Top Stories for Week of April 20, 2020

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Trump gives governors 3-step plan to revive economy soon; many experts doubt it will happen.

The White House is encouraging states to begin opening back up and lifting social-distancing measures put in place to stop the spread of the coronavirus. But Bloomberg News says a review of the outbreaks in states mentioned by the administration as ready to go indicated that they don’t actually meet the criteria to do so. On Thursday (April 16, 2020), President Donald Trump cited several states including Montana and Utah as being “close to safe” to reopen, and said that 29 states will be able to reopen “relatively soon.”

He followed up Friday (April 17, 2020) morning, tweeting that states such as Minnesota, Michigan and Virginia, should “liberate” themselves. Under White House guidelines released Thursday, for states to open up they should have decreasing signs of illness as monitored by health surveillance networks and fewer cases being confirmed by tests over a two-week period, a healthcare system capable of treating all patients, and sufficient diagnostic capacity in place.

Trump added, “You’re talking about those states that are in great shape already.”

When asked about when states would meet the White House criteria, Trump added, “They will be able to go literally tomorrow, yes–because they’ve met all of the guidelines.”

Few of the states name-checked by Trump actually appear to meet the task force’s criteria, however. Responding to a question Thursday, Trump suggested that Hawaii was ready to go. But a spokesperson for Hawaii Governor David Ige, a Democrat, told Bloomberg that the islands haven’t met the goals laid out by the administration. The state has in fact seen a steady increase in documented cases in the last 14 days, and the Hawaii Health Department’s data shows a decrease in the volume in tests in that period. Under the White House criteria, states can open up if a smaller percentage of tests are coming back positive–but only if the number of tests is steady or increasing.

Some states are moving ahead. On Friday, Texas Governor Greg Abbott, a Republican, announced he’d relax restrictions this week. In Idaho, the state is beginning to reopen some non-essential businesses, including flower shops and jewelry stores for curbside pickup ahead of Mother’s Day. North Dakota Governor Doug Burgum, also a Republican, has set guidelines for a gradual reopening process after April 30. Montana will start a “phased reopening” from April 24, Governor Steve Bullock tweeted on Friday, adding, “Because once we begin to reopen, we want to be able to stay open.”

Health experts question the White House’s rules and say they’re too easy to meet. Under the White House guidelines, state health departments should show a downward trajectory of documented cases or of positive tests as a percentage of total tests, within a 14 day period. Healthcare experts take issue with the “or,” saying both should be proven before reopening.

“You can have a downward slope and it’s meaningless,” said George Rutherford, the head of infectious disease and global epidemiology at the University of California San Francisco.

A state with 5,000 positive cases per day that fall to 4,000, and a state that had 100 cases that drop to 20, would both meet the criteria despite huge differences in the prevalence of the virus, he explained.

According to The New York Times, some public health experts feel that American ingenuity, once fully engaged, might well produce advances to ease the burdens. The path forward depends on factors that are certainly difficult but doable, they said: a carefully staggered approach to reopening, widespread testing and surveillance, a treatment that works, adequate resources for healthcare providers, and eventually, an effective vaccine.

Still, it was impossible to avoid gloomy forecasts for the next year. The scenario that Mr. Trump has been unrolling at his daily press briefings–that the lockdowns will end soon, that a protective pill is almost at hand, that football stadiums and restaurants will soon be full–is a fantasy, most experts said.

“We face a doleful future,” said Dr. Harvey V. Fineberg, a former president of the National Academy of Medicine.

COVID-19 Addenda: 1) WHO unsure antibodies protect against COVID-19; 2) GM dispatches first batch of ventilators; and 3) Virus vaccine may be ready for mass production by autumn, Oxford professor says.

The World Health Organization is not sure whether the presence of antibodies in blood gives full protection against reinfection with the new coronavirus, Mike Ryan, the WHO’s top emergencies expert, told a briefing on Friday. Ryan also said that even if antibodies were effective there was little sign that large numbers of people had developed them and were beginning to offer so-called “herd immunity” to the broader population.

“A lot of preliminary information coming to us right now would suggest quite a low percentage of [the] population have seroconverted (to produce antibodies),” he said. “The expectation that…the majority in society may have developed antibodies, the general evidence is pointing against that, so it may not solve the problem of governments.”

General Motors said on Friday (April 17, 2020) it had started delivering the first batch of 54 ventilators to US hospitals treating severely ill COVID-19 patients. GM said the Franciscan Health Olympia Fields hospital in Olympia Fields, Illinois, and Chicago’s Weiss Memorial Hospitals will receive shipments of 10 ventilators each via package delivery company UPS Inc. on Friday.

