Top Stories for Week of May 11, 2020

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Quarrel flares up between White House and the CDC over reopening guidelines.

The Centers for Disease Control and Prevention has repeatedly found its suggestions for fighting the coronavirus outbreak taking a backseat to other concerns within the Trump administration. That leaves public health experts outside government fearing the agency’s decades of experience in beating back disease threats are going to waste.

“You have the greatest fighting force against infectious diseases in world history. Why would you not use them?” said Dr. Howard Markel, a public health historian at the University of Michigan.

The complaints have sounded for months. But they have become louder following repeated revelations that transmission-prevention guidance crafted by CDC scientists was never adopted by the White House. The latest instance surfaced Thursday, when The Associated Press reported that President Donald Trump’s administration shelved a CDC document containing step-by-step advice to local authorities on how and when to reopen restaurants and other public places during the current pandemic.

The administration has disputed the notion that the CDC had been sidelined, saying the agency is integral to the administration’s plans to expand contact tracing nationwide. But it’s clear that the CDC is playing a much quieter role than it has during previous outbreaks. The nation’s COVID-19 response has seen a strange turn for the CDC, which opened in 1946 in Atlanta as The Communicable Disease Center to prevent the spread of malaria with a $10 million budget and a few hundred employees.

Today, the agency has a core budget of more than $7 billion–a sum that has been shrinking in recent years–and employs nearly 11,000 people. The CDC develops vaccines and diagnostic tests. Its experts advise doctors how best to treat people, and teach state, local and international officials how to fight and prevent disease. Among the CDC’s elite workforce are hundreds of the world’s foremost disease investigators–microbiologists, pathologists and other scientists dispatched to investigate new and mysterious illnesses.

In 2009, when a new type of flu virus known at the time as swine flu spread around the world, the CDC held almost daily briefings. Its experts released information on a regular basis to describe the unfolding scientific understanding of the virus and the race for a vaccine. The federal response to the coronavirus pandemic initially followed a similar pattern. CDC first learned in late December of the emergence of a new disease in China, and the US identified its first case in January.

In those early days, the CDC held frequent calls with reporters. It also quickly developed a test it could run at its labs, and a test kit to be sent to state health department labs to detect the virus. But February proved to be a disaster. The test kit was flawed, delaying the ability of states to do testing. A CDC-run surveillance system, meant to look for signs of the virus in people who had thought they had the flu, was slow to get off the ground. Officials at the CDC and at other federal agencies were slow to recognize infections from Europe were outpacing ones from travelers from China.

Meanwhile, US deaths from the novel coronavirus have topped 78,000 deaths as of Saturday, according to a Reuters tally. Deaths in the US, the epicenter of the global pandemic, have averaged 2,000 a day since mid-April despite efforts to slow the outbreak. The death toll is higher than any fatalities from the seasonal flu going back to 1967 and represents more US deaths than during the first 10 years of the AIDS epidemic, from 1981 to 1991.

US cases are over 1.32 million as new infections continue to rise in many states. Some health experts are predicting a resurgence in deaths later this summer as US states lift stay-at-home orders and Americans begin eating out at restaurants and going to gyms again.

COVID-19 Addenda: 1) An aide to Pence tested positive on Friday; 2) Malaria drug touted by Trump for coronavirus fails another test; 3) With CRISPR, a possible quick test for the Coronavirus; 4) China open to probe of origins of coronavirus says envoy report, and 5) Scientists create antibody that defeats Coronavirus in lab.

An aide to Vice President Mike Pence tested positive for the coronavirus on Friday (May 8, 2020) morning, delaying a scheduled flight to Des Moines for more than an hour. Several Pence aides were escorted from the plane at Joint Base Andrews before departure, according to an administration official with knowledge of the situation. It was the second confirmed case to rattle the White House last week. After a military aide at the White House tested positive for the virus, Mr. Trump said on Thursday that he and Mr. Pence, as well as other members of the White House staff who were in contact with the aide, would be tested every day.

The malaria treatment repeatedly championed by US President Donald Trump as a “game changer” in the fight against the novel coronavirus has again failed to show a benefit in patients hospitalized with COVID-19, according to a study released on Thursday (May 7, 2020). While the study being published in the New England Journal of Medicine had certain limitations, doctors reported that the use of hydroxychloroquine neither lessened the need for patients requiring breathing assistance nor the risk of death.

A team of scientists has developed an experimental prototype for a fairly quick, cheap test to diagnose the coronavirus that gives results as simply as a pregnancy test does. The test is based on a gene-editing technology known as CRISPR, and the researchers estimated that the materials for each test would cost about $6. “

We’re excited that this could be a solution that people won’t have to rely on a sophisticated and expensive laboratory to run,” said Feng Zhang, a researcher at the Broad Institute in Cambridge, MA, and one of the pioneers of CRISPR technology.

Dr. Zhang and his colleagues’ method has not yet been tested by other scientists, nor have their findings been published by a scientific journal that subjected them to scrutiny by independent experts.

China is open to an independent investigation to determine the origins of the coronavirus now sweeping the world, its ambassador to Berlin told a German magazine on Friday, amid US allegations that it came from a laboratory. China has dismissed as groundless US and Australian questioning of how it had handled the coronavirus pandemic, saying it had been open and transparent, despite growing skepticism about the accuracy of its official death toll.

“We are open to an international investigation,” Wu Ken told Der Spiegel magazine in an interview. “We support the exchange of research among scientists.”

And scientists created a monoclonal antibody that can defeat the new coronavirus in the lab, an early but promising step in efforts to find treatments and curb the pandemic’s spread. The experimental antibody has neutralized the virus in cell cultures. While that’s early in the drug development process–before animal research and human trials–the antibody may help prevent or treat COVID-19 and related diseases in the future, either alone or in a drug combination, according to a study published last Monday in the journal Nature Communications. More research is needed to see whether the findings are confirmed in a clinical setting and how precisely the antibody defeats the virus.

Jobless rate soars to 14.7%, highest since Great Depression.

It took just one month for the labor market in the world’s largest economy to sink like a brick. It will take longer for the damage to be fully realized. In the harshest downturn for American workers in history, employers cut an unprecedented 20.5 million jobs in April, tripling the unemployment rate to 14.7%, the highest since the Great Depression era of the 1930s. And Bloomberg News says it’s only set to worsen in May, as cuts spread further into white-collar work.

“It’s devastating,” said Ryan Sweet, head of monetary policy research at Moody’s Analytics. “There’s someone behind each of these numbers. It’s going to take years to recover from this. There’s a case to be made that a lot of these are temporary layoffs, so hopefully people can return to work quickly as we begin to reopen the economy–but there’s no guarantee in that.”

The coronavirus pandemic brought the US economy to a standstill after a record-long expansion, with April’s losses erasing roughly all of the jobs added over the past decade. It also laid bare just how precarious employment is for vast swaths of Americans, with an outsize impact on lower-paid workers as well as women and minorities.

With a steep recession underway, the destruction of jobs heaps election-year pressure on President Donald Trump to restart the economy and show results by November. But with little containment of a contagious disease that’s killed over 78,000 Americans and counting, business is returning unevenly and slowly if at all, and signs are mounting that many employers will be forced to make the cuts permanent. The pandemic’s initial tremors hit those least able to absorb the blow, with April’s job losses concentrated in lower-wage labor, from hospitality to retail and restaurants. In May, layoffs will extend further into white-collar positions, according to Lydia Boussour of Oxford Economics.

The April report “really reflects the first-round effect of the COVID-19 crisis, so all these industries that are really on the front line were directly hit by the lockdowns and fear,” she said.

In May, the job losses will likely be in the “second-round” of companies including more professional positions, corporate offices, and higher-earners, she said.

With stimulus checks from the US government making up a smaller share of income for such people, the deepening employment hole could fan calls for a fourth round of fiscal aid from Congress–on top of trillions of dollars already dispatched. The Federal Reserve is likely to keep pumping money into the economy while leaving interest rates near zero for an extended period. There’s also risk in coming months that a recession will morph into a deeper depression, or a prolonged and sustained downturn–if a second wave of infections closes down business again after some states reopen. That’s becoming more and more likely, according to Moody’s Analytics, which projects a peak unemployment rate in May of about 17%.

Gilead signals steps to widen global access to remdesivir for COVID-19 patients, but access is highly random.

National Institute of Allergies and Infectious Diseases (NIAID) chief Anthony Fauci greeted recent positive data on remdesivir as a pivotal moment in the fight against COVID-19, and doctors across the country welcomed the news that they would, at last, be able to give patients a drug that had at least some proven effect. But since the FDA authorized its use last Friday, the process of getting that drug to patients has been far from smooth, says Endpoints.

Unlike with emergency-authorized drugs in previous outbreaks, such as when the FDA authorized peramivir during the 2009 H1N1 flu pandemic, the federal government has not created a portal for hospitals to apply for medication or outlined criteria for how the drug will be distributed and to whom. The system has provoked outrage among doctors, who say the drug has not always gone to the places with the highest caseloads and that they don’t know how to get access, sometimes leading to wrenching conversations with patients who saw the news and want the best possible care.

Gilead Sciences Inc. (Foster City CA), the drugmaker, said it will donate enough remdesivir for around 140,000 patients to the federal government, who will be in charge of distributing it. When pressed, HHS and FEMA have shifted blame over who will be in charge of allocating that donation. Last Tuesday, 32,000 doses were shipped to Indiana, Massachusetts, New Jersey, New York, Rhode Island, Tennessee and Virginia, Axios reported, but many went to “less impacted counties.”

