Top Stories for Week of July 20, 2020

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COVID-19 cases surge in US, elsewhere, with no end in sight; mask wearing, school openings still contentious.

Divided Americans clashed anew over mask mandates and the reopening of schools on Friday, with states and localities choosing conflicting strategies in the face of surging coronavirus cases. In the state of Georgia, Governor Brian Kemp sued Atlanta’s mayor to prevent her from mandating masks, while Chicago Mayor Lori Lightfoot, leader of the country’s third-largest school district, unveiled a plan to offer both in-person and remote instruction over the objection of the teachers’ union.

The mask defiance has touched a nerve among medical professionals, especially as more of them–1,200 including 161 nurses–have died from the coronavirus in the US, according to the National Nurses United union. With school set to resume in a few weeks, educators across the country have announced a variety of plans to restart teaching amid the pandemic, Reuters reports. California Governor Gavin Newsom, who until now has allowed school districts in his state of 40 million people to set their own policies, issued guidance on Friday that schools could start in-person instruction if they are in counties that have stayed off the state’s monitoring list for 14 days.

But 30 of California’s 58 counties are on the “watch list” and schools there must remain closed. Among them are Los Angeles, Sacramento and San Diego counties, accounting for nearly 40% of the state’s population, where school districts already announced they were opting for full remote learning. Amid the patchwork of policies, the US reported a daily global record of more than 77,000 new infections on Thursday, raising the total to more than 3.5 million cases, with nearly 140,000 deaths.

Through it all, President Donald Trump has urged a return to normal, stressing the importance of reigniting the economy. The Trump administration and some health experts argue children are better off in classrooms for their development, and also to allow parents to return to work. But the Chicago Teachers Union contends classes should only be taught remotely because “there is no safe way to reopen anything during a pandemic,” union President Jesse Sharkey said. Public health experts have pleaded with people to cover their mouths and noses amid a wider cultural divide in the US.

Trump and his followers have resisted a full-throated endorsement of masks and have been calling for a return to normal economic activity following pandemic-induced shutdowns.

Top US infectious disease expert Anthony Fauci on Friday said he “would urge the leaders–the local political leaders in states and cities and towns–to be as forceful as possible in getting your citizenry to wear masks.”

Georgia governor Brian Kemp, a fellow Republican and Trump supporter, urged all Georgians to wear masks for at least four weeks but said mandates were unenforceable and suggested they would hobble the economy.

“Brian Kemp does the bidding of President Trump,” Atlanta’s Democratic Mayor Keisha Lance Bottoms, who has tested positive for the coronavirus, told CNN on Friday. “Over 130,000 people in our state have tested positive for COVID-19…and this governor is taking taxpayer money to sue me personally.”

According to Johns Hopkins Medical, as of Saturday, July 18, there were more than 14 million COVID-19 global cases confirmed, and over 600,000 deaths. Confirmed cases in the US totaled 3.6 million with nearly 139,000 deaths. Both of the US figures comprise 26% and 23%, respectively, of the global totals.

2) COVID-19 Addenda: 1) COVID-19 death rates in ICUs down; 2) Australian researchers invent 20 minute coronavirus blood test; 3) COVID-19 risk doesn’t depend much on blood type; 4) Hydroxychloroquine ineffective against mild COVID-19, US study shows; and (5) One in three South Korean COVID-19 patients improve with remdesivir.

Overall mortality of patients with COVID-19 in intensive care units (ICUs) across Europe, Asia, and North America has dropped from nearly 60% at the end of March to nearly 42% at the end of May, according to a systematic review and meta-analysis. The study by R.A. Armstrong, a fellow at Severn Deanery in Bristol, United Kingdom, and colleagues was published online July 15 in Anesthesia. It is the first systematic review and meta-analysis of outcomes of patients with COVID-19 in ICUs. Armstrong and colleagues searched the MEDLINE, EMBASE, PubMed, and Cochrane databases for studies through May that reported ICU mortality for adult patients admitted with COVID-19. They calculated that combined ICU mortality across all the studies was 41.6%, down by about one third from the 59.5% ICU mortality seen in the studies to the end of March.

