Top Stories for Week of June 1, 2020

US coronavirus deaths top 100,000 as country reopens; Trump cuts ties with WHO.

President Donald Trump on Thursday offered his first expression of sympathy in observance of the milestone of 100,000 American coronavirus deaths, tweeting his condolences after drawing criticism for failing to reflect on the human cost of the outbreak in recent days.

“We have just reached a very sad milestone with the coronavirus pandemic deaths reaching 100,000,” Trump wrote online. “To all of the families & friends of those who have passed, I want to extend my heartfelt sympathy & love for everything that these great people stood for & represent. God be with you!”

His social media post came after the number of reported fatalities in the US from COVID-19 climbed past six figures Wednesday, prompting public displays of mourning from various elected officials. In a video message posted Wednesday afternoon, former Vice President Joe Biden addressed the death toll, remarking that:

“there are moments in our history so grim, so heart-rending, that they’re forever fixed in each of our hearts as shared grief. Today is one of those moments.”

The President went on to describe the 100,000 deaths as a “fateful milestone we should have never reached–that could have been avoided.” Trump also mentioned the grim turning point in a tweet earlier last week, Politico reports, but only to promote his administration’s handling of the public health crisis and defend his efforts to halt the spread of the highly infectious disease.

“For all of the political hacks out there, if I hadn’t done my job well, & early, we would have lost 1 1/2 to 2 Million People, as opposed to the 100,000 plus that looks like will be the number,” Trump wrote last Tuesday. “That’s 15 to 20 times more than we will lose. I shut down entry from China very early!”

In a subsequent message, the President acknowledged that “One person lost to this invisible virus is too much,” but insisted he “made the right decisions” and ridiculed “Crazy Nancy” Pelosi, the House speaker.

However, globally as of Saturday morning, there were 5.95 million confirmed cases and over 365,000 deaths from COVID-19. More than 1.9 million people have become infected with COVID-19 in the US, the global epicenter of the coronavirus pandemic, and over 104,000 Americans have died from the disease, according to a Johns Hopkins University tracker. As for Trump’s claim for a job well done, the US cases comprise 30% of the total worldwide, and US deaths are 28% of the total. The US population is equivalent to just 4.25% of the total world population.

Separately, Trump on Friday said he is terminating the US relationship with the World Health Organization over its handling of the coronavirus, saying the WHO had essentially become a puppet organization of China. Appearing in the White House Rose Garden, Trump went ahead with repeated threats to eliminate American funding for the group, which amounts to several hundred million dollars a year.

Trump said the WHO had failed to make reforms to the organization that the President had demanded in a May 18 letter to WHO Director-General Tedros Adhanom Ghebreyesus. That letter had given the WHO 30 days to commit to reforms. At his Rose Garden appearance, Trump tied the WHO closely with China, where the coronavirus originated. He said Chinese officials “ignored their reporting obligations” about the virus to the WHO and pressured the WHO to “mislead the world” when the virus was first discovered by Chinese authorities.

COVID-19 Addenda: 1) Study linking hydroxychloroquine to COVID risks questioned; 2) GlaxoSmithKline aims to produce one billion doses of COVID-19 vaccines; 3) Want COVID-19 herd immunity? Get 40% of population vaccinated says former FDA chief Gottlieb; and 4) WHO warns of 2nd peak and cautions against scaling back restrictions too soon.

Scientists are raising questions about a study that linked antimalarial drugs to increased heart risks and death among COVID-19 patients. The study, published the prior week in The Lancet medical journal, found high rates of dangerous side effects in patients treated with hydroxychloroquine and chloroquine, and some work on testing the drugs in patients has been suspended based on the concerns it raised.

A group of some 120 researchers signed a letter pointing out inconsistencies, calling on the authors and The Lancet to reveal more details about their analysis. Backed by US President Donald Trump, who has said he took a course of hydroxychloroquine to ward off the virus, the drugs have become a political and medical bone of contention. Not long after The Lancet study was published, the World Health Organization suspended a portion of a global study of potential COVID-19 treatments that included the antimalaria drugs because of safety concerns.

GlaxoSmithKline PLC (London) announced Thursday that it plans to manufacture one billion doses of its pandemic vaccine adjuvant system next year to support the development of adjuvanted COVID-19 vaccine candidates. The company noted that the move comes after it completed a review of its global manufacturing operations and decided to invest in expanding the capacity. According to GlaxoSmithKline, it has already started manufacturing the adjuvant at risk, with production at sites in the US, Canada and Europe. The drugmaker added that it is in discussions with governments and global institutions about funding for production and supply of the adjuvant.

Former FDA Commissioner Scott Gottlieb has a ballpark estimate for the number of vaccinated people to reach herd immunity for COVID-19.

Because about 20% of people may have already been infected by the time a COVID-19 vaccine is launched, “we’d need to get perhaps 40% utilization to achieve herd immunity,” he tweeted. How does that stand up to adoption of vaccines we’re all familiar with? It’s about on par with seasonal flu shots, which are administered to around 45.4% of the eligible US population each year. Shingles vaccine, though, has around 34.9% utilization in the US. Gottlieb’s herd immunity total of 60% comes roughly close to the 70% overall immunity suggested by two epidemiologists at the Johns Hopkins Bloomberg School of Public Health.

The World Health Organization last week warned nations against scaling back coronavirus restrictions too quickly, saying a premature push to return to normalcy could fuel a rapid acceleration of new cases, according to The Washington Post.

“We cannot make assumptions that just because the disease is on the way down now that it’s going to keep going down,” Mike Ryan, head of the WHO’s health emergencies program, told reporters during a briefing.

He cautioned that countries could face another peak of coronavirus cases even ahead of a presumed second wave of infections months from now.

“The disease can jump up at any time,” he added.

AstraZeneca seals vaccine manufacturing deal with Oxford Biomedica.

The CEO of AstraZeneca PLC (London), which is developing a leading coronavirus vaccine with Oxford University, said it is too early to deliberately expose trial participants to the pathogen, but it may become an option if ongoing tests hit a snag. The British drugmaker last week started Phase 2 and 3 trials of the vaccine, looking to recruit around 10,000 adults and children in Britain.

A certain number of participants will have to become infected in the course of their normal lives to achieve a reliable reading from the study over the next few months, Reuters reports. So-called human challenge trials have been discussed as an alternative option by scientists, whereby vaccinated volunteers are infected intentionally.

“We are running against time. We are seeing already in Europe the disease is declining,” Soriot told an online press briefing. “Very soon the disease intensity will be low, and it will become difficult, so we have to move very quickly.” He added, “If the disease gets to a very low level, maybe challenge studies will have to be considered. But we felt it’s too early today to do that.”

Companies and research institutions are currently working on more than 100 vaccines, about 10 of which are being tested on humans, in a bid to stop the respiratory illness that at present has no treatment and has killed about 350,000 people. Soriot said some of the Oxford University team that started early-stage human trials of the vaccine in April to test for safety and signs of an immune response were already privy to initial results, and that publication was imminent.

“We should see the results very soon,” Soriot said.

Oxford University has said that the read-out of the wider trials may take between two and six months, depending on how many participants still catch the virus in the face of public-health efforts to suppress its spread.

Movement-based yoga appears to ease depressive symptoms in a wide range of mental health disorders, a new systematic review and meta-analysis suggest. Results of the research, which included 19 studies and more than 1,000 patients with a variety of mental health diagnoses, showed those who practiced yoga experienced greater reductions in depressive symptoms vs. those undergoing no treatment, usual treatment, or attention-control exercises. In addition, there was a dose-dependent effect such that more weekly yoga sessions were associated with the greatest reduction in depressive symptoms.

“Once we reviewed all the existing science about the mental health benefits of movement-based yoga, we found that movement-based yoga–which is the same thing as postural yoga or asana–helped reduce symptoms of depression,” study investigator Jacinta Brinsley, BClinExPhys, University of South Australia, Adelaide, told Medscape. “We also found those that practiced more frequently had bigger reductions. However, it didn’t matter how long the individual sessions were; what mattered was how many times per week people practiced,” she added.

The researchers note the study is the first to focus specifically on movement-based yoga.

“We excluded meditative forms of yoga, which have often been included in previous reviews, yielding mixed findings. The other thing we’ve done a bit differently is pool all the different diagnoses together and then look at depressive symptoms across them,” said Brinsley.

Researchers also performed a series of meta-regression analyses, which showed that the number of yoga sessions performed each week had a significant effect on depressive symptoms. Indeed, individuals with higher session frequencies demonstrated a greater improvement in symptoms. These findings, said Brinsley, suggest yoga may be a viable intervention for managing depressive symptoms in patients with a variety of mental disorders. The study was published online May 18 in the British Journal of Sports Medicine.

