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Eli Lilly pauses trial of antibody drug Trump touted as COVID-19 ‘cure’ over safety concern

By Michael Erman and Carl O’Donnell

(Reuters) – Eli Lilly and Co said on Tuesday that the government-sponsored clinical trial of its COVID-19 antibody treatment similar to one taken by U.S. President Donald Trump has been paused because of a safety concern.

Trump touted the Lilly drug, along with the antibody treatment from Regeneron Pharmaceuticals Inc that he received for his COVID-19, as tantamount to a cure in a video he posted last week.

The announcement comes one day after Johnson & Johnson said it was forced to pause a large high-profile trial of its experimental coronavirus vaccine because a volunteer fell ill. J&J said it does not yet know if that person was given the vaccine or a placebo.

AstraZeneca Plc’s U.S. trial for its experimental COVID-19 vaccine has also been on hold for over a month after a volunteer in its UK study fell ill. Trials of that vaccine resumed in other regions after a brief halt.

Lilly said earlier this month it was applying for emergency use authorization (EUA) for the antibody drug, LY-CoV555, for patients with mild to moderate COVID-19 based on data from another clinical trial.

It is not uncommon to pause drug trials to investigate safety concerns, and such actions do not necessarily indicate a serious problem. Because of the urgent need for drugs and vaccines to tackle a pandemic that has claimed over 1 million lives worldwide – and the speed with which they are being developed – these trials have come under intense scrutiny.

“Out of an abundance of caution, the ACTIV-3 independent data safety monitoring board (DSMB) has recommended a pause in enrollment,” Lilly spokeswoman Molly McCully said in an emailed statement. “Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study.”

The Indianapolis-based drugmaker did not comment on the implications for the paused trial, called ACTIV-3, which is testing the treatment on COVID-19 patients who require hospitalization, or on its other ongoing trials. It is also testing the drug in nursing homes to see if it can prevent staff and residents from getting infected.

The U.S. Food and Drug Administration and the National Institutes of Health did not immediately reply to requests for comment.

Lilly began its ACTIV-3 trial in August and is aiming to recruit 10,000 patients primarily in the United States.

The trial compares patients who receive its antibody drug plus Gilead Sciences Inc’s antiviral drug remdesivir with those who receive remdesivir alone.

Lilly sought the EUA from U.S. regulators after publishing data in September showing LY-CoV555 helped cut hospitalization and emergency room visits for COVID-19 patients. The treatment is being developed with Canadian biotech AbCellera.

Lilly shares closed nearly 3%.

(Reporting by Michael Erman and Carl O’Donnell in New York; Additional reporting by Deena Beasley in Los Angeles; Editing by Bill Berkrot)

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U.S., AstraZeneca strike deal for COVID-19 antibody treatment touted by Trump

(Reuters) – The U.S. government has awarded $486 million to AstraZeneca Plc to develop and secure supplies of up to 100,000 doses of COVID-19 antibody treatment, a similar class of drug that was used in treating President Donald Trump.

The agreement, under the Trump administration’s Operation Warp Speed, is for developing a monoclonal antibody cocktail that can prevent COVID-19, especially in high-risk population like those over 80 years old, the U.S. Department of Health and Human Services said.

The treatment has come under the spotlight after Trump was treated with Regeneron Pharmaceuticals’ antibody drug last week. The president has also released a video on Twitter touting its benefits.

In a call earlier on Friday, a top U.S. health official said the government was expecting to provide more than 1 million free doses of antibody treatments to COVID-19 patients, similar to the one that was administered to Trump.

Regeneron and Eli Lilly have both applied to the U.S. Food and Drug Administration for emergency use authorizations of their antibody treatments.

AstraZeneca said it was planning to supply up to 100,000 doses starting toward the end of 2020 and that the U.S. government could acquire up to an additional one million doses in 2021 under a separate agreement.

Regeneron signed a $450 million deal in July to sell Operation Warp Speed enough doses of its antibody treatment, REGN-COV2, to treat around 300,000 people.

Eli Lilly said on Friday it had not signed an agreement with Operation Warp Speed.

AstraZeneca plans to evaluate the treatment, AZD7442, which is a cocktail of two monoclonal antibodies, in two studies.

One trial will evaluate the safety and efficacy of the experimental treatment to prevent infection for up to 12 months in about 5,000 participants, while the second will evaluate post-exposure preventative and pre-emptive treatment in roughly 1,100 participants.