Researchers in Australia have devised a test that can determine novel coronavirus infection in about 20 minutes using blood samples in what they say is a world-first breakthrough. The researchers at Monash University said their test can determine if someone is currently infected and if they have been infected in the past.

“Short-term applications include rapid case identification and contact tracing to limit viral spread, while population screening to determine the extent of viral infection across communities is a longer-term need,”

The researchers said in a paper published in the journal ACS Sensors on Friday. The research team was led by BioPRIA and Monash University’s Chemical Engineering Department. Their test, using 25 microlitres of plasma from blood samples, looks for agglutination, or a clustering of red blood cells, that the coronavirus causes.

New studies show that people with Type A blood are not at greater risk of getting sick, as previous studies had suggested, says The New York Times. Early in the COVID-19 pandemic, researchers found preliminary evidence suggesting that people’s blood type might be an important risk factor–both for being infected by the virus and for falling dangerously ill. But over the past few months, after looking at thousands of additional patients with COVID-19, scientists are reporting a much weaker link to blood type.

Two studies–one at the Massachusetts General Hospital and the other at Columbia Presbyterian Hospital in New York–did not find that Type A blood increases the odds that people will be infected with COVID-19. The new reports do find evidence that people with Type O blood may be slightly less likely to be infected. But the effect is so small that people shouldn’t count on it. “No one should think they’re protected,” said Nicholas Tatonetti, a data scientist at Columbia University.

The anti-malaria drug touted by US President Donald Trump as a COVID-19 treatment was ineffective for patients with a mild version of the disease in a study conducted by researchers at the University of Minnesota. About 24% of the patients given hydroxychloroquine in the study had persisting symptoms over a 14-day period, while roughly 30% of the group given a placebo were determined to have persistent symptoms over the same period. The difference was not statistically significant, the researchers said.

“Hydroxychloroquine did not substantially reduce symptom severity or prevalence over time in non-hospitalized persons with early COVID-19,” the researchers wrote in an article to be published in the Annals of Internal Medicine journal on Thursday.

And one in three South Korean patients seriously ill with COVID-19 showed an improvement in their condition after being given Gilead Sciences Inc.’s (Foster City CA) antiviral remdesivir, health authorities said. More research was needed to determine if the improvement was attributable to the drug or other factors such as patients’ immunity and other therapies, they said, according to Reuters. Remdesivir has been at the forefront of the global battle against COVID-19 after the intravenously administered medicine helped shorten hospital recovery times in a US clinical trial. Several countries including South Korea have added the drug to the list of treatment for the disease caused by SARS-CoV-2.

Moderna Phase 1 results indicate coronavirus vaccine safe; provokes immune response.

The first COVID-19 vaccine tested in the US revved up people’s immune systems just the way scientists had hoped, researchers reported last week–as the shots are poised to begin key final testing.

“No matter how you slice this, this is good news,” Dr. Anthony Fauci, the US government’s top infectious disease expert, told The Associated Press.

The experimental vaccine, developed by Fauci’s colleagues at the National Institutes of Health and Moderna Inc. (Cambridge MA), will start its most important step around July 27: A 30,000-person study to prove if the shots really are strong enough to protect against the coronavirus. But last Tuesday, researchers reported anxiously awaited findings from the first 45 volunteers who rolled up their sleeves back in March. Sure enough, the vaccine provided a hoped-for immune boost. Those early volunteers developed what are called neutralizing antibodies in their bloodstream–molecules key to blocking infection–at levels comparable to those found in people who survived COVID-19, the research team reported in the New England Journal of Medicine.

“This is an essential building block that is needed to move forward with the trials that could actually determine whether the vaccine does protect against infection,” said Dr. Lisa Jackson of the Kaiser Permanente Washington Research Institute in Seattle, who led the study.

There’s no guarantee but the government hopes to have results around the end of the year–record-setting speed for developing a vaccine. The vaccine requires two doses, a month apart. There were no serious side effects. But more than half the study participants reported flu-like reactions to the shots that aren’t uncommon with other vaccines–fatigue, headache, chills, fever and pain at the injection site. For three participants given the highest dose, those reactions were more severe; that dose isn’t being pursued. Some of those reactions are similar to coronavirus symptoms but they’re temporary, lasting about a day and occur right after vaccination, researchers noted.

“Small price to pay for protection against COVID,” said Dr. William Schaffner of Vanderbilt University Medical Center, a vaccine expert who wasn’t involved with the study. He called the early results “a good first step,” and is optimistic that final testing could deliver answers about whether it’s really safe and effective by the beginning of next year. “It would be wonderful. But that assumes everything’s working right on schedule,” Schaffner cautioned.

Last week’s results only included younger adults. The first-step testing later was expanded to include dozens of older adults, the age group most at risk from COVID-19. Those results aren’t public yet but regulators are evaluating them. Fauci said final testing will include older adults, as well as people with chronic health conditions that make them more vulnerable to the virus–and Black and Latino populations likewise affected. Moderna closed the week up 51% at $94.85.

Exercise prompts the liver to pump out a little-known protein that appears to rejuvenate the brain, a new study found. Exercise may help change exercisers’ brains in surprising ways, according to a new study of physical activity and brain health. The study, which included both mice and people, found that exercise prompts the liver to pump out a little-known protein, and that chemically upping the levels of that protein in out-of-shape, elderly animals rejuvenates their brains and memories.

The findings, says The New York Times, raise provocative questions about whether the brain benefits of exercise might someday be available in a capsule or syringe form–essentially “exercise in a pill.” We already have considerable evidence, of course, that physical activity protects brains and minds from some of the declines that otherwise accompany aging. In past rodent studies, animals that ran on wheels or treadmills produced more new neurons and learned and remembered better than sedentary mice or rats. Similarly, older people who took up walking for the sake of science added tissue volume in portions of their brains associated with memory.

But many questions remain unanswered about how, at a cellular level, exercise remodels the brain and alters its function. Most researchers suspect that the process involves the release of a cascade of substances inside the brain and elsewhere in the body during and after exercise. But what the substances are, where they originate and how they meet and mingle has remained unclear.

So, for the new study, which was published this month in Science, researchers at the University of California, San Francisco, decided to look inside the minds and bloodstreams of mice. In past research from the same lab, the scientists had infused blood from young mice into older ones and seen improvements in the aging animals’ thinking. It was like “transferring a memory of youth through blood,” says Saul Villeda, a professor at UCSF. They then zeroed in on one little-studied protein known as GPLD1 (its scientific name is long and unpronounceable). The slightly mysterious protein is known to be produced mostly in the liver. But levels of the protein were elevated enough after exercise to justify more investigation.

So, the researchers then employed genetic engineering to amplify the release of GPLD1 from the livers of old, inactive mice. Afterward, those animals performed almost like young mice on tests of learning and memory, and their brains teemed with far more newborn neurons than in other old mice. In effect, they gained the brain benefits of exercise without the effort of actually exercising.

To ensure that this reaction was not purely rodent-based, the scientists also checked blood drawn from elderly people. The older men and women who habitually walked for exercise showed higher levels of GPLD1 in their bloodstreams than those who did not. The upshot of these findings seems to be that exercise improves brain health in part by prompting the liver to pump out extra amounts of GPLD1, Dr. Villeda says, although it is not yet clear how the protein then changes the brain.

