Top Stories for Week of November 2, 2020

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As elections draw near, US breaks record for new coronavirus cases.

After fighting the coronavirus for eight months, the US recorded over 99,000 new cases on Friday–a global record–according to The New York Times. Two dozen states reported their worst weeks for new cases; none showed any recovery. Fourteen states reported single-day records for new cases on Friday and at least 1,200 counties–a full third of the country–now qualify as a “virus hot spot,” Dr. Deborah Birx, the White House coronavirus response coordinator, said.

But on the same day, President Trump once again sought to play down the severity of the coronavirus. At a campaign rally in Michigan, he ridiculed a reporter for wearing a mask, claimed that “doctors get more money if somebody dies from COVID” and implied that deaths from the virus were artificially inflated. Hospitalizations and deaths are also trending upward. Across the nation, more than 46,600 people were hospitalized with the virus on Friday, an increase of about 25% over the past two weeks, according to The COVID Tracking Project. The country has averaged just over 800 deaths a day over the past week.

On Thursday, more than 1,000 Americans died from COVID-19, an increase of 16% from two weeks ago. On the same day, Donald Trump Jr., the President’s son, said in an appearance on Fox News that deaths were down to “almost nothing.” In total, more than 229,000 Americans have died from the virus. Trump has repeatedly played down the virus, saying for weeks that the country is “rounding the turn,” even as new cases and hospitalizations soared.

He maintained his upbeat tone in a tweet on Friday, saying the country was doing much better than Europe had in confronting the pandemic. Biden and fellow Democrats in Congress have criticized the president for his handling of the health crisis. In the US House of Representatives, Democrats released a report on Friday condemning the Trump administration’s pandemic response as being “among the worst failures of leadership in American history.” At least six million Americans have been thrust into poverty and millions more are jobless, it said.

After his hospitalization with COVID-19 in early October, Trump resumed the large campaign rallies that draw thousands of supporters packed together, many not wearing masks. The Trump campaign says the rallies are safe and that masks and social distancing are encouraged. But a CNN investigation found that 14 out of 17 counties surveyed showed an increased rate of new COVID-19 cases one month after hosting Trump rallies. (Ref: Reuters)

Separately, according to Johns Hopkins Medical, as of Saturday, October 31, there were 46 million COVID-19 global cases confirmed, and some 1.19 million deaths. Confirmed cases in the US totaled over 9 million with nearly 230,000 deaths. The US figures comprise 20% and 19% respectively of the global totals.

COVID-19 Addenda: Transmission risks of COVID-19 during airline flights are very low and below other routine activities during the pandemic such as grocery shopping or going out to dinner, when using face coverings and taking other steps, researchers at the Harvard School of Public Health said. The report found transmission risks can be “reduced to very low levels through the combination of layered infection control measures.”

The report, funded by Airlines for America–a trade group representing American Airlines, United Airlines, Delta Air Lines and others–and a consortium of aircraft and equipment manufacturers and airport operators, comes as US airlines lose billions of dollars a month as passenger demand remains down 65% year on year because of the coronavirus. US carriers are operating just 50% the flights they did in 2019, according to Reuters. Some carriers have recently announced new plans to end blocking of middle seats during the pandemic. The Aviation Public Health Initiative team at Harvard recommended strategies to mitigate transmission risk on aircraft, during boarding and exiting.

Elsewhere, as people eagerly await new updates about potential coronavirus vaccines, questions still remain about how well they will work and what they will do to stem the pandemic. Importantly, the initial COVID-19 vaccines will prevent symptoms in those who become infected with the coronavirus rather than kill the virus itself, Anthony Fauci, MD, director of the National Institute for Allergy and Infectious Diseases, said during the Yahoo Finance All Markets Summit last Monday.

“The primary thing you want to do is that if people get infected, prevent them from getting sick, and if you prevent them from getting sick, you will ultimately prevent them from getting seriously ill,” he said. Preventing symptoms is a “primary endpoint” in the vaccine development process, Fauci said. Getting rid of the virus altogether is considered a “secondary endpoint.” He added, “What I would settle for, and all of my colleagues would settle for, is the primary endpoint to prevent clinically recognizable disease. And that’s what we hope happens, and if we do, that will go a long way to diffusing this very difficult crisis that we’re in.”

Immunity to COVID-19 infection lingers for at least five months, researchers reported–and probably longer than that, according to CNN. While the report may seem confusing and contradictory to a similar report out of Britain last week, it really isn’t. There is more than one wave of infection control in the human body. People’s bodies produce an army of immune compounds in response to an infection and some are overwhelming at first, dying off quickly, while others build up more slowly.

Measurements that show a waning antibody response in the first months after infection might be measuring this first wave–but there’s a second team building its forces in the background. The new report out last Wednesday shows 90% of people who recover from COVID-19 infections keep a stable overall antibody response.

“While some reports have come out saying antibodies to this virus go away quickly, we have found just the opposite–that more than 90% of people who were mildly or moderately ill produce an antibody response strong enough to neutralize the virus, and the response is maintained for many months,” Florian Krammer, a professor of vaccinology at the Icahn School of Medicine at Mount Sinai, who led the study team, said. (Ref: the journal Science)

And the White House and many Americans have pinned their hopes for defeating the COVID-19 pandemic on a vaccine being developed at “warp speed.” But according to Modern Healthcare, some scientific experts warn they’re all expecting too much, too soon.

“Everyone thinks COVID-19 will go away with a vaccine,” said Dr. William Haseltine, chair and president of Access Health International, a foundation that advocates for affordable care.

Ongoing clinical trials are primarily designed to show whether COVID-19 vaccines prevent any symptoms of the disease–which could be as minor as a sore throat or cough. But the trials, which will study 30,000 to 60,000 volunteers, will be too short in duration and too small in size to prove that the vaccines will prevent what people fear most–being hospitalized or dying–by the time the first vaccine makers file for emergency authorization, expected to occur later this year, Haseltine said.

The US should hold out for an optimal vaccine, with more proven capabilities, Haseltine argued. Others say the crushing toll of the pandemic–which has killed at least 225,000 Americans–demands that the country accept the best vaccine it can achieve within the next few months.

Gilead records $873 million in Q3 sales of remdesivir.

Gilead Sciences Inc.’s (Foster City CA) third-quarter revenues jumped 17% on sales of COVID-19 therapy remdesivir (Veklury). Headline results for the third quarter included: product sales of $6.5 billion, up 18%; total revenue of $6.6 billion (forecasts of $6.3 billion), up 17%; profit of $360 million, vs. the loss of $1.2 billion in the same period last year. Gilead reported that sales of its antiviral drug remdesivir (Veklury), which recently became the first treatment to receive full FDA approval to treat COVID-19 patients, were $873 million for the third quarter. The drug was previously prescribed in the US under an emergency-use authorization, while it has also been available to treat COVID-19 in other countries as well. Excluding Veklury, product sales rose 2% year-over-year to $5.6 billion for the third quarter, primarily due to Gilead’s core HIV products.

Meanwhile, CEO Daniel O’Day said “the recent acquisition of Immunomedics has effectively transformed Gilead’s growth story,” adding “we have now significant opportunity to drive additional growth at an accelerated pace.”

The $21-billion purchase gave Gilead access to the Trop-2 directed antibody-drug conjugate Trodelvy (sacituzumab govitecan), “an approved medicine with extensive potential for patients with a range of tumor types,” O’Day said. Other results included total HIV product sales: $4.5 billion, up 8%, with Gilead attributing the performance to the “underlying strength” of its HIV franchise, while the market share for Biktarvy totaled $1.9 billion, up from $1.3 billion, while analysts expected sales of $1.8 billion.