(Reporting by Ankur Banerjee in Bengaluru; Editing by Anil D’Silva)

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Antibody Drugs Touted by Trump Could Be Next to Get Authorized for Covid-19

President Trump’s endorsement of an experimental Covid-19 drug from

Regeneron Pharmaceuticals Inc.


REGN 0.37%

has raised expectations for a type of medicine that could be authorized for public use within weeks or even days.

Regeneron is racing against rival

Eli Lilly & Co.


LLY 2.20%

to bring the first monoclonal antibody drug on the market to treat Covid-19 patients who aren’t sick enough to be hospitalized. Both companies said Wednesday they had asked the U.S. Food and Drug Administration to authorize use, and they had already made tens of thousands of doses for patients.

If greenlighted, the shots would begin to fill a big hole in the Covid-19 medicine chest for treatment of early and less-severe cases. After more testing, they could offer temporary protection against infections until vaccines arrive. But supply is unlikely to meet demand until next year at the earliest.

Monoclonal antibodies, which are also used to treat cancer and other diseases, take a page from the body’s own soldiers for fighting pathogens. Both Lilly and Regeneron researchers derived their drugs from naturally occurring Covid-19 antibodies.

Each of the companies has released encouraging data from early-stage clinical trials showing their drugs helped reduce coronavirus levels and improve symptoms in patients not sick enough to be hospitalized. Lilly and Regeneron have already started studies to see if their antibody drugs can prevent Covid-19.

Given the urgent need, the companies asked the FDA to use a special review process reserved for emergencies such as pandemics and authorize use before the therapies have finished all the stages of testing normally required for approval.

The FDA could issue the go-ahead for the monoclonal antibody drugs as soon as Friday, SVB Leerink analyst Geoffrey Porges said. The agency could feel comfortable making a quick decision, he said, because it is already familiar with the way antibody drugs work, having approved many of them over the years to treat other diseases.

The FDA declined to comment about its review of the applications or the timing of a decision.

The agency has granted emergency-use authorizations for two therapies for hospitalized Covid-19 patients, the antiviral remdesivir from

Gilead Sciences Inc.

and antibody-rich convalescent plasma taken from recovered coronavirus patients. An antibody drug could be the next agent to be permitted for use.

Last Friday, Mr. Trump was given a high dose of Regeneron’s drug, code-named REGN-COV2, under a program that allows patients to take experimental drugs outside of clinical trials. He was later given the antiviral drug remdesivir, which the FDA authorized in May, and the already approved steroid dexamethasone.

Mr. Trump’s doctors have said he is symptom free. In a video released late Wednesday, the president attributed his return to health to Regeneron’s drug.

A growing number of hospitals are investigating antibody testing and blood plasma therapy as a way to combat the new coronavirus in sick patients. WSJ’s Daniela Hernandez explains. Photo illustration: Laura Kammermann

“They gave me Regeneron, and it was like, unbelievable. I felt good immediately,” he said. Independent doctors

COVID drug Trump touted as a “cure” was developed using cells derived from aborted fetal tissue

The antibody cocktail that President Trump received for his COVID-19 infection and touted on Wednesday evening as a “cure” for the deadly virus was developed using cells derived from aborted fetal tissue, a practice the White House and anti-abortion rights groups oppose.

Last week, Mr. Trump received Regeneron Pharmaceuticals’ cocktail of monoclonal antibodies, an experimental therapeutic for coronavirus that is still undergoing testing and is not FDA approved. In a nearly five-minute video posted to Twitter on Wednesday, the president lauded its effects, calling it “the key.”

“I think this was a blessing from God that I caught [the virus], I think it was a blessing in disguise,” Mr. Trump said in the video. “I caught it, I heard about this drug, I said, ‘Let me take it’ … and it was incredible the way it worked.”

But the way in which the antibody cocktail was developed is at odds with the Trump administration’s position on stem cell research. The drug’s potency was tested in a lab using HEK 293T cells, a cell line originally derived from the kidney tissue of a fetus aborted in the Netherlands in the 1970s, said a spokesperson for Regeneron in an email to CBS News on Thursday. The cells “were used in testing the antibody candidates’ ability to neutralize the virus” and helped researchers “determine the ‘best’ two antibodies, which now make up the REGN-COV2 cocktail,” the spokesperson said.  

There is no fetal tissue present in the final product.

Remdesivir, an antiviral drug Mr. Trump received, also was tested using the HEK 293T cells.

Last year, the Trump administration said it would no longer support long-standing funding for medical research by government scientists using human fetal tissue, a move that countered advice from physicians and researchers. The decision was seen as a major victory for anti-abortion rights groups.

Because the fetal cells used in developing Regeneron’s antibody cocktail were originally derived from an abortion prior to the funding ban, a White House official told CBS News on Thursday that the therapeutic wasn’t in violation of the administration’s new policy.

“The Administration’s policy on the use of human fetal tissue from elective abortions in research specifically excluded ‘already-established (as of June 5, 2019) human fetal cell lines,” the official said. “Thus, a product made using extant cell lines that existed before June 5, 2019 would not implicate the Administration’s policy.”

Anti-abortion groups, which generally oppose the use of fetal tissue in pharmaceutical research, did not raise issue with the therapeutics used and promoted by the president.

“The president was not given any medicines to treat COVID-19 that involved the destruction of human life,” wrote David Prentice, Ph.D., and Tara Sander Lee, Ph.D., of the Charlotte Lozier Institute, the research arm of the anti-abortion rights political group the Susan B. Anthony List, in a statement emailed to CBS News Wednesday afternoon. “No human embryonic stem cells or human fetal tissue were used to produce the treatments President Trump received – period.”

The researchers did not

GA Coronavirus Progress Touted By Kemp During Wednesday Briefing

ATLANTA, GA — Gov. Brian Kemp took a victory lap during his coronavirus briefing Wednesday morning, touting Georgia’s 64-percent reduction in new COVID-19 since a peak on July 24.

“We needed Georgians to be part of the solution and not part of the problem, and I’m very proud of the fact that Georgians have stepped up to the plate and have done the right thing,” Kemp said. “The key for now is for us to keep doing this. We cannot take our foot off the gas.”

Both Kemp and Dr. Katherine Toomey, commissioner of the Georgia Department of Public Health, urged Georgians to “wear a mask, watch your distance, wash your hands and follow the guidance” of health experts.

Kemp noted other signs of progress as well, with confirmed hospitalizations down 60 percent from their peak and COVID-19 cases comprising only 8.8 percent of Georgia’s total hospital population.

Kemp noted that Georgia’s unemployment rate is below the national average and that the state has maintained its triple-A bond rating through the pandemic.

“We have worked hard to protect people and their paychecks,” Kemp said, “and, yes, we can do both.”

Kemp sidestepped a reporter’s question about what kind of example he’d set by attending last week’s Faith and Freedom Coalition conference, in which most attendees were close and maskless.

Instead, Kemp pointed out that at least he was wearing a mask and that participants in similar events — including “demonstrations” and “protests” — have First Amendment rights.

But when another reporter challenged Kemp’s positive outlook by pointing out that the most recent seven-day average of new COVID-19 cases had risen slightly, Kemp pushed back

“You know, cherry picking the worst figures like you’ve done in the past is a little disingenuous to the public,” Kemp answered, urging the public to bypass the media and read Toomey’s reports firsthand.

Kemp ended the briefing with a pitch to vote.

“We have one of the greatest states in the country for access to the ballot,” Kemp said. “We’re a state that wants to make it easy to vote and hard to cheat.”

GEORGIA CORONAVIRUS NUMBERS FOR OCT. 7, 2020

The Georgia Department of Public Health in Atlanta reported a total of 326,142 confirmed cases of COVID-19 at 2:50 p.m. Wednesday, Oct. 7. According to the health department’s website, that includes 1,554 newly confirmed cases over the last 24 hours.

Georgia also reported 7,259 deaths so far from COVID-19, with 32 more deaths recorded in the last 24 hours. In addition, the state reported 29,308 hospitalizations — 154 more than the day before — and 5,439 admissions so far to intensive-care units.

No information is available from Georgia about how many patients have recovered.

Counties in or near metro Atlanta and other metropolitan areas continue to have the highest number of positives, with Fulton County still in the lead.

  1. Fulton County: 28,392 cases — 134 new

  2. Gwinnett County: 28,328 cases — 121 new

  3. Cobb County: 20,224 cases — 104 new

  4. DeKalb County: