Top Stories for Week of June 15, 2020

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Fears of second surge of SARS-CoV-2 follow big spike in hospitalizations.

States are rolling back lockdowns, but the coronavirus isn’t done with the US. Not by a long shot, says the Associated Press. Cases are rising in nearly half the states, according to an AP analysis, a worrying trend that could intensify as people return to work and venture out during the summer.

In Arizona, hospitals have been told to prepare for the worst. Texas has more hospitalized COVID-19 patients than at any time before. And the governor of North Carolina said recent jumps caused him to rethink plans to reopen schools or businesses. There is no single reason for the surges. In some cases, more testing has revealed more cases. In others, local outbreaks are big enough to push statewide tallies higher.

But experts think at least some are due to lifting stay-at-home orders, school and business closures, and other restrictions put in place during the spring to stem the virus’s spread. The increase in infections pulled stocks down sharply Thursday on Wall Street, dragging the Dow Jones Industrial Average more than 1,800 points lower and giving the S&P 500 its worst day in nearly three months. The infections deflated recent optimism that the economy could recover quickly from its worst crisis in decades.

The virus is also gradually fanning out.

“It is a disaster that spreads,” said Dr. Jay Butler, who oversees coronavirus response work at the US Centers for Disease Control and Prevention. “It’s not like there’s an entire continental seismic shift and everyone feels the shaking all at once.”

That is also happening globally. Places that suffered early on such as China, Italy and Spain have calmed down but Brazil, India and other countries that were spared initially are seeing large increases. The world is seeing more than 100,000 newly-confirmed cases every day, according to data from Johns Hopkins University. The virus first landed on the US coasts carried by international travelers infected abroad. For months, the epicenter was in northeastern states. More recently, the biggest increases have been in the South and the West.

Looking ahead, the point of lockdowns was to avoid a tidal wave of infection and death, to at least flatten the curve so hospitals weren’t overwhelmed, notes Bloomberg News.

“We now know that had America started lockdowns a few weeks earlier, most of its 113,000 dead could have been spared. Medical experts repeatedly warned that reopening too soon would cause new spikes, and force a second shutdown.”

With the US now surpassing 2 million confirmed COVID-19 infections, Treasury Secretary Steve Mnuchin said there shouldn’t be a second shutdown even if there is a second wave. That decision, of course, is up to governors, not the White House. Texas, like Florida, is one of the states that reopened earlier than advised, and it’s in trouble. Houston is considering doing what Mnuchin said shouldn’t be done, since its mayor said the city is “approaching the precipice of a disaster.” The US has witnessed over one-quarter of all coronavirus deaths on Earth, and more than one-quarter of all confirmed infections. These are all the more staggering statistics with the US population a mere 4.25% of the global total.

COVID-19 Addenda: 1) Oxford study finds no clinical benefit for hydroxychloroquine in hospitalized COVID-19 patients; 2) California startup aims to monitor social distancing and face masks using drones; 3) Potential COVID-19 vaccine from China shows promise in animal tests; and 4) Widespread mask wearing could prevent COVID-19 second waves.

The University of Oxford reported Friday that data from the RECOVERY trial of drugs for COVID-19 indicate that hydroxychloroquine provided “no clinical benefit” to patients hospitalized with the infection, and enrollment in this arm of the study has stopped. “These data convincingly rule out any meaningful mortality benefit of hydroxychloroquine in [these] patients,” chief investigators Peter Horby and Martin Landray said in a joint statement, adding that full results would be made available as soon as possible.

A total of 1,542 patients were randomized to hydroxychloroquine and compared with 3,132 patients who received usual care alone. The Oxford researchers said 28-day mortality for the two groups was 25.7% and 23.5%, respectively, a difference that was not statistically significant. They added that there was also “no evidence of beneficial effects” on hospital stay duration or other outcomes.

Airspace Systems Inc., a San Leandro, CA-based startup company that makes drones that can hunt down and capture other drones, on Thursday released new software for monitoring social distancing and face-mask wearing from the air. The software analyzes video streams captured by drones and can identify when people are standing close together or points where people gather in clusters. The software can detect when people are wearing masks.

The system can also process video captured by ground-based cameras, and Airspace aims to sell the system to cities and police departments. Airspace says the system does not use facial recognition and does not save images of people or pass those images to Airspace’s customers. Instead, it generates text-based data on how many people in a given area are crowded together and what percentage of people are wearing masks, generating alerts.

A potential COVID-19 vaccine being developed by Chinese researchers showed promise in trials in monkeys, triggering antibodies and raising no safety issues, researchers said, and a human trial with more than 1,000 participants is under way. The vaccine candidate, called BBIBP-CorV, induced high-level neutralizing antibodies that can block the virus from infecting cells in monkeys, rats, guinea pigs and rabbits, researchers said in a paper published online by the medical journal Cell.

“These results support the further evaluation of BBIBP-CorV in a clinical trial,” researchers said in the paper.

BBIBP-CorV, developed by Beijing Institute of Biological Products affiliated to state-owned China National Pharmaceutical Group (Sinopharm), is among five candidates China is testing in humans.

And population-wide face mask use could push COVID-19 transmission down to controllable levels for national epidemics, and could prevent further waves of the pandemic disease when combined with lockdowns, according to a study published in the “Proceedings of the Royal Society A” scientific journal. The research, led by scientists at Britain’s Cambridge and Greenwich Universities, suggests lockdowns alone will not stop the resurgence of the new SARS-CoV-2 coronavirus, but that even homemade masks can dramatically reduce transmission rates if enough people wear them in public.

“Our analyses support the immediate and universal adoption of face masks by the public,” said Richard Stutt, who co-led the study at Cambridge.

He said combining widespread mask use with social distancing and some lockdown measures, could be “an acceptable way of managing the pandemic and re-opening economic activity” before the development of an effective vaccine.

Moderna extolls its Phase 3 COVID-19 vaccine with promising mouse data.

A study of Moderna Inc.’s (Cambridge MA) COVID-19 vaccine in mice lends some assurance that it will not increase the risk of more severe disease, and that one dose may provide protection against the novel coronavirus, according to preliminary data released on Friday. Prior studies on a vaccine for SARS–a close cousin to the new virus that causes COVID-19–suggests vaccines against this type of virus might have the unintended effect of causing more severe disease when the vaccinated person is later exposed to the pathogen, especially in individuals who do not produce an adequately strong immune response.

Scientists have seen this risk as a key hurdle that must be cleared before vaccines can be safely tested in thousands of healthy people, Reuters reports. While the data released by the US National Institutes of Allergy and Infectious Disease (NIAID) and Moderna was encouraging, mouse data are no guarantee of what will happen in humans. The vaccine is currently in midstage testing in healthy volunteers. Moderna said on Thursday it plans to begin final-stage trials enrolling 30,000 people in July.

In the new study, six-week-old mice received one or two shots of a variety of doses of Moderna’s vaccine, including doses considered not strong enough to elicit a protective immune response. Researchers then exposed the mice to the virus. Subsequent analyses looking for signs of disease enhancement suggest that “sub-protective” immune responses do not cause what is known as vaccine-associated enhanced respiratory disease, a susceptibility to more severe disease in the lungs.

“Subprotective doses did not prime mice for enhanced immunopathology following (exposure),” Dr. Barney Graham of the Vaccine Research Center at NIAID and colleagues wrote in the not yet peer reviewed manuscript, posted on the bioRxiv website.

Further testing also suggested that the vaccine induces potent neutralizing antibody responses needed to block the virus from infecting cells.

The vaccine also appeared to protect against infection by the coronavirus in the lungs and noses without evidence of toxic effects, the team wrote. They noted that the mice that received just one dose of the vaccine before exposure to the virus seven weeks later were “completely protected against lung viral replication,” suggesting that a single vaccination prevented the virus from making copies of itself in the lungs.

Low or asymmetrical handgrip strength may be an indicator of cognitive decline in seniors, new research suggests. Investigators analyzed handgrip strength in over 17,000 adults aged 50 years and older and found that those with both asymmetry and weakness had a twofold increase risk of accelerated cognitive decline. In particular, those with the greatest odds for lower cognitive functioning had considerably more strength in their nondominant than their dominant hand.

“Having weakness, as measured by maximal handgrip strength, and/or wide strength differences between hands, could be a clue for low cognitive functioning,” lead author Ryan McGrath, PhD, assistant professor in the Department of Health, Nutrition, and Exercise Sciences, North Dakota State University, told Medscape. “If a person has weakness and/or handgrip strength asymmetry, a more comprehensive cognitive evaluation may want to be considered–or even evaluations of other age-related health conditions such as frailty,” McGrath said.

The study was published May 30 in the Journal of the American Geriatric Society.

“There is an accumulating amount of evidence that physical measures, such as handgrip strength, are associated with cognitive impairment,” McGrath said.

Previous studies focusing on cognition indicate that imbalances in muscle strength “could be linked to the neural system deficits that drive low cognitive functioning.” The researchers therefore “wanted to enhance handgrip strength protocols by also evaluating handgrip strength asymmetry because we are usually only interested in maximal handgrip strength,” said McGrath. Keith Fargo, PhD, director of scientific engagement for the Alzheimer’s Association, encourages healthcare providers “to use measure of handgrip strength, given the robust health information it provides and procedural ease.”

However, he cautioned, handgrip strength “methodologies are continually evolving and the associations of handgrip strength with clinically relevant outcomes are wide-ranging, thus healthcare providers should understand how to administer handgrip strength protocols and what handgrip strength is assessing.”

IPO Sector: Burning Rock Biotech Co. Ltd., which provides DNA sequencing-based cancer therapy selection tests in China, raised $223 million by offering 13.5 million ADSs at $16.50, above the range of $13.50 to $15.50. The company provides next generation sequencing-based (NGS-based) cancer therapy selection tests that are used to assist physicians in selecting the most effective therapy for cancer patients.

It currently offers 13 NGS-based cancer therapy selection tests applicable to a broad range of cancer types, including lung, gastrointestinal, prostate and breast, among others. The Guangzhou, China-based company was founded in 2014 and booked $49 million in revenue for the 12 months ended March 31, 2020. At pricing, Burning Rock commands a $1.7 billion market cap. Burning Rock lists on the Nasdaq under the symbol “BNR.” Morgan Stanley, BofA Securities, and Cowen acted as lead managers on the deal. Shares closed the week up 49% to $24.63.

Elsewhere, Vaxcyte Inc., a preclinical biotech developing next-generation pneumococcal vaccines, raised $250 million by offering 15.6 million shares at $16, the high end of the range of $14 to $16. Vaxcyte offered 1.6 million more shares than anticipated.

The company’s pipeline contains pneumococcal conjugate vaccine (PCV) candidates that it believes are the most broad-spectrum PCV candidates currently in development. Its lead candidate, VAX-24, is a 24-valent investigational PCV designed to provide broad-spectrum coverage of Pneumovax 23 with an immunogenicity profile comparable to Prevnar 13. Vaxcyte expects to advance VAX-24 into clinical trials in the 2H 2021. The Foster City, CA-based company was founded in 2013 and lists on the Nasdaq under the symbol “PCVX.” At pricing, the company commands a fully diluted market value of $841 million. BofA Securities, Jefferies, and Evercore ISI were lead managers on the deal. Shares closed the week up 63% to $26.15.

Avidity Biosciences Inc., a preclinical biotech developing antibody therapies for muscle disorders, raised $259 million by offering 14.4 million shares at $18, the high end of the upwardly revised range of $17 to $18. Earlier on Thursday, the La Jolla, CA-based company raised the proposed IPO range and the shares on offer to 12 million; it originally planned to offer 10 million shares at $14 to $16.

The company’s pipeline contains lead candidate AOC 1001, which is designed to treat rare monogenic muscle disease myotonic dystrophy type 1. It expects to submit an IND application in 2021 and plans to initiate a Phase 1/2 clinical trial by the end of the same year. Other programs include muscle atrophy, Duchenne muscular dystrophy, facioscapulohumeral muscular dystrophy and Pompe disease. Avidity was founded in 2012 and booked $4 million in collaboration and contract research revenue for the 12 months ended March 31, 2020. Avidity Biosciences lists on the Nasdaq under the symbol “RNA.” Cowen, SVB Leerink, Credit Suisse and Wells Fargo Securities acted as lead managers on the deal. Shares closed the week up 58% to $28.50.

Generation Bio Inc., a preclinical biotech developing gene therapies for rare diseases, raised $200 million by offering 10.5 million shares at $19, the high end of the revised range of $18 to $19.

The company’s pipeline includes eight programs for rare and prevalent diseases of the liver and retina, initially prioritizing rare monogenic diseases that have well-established biomarkers and clear clinical and regulatory pathways. Its most advanced liver disease programs are in phenylketonuria and hemophilia A, which are in the preclinical stage of development. Its most advanced retina disease programs are in Leber’s Congenital Amaurosis and Stargardt disease, which are in the lead optimization. The Cambridge, MA-based company was founded in 2016. At pricing, the company commands a fully diluted market cap of $916 million. Generation Bio lists on the Nasdaq under the symbol “GBIO.” J.P. Morgan, Jefferies, and Cowen acted as lead managers on the deal. Shares closed the week up 30% to $24.69.

And Lantern Pharma Inc., a biotech redeveloping abandoned drugs for non-small cell lung cancer, raised $26 million by offering 1.8 million shares at $15, the low end of the range of $15 to $17.

The Dallas, TX-based 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 with out-licensing partner Oncology Venture. Lantern Pharma was founded in 2013 and lists on the Nasdaq under the symbol “LTRN.”  ThinkEquity acted as a lead manager on the deal. Shares closed the week off 2% at $14.75.

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