IPO Sector: Forma Therapeutics Inc., a Phase 1 biotech company developing therapies for hematologic diseases and cancers, filed on Friday with the SEC to raise up to $150 million in an initial public offering. The company’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 plans to list on the Nasdaq under the symbol “FMTX.” Jefferies, SVB Leerink and Credit Suisse are the joint bookrunners on the deal. No pricing terms were disclosed.

Elsewhere, Legend Biotech Inc., a clinical stage CAR-T immuno-oncology biotech being spun out of GenScript, announced terms for its IPO on Friday. The company plans to raise an additional $12 million in a concurrent private placement to GenScript. The Somerset, NJ-based company plans to raise $350 million by offering 18.4 million ADSs at a price range of $18 to $20.

At the midpoint of the proposed range, Legend would command a fully diluted market value of $2.6 billion. Legend Biotech was founded in 2014 and booked $59 million in revenue for the 12 months ended March 31, 2020. It plans to list on the Nasdaq under the symbol “LEGN.” Morgan Stanley, J.P. Morgan, and Jefferies are the joint bookrunners on the deal. It is expected to price this week.

Vaxcyte Inc., a preclinical biotech developing pneumococcal vaccines, filed with the SEC to raise up to $100 million in an IPO. 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. The company expects to advance VAX-24 into clinical trials in the 2H 2021. The Foster City, CA-based company was founded in 2013 and plans to list on the Nasdaq under the symbol “PCVX.” Vaxcyte filed confidentially on October 11, 2019. BofA Securities, Jefferies, and Evercore ISI are the joint bookrunners on the deal. No pricing terms were disclosed.

Progenity Inc., which provides in vitro molecular diagnostic products for a variety of indications, filed with the SEC to raise up to $100 million in an IPO. 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 plans to list on the Nasdaq under the symbol “PROG.” Progenity filed confidentially on December 19, 2019. Piper Sandler, Wells Fargo Securities, Baird, Raymond James, and BTIG are the joint bookrunners on the deal. No pricing terms were disclosed.

Pliant Therapeutics Inc., a Phase 2 biotech developing therapies for the treatment of fibrosis, announced terms for its IPO. The company plans to raise an additional $10 million through a concurrent private placement to Novartis. The South San Francisco, CA-based company plans to raise $90 million by offering 6 million shares at a price range of $14 to $16. At the midpoint of the proposed range, Pliant would command a fully diluted market value of $496 million. Pliant Therapeutics was founded in 2016 and booked $86 million in revenue for the 12 months ended March 31, 2020. It plans to list on the Nasdaq under the symbol “PLRX.” Citi, Cowen, and Piper Sandler are the joint bookrunners on the deal. It is expected to price this week.

Royalty Pharma Inc., which buys royalty interests in marketed and late-stage biopharmas, filed with the SEC to raise up to $100 million in an IPO. However, this is likely a placeholder for a deal we estimate could raise up to $2 billion. The company’s portfolio consists of royalties on more than 45 marketed therapies and four development-stage product candidates, addressing therapeutic areas such as rare diseases, oncology, neurology, HIV, cardiology, and diabetes. The NYC-based company was founded in 1996 and booked $1.9 billion in revenue for the 12 months ended March 31, 2020. It plans to list on the Nasdaq but has not selected a ticker yet. Royalty Pharma filed confidentially on February 13, 2020. J.P. Morgan, Morgan Stanley, BofA Securities, Goldman Sachs, Citi, and UBS Investment Bank are the joint bookrunners on the deal. No pricing terms were disclosed.

Avidity Biosciences Inc., a preclinical biotech developing antibody therapies for muscle disorders, filed with the SEC to raise up to $100 million in an IPO. 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. The La Jolla, CA-based company was founded in 2012 and booked $4 million in collaboration and contract research revenue for the 12 months ended March 31, 2020. It plans to list on the Nasdaq under the symbol “RNA.” Cowen, SVB Leerink, and Credit Suisse are the joint bookrunners on the deal. No pricing terms were disclosed.

And Generation Bio Inc., a preclinical biotech developing gene therapies for rare diseases, filed with the SEC to raise up to $125 million in an IPO. 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 and plans to list on the Nasdaq under the symbol “GBIO.” No pricing terms were disclosed.

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