Top Stories for Week of July 13, 2020

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Fierce US surge adds over one million new coronavirus cases the past four weeks, ending months of declining national death totals.

Since the first US case of the new coronavirus was reported on Jan. 20 in Washington state, more than 3.2 million people have been diagnosed, with massive clusters around New York City, Seattle and in California. While New York state, once the epicenter, has reigned-in the virus–on June 16, Governor Andrew Cuomo boasted the state now has one of the lowest infection rates in the country–other states are seeing resurgences weeks into the reopening of their economies.

That same day, Texas reported its highest number of new cases as well as a record 8.3% rise in hospitalizations. In Florida, where some theme parks have begun reopening, the rolling seven-day tally is at its highest ever, according to Bloomberg. Late last week, the director-general of the World Health Organization has condemned a “lack of leadership” in fighting the coronavirus pandemic and made an emotional plea for global unity, as cases soar in multiple countries and the world struggles to contain the devastating virus more than six months after it was first identified.

“My friends, make no mistake: The greatest threat we face now is not the virus itself,” Tedros Adhanom Ghebreyesus said in a passionate speech in Geneva on Thursday. “Rather, it’s the lack of leadership and solidarity at the global and national levels.”

His intervention, CNN reports, was seen as a thinly veiled jab at leaders including US President Donald Trump, who has waged a public battle against WHO while failing to suppress the world’s worst COVID-19 outbreak in his own country.

“This is a tragedy that is forcing us to miss many of our friends, losing many lives. We cannot defeat this pandemic as a divided world,” Tedros said, his voice trembling.

The US is regularly reporting single-day record rises in cases and topped three million confirmed infections earlier last week, throwing its early attempts to reopen the economy into chaos. The situation is almost as bleak in other regions. Brazil’s President, Jair Bolsonaro, has contracted COVID-19 after playing down its severity for months. India announced its biggest single-day rise in cases on Thursday, and the spread of the virus is picking up pace in Mexico. Australia, hailed as an early success story in the fight against the pandemic, has been forced to seal off more than 6 million people in the state of Victoria after a renewed surge of the disease in Melbourne.

“How is it difficult for humans to unite to fight a common enemy that’s killing people indiscriminately?” Tedros asked during his plea, made during a WHO meeting. “Are we unable to distinguish or identify the common enemy? Can’t we understand that the divisions or the cracks between us actually are the advantage for the virus?”

According to Johns Hopkins Medical, as of Saturday, July 11, there were nearly 12.6 million COVID-19 global cases confirmed, and over 562,000 deaths. Confirmed cases in the US totaled over 3 million with nearly 135,000 deaths. Both of the US figures comprise 24% of the global totals.

COVID-19 Addenda: 1) Face masks reduce wearers’ COVID infection risk by 65%; 2) FDA says to defeat COVID-19 deliver a 70% effective vaccine and get 70% of people to take it; 3) Trump and Navarro press FDA again for hydroxychloroquine; 4) Breakthrough drug for COVID-19 maybe risky for mild cases; and (5) Fauci says vaccines likely to offer only finite protection.

Wearing a facial covering not only curbs the spread of the coronavirus but reduces a mask wearer’s risk of catching the virus by 65%, said Dean Blumberg, MD, chief of pediatric infectious diseases at UC Davis Children’s Hospital. Blumberg, speaking on a college livestream about the coronavirus, said that a “standard rectangular surgical mask…will decrease the risk of infection to the person wearing the mask by about 65%” and that homemade masks also “should work quite well.”

N95 masks are the most effective but should be reserved for medical personnel, he added. The masks mainly provide a physical barrier to respiratory droplets that are about one-third the size of a human hair, he said. Those drops are one of the major ways the virus is transmitted.

“People who say ‘I don’t believe masks work’ are ignoring scientific evidence,” Blumberg said. “It’s not a belief system. It’s like saying, ‘I don’t believe in gravity.’”

