Coronavirus updates, March 11

U.S. coronavirus cases have topped 1,000 nationwide, according to Johns Hopkins University data, and at least 28 people have died from the disease.

Coronavirus cases are “coming in so intensely now that we’re not able to give a detailed case breakdown,” NYC Mayor Bill de Blasio told reporters, adding that “there are so many [cases] coming forward.”

Washington state COVID-19 cases could reach 64,000 by May if health officials and the public fail to take action to stop the spread now, warned Governor Jay Inslee.

The Port of Los Angeles reported a 22.9% annual drop in container volume for February as low output from Chinese factories dented trans-Pacific maritime trade.

The New York Auto Show and Coachella Valley Music and Arts Festival have been postponed.

https://seekingalpha.com/news/3550405-coronavirus-updates-coming-in-intensely-now

Futures down sharply in nighttime action

The up one day/down the next action continues, and on Wednesday it’s apparently going to be down’s turn again.

Dow, S&P 500, and Nasdaq 100 futures are all lower by more than 2% just after 10 PM ET.

Oil continues its modest rebound, up another 2.9% to $35.36 per barrel.

The 10-year Treasury yield is down 12 basis points 0.68%.

https://seekingalpha.com/news/3550397-futures-down-sharply-in-nighttime-action

FDA Cancels or Postpones Meetings Amid COVID-19 Concerns

Officials at the Food and Drug Administration’s Center for Drug Evaluation and Research are taking the precautionary step of canceling or postponing advisory committee meetings and limiting staff travel in an effort to help curb the spread of the COVID-19.
“The outbreak of respiratory illness caused by a novel coronavirus, COVID-19, that started in China is spreading to other countries, including the United States,” CDER Director Janet Woodcock, MD, said in a memo to CDER staff. “As a precaution, FDA is canceling foreign official agency travel and limiting domestic travel to mission critical only, effective immediately and through April.”
Additionally, the memo notes that “CDER-organized external meetings, conferences, and workshops will be postponed or canceled from March 10 through April.”

“To mitigate the impact on our work, I encourage you to hold meetings with external stakeholders through teleconference, when possible,” she wrote.

Thus far, only a few CDER events on the FDA’s meeting webpage are listed as being canceled or postponed. Some of the affected meetings include a March 10 public meeting on patient-focused drug development for stimulant-use disorder, a March 11 meeting of the Nonprescription Drug Advisory Committee, and a March 30 public meeting on patient-focused drug development for vitiligo, all of which are postponed until further notice. The Center for Biologics Evaluation and Research also has postponed until further notice its U.S.–Japan Cellular and Gene Therapy Conference, originally scheduled for March 12.
Dr. Woodcock also noted in the memo that in relation to inspections, “we plan to use technology and established agreements with our foreign counterparts to minimize disruptions to the drug supply chain and to applications under review, so that Americans can continue to get their medications.”
https://www.medscape.com/viewarticle/926596

Virtual screening for active substances against the coronavirus

The University of Basel is part of the global search for a drug to fight the rampant coronavirus. Researchers in the Computational Pharmacy group have so far virtually tested almost 700 million substances, targeting a specific site on the virus—with the aim of inhibiting its multiplication. Due to the current emergency, the first results of the tests will be made available to other research groups immediately.

Over the past few weeks, the research group in the Department of Pharmaceutical Sciences, led by Professor Markus Lill, has been working with computer-aided methods to identify possible new drugs to combat the current coronavirus outbreak and similar epidemics in the future. In the process, the researchers have tested, albeit virtually, more than 680 substances on one of the virus’s key proteins: its central protease.
This “virtual screening” has already identified several interesting substances that have the potential to inhibit the virus’s critical enzyme—and thus its further multiplication. “Even if the complete development of a drug to fight this particular coronavirus is likely to exceed the duration of the current epidemic, it is important to develop drugs for future coronaviruses. This will make it possible to nip health crises like this one in the bud in the future,” says Lill.
Test results made public
In light of the current crisis, the group took an unusual decision by immediately making the test results publicly available in the form of an open-source preprint. The publication was consulted more than 3,000 times during the first 48 hours alone.
The Basel researchers hope that a larger number of research groups worldwide will test their proposals on the virus and initiate further trials. Normally, when it comes to drug design, the molecules of interest would be experimentally tested with other groups before the results were patented and published. The main focus of other ongoing coronavirus trials is currently on the usability of existing antiviral drugs or the realignment of other drugs.

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Preventing spread of SARS coronavirus-2 in humans

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More information: Inhibitors for Novel Coronavirus Protease Identified by Virtual Screening of 687 Million Compounds: chemrxiv.org/articles/Inhibito … Compounds/11923239/1

https://medicalxpress.com/news/2020-03-virtual-screening-substances-coronavirus.html

Low-risk virus patients urged not to overwhelm hospitals

People at low risk of falling seriously ill with the new coronavirus must do everything possible to avoid overwhelming hospitals, experts have warned.

The nightmare scenario of health authorities around the world involves a sudden explosion of cases that clogs hospitals and health resources.
This is what happened in Wuhan, China where the virus first erupted, with patients lying—and dying—on hospital floors for lack of beds, and health workers crumbling from exhaustion.
The medical experts want to avoid that happening elsewhere and are using social media to tell people, most of whom are not in danger of dying from coronavirus, to #FlattenTheCurve.
“Up to now, people have the impression that this disease poses an individual danger, when in fact the danger is for the population as a whole,” explained Philippe Devos, a Belgian emergency-medicine physician.
“With very rare exceptions, young people are not dying, but when they clog up hospitals that are taking the place of others who will die without proper treatment,” he told AFP.
So far, 80 percent of infections are benign, and the vast majority of fatalities have been among the very elderly already struggling with underlying health problems.
“Every day we can slow down the epidemic is another day hospitals can prepare themselves for cases,” World Health Organization head Tedros Adhanom Ghebreyesus has said on several occasions.
‘Fires blazing’
The progression of infection—known at an epidemic curve—unfolds in three phases corresponding to the rise, peak and decline in the number of cases.
Currently, most countries outside China are in Phase One.
“The longer we can stay in Phase One, the better we can prepare Phase Two,” said Siouxsie Wiles, an associate professor at the University of Auckland.
During Phase Two, holding the number of new cases each day to a minimum— keeping the epidemic curve as flat as possible—is critical.
“Think of COVID-19 as several fires blazing away, with embers shooting off in all directions,” said Wiles.
“Our goal is to stop those embers from turning into another blazing fire.”
Hospitals scrambling to cope with the virus outbreak are hard-put to handle their normal caseload, especially when personnel come down with virus too.
More than 3,300 doctors, nurses and hospital staff in China have been infected with the virus, and at least 13 have died, according to official statistics as of March 4.
“Because of these double whammy—more work with less health workers—patients with serious illnesses will no longer be treated as quickly, and stand a higher risk of dying,” said Devos.
In Italy—the worst-hit country outside China, with more than 10,000 confirmed cases and 631 deaths—front-line healthcare workers have already been forced into triage.
“We decide on the basis of age and health status, as in a war-time situation,” anaesthesiologist Christian Salaroli told the Il Corriere della Sera newspaper.
“Because there is a gap between the number of intensive-care beds and the critically ill, not everyone can be hooked up,” he added.
“If someone between 80 and 95 has serious respiratory failure, it is likely that we won’t be able to follow up.”
#FlattenTheCurve
Doctors and health officials around the world have taken to Facebook and Twitter to promote daily habits that can hold infection rates down, using the hashtag #FlattenTheCurve.
The most important, they say, are washing hands, avoiding unneccessary physical contact (such as shaking hands), coughing in the crook of one’s elbow, and self-isolating when infected.
If the same number of cases are spread over a longer time period, health systems stand a better chance of being able to cope.
With over 1,600 cases and 30 deaths attributed to COVID-19 as of Tuesday, France is “preparing intensive-care units” for a surge of new cases, said health minister Olivier Veran.
Even in normal times, some physicians—once every few years—have been in the unenviable position of deciding who among two or more patients is going to get the last bed in an intensive-care unit.
With the new coronavirus, “that situation is certainly going to arise,” Devos told AFP. “But we want to make sure that such a period lasts a few days, not a few weeks.”
Which is why, he insisted, everyone must adapt their behaviour in ways that minimise the risk of the virus spreading.
“It is a responsibility that each of us has towards others,” he said.
https://medicalxpress.com/news/2020-03-experts-urge-low-risk-virus-patients.html

How Close Are Biotechs To Bringing A COVID-19 Treatment To Market?

The COVID-19 virus has sent the market and the global economy into a tailspin. The Organisation for Economic Co-operation and Development slashed its global growth forecast for 2020 Monday by 0.5 points to 2.5% versus already-weak 2.9% growth in 2019.
Global banks have begun talking up the economy with the promise of stimulus injection.
As the world and China in particular battle the deadly pandemic, a small batch of biotechs and a handful of big pharma companies are racing against time to bring to the market potential treatment and/or vaccines to combat the virus.

Rocky R&D Pathway For Coronavirus Products

Investors scurrying for cover amid the bloodbath in the stock market are investing in biotechs that are targeting the new coronavirus.

COVID-19 levered biotechs are offering investors an opportunity due to the kind of returns the stocks can generate in the eventuality that R&D efforts come to fruition.
Given that most of the investigational therapies are vaccines are only in the animal testing stage, is it too early to take a headlong plunge into these stocks?
“Given the community spread in the U.S., particularly in the states of Washington and California, we believe the current administration’s support for rapid development of vaccines and therapies in the U.S. could pave the way for an accelerated regulatory pathway to be made available by government agencies for the rapid market entry of such products that show conclusive efficacy against COVID-19,” H.C. Wainwright analyst Raghuram Selvaraju said in a note.
The analyst estimates it would take around 18-24 months to complete the clinical development of a COVID-19 vaccine.
Benzinga reviewed the COVID-19-related updates from biotechs to gain an understanding of how close each is in bringing a treatment or vaccine to market.

Gilead: The Frontrunner?

Large-cap biopharma Gilead Sciences, Inc.’s GILD 1.61% investigational drug remdesivir has the World Health Organization’s seal of approval.
“There is only one drug right now that we think may have real efficacy and that’s remdesivir,” WHO assistant director-general Bruce Aylward said at a late February press briefing in China.
Remdesivir is an investigational nucleotide analog with broad spectrum antiviral activity that has shown in vitro and in vivo activity in animal models against the viral pathogens MERS and SARS.
Gilead has initiated two Phase 3 studies in adults diagnosed with COVID-19 following the FDA’s rapid review and acceptance of the IND filed by the company.
The company said it expects to enroll 1,000 patients at medical centers, mainly in Asia, beginning in March.
Chinese health authorities have initiated two trials with remdesivir in infected patients in the Hubei province, and those clinical trial results are anticipated in April.
The U.S. National Institute of Allergy and Infectious Diseases, or NIAID, has initiated a Phase 2 study to test remdesivir in hospitalized adult patients diagnosed with COVID-19.

Inovio Sets Timeline

Inovio Pharmaceuticals Inc INO 42.01% is working with Chinese contract development manufacturer Beijing Advaccine Biotechnology to develop INO-4800, a DNA vaccine for COVID-19, unveiled an accelerated development timeline.
The company expects to commence a Phase 1 trial in April and mass produce the vaccine by the end of 2020 to be used in case of emergency or for further trials.
One advantage of DNA vaccines is that they do not require refrigeration or cold chain logistics, according to H.C. Wainwright.

Moderna’s Vaccine Candidate To Enter Clinics

Moderna Inc MRNA 8.03% said in late February it has shipped MRNA-1273, its mRNA vaccine targeting COVID-19, to the NIAID to be used in a Phase 1 study.
H.C. Wainwright said Moderna could begin Phase 1 trials around the same time as Inovio.

Novavax In Animal Testing

Novavax, Inc. NVAX 6.29% said in late February that it is assessing multiple nanoparticle vaccine candidates in animal models to zero in on an optimal candidate for human testing.
The company said it expects clinical trials to begin by the end of spring 2020.

Vir Biotech Identifies Antivirals

Vir Biotechnology Inc VIR 23.31% is working with WuXi Biologics on a COVID-19 treatment. The company said it has identified a number of monoclonal antibodies that bind to COVID-19 and is conducting research to determine if these can be effective as treatment and/or prophylaxis against the virus.

Cocrystal Pharma Licenses Treatment Candidates

Cocrystal Pharma Inc COCP 16.43% said Feb. 24 it has licensed from the Kansas State University Research Foundation antiviral compounds to treat norovirus and coronavirus infections. The company said it plans to pursue preclinical and clinical development of these compounds.

NanoViricides Screens Compounds

NanoViricides Inc NNVC 22.25% said in its fourth-quarter earnings release Feb. 24 it intends to perform initial testing of drug candidates for safety and effectiveness in cell culture studies in its own BSL-2 virology laboratory at its Shelton campus, using low-threat coronavirus strains.

Vaxart’s Vaccine Program Kicks Off

Vaxart Inc VXRT 31.16% said in late January it has begun work on a program to develop an oral COVID-19 vaccine.
The company said it plans to generate vaccine candidates based on the published genome of the coronavirus.

Glaxo Lends Tech To Enhance Vaccine Efficiency

GlaxoSmithKline plc GSK 0.71%, though not developing a vaccine, has forged two tie-ups to aid COVID-19 vaccine research.
The company announced a collaboration with the Coalition of Epidemic Preparedness Innovations, or CEPI, to provide its pandemic vaccine adjuvant vaccine technology to enhance the development of an effective vaccine against COVID-19.
An adjuvant is added to vaccines to enhance its immune response. CEPI will work with Glaxo and entities funded by it that want to test their vaccine platform with Glaxo’s adjuvant technology.
Glaxo also announced Feb. 24 a research collaboration with Chinese biotech Clover for the latter’s protein-based COVID-19 vaccine candidate S-Trimer, which is to be tested with the former’s pandemic adjuvant system in preclinical studies.

J&J, Sanofi Work With BARDA

Johnson & Johnson JNJ 3.96% said in mid-February that its Janssen unit will work along with the Biomedical Advanced Research and Development Authority, or BARDA, on potential treatments for COVID-19.
Janssen will work with the Belgium-based Rega Institute for Medical Research for screening potential compounds.
The company said it is working with BARDA on a COVID-19 vaccine that will leverage its AdVac and PER.C6 technologies, which the company said will help rapidly upscale production of an optimal vaccine candidate.
Sanofi SA SNY 2.08% also has a working relationship with BARDA to develop a COVID-19 vaccine using its recombinant DNA platform that it said will help produce an exact genetic match to proteins or antigenfound on the surface of the virus.
This could be formulated to stimulate an immune response to protect against the virus, Sanofi said.

Pfizer Joins The Race

Pfizer Inc. PFE 2.46% reportedly said Monday it has identified some antiviral compounds from its development pipeline that could potentially treat COVID-19 infection.
The pharma company said it plans to work with a third party to screen the compounds, with the results from the screening expected by the end of March. If they are found effective, Pfizer said it plans to begin clinical trials by the end of the year.

The Race For COVID-19 Drugs

Gilead as well as Moderna and Inovio could have an edge over the others, as Gilead’s remdesivir is already in the clinics, while the latter two are set to start Phase 1 trials soon.
Most others are still screening compounds or pursuing animal testing.
The sell-side is guarded in its view regarding the value a potential therapy/vaccine could bring to its developer.
“Previous potential therapeutics for pandemics have failed to generate value in the medium-to-long term,” Baird analyst Madhu Kumar said in a recent note.
https://www.benzinga.com/analyst-ratings/analyst-color/20/03/15470079/how-close-are-biotechs-to-bringing-a-covid-19-treatment-to-market

We’re learning how to beat coronavirus, but health workers need more training

There is good news and bad news about coronavirus.
First, there is reason for optimism. The virus struck only four months ago, yet we ­already know its genetic features. It took scientists years to get that far with HIV. Antiviral drugs are in development, and a vaccine could be available within 18 months. The pace of scientific progress is breathtaking.
So is human ingenuity. The Bill and Melinda Gates Foundation will soon offer home coronavirus testing kits, starting in the hard-hit Seattle area. Anyone who is worried can fill out an online questionnaire, receive a nasal swab kit in the mail, use it and send it to the lab. Positive results will be shared with public-health officials, who will help infected people get medical care and self-quarantine. That’s progress.
Meanwhile, the Centers for Disease Control and Prevention announced Monday that in ­Korea, no one under 30 has died from coronavirus. In Japan, no one under 50. Our children ­appear safe. That’s a blessing.
But there are serious concerns. Doctors at Johns Hopkins University are cautioning that hospitals could become “disease amplifiers.” If you don’t have coronavirus before you go into the hospital, the risk is you will get it while you are there.
The CDC is warning that the outbreak is only beginning, and “there’s a good chance many will become sick.”
No one knows how many will need hospital care. But hospitals in New York and across the nation expect to be overwhelmed. The impact will be “severe in the best of circumstances,” warns the Johns Hopkins report.
To make room for the infected, hospitals are already ­devising emergency strategies that include discharging other patients sooner than usual, converting single rooms into doubles, creating makeshift isolation facilities, buying nearby motels and even erecting temporary wards in parking lots.
Surgeons are alerting patients that elective procedures may have to be canceled.
Hospitals will be short on space and equipment, and worst of all, short on staff. Already the coronavirus is infecting some health-care workers, and forcing others into self-quarantine ­because they have been exposed.
Last week, Congress enacted a whopping $8.3 billion coronavirus emergency bill. It’s larded with giveaways to international groups and projects overseas, including money for the CDC to purchase “official motor vehicles in foreign countries.” The agency ought to be called the Center for the Disbursement of Cash Around the World.
Paying to fight disease overseas is smart, but the bill goes overboard. The bureaucrats running the federal health agencies need to adjust their globalist biases and focus on protecting Americans.

The bill ignores one of the most urgent needs — an aggressive infection-control campaign to prepare hospital staff. That’s a serious oversight. The incident last week at St. John’s Episcopal Hospital in Far Rockaway, Queens, shows why.
On March 3, an Uber driver walked into the St. John’s emergency room unknowingly ­infected. He complained of flu-like symptoms, but the staff sent him home. He returned sicker a few hours later. By the time he was put in isolation, up to 40 doctors, nurses and other hospital staff had contact with him and are now being monitored. Worse, the incident exposed ­numerous patients and hospital visitors to the virus.
Expect this mistake to be ­repeated all over the city and nation, needlessly infecting patients and hospital staff.
American health-care workers need additional training on how to recognize patients at risk of infection and isolate them quickly. They need to get up to speed on cleaning their hands, wearing protective gear and making sure medical equipment like wheelchairs and blood-pressure cuffs are disinfected between each use.
On another front, research ­announced Monday explains why coronavirus is so menacing. People infected with it shed 1,000 times more virus than people infected with SARS, an earlier global virus. Shedding the virus in saliva, sputum and other bodily fluids is what makes people contagious. SARS infected only 8,000 people before petering out, while the new coronavirus has already infected 110,000 worldwide and continues to spread.
Fortunately, scientists are arming us with knowledge to battle this contagion.
Betsy McCaughey, a former lieutenant governor of New York, is chairwoman of the Committee to Reduce Infection Deaths.
https://nypost.com/2020/03/10/were-learning-how-to-beat-coronavirus-but-health-care-workers-need-more-training/