A third shipment comprising 34 ventilators will be delivered by UPS to the US Federal Emergency Management Agency at the Gary/Chicago International Airport on Saturday to be distributed at other locations. The deliveries are part of a contract awarded to GM by the US Department of Health and Human Services for 30,000 ventilators by the end of August. The contract is worth $489.4 million. GM is working with ventilator firm Ventec Life Systems to produce the equipment.

And, a coronavirus vaccine trial by University of Oxford researchers aims to get efficacy results by September, and manufacturing is already underway. A team led by Sarah Gilbert, a professor of vaccinology, has recruited 500 volunteers from the ages of 18 to 55 for the early- and mid-stage randomized controlled trial. It will be extended to older adults and then to a final stage trial of 5,000 people. Gilbert said that the timing is ambitious but achievable.

“We would hope to have at least some doses that are ready to be used by September,” she said in an interview. “There won’t be enough for everywhere by then, but the more manufacturing we can do starting from now, then the more doses there will be.”

Volunteers to take part in the trial have been abundant, she said, and it’s no longer accepting new subjects.

Despite misgivings, Gilead arthritis drug to be tested in coronavirus study.

Shares in Gilead Sciences Inc. (Foster City CA) jumped 14% over the week to $83.99 after a report suggested that patients with COVID-19 who were treated with remdesivir were “seeing rapid recoveries in fever and respiratory symptoms.” The early data, which were reported in STAT, come from patients treated at the University of Chicago Medicine as part of Gilead’s two Phase 3 studies of the experimental antiviral. According to STAT, the University of Chicago Medicine recruited 125 patients with COVID-19 into the trials, with 113 of these subjects having severe disease.

“The best news is that most of our patients have already been discharged, which is great. We’ve only had two patients perish,” remarked Kathleen Mullane, who is overseeing the studies at the University of Chicago Medicine.

Mullane suggested that data for the first 400 patients in the study would be “locked” by Gilead on April 16, indicating that results would shortly follow.

In a video seen by STAT, Mullane said, “When we start [the] drug, we see fever curves falling,” adding, “We have seen people come off ventilators a day after starting therapy. So, in that realm, overall our patients have done very well.”

However, Mullane also offered caution, partly because the study of patients with severe disease, which includes 2400 participants, does not include a placebo group for comparison.

“Most of our patients are severe and most of them are leaving at six days, so that tells us duration of therapy doesn’t have to be 10 days. We have very few that went out to 10 days, maybe three,” she said.

A spokesperson for the University of Chicago also urged caution on the results, noting that “partial data from an ongoing clinical trial is by definition incomplete and should never be used to draw conclusions about the safety or efficacy of a potential treatment that is under investigation.” Meanwhile, in response to the news, Gilead said “anecdotal reports, while encouraging, do not provide the statistical power necessary to determine the safety and efficacy profile of remdesivir as a treatment for COVID-19.”

Commenting on the study in patients with severe disease, Evercore ISI analyst Umer Raffat noted that it specifically excluded those who are on mechanical ventilation. The trial is investigating five- and 10-day treatment courses of remdesivir and has a primary endpoint of a comparison of patient improvement between the two treatment arms, as measured using a seven-point numerical scale that encompasses death and discharge from hospital, with various degrees of supplemental oxygen and intubation in between.

Other recent findings also support the potential of remdesivir, with results from a cohort analysis demonstrating that the drug improved clinical outcomes in 68% of 53 hospitalized patients with severe complications from COVID-19. However, analysts have been quick to weigh-in on the data, cautioning about drawing any firm conclusions. (Ref: FirstWordPharma)

Former GlaxoSmithKline CEO Andrew Witty to co-lead WHO’s vaccine effort.

UnitedHealth Group Inc.’s (Minnetonka MN) Sir Andrew Witty will take a leave of absence running Optum to “co-lead a global effort of the World Health Organization” to develop a vaccine for the coronavirus strain COVID-19, the company said last week. Witty is CEO of UnitedHealth Group’s fast-growing Optum health services business and previously ran the global drug and vaccine maker GlaxoSmithKline PLC. Witty, who joined the executive suite of UnitedHealth Group when he became CEO of Optum in March of 2018, will take his leave of absence effective April 20 and plans to return to UnitedHealth and Optum by the end of this year, the company said.

Prior to joining UnitedHealth and Optum, Witty was CEO and a director of GSK from 2008 until 2017, having joined the global drug and vaccine giant in 1985. “While CEO of GSK, he gained global recognition for his efforts to develop and expand access to critically needed vaccines,” UnitedHealth said in its statement.

“I am deeply honored to help lead this mission to seek a COVID-19 vaccine and am confident the people of Optum will remain relentless in their work to help their customers, communities and each other each day,” Witty said in a statement from UnitedHealth Wednesday morning.

During Witty’s temporary assignment, UnitedHealth Group CEO David Wichmann will oversee Optum, the company said. “

Andrew brings the perfect combination of deep global health expertise, innovation and operating skills and, above all, a passion for, and considerable success in, developing vaccines to drive this critical effort,” Wichmann said. “The pride we take in Andrew’s willingness to serve during this global health crisis is exceeded only by our confidence in his ability to support the global vaccine development effort as quickly and effectively as possible.”

The announcement of Witty’s departure to WHO came less than 24 hours after President Donald Trump said he would stop funding the health organization, Forbes reports. Trump’s move, amid criticism of his response to combatting COVID-19, was widely criticized by global health leaders both in the US and abroad given the international fight against the deadly virus.

“During the worst public health crisis in a century, halting funding to the World Health Organization (WHO) is a dangerous step in the wrong direction that will not make defeating COVID-19 easier,” American Medical Association president Dr. Patrice A. Harris said. “Fighting a global pandemic requires international cooperation and reliance on science and data. Cutting funding to the WHO–rather than focusing on solutions–is a dangerous move at a precarious moment for the world.”

BARDA awards up to $483 million to help advance Moderna’s COVID-19 vaccine candidate.

The Biomedical Advanced Research and Development Authority (BARDA) has agreed to gamble up to $483 million on Moderna Inc.’s (Cambridge MA) clinical-stage vaccine to guard against SARS-CoV-2–a move that will fund development through a hoped-for BLA filing for accelerated approval while opening the door to a pivotal study as early as the fall of this year. And Endpoints reports that the biotech is launching a recruitment campaign to hire 150 staffers to ramp up a 24/7 schedule on manufacturing designed to quickly scale up to tens of millions of doses.

For Moderna, which invested heavily in its own manufacturing operations early on as part of an ambitious plan to create a groundbreaking player armed with new technology, it’s a chance to make a breakthrough in vaccine development that could establish it as a major new player in a field long dominated by a few giant producers. Their plans now call for producing millions of doses in the fall, and tens of millions next year. The stakes are enormous, for everyone, as the pandemic afflicts millions and the global death count climbs toward 200,000. And they are going all out to make it happen.

Moderna’s messenger RNA tech quickly produced a vaccine candidate dubbed mRNA-1273 that was hustled from the lab straight into a Phase 1 that launched on March 16. Provided the safety data come through, a Phase 2 can get started in this quarter. Phase 3 can get going soon after. Moderna CEO Stéphane Bancel isn’t wasting a minute.

He said that the company has already kicked off a hiring campaign–at risk–that will boost his manufacturing team with additional engineers to manage process and scale-up clinical and regulatory staff needed to back clinical development. And they have more hiring to do to get the full team together as they move from two shifts, five days a week, to nonstop, round-the-clock work every day of the week. In a field where development teams can work decades on 1 vaccine, this is beyond fast, says Endpoints.

It is an attempt to set a new world record that would be tough to beat under any circumstances. Vaccine development typically takes years, sometimes decades. But the global emergency locking down countries and states calls for taking chances that would never have been contemplated before the pandemic frightened billions of people all over the world.

Bancel–whose team, Endpoints argues, is leading the most advanced program in the US–says he is “cautiously optimistic” that they’ll get the safety profile they’re looking for with evidence of neutralizing antibodies needed to guard against the virus.

“Molecular biology is not black magic,” says Bancel, who’s been hammering away at this for the past decade. “With the caveat that the biology, you always learn to be humble.”

But they’ve seen clinical success in CMV, indicating that they know how to reproduce that success for COVID-19. Moderna shares closed the week up a massive 47% to $46.85.

IPO Sector: Once again, there are no initial public offerings scheduled for this week. Renaissance Capital reports there have been 27 IPOs priced so far this year, a -21% change from last year.

Meanwhile last week, Lantern Pharma Inc., a clinical stage oncology biotech using machine learning for drug discovery, filed on Thursday with the SEC to raise up to $29 million in an initial public offering. The company’s AI platform, RADR, allows Lantern Pharma to identify potential therapies which were deemed ineffective in previous studies but may show promise in alternative indications.

Lantern Pharma’s most advanced candidate is LP-100, a potential treatment for prostate cancer that is in a Phase 2 trial. The company has two drugs in the clinic which initially showed promise but failed to pass muster in late-stage studies. The failures can be attributed to a “lack of patient stratification driven by an inability to develop biomarker-driven, precision oncology trials,” Lantern suggested in the SEC filing, indicating its AI capabilities could reverse the compounds’ fortunes.

Dallas, TX-based Lantern was founded in 2013 and plans to list on the Nasdaq under the symbol “LTRN.” The company filed confidentially on January 24, 2020. ThinkEquity and Dougherty & Company are the joint bookrunners on the deal. No pricing terms were disclosed.

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