One of public health’s greatest accomplishments was eradicating smallpox back in 1979. To eradicate SARS-CoV-2, the virus that causes COVID-19 illness, we’ll need a vaccine that’s 70% effective—and 70% of the population will need to receive it, an FDA vaccine official said last Wednesday. That’s a higher bar than the FDA set the previous week, according to FiercePharma.

To pass muster at the agency, a COVID-19 vaccine will need to be at least 50% more effective than placebo, according to new FDA guidelines. But the agency felt a 50% efficacy requirement was a “reasonable place” and about comparable to a flu vaccine on a good year, said Peter Marks, director of the Center for Biologics Evaluation and Research (CBER), during a webinar hosted by the Alliance for a Stronger FDA. And despite R&D moving at record speeds, Marks cautioned that vaccines are still several months away.

Speaking to a White House pool reporter last week, economist and Trump advisor Peter Navarro said that four Detroit doctors were, based on a single disputed study, filing for the FDA to again issue an emergency authorization for hydroxychloroquine, the anti-malarial pill that President Trump hyped for months as a COVID-19 treatment over the objections of his own scientists. Then, while avoiding directly calling for the FDA to OK the drug, blasted the agency. He said its decision to pull an earlier authorization “was based on bad science” and “had a tremendously negative effect” on doctors and patients. Taking to Twitter, the President was more explicit. “Act Now,” he wrote, tagging the FDA’s official handle.

Scientists in Britain announced a major breakthrough in the battle against the coronavirus recently, reporting they had found the first drug to reduce deaths among critically ill COVID-19 patients. The results were first made public in a sparsely detailed news release says The New York Times. Now the full study, neither peer reviewed nor published, has been posted online, and it holds a surprise.

The drug–a cheap, widely available steroid called dexamethasone–does seem to help patients in dire straits, the data suggest. But it also may be risky for patients with milder illness, and the timing of the treatment is critical. Following the announcement last week, officials at some American hospitals said that they would begin to treat coronavirus patients with dexamethasone, and the World Health Organization called for accelerating production to ensure an adequate supply.

And any vaccine developed to ward off the novel coronavirus would likely be limited in how long it would shield against infection, top US infectious disease expert Anthony Fauci said last week.

“You can assume that we’ll get protection at least to take us through this cycle,” Fauci, director of the National Institute of Allergy and Infectious Diseases, said in an appearance on a live-streamed video conference hosted by the National Institutes of Health. “We’re still knee-deep in the first wave” of the pandemic, Fauci said.

Health officials are assuming a shot would offer a degree of protection, though it’s likely “going to be finite.” A shot to protect against COVID-19 won’t work like the measles vaccine, which lasts throughout a person’s lifetime, Fauci said. “We may need a boost to continue the protection, but right now we don’t know how long it lasts.” (Ref: Bloomberg)

Regeneron signs $450 million deal with US government to supply COVID-19 therapy.

The US government signed a $450 million contract with Regeneron Pharmaceuticals Inc. (Tarrytown NY) for its potential COVID-19 antibody cocktail, the drugmaker said last week. The agreement, the first by the Trump administration to support a therapy, comes under the government’s “Operation Warp Speed” program that is aimed at faster distribution of vaccines and treatments to fight the new coronavirus when trials are successful.

The US is also funding manufacturing and several trials for potential vaccines and has rushed to secure billions of doses of the vaccines being tested by companies around the world, according to Reuters. Earlier in the week, Novavax Inc. (Gaithersburg MD) received a $1.6 billion grant, the biggest award yet from Operation Warp Speed, to cover testing, manufacturing and sale of a potential coronavirus vaccine. Under the contract with Regeneron, signed with the HHS’s Biomedical Advanced Research and Development Authority (BARDA) and the Department of Defense, the doses manufactured under the project will be owned by the federal government.

Regeneron’s cocktail, REGN-COV2, contains an antibody made by the company and another isolated from recovered COVID-19 patients. Rivals Eli Lilly & Co. and AbbVie Inc. are also pursuing antibody therapies for the respiