Top Stories for Week of June 22, 2020

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WHO warns coronavirus pandemic accelerating in 81 countries, especially the Americas; California orders residents to wear masks outside.

The world has entered a “new and dangerous phase” of the coronavirus pandemic, a top official from the World Health Organization said on Friday, a stark warning that came as the US struggled to control spiraling outbreaks and as business leaders signaled growing unease with the country’s ability to effectively contend with the virus. Coronavirus cases spiked sharply across the American South and West, particularly in states that loosened restrictions on businesses several weeks ago, says The New York Times.

In Florida, Oklahoma, South Carolina and Arizona, daily counts of new coronavirus cases reached their highest levels of the pandemic last week. Texas, which has seen known cases double in the past month, became the sixth state to surpass 100,000 cases, according to a New York Times database of cases in the US. Around the country, there were indications that major companies and sports teams were changing their own plans as the new surges emerged.

Apple Inc. (Cupertino CA) said it was temporarily closing 11 retail stores across four states amid an uptick in cases. AMC Entertainment reversed course on its mask policy on Friday, saying it will now require patrons to wear face coverings when movie theaters reopen next month.

Across the globe, the outlook for containing the coronavirus worsened. The pandemic is accelerating, with Thursday’s 150,000 new cases the highest in a single day, and nearly half of those in the Americas, WHO said. A pandemic that had been defined early on by a series of shifting epicenters–including Wuhan, China; Iran; northern Italy; Spain; and New York– is now distinguished by a wide and expanding scope. Eighty-one nations have seen a growth in new cases over the past two weeks, especially in South America. Only 36 have seen declines.

“Many people are understandably fed up with being at home,” Dr. Tedros Adhanom Ghebreyesus, the director general of the WHO, said in a news conference in which he described the new phase of the virus. “Countries are understandably eager to open up their societies and their economies. But the virus is still spreading fast. It is still deadly and most people are still susceptible.”

A sobering lesson in the virus’s tenacity came in China, where officials had recently proclaimed that they had vanquished the virus–only to see it surge back in Beijing. That metropolis of 21 million people is facing new restrictions on travel and renewed school closures. Seoul, South Korea, also reported a new surge in cases on Friday.

California’s health department announced Thursday that the state’s roughly 40 million residents must cover their faces in “most settings outside the home.” California embraced especially strict measures the same day it reported record-high new coronavirus infections, according to The Washington Post. Meanwhile, mask mandates continue to generate controversy around the country. The governor of Nebraska said any local government that requires masks in its offices and courts would not get federal coronavirus funding allocated by the Cares Act. However, the mayor of Orange County, FL, announced plans to sign an executive order that requires every person to wear a mask starting Saturday.

Globally, more than 461,000 people have died of the SARS-CoV-2 virus as of Saturday, with more than 8.7 million cases diagnosed. More than 119,000 (26% of the global total) are reported to have died of the virus in the US, with more than 2.2 million cases (26% of the global total) diagnosed.

COVID-19 Addenda: 1) WHO cancels hydroxy trial for the last time as researchers conclude it doesn’t work against COVID-19; 2) Fauci on coronavirus infections: We’re still in a first wave; 3) Operation Warp Speed cut to seven candidates; and 4) Coronavirus death toll in the US has officially surpassed that of WWI.

The on and off WHO study involving hydroxychloroquine is off again. WHO officials put out word last Wednesday that they were shelving the hydroxy part of the Solidarity trial after concluding that the drug was unlikely going to be effective against COVID-19. The latest setback for hydroxy comes just days after the FDA pulled its emergency use authorization for the drug, which has been frequently touted by President Donald Trump as a potential lifesaver for people afflicted by the virus.

He also took the drug himself and has never stopped supporting the therapy, regardless of the data. Three weeks ago the WHO temporarily suspended the trial after The Lancet published a study raising questions about its safety. But that study didn’t hold up under examination, and researchers went back to the test two weeks ago. At this stage there’s little likelihood that the drug will remain available for coronavirus in the US.

Anthony Fauci, the nation’s top infectious disease expert, is warning that the US has to yet get through the first wave of the coronavirus outbreak.

“People keep talking about a second wave,” Fauci said in an interview with The Wall Street Journal last week. “We’re still in a first wave.”

The comments arrived as pockets of the US experience surges in new coronavirus cases and hospitalizations. California, Texas, Arizona and Florida are among states reporting consistent increases in case counts. In Texas, health authorities registered the state’s highest number of hospitalizations due to COVID-19. President Trump and Vice President Pence have cast the increases as largely a product of an uptick in the nation’s testing capacity. But Fauci told the Journal that higher percentages of positive tests in some states “cannot be explained by increased testing.”

The New York Times reported earlier this month that the Trump administration had whittled Operation Warp Speed from 14 to five different vaccine candidates, but HHS said that there would be seven candidates that move beyond the initial list. And for “vulnerable” Americans, any vaccine that comes out of the project will be free. The number of candidates beyond the initial list, in line with early reporting from Bloomberg, gives renewed hope for vaccine developers who were left off the initial reported list.

That includes Novavax and Inovio, both of which are in Phase 1, and Sanofi, a company long backed by HHS and which expects to put their vaccine into clinical testing by the end of the year. The list of seven will then be sorted to a smaller, unspecified number of finalists. The seven will receive funding and assistance for early trials, and the final few will receive aid for large-scale testing and manufacture.

And as of Saturday, the coronavirus has infected over 2.2 million Americans and claimed more than 119,000 lives, according to data collected by Johns Hopkins University. The number of Americans killed by COVID-19 is higher than the 116,516 killed during World War I–a war waged from 1914 to 1918 that reshaped the globe. Deaths from COVID-19 in the US had already topped all US deaths from every war since the 1950 start of the Korean War. And deaths from COVID-19 already surpassed those from the 1968 pandemic, which claimed 100,000 lives. However the number killed by COVID-19 is still far below the 675,000 deaths from the 1918 Spanish flu.

Common steroid drug improves COVID-19 survival in trial.

An inexpensive, readily available steroid drug reduced deaths by a third in patients hospitalized with COVID-19 in a large study, the first time a therapy has been shown to possibly improve the odds of survival with the condition in the sickest patients. Full data from the study have not been published or subjected to scientific scrutiny. But outside experts last week immediately embraced the top-line results.

The drug, dexamethasone, is widely available and is used to treat conditions including rheumatoid arthritis, asthma, and some cancers, says STAT News. In a statement, Patrick Vallance, the UK government’s chief scientific adviser, called the result “tremendous news” and “a ground-breaking development in our fight against the disease.” Scott Gottlieb, a former commissioner of the US Food and Drug Administration, called it “a very positive finding” in an interview on CNBC.

“I think it needs to be validated, but it certainly suggests that this could be beneficial in this setting.” Atul Gawande, the surgeon, writer and public health researcher, urged caution, tweeting, “after all the retractions and walk backs, it is unacceptable to tout study results by press release without releasing the paper.”

The study randomly assigned 2,104 patients to receive six milligrams of dexamethasone once a day, by mouth or intravenous injection. These were compared to 4,321 patients assigned to receive usual care alone. In patients who needed to be on a ventilator, dexamethasone reduced the death rate by 35%, meaning that doctors would prevent one death by treating eight ventilated patients. In those who needed oxygen but were not ventilated, the death rate was reduced 20%, meaning doctors would need to treat 25 patients to save one life. Both results were statistically significant. There was no benefit in patients who didn’t require any oxygen. The researchers running the study, called RECOVERY, decided to stop enrolling patients on dexamethasone on June 8 because they believed they had enough data to get a clear result.

“Dexamethasone is the first drug to be shown to improve survival in COVID-19,” Peter Horby, one of the lead investigators of the study and a professor in the Nuffield Department of Medicine at the University of Oxford, said.

He added that the drug should now become the standard treatment for patients with COVID-19 who need oxygen. “Dexamethasone is inexpensive, on the shelf, and can be used immediately to save lives worldwide.” A different arm of the same study showed on June 5 that hydroxychloroquine, widely touted as a potential COVID treatment, had no benefit in hospitalized patients. Last week, based in part on those results, the FDA revoked an Emergency Use Authorization for using hydroxychloroquine in those patients.

A person’s blood type and other genetic factors may be linked with severity of coronavirus infection, according to European researchers looking for further clues about why COVID-19 hits some so much harder than others. The findings, published in The New England Journal of Medicine last Wednesday, suggest people with type A blood have a higher risk of being infected with the coronavirus and developing worse symptoms.

At the peak of the epidemic in Europe, researchers analyzed the genes of more than 4,000 people to look for variations that were common in those who became infected with the coronavirus and developed severe COVID-19. A cluster of variants in genes that are involved with immune responses was more common in people with severe COVID-19, they found.

These genes are also involved with a cell-surface protein called ACE2 that the coronavirus uses to gain entry to and infect cells in the body. The researchers, led by Dr. Andre Franke from Christian-Albrecht-University in Kiel, Germany, and Dr. Tom Karlsen, from Oslo University Hospital in Norway also found a relationship between COVID-19 severity and blood type.

The risk for severe COVID-19 was 45% higher for people with type A blood than those with other blood types. It appeared to be 35% lower for people with type O.

“The findings…provide specific clues as to what disease processes may be going on in severe COVID-19,” Karlsen said, noting that additional research is needed before the information becomes useful. “The hope is that these and other findings…will point the way to a more thorough understanding of the biology of COVID-19,” US National Institutes of Health director and genetics expert Francis Collins wrote in his blog Thursday. “They also suggest that a genetic test and a person’s blood type might provide useful tools for identifying those who may be at greater risk of serious illness.”

IPO Sector: Forma Therapeutics Inc., a Phase 1 biotech developing therapies for sickle cell and hematologic diseases, raised $278 million in an upsized IPO by offering 13.9 million shares at $20, well above the range of $16 to $18. The company originally planned to offer 11.8 million shares. Forma’s lead candidate, FT-4202, is a once-a day oral treatment for sickle cell disease currently in a Phase 1 trial. Forma also has licensing agreements with Bristol-Meyer Squibb and Boehringer Ingelheim for possible NASH treatments. The Watertown, MA-based company was founded in 2007 and booked $29 million in collaboration revenue for the 12 months ended March 31, 2020. It lists on the Nasdaq under the symbol “FMTX.” Jefferies, SVB Leerink and Credit Suisse are the joint bookrunners on the deal. Shares closed the week up 95% to $39.

Elsewhere, Genetron Holdings Ltd., which provides DNA sequencing-based diagnostic services for cancer patients in China, raised $256 million by offering 16 million ADSs at $16, well above the range of $11.50 to $13.50. The Beijing-based company upsized its offering on Thursday from 13 million ADSs. At pricing, the company commands a fully diluted market value of $1.5 billion (+34% vs. midpoint). Genetron Holdings lists on the Nasdaq under the symbol “GTH.” Credit Suisse, CICC, BTIG and Canaccord Genuity acted as lead managers on the deal. Shares closed the week unchanged at $16.

Repare Therapeutics Inc., a preclinical biotech developing gene therapies for solid tumors, raised the proposed deal size for its upcoming initial public offering. The Cambridge, MA-based company now plans to raise $190 million by offering 10 million shares at a price range of $18 to $20. Repare Therapeutics develops precision oncology treatments based on synthetic lethality (SL), an approach to drug development focused on genomic instability, including DNA damage repair. SL pertains to a deficiency in either of two genes that is tolerated in cells, but leads to cell death when both genes are present. Repare Therapeutics was founded in 2016 and plans to list on the Nasdaq under the symbol “RPTX.” Morgan Stanley, Goldman Sachs, Cowen, and Piper Sandler are the joint bookrunners on the deal.

Royalty Pharma Inc. shares surged last week after the biggest US initial public offering of the year so far. The listing raised $2.2 billion dollars after the sale of 77.7 million shares at $28 each by the company and existing shareholders. At the IPO price, which was set at the top of the marketed range, Royalty was valued at $16.7 billion. The company launched in 1996 and earns money on royalties paid by pharmaceutical companies such as Merck, Gilead and Johnson & Johnson for producing drugs. The bulk of the money raised would go towards acquiring more royalty rights, the group said. Royalty Pharma lists on the Nasdaq under the symbol “RPRX.” There were 13 banks underwriting the deal, led by J.P. Morgan. Shares closed the week up 75% to $49.

Progenity Inc., which sells in vitro molecular tests for prenatal and disease screening, raised $100 million by offering 6.7 million shares at $15, within the range of $14 to $16. Progenity’s current suite of products includes chromosomal and monogenic prenatal tests, preconception and early pregnancy tests, hereditary cancer screens, and anatomic and molecular pathology tests. Since its inception, the company has provided approximately 1.5 million tests in the US with strong growth in test volume, but it is currently observing a slowdown as a result of the COVID-19 pandemic. The San Diego, CA-based company was founded in 2011 and booked $113 million in revenue for the 12 months ended March 31, 2020. It lists on the Nasdaq under the symbol “PROG.” Shares closed the week down 13% to $13.12.

GoHealth Inc., a Medicare-focused health insurance marketplace, filed on Friday with the SEC to raise up to $100 million in an initial public offering. Over the last four years, GoHealth has shifted its focus towards Medicare products over individual and family health insurance products. In 2019, the company generated over 42.2 million consumer interactions and over four million consumer leads. The Chicago-based company was founded in 2001 and booked $611 million in net revenue for the 12 months ended March 31, 2020. It plans to list on the Nasdaq under the symbol “GHTH.” Goldman Sachs, BofA Securities, Morgan Stanley, and Barclays are among the joint bookrunners on the deal. No pricing terms were disclosed.

Poseida Therapeutic Inc., a Phase 2 biotech developing CAR T cell therapies for multiple myeloma, filed on Friday with the SEC to raise up to $115 million in an initial public offering. The company previously filed to raise $115 million in January 2019, but withdrew the offering after raising $142 million in a Series C round led by Novartis AG. The company’s pipeline contains lead candidate P-BCMA-101, an autologous CAR-T currently in a potentially registrational Phase 2 trial for multiple myeloma. The San Diego, CA-based company was founded in 2014 and plans to list on the Nasdaq under the symbol “PSTX.” BofA Securities, Piper Sandler, and William Blair are the joint bookrunners on the deal. No pricing terms were disclosed.

Inventiva SA, a Phase 2 French biotech developing therapies for NASH and other diseases, filed on Friday with the SEC to raise up to $90 million in an initial public offering. The company’s pipeline contains lead candidate lanifibranor, an oral small molecule therapy for the treatment of NASH. The company announced positive topline results from its NATIVE Phase 2b trial for lanifibranor, and end of Phase 2b meetings are expected in the 4Q20. Inventiva is currently listed on the Euronext Paris under the symbol “IVA.” The Daix, France-based company was founded in 2011 and booked $11 million in revenue for the 12 months ended March 31, 2020. It plans to list on the Nasdaq under the symbol “IVA.” Jefferies, Stifel, Guggenheim Securities are among the joint bookrunners on the deal. No pricing terms were disclosed.

Nkarta Inc., a preclinical biotech developing off-the-shelf cancer therapies based on natural killer cells, filed on Friday with the SEC to raise up to $100 million in an initial public offering. The company submitted an IND for its product NKX101 for the treatment of relapsed or refractory acute myeloid leukemia and higher-risk myelodysplastic syndromes (MDS) in May 2020. The South San Francisco, CA-based company was founded in 2015 and plans to list on the Nasdaq under the symbol “NKTX.” Nkarta filed confidentially on February 28, 2020. Cowen, Evercore ISI, Stifel and Mizuho Securities are the joint bookrunners on the deal. No pricing terms were disclosed.

And Canada’s InMed Pharmaceuticals Inc., a Phase 1 developing cannabinoid-based products, filed on Friday with the SEC to raise up to $12 million in an initial public offering. The company is currently listed on the TSX under the symbol “IN” and on the OTCQX under the symbol “IMLFF.” InMed Pharmaceuticals is developing an API using a synthetic cannabinoid named cannabinol, or CBN, and plans to develop its two products INM-755 for rare skin disease Epidermolysis Bullosa (EB) and INM-088 for glaucoma. INM-755 is currently in a Phase 1 trial in The Netherlands. The Vancouver, Canada-based company was founded in 2014 and plans to list on the Nasdaq under the symbol “INM.” Roth Capital is the sole bookrunner on the deal. No pricing terms were disclosed.

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