Looking ahead, Gilead revised its outlook for the year, saying it now anticipates earnings per share between $6.25 and $6.60, whereas the top end of the range was $7.65 per share at its last quarterly update in July. The company also now expects revenue of $23 billion to $23.5 billion for the full year, after previously projecting $23 billion to $25 billion, while analysts are estimating sales of $24 billion. Meanwhile, Gilead indicated that a portion of its Veklury sales during the third quarter is being held in inventory for use in the fourth quarter. “Veklury revenue is generated in a highly dynamic and complex global health environment, which continues to evolve. As a result, Veklury revenue is subject to significant volatility and uncertainty,” the drugmaker cautioned. (Ref: FirstWord Pharma)

Moderna posts $1.1 billion in COVID-19 vaccine orders.

Moderna Inc. (Cambridge MA) CEO Stéphane Bancel stated Thursday alongside the company’s quarterly results presentation that it is “actively preparing” for the launch of its mRNA-1273 coronavirus vaccine candidate. “We have signed a number of supply agreements with governments around the world,” he said, with Moderna noting it received $1.1 billion in customer deposits for mRNA-1273 during the third quarter, which it is recording as deferred revenue.

Last month, the company said the Phase 3 COVE study testing the vaccine candidate was fully enrolled with 30,000 participants, and that it would decide whether to seek emergency-use authorization once it has accrued two months of median safety follow-up data. Bancel recently suggested the US could authorize emergency use of mRNA-1273 in December. Moderna noted that the COVE study participants are in locations or circumstances that put them at “appreciable risk of acquiring COVID-19 and/or SARS-CoV-2 infection.” The trial is evaluating two injections of the mRNA-1273 given 28 days apart. A first interim analysis, expected this month, will not be performed until approximately 53 COVID-19 cases are diagnosed.

Researchers will take a second look at the trial data after 106 cases, while the formal study efficacy analysis will be triggered at 151 cases. Moderna said it wants to see over 74% efficacy at the first interim analysis, and over 57% efficacy at the second, before it conducts the primary analysis, which will determine whether to proceed with regulatory submissions. If it does not meet these statistical hurdles, the trial will either continue or be considered futile. The company said it is “committed to full transparency and will share the outcome of each interim analysis.”

Currently, Moderna is anticipating that production of mRNA-1273 will be about 20 million doses by the end of 2020. The company plans to use its existing infrastructure for distribution of the vaccine, which must be stored at minus 4 degrees Fahrenheit, preserving it for use up to six months. Bancel remarked “I believe that if we launch our COVID-19 vaccine, 2021 could be the most important inflection year in Moderna’s history.”

IPO Sector: Included among recent SEC filings for initial public offerings, Maravai LifeSciences Inc., which provides acid production, safety testing, and protein detection products for biotechs, registered up to $100 million worth of common stock. Maravai provides critical products to enable the development of drug therapies, diagnostics, novel vaccines and support research on human diseases. Its more than 5,000 customers as of September 30, 2020 include the top 20 global biopharmaceutical companies ranked by research and development expenditures according to industry consultants, and many other emerging biopharmaceutical and life sciences research companies, as well as leading academic research institutes and in vitro diagnostics companies. The San Diego, CA-based company was founded in 2014 and booked $222 million in sales for the 12 months ended September 30, 2020. It plans to list on the Nasdaq under the symbol “MRVI.” Morgan Stanley and Jefferies, Goldman Sachs, BofA Securities, Credit Suisse, UBS Investment Bank, Baird are among the joint bookrunners on the deal. No pricing terms were disclosed.

Elsewhere, Olema Pharmaceuticals Inc., a clinical-stage biotech developing therapies for women’s cancers, registered up to $100 million in an IPO. Olema is focused on the discovery, development and commercialization of next generation targeted therapies for women’s cancers. The company is studying the structure and function of the estrogen receptor (ER), a key driver of breast cancer in approximately 75% of patients, in order to develop more potent, oral therapies that completely inactivate this signaling pathway. The lead product candidate, OP-1250, has combined activity as both a complete ER antagonist and a selective ER degrader and was initiated in an ongoing Phase 1/2 trial in August of this year, with initial data expected in the second half of 2021. The San Francisco, CA-based company was founded in 2007 and plans to list on the Nasdaq under the symbol “OLMA.” Olema Pharmaceuticals filed confidentially on September 21, 2020. J.P. Morgan, Jefferies, Cowen and Canaccord Genuity are the joint bookrunners on the deal. No pricing terms were disclosed.

SQZ Biotechnologies Inc., a Phase 1 biotech developing cell therapies for solid tumors and other indications, raised $71 million by offering 4.4 million shares at $16, the low end of the range of $16 to $18. The company is developing cell therapies for cancer, infectious diseases, and other serious conditions. Its most advanced platform, SQZ Antigen Presenting Cells (SQZ APC), is currently in a Phase 1 trial in HPV+ tumors, with initial data expected in the 2H21. The Watertown, MA-based company was founded in 2013 and booked $23 million in revenue for the 12 months ended June 30, 2020. BofA Securities, Evercore ISI and Stifel acted as lead bookrunners on the deal. Shares closed the week down 17% to $13.25.

Galecto Inc., a Phase 2 biotech developing therapeutics for fibrosis and related diseases, raised $85 million by offering 5.7 million shares at $15, the midpoint of its range of $14 to $16. Galecto’s initial focus is on the development of small-molecule inhibitors of galectin-3 and lysyl oxidase-like 2, which play key roles in regulating fibrosis. Its lead product candidate, GB0139, is an inhaled inhibitor of galectin-3 for the treatment of severe fibrotic lung diseases such as idiopathic pulmonary fibrosis (IPF). The company has conducted a Phase 2a trial in 24 IPF patients and has initiated a Phase 2b trial in 450 IPF patients, with topline results expected in 2022. The Copenhagen-based company was founded in 2011 and lists on the Nasdaq under the symbol “GLTO.” BofA Securities, SVB Leerink and Credit Suisse acted as join bookrunners on the deal. Shares closed the week unchanged at $15.

Biodesix Inc., which provides diagnostic tests and services for lung disease and other unmet needs, raised $72 million by offering 4 million shares at $18, the midpoint of its range of $17 to $19. The company had originally filed to offer 4.2 million shares. The company provides data-driven diagnostic solutions to discover, develop, and commercialize solutions for clinical unmet needs, with a primary focus in lung disease. It operates through two segments, diagnostic tests (78% of 1H20 revenue) and diagnostic services (22%). Biodesix currently has four diagnostic blood-based tests across the lung cancer continuum of care. The Boulder, CO-based company was founded in 2005 and booked $22 million in revenue for the 12 months ended June 30, 2020.  Biodesix lists on the Nasdaq under the symbol “BDSX.” Morgan Stanley and William Blair are among the joint bookrunners on the deal. Shares closed the week down 31% at $12.43.

And Atea Pharmaceuticals Inc., a Phase 2 biotech developing therapies for COVID-19 and other viral diseases, raised $300 million by offering 12.5 million shares at $24, the high end of the range of $22 to $24 according to an S-1MEF filed with the SEC. The company originally filed to offer 11.0 million shares. Atea Pharmaceuticals is developing antiviral therapeutics for life-threatening viral infections. The company has built a proprietary purine nucleotide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of severe viral diseases. The company’s most advanced candidate, AT-527, is currently in a Phase 2 trial in approximately 190 adult patients with moderate COVID-19, with topline data expected in the 1H21. Atea Pharmaceuticals was founded in 2014 and lists on the Nasdaq under the symbol “AVIR.” J.P. Morgan and Morgan Stanley were among the lead managers on the deal. Shares closed the week up 26% at $30.34.

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