IPO Sector: Berkeley Lights Inc., which provides a single cell manipulation platform for drug discovery and development, raised $178 million by offering 8.1 million shares at $22, above the upwardly revised range of $19 to $20. At pricing, Berkeley Lights commands a fully diluted market cap of $1.5 billion. The self-described “digital cell biology company” reported having 45 total customers at the end of last year, including eight of the 10 largest biopharmaceutical companies as measured by revenue. Other customers include biotechs, contract research organizations, synthetic biology companies, and academic institutions. Berkeley Lights reported $56.7 million in revenue for 2019, a more than 81% increase compared to the prior year. The Emeryville, CA-based company was founded in 2011 and booked $58 million in revenue for the 12 months ended March 31, 2020. Berkeley Lights lists on the Nasdaq under the symbol “BLI.” J.P. Morgan, Morgan Stanley, and Cowen acted as lead managers on the deal. Shares nearly tripled over the week to $65.45.

Relay Therapeutics Inc., a Phase 1 biotech developing precision small molecule therapies for solid tumors, raised $400 million by offering 20 million shares at $20, above the upwardly revised range of $18 to $19. At pricing, the company commands a fully diluted market cap of $1.8 billion. The most advanced Relay compound, RLY-1971, is designed to hit a cancer target called SHP2. In the first quarter of this year, the company began a Phase 1 study testing the drug in patients with advanced solid tumors. A second compound, RLY-4008, is designed to block another cancer protein, FGFR2. The company expects to begin a Phase 1 study for that compound in the second half of this year, testing it in patients whose advanced solid tumors have FGFR2 alterations. Relay lists on the Nasdaq under the symbol “RLAY.” JP Morgan, Goldman Sachs, Cowen, and Guggenheim acted as lead managers on the deal. Shares closed the week up 220% to $43.98.

Acutus Medical Inc., which manufactures tools for catheter-based ablation procedures to treat arrhythmia, filed with the SEC to raise up to $75 million in an IPO. The company’s diverse product portfolio includes its foundational product, the AcQMap imaging and mapping system. Early versions have been available in the US since May 2018 and in Western Europe since July 2016, though it fully commenced the launch of its commercial-grade console and software products in the 1Q20. Its installed base, the number of AcQMap consoles and workstations placed into service at customer sites, was 31 as of March 31, 2020. The Carlsbad, CA-based company was founded in 2011 and booked $4 million in sales for the 12 months ended March 31, 2020. It plans to list on the Nasdaq under the symbol “AFIB.” J.P. Morgan, BofA Securities, and William Blair are the joint bookrunners on the deal. No pricing terms were disclosed.

BioVie Inc., a Phase 2 biotech developing therapies for cirrhosis, submitted an amendment with the SEC. The filing indicates that the company plans to raise up to $18 million in an IPO. The company is currently listed on the OTCQB (BIVI) and last closed at $9. The company originally filed to raise $15 million in April 2019 and postponed the following August. BioVie’s lead candidate, BIV201, is based on a drug (terlipressin) that is approved in about 40 countries to treat related complications of liver cirrhosis but is not yet available in the US. The company announced top-line results for its Phase 2a trial in April 2019, and it plans to begin a randomized 24-patient Phase 2 study in 2020 followed by a larger pivotal Phase 3 clinical trial targeted to begin in 2021. The Los Angeles, CA-based company was founded in 2013 and plans to list on the Nasdaq under the symbol “BIVI.” Kingswood Capital Markets is the sole bookrunner on the deal. No pricing terms were disclosed.

Pandion Therapeutics Inc., a Phase 1 biotech developing engineered T cells for autoimmune diseases, raised $135 million by offering 7.5 million shares at $18, the high end of the $16 to $18 range. Watertown, MA-based Pandion is developing alternatives to current therapies that treat autoimmune disease by suppressing one pathway of the immune system, which leaves patients with chronic, residual effects of their disease or a worsening of the condition. The company says its proprietary “TALON” technology develops drugs that act at points of the immune system called control nodes, “which we believe will enable us to design and develop treatments for autoimmune diseases that provide a durable clinical benefit.” Pandion’s lead drug candidate, PT101, is designed to expand regulatory T cells, the type of immune cells that tamp down immune system activity. The company says its drug achieves this without activating inflammation-triggering cells. Pandion Therapeutics lists on the Nasdaq under the symbol “PAND.” Goldman Sachs, Morgan Stanley, SVB Leerink and BMO Capital Markets acted as lead managers on the deal. Shares closed the week up 1% at $18.10.

Renalytix AI Inc., which is commercializing AI-powered diagnostic tests for kidney disease, raised $74 million by offering 5.5 million ADS equivalents at $13.50, below the as-converted last close of its shares on London’s AIM board (RENX). At pricing, the NYC-based company commands a fully diluted market cap of $490 million. The Renalytix diagnostic technology, KidneyIntelX, uses AI to crunch data and produce a risk score that predicts the progression of a patient’s kidney function decline. The technology was developed for patients who have type 2 diabetes and chronic kidney disease. Renalytix says in its prospectus that its kidney risk scores are intended to help physicians and health systems make treatment decisions. The company says it plans to use between $25 million and $30 million of the IPO proceeds for KidneyIntelX’s continued development and planned commercialization. Renalytix AI lists on the Nasdaq under the symbol “RNLX.” J.P. Morgan and Stifel acted as lead managers on the deal. Shares closed the week unchanged at $13.50.

ALX Oncology Inc., a Phase 1 immuno-oncology biotech developing CD47 checkpoint inhibitors, raised $162 million by offering 8.5 million shares at $19, above the range of $15 to $17. At pricing, the company commands a fully diluted market cap of $730 million. ALX Oncology has already had a successful fundraising year, hauling in $105 million in February to fund a range of mid-stage studies on its only pipeline candidate–an antibody targeting CD47. ALX’s candidate hopes to reduce toxicity by not attracting macrophages. The Burlingame, CA-based company was founded in 2015 and booked $4 million in revenue for the 12 months ended March 31, 2020. ALX Oncology lists on the Nasdaq under the symbol “ALXO.” Jefferies, Credit Suisse, Piper Sandler and Cantor Fitzgerald acted as lead managers on the deal. Shares closed the week up 579% at $30.

Checkmate Pharmaceuticals Inc., a clinical stage immuno-oncology biotech developing therapies for solid tumors, filed on Friday with the SEC to raise up to $75 million in an IPO. The company’s sole candidate, CMP-001, is a differentiated Toll-like receptor 9 agonist delivered as a biologic virus-like particle utilizing a CpG-A oligonucleotide as a key component. The company states that its goal is to establish CMP-001 as a foundational immuno-oncology therapy for patients with a broad range of solid tumors. To date, CMP-001 has been studied in more than 200 melanoma patients. In its Phase 1b trial for advanced anti-PD-1 refractory melanoma, in combination with pembrolizumab and as a monotherapy, the company has observed a best objective response rate of 28%. The Cambridge, MA-based company was founded in 2015 and plans to list on the Nasdaq under the symbol “CMPI.” BofA Securities, Jefferies, BMO Capital Markets, and BTIG are the joint bookrunners on the deal. No pricing terms were disclosed.

And GoHealth Inc., a Medicare-focused health insurance marketplace, raised $914 million by offering 43.5 million shares at $21, above the range of $18 to $20. At the IPO price, GoHealth commands a fully diluted market cap of $6.7 billion. GoHealth sells health insurance online, a business that has grown rapidly since the passage of the Affordable Care Act in 2010. The Chicago-based company has since expanded to various US health insurance markets, including selling Medicare plans to senior citizens through its website. GoHealth expects to see continuous growth as more baby boomers, who are used to buying services online, turn 65. Last year, GoHealth’s net revenue increased 138.5% to $539.5 million. GoHealth was founded in 2001 and booked $611 million in revenue for the 12 months ended March 31, 2020. It lists on the Nasdaq under the symbol “GOCO.” Goldman Sachs, BofA Securities and Morgan Stanley, were among lead managers on the deal. Shares closed the week up 1% at $21.30.

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