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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 The numbers in this early release of information were small and the data has not been peer reviewed yet.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: 308737

Reported Deaths: 7139
CountyCasesDeaths
DeSoto20931250
Hinds19961410
Harrison17562303
Rankin13369277
Jackson13156243
Madison9950212
Lee9890170
Jones8310161
Forrest7542148
Lauderdale7221237
Lowndes6289144
Lamar613384
Lafayette6072117
Washington5291133
Bolivar4776129
Oktibbeha457197
Panola4458103
Pearl River4437141
Warren4299119
Marshall4286102
Pontotoc417572
Monroe4062132
Union404675
Neshoba4005176
Lincoln3886109
Hancock373385
Leflore3471124
Sunflower331589
Tate325384
Pike3215105
Scott311472
Yazoo305069
Alcorn299465
Itawamba297877
Copiah293965
Coahoma290479
Simpson289586
Tippah285168
Prentiss276659
Marion266279
Leake261773
Wayne261541
Grenada256484
Covington255280
Adams246982
Newton245761
George238547
Winston226081
Tishomingo222567
Jasper220048
Attala213673
Chickasaw205457
Holmes187172
Clay183254
Stone179733
Clarke177776
Tallahatchie176140
Calhoun165431
Yalobusha160136
Smith159334
Walthall131043
Greene129633
Lawrence126623
Noxubee126534
Montgomery125742
Perry125238
Carroll120926
Amite120741
Webster113832
Jefferson Davis105532
Tunica103225
Claiborne101330
Benton97525
Kemper95628
Humphreys94632
Franklin82923
Quitman78916
Choctaw73917
Wilkinson65128
Jefferson64828
Sharkey49817
Issaquena1686
Unassigned00

Alabama Coronavirus Cases

Cases: 521623

Reported Deaths: 10739
CountyCasesDeaths
Jefferson754061493
Mobile39067799
Madison34040496
Tuscaloosa25367444
Montgomery24019567
Shelby23186239
Baldwin20701302
Lee15589165
Calhoun14342311
Morgan14158271
Etowah13685346
Marshall11995220
Houston10404278
Elmore10011200
Limestone9852147
Cullman9503189
St. Clair9463234
Lauderdale9265228
DeKalb8757181
Talladega8115171
Walker7139275
Jackson6756110
Autauga6750103
Blount6519134
Colbert6229130
Coffee5424113
Dale4772111
Russell430038
Franklin420782
Chilton4101109
Covington4061114
Tallapoosa3907146
Escambia390174
Dallas3525149
Chambers3514122
Clarke347060
Marion3072100
Pike306176
Lawrence295995
Winston273172
Bibb256059
Marengo248361
Geneva246075
Pickens233259
Barbour226455
Hale218575
Butler212967
Fayette209460
Henry188044
Cherokee182644
Randolph177241
Monroe172540
Washington165238
Macon155648
Clay150155
Crenshaw149457
Cleburne146741
Lamar139734
Lowndes136553
Wilcox124427
Bullock121640
Conecuh109428
Perry107626
Sumter103232
Coosa99428
Greene91434
Choctaw58824
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