Axios quotes one senior HHS official as saying, “Some went to the wrong places, some went to the right places. We don’t know who gave the order. And no one is claiming responsibility.”

Subsequently, at Wednesday’s White House Task Force meeting, Vice President Mike Pence reportedly told HHS Secretary Alex Azar to take responsibility for distribution. A White House spokesperson then said HHS will send the second tranche of the drug to 16 states Thursday night and Friday.

In the meantime, at least one infectious disease doctor in San Francisco has been publicly keeping track of hospitals that have been approved or rejected to receive the drug. The data are here.

The Belgian startup miDiagnostics NV (Flanders) is developing technology to diagnose diseases quickly, accurately and at the point-of-care using a silicon lab-on-a-chip and nanoscale-precision microfluidics. Having good diagnostics in place can save lives. This principle is especially true in times of crisis, such as the current coronavirus pandemic.

However, producing good diagnostics isn’t a simple task, says Labiotech.eu. In modern healthcare systems, diagnostic tests generally involve a trade-off between speed, accuracy, and cost. Most tests are carried out centrally in dedicated labs, which can be limited by time and capacity. Although there are options available for quicker point-of-care diagnoses, they often involve expensive machinery or aren’t accurate enough to base clinical decisions on.

Spun off from the Leuven-based Interuniversity Microelectronics Centre (IMEC) in 2015, miDiagnostics aims to overcome this issue by developing a diagnostic lab-on-a-chip platform that could reconcile speed with cost and accuracy of testing. Its technology consists of tiny disposable silicon chips that analyze biomarkers in a drop of blood such as viral and bacterial DNA, and return results in around ten minutes.

“Our silicon chip allows miniaturization of diagnostic tests, reducing the cost per test and enabling them to be conducted as close as possible to the patient, with an almost immediate read-out of results,” Nicolas Vergauwe, CEO of miDiagnostics, said. “They can also be easily mass-produced, leveraging existing silicon chip manufacturing technologies available across the globe.”

The labs-on-chips use capillary forces to process the blood samples, such as detecting the amount of blood and diluting it. The samples are then analyzed by a specially designed reader device, which can be adapted to detect cells, genetic material from pathogens, or proteins and small molecules. The company uses the term “nanofluidic processor” for its silicon chips.

According to Vergauwe, this means that the chips’ measurements are precise to within a tenth of a nanoliter, or around a millionth of a drop of water.

“To our knowledge, such a level of control is only possible by applying silicon chip technology,” Vergauwe explained. “The centralized, lab-based model isn’t working [anymore],” he concluded. “We predict a paradigm shift in the way diagnostics are carried out–moving from the lab to other appropriate settings–whether a community health center or someone’s home.”

IPO Sector: Ayala Pharmaceuticals Inc., a Phase 2 biotech developing small-molecule therapies for aggressive cancers, raised $55 million by offering 3.7 million shares at $15, the midpoint of the $14 to $16 IPO range. The Israeli biotech raised 10% more than expected; it originally filed to offer 3.3 million shares. Ayala Pharmaceuticals now commands a fully diluted market value of $189 million.

Ayala’s lead candidate AL101 is an injectable small molecule gamma secretase inhibitor (GSI) in an ongoing Phase 2 trial for recurrent or metastatic adenoid cystic carcinoma in patients with Notch pathway mutations. The company’s second candidate, AL102, is an oral GSI being developed for the treatment of desmoid tumors. Ayala in-licensed both candidates from Bristol-Myer Squibb in late 2017. Ayala Pharmaceuticals was founded in 2017 and lists on the Nasdaq under the symbol “AYLA.” Citi and Jefferies are the joint bookrunners on the deal. Shares closed the week up 3 cents at $15.03.

Elsewhere, Renaissance Capital reports that scientists from several institutions have developed a treatment using antibodies found in llamas, called single-domain antibodies, to fight SARS-CoV-2 (COVID-19), a strain naturally found in bats. Two biotech IPOs from 2017 are developing therapies using llama-derived single-domain antibodies. Ablynx (ABLX) yielded strong returns following its public debut in October 2017, capped by Sanofi’s $4 billion acquisition in June 2018 at a 200% premium to the IPO price.

Ablynx is now working with Translate Bio to develop an mRNA vaccine for COVID-19. Argenx (ARGX), which IPO’d a few months before Ablynx, is also developing therapies using llama antibodies, and has traded up over 10% in the last month for a 756% return from IPO. While not focused on llama antibodies, 2018 IPO Moderna (MRNA) has risen steadily since announcing its progress developing a COVID-19 vaccine based on its messenger RNA platform.

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