, an association that represents major biotechnology companies.

Regeneron said that there will be more data to come from this trial, from a trial involving hospitalized patients, and one that is testing the antibody cocktail as a prevention for people who have contact with someone in their household who has Covid-19.

Schleifer said Regeneron is in talks with regulators about these results to see if the US Food and Drug Administration would consider an emergency authorization of the drug. They have additional data the company will submit for formal approval.

Regeneron co-founder George Yancopoulous said during a call with shareholders Tuesday that it is up to regulators to decide if this is enough information to make this therapeutic intervention available sooner to patients who might need it.

'I think that this deserves to be discussed with regulatory authorities, because of all of the societal implications,' Yancopoulous said.

'We think that there's a lot of evidence here to suggest that this is a therapeutic solution that could really benefit quite a number of individuals and patients.'

Mississippi Coronavirus Cases

Data is updated nightly.

Cases: 156868

Reported Deaths: 3851
CountyCasesDeaths
DeSoto10409104
Hinds10279202
Harrison7313112
Jackson6566128
Rankin5887106
Lee529496
Madison5014107
Forrest389786
Jones369088
Lauderdale3594147
Lafayette338253
Washington3246108
Lamar297850
Oktibbeha252362
Lowndes247064
Bolivar244384
Panola232653
Neshoba2249121
Marshall222851
Leflore208591
Monroe206778
Pontotoc204231
Lincoln197366
Sunflower192655
Warren180258
Tate177751
Union171926
Copiah167940
Pike165359
Yazoo160140
Scott159430
Itawamba157635
Alcorn155628
Pearl River155368
Coahoma152743
Simpson152653
Prentiss151331
Adams144752
Grenada143345
Leake139744
Holmes133461
Covington128639
Tippah128430
George128325
Winston125526
Hancock124341
Wayne121323
Marion119446
Attala119334
Tishomingo112443
Chickasaw109432
Newton108229
Tallahatchie98127
Clay94727
Clarke93653
Jasper85223
Stone80615
Calhoun78713
Walthall77629
Montgomery76926
Carroll74115
Lawrence73814
Smith73216
Yalobusha73128
Noxubee72717
Perry68326
Tunica62619
Greene61522
Jefferson Davis59017
Claiborne58916
Amite56615
Humphreys54719
Benton50018
Quitman5007
Webster46714
Kemper45018
Wilkinson40522
Jefferson37112
Choctaw3617
Franklin3555
Sharkey32417
Issaquena1204
Unassigned00

Alabama Coronavirus Cases

Cases: 252900

Reported Deaths: 3638
CountyCasesDeaths
Jefferson33526501
Mobile20103365
Madison13723151
Tuscaloosa13366154
Montgomery12552236
Shelby1079677
Baldwin9051137
Lee787266
Morgan696451
Calhoun6598121
Etowah656167
Marshall647357
Houston541038
DeKalb498137
Cullman462443
St. Clair441956
Limestone440445
Lauderdale426754
Elmore421164
Walker3735111
Talladega370157
Jackson340423
Colbert332042
Blount306140
Autauga281842
Franklin257434
Coffee250015
Dale239054
Dallas231532
Chilton228939
Russell22663
Covington225034
Escambia202331
Tallapoosa187291
Chambers182750
Pike161514
Clarke161019
Marion144736
Winston137523
Lawrence133436
Pickens126518
Geneva12508
Marengo123424
Bibb120418
Barbour118911
Butler118642
Randolph105522
Cherokee105124
Hale98131
Fayette94616
Washington93219
Clay92824
Henry8896
Monroe83011
Lowndes80929
Cleburne78814
Macon75522
Crenshaw72230
Bullock70119
Lamar7018
Conecuh70014
Perry6916
Wilcox64818
Sumter58622
Greene43518
Choctaw43114
Coosa3664
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