Covid-19 roundup: Inovio gets FDA greenlight to enter human trials; Trump pushes untested malaria drugs again
Inovio, one of the clutch of companies working on a Covid-19 vaccine, has been cleared by the FDA to kick off in-human studies of its experimental vaccine candidate. The Pennsylvania company secured funding from the Coalition for Epidemic Preparedness Innovations (CEPI) and the Bill and Melinda Gates Foundation to support its effort.
The trial testing the DNA vaccine, INO-4800, in up to 40 healthy volunteers is set to begin this week, and the first dose is planned to be administered today. Each participant will receive two doses of INO-4800 a month apart, and the initial immune responses and safety data from the study are expected by late summer, the company said. Shares of Inovio — which in four decades of existence has not successfully developed a product — $INO jumped about 11% to $8.60 in premarket trading.
People are rightfully skeptical about $INO given the company's track record, but think you have to give them (or anybody) credit for being the 3rd company to dose a vaccine and only weeks behind the first two. We're pulling for everyone.
— Brad Loncar (@bradloncar) April 6, 2020
Scientists estimate the earliest a viable vaccine can be approved, even with expedited R&D and regulatory review, is between 12 to 18 months. The only other vaccines to be in human studies are from Moderna Therapeutics, which is collaborating with the NIH, as well as China’s CanSino Biologics. Moderna got their vaccine into Phase I within 42 days, but did so by controversially putting into humans before completing the ordinary animal testing, a fact Inovio CEO Joseph Kim noted obliquely in an interview.
“In less than 3 months, we were able to design the vaccine, along the way conducting all the tests,” Kim told Endpoints News. “We did not take those risky shortcuts. We just did things faster.”
Still, researchers broadly have greater expectations for the mRNA vaccine being developed by Moderna and others, in part because mRNA vaccines can just enter the cell, while DNA vaccines have to reach the cell nucleus. For that reason, after receiving the DNA vaccine itself, the volunteers in Inovio’s study will receive 3 shots of electrophoresis that guide the DNA to the desired spot.
It’s “a little bit more difficult from a molecular biology perspective compared to mRNA,” CEPI programs and technology R&D chief Nick Jackson told Endpoints in February.
Kim said they are working with the FDA on designing Phase II and Phase III studies. The Phase II could begin as early as this summer, a similar timeline to the one put forth by Moderna.
Trump lauds malaria drugs again
In a White House briefing on Sunday, President Trump once again issued an impassioned endorsement of malaria drugs chloroquine and hydroxychloroquine as treatments for Covid-19, as the virus behind the disease ravages the United States.
“I want people to live, and I’m seeing people dying. I’ve seen people dying without it! They should do it (use the drugs), what really do we have to lose?” he said. “This medicine’s been tested for many years, for malaria and for lupus and its been out there, so it’s out there and it doesn’t kill people. We have some very good results and some very good tests — but we don’t have time to say gee, let’s take a couple of years and test it out, and let’s go and test with the test tubes and the laboratories.”
Trump, who is not a physician, has been touting the pair of drugs as Covid-19 treatments for weeks now, despite caution from his own scientific advisors, including infectious disease expert and NIAID chief Anthony Fauci who has insisted that there is no strong scientific proof backing their efficacy against Covid-19. When a reporter tried to engage Fauci directly to weigh in on the drugs on Sunday, Trump intervened.
A few tiny trials out of France and China have so far yielded inconclusive evidence on the use of the drugs in patients with Covid-19.
Eric Topol — cardiologist, author and founder of the Scripps Research Translational Institute — underscored that data on the use of the drugs in Covid-19 is incoming, that they can cause serious side effects, and that the treatments are not approved by the FDA as asserted by Trump.
Clarity on Hydroxychloroquine and Azithromycin.
Below are the list of trials that show any convincing evidence of safety and efficacy.
Despite @POTUS's assertion and strong testimonial, and his blocking Tony Fauci's ability to respond to the question at today's press conference pic.twitter.com/zCrUZrZZLA
— Eric Topol (@EricTopol) April 6, 2020
In the middle of March, Trump personally pressed federal health officials to make the malaria drugs available to treat the new coronavirus, Reuters reported. Soon after, the FDA cited limited in-vitro and anecdotal clinical data to endorse the emergency use of the two therapies to treat malaria and lupus among other disorders for Covid-19 when clinical trials are not available, or participation is not feasible.
“The president is short-circuiting the process with his gut feelings,” said Jeffrey Flier, a former dean of Harvard Medical School told Reuters. “We are in an emergency and we need to rely on our government to ensure that all these potential therapies are tested in the most effective and objective way.”
In a statement to the wire agency, the White House denied the president had launched a “pressure campaign,” and suggested he was taking “appropriate action.”
Rudy Giuliani, former New York City mayor and unpaid private attorney to Trump during the impeachment proceedings, has taken it upon himself to become a personal science adviser to Trump, the Washington Post reported.
Giuliani, who has publicly lauded the drugs on his Twitter feed and a podcast that he records in a studio installed at his New York City apartment, said he had not discussed the drugs with Fauci, but that Trump agrees with him. “I’m sure he thinks I am an ignoramus,” he said of Fauci, to the Post.
“They’ve thrown cold water on it because they are academics,” he said of scientists like Fauci. “ ‘You can’t blind test it.’ I know you can’t blind test it. But we’ve got thousands of people dying, sweetheart. And by the time you blind test it, we’ll have 100,000 people who are dead. Why don’t we get in the real world of being a doctor instead of being an academic?”
Meanwhile, there is growing strife between Trump’s medical advisors and the president, the New York Times reported. On Friday, when the government advised Americans wear masks when out in public, Trump refused to follow suit. While health advisors and some lawmakers are pushing for a unified response to the pandemic such as a uniform stay-at-home order for the entire nation, Trump has resisted and instead shifted blame to the states for being unprepared to deal with the virus.
“I don’t understand why that’s not happening,” Fauci said Thursday night on CNN. “The tension between federally mandated versus states’ rights to do what they want is something I don’t want to get into. But if you look at what is going on in this country, I don’t understand why we’re not doing that. We really should be.”
Takeda enlists partners to assist with its plasma therapy effort
Takeda, which is developing a plasma-derived therapy from the blood of coronavirus patients who have recovered from the respiratory disease, has enlisted blood products company CSL Behring in its mission. Biotest, BPL, LFB, and Octapharma have joined also joined the alliance, which is open to other companies pitching in.
“Leaders lead during uncertainty,” said Bill Mezzanotte, CSL Behring’s head of R&D. “This effort aims to accelerate a reliable, scaleable and sustainable option for caregivers to treat patients suffering from the impact of COVID-19. In addition to pooling industry resources, we will also collaborate with government and academic efforts as a single alliance whenever we can, including important activities like clinical trials. This will make it more efficient in these hectic times for these stakeholders as well.”
British PM Boris Johnson, who has tested positive for Covid-19, is admitted to hospital
The 55-year old Johnson was admitted to the hospital for undisclosed tests as a “precautionary step” on Sunday, after suffering persistent coronavirus symptoms ten days after testing positive for the virus. The news emerged soon after Queen Elizabeth made a rare address — only her fifth such speech in her 68-year reign — urging the nation to follow government rules to stay at home and praised those “coming together to help others.”
Downing Street has said Johnson remains in charge of the government — although foreign Secretary Dominic Raab will chair the government’s emergency COVID-19 meeting on Monday.
Johnson’s pregnant fiancée, Carrie Symonds, said she had spent the past week in bed with symptoms of Covid-19, but said is feeling stronger and is “on the mend.”
Scotland’s chief medical officer Catherine Calderwood — one of the cadre of lawmakers charged with urging the public to stay at home to save lives and protect the National Health Service — has resigned after pictures of her family trip to a second home during the lockdown were published.
“I am deeply sorry for my actions and the mistakes I have made,” she said in a statement.
Bill Gates will contribute billions to Covid-19 vaccine development
Bill Gates, one of the richest people in the world, said the Bill and Melinda Gates Foundation will spend billions to fund the construction of factories for the most promising vaccine efforts, in an interview with comedian Trevor Noah on Thursday. The Foundation has already committed $125 million effort to identify and develop treatments to fight the virus.
More drug developers join the race to develop a Covid-19 treatment
- AI drug discovery company Healx is using its platform to develop drug combinations from approved drugs, in a bid to simultaneously target different aspects of Covid-19 pathology.
- XBiotech and the non-profit BioBridge Global have said they are joining forces to participate in an FDA investigational program for US blood centers to begin collecting and distributing convalescent plasma from individuals who have recovered from Covid-19. XBiotech has developed an antibody test to identify those individuals, while a subsidiary of BioBridge will collect plasma from these donors.
Pfizer joins big drugmakers in offering funds to combat the global effort against Covid-19
Pfizer has committed $40 million in medical and charitable cash grants to address the needs of partners who are working to slow the spread of the virus within communities, it said on Monday. The company joins fellow drugmakers such as Amgen, AstraZeneca, and Takeda in making donations in cash or equipment.
Animals to humans to animals again
It may be unclear how the SARS-CoV-2 virus was contracted by humans in China, but over the weekend a tiger at New York’s Bronx Zoo tested positive for the virus, reportedly via a zoo employee who was asymptomatic.
Nadia, a 4-year-old Malayan tiger that tested positive, was screened for Covid-19 after developing a dry cough along with three other tigers and three lions, said the Wildlife Conservation Society, which manages the zoo, in a statement. All of the cats are expected to recover, it added.
Additional reporting by Jason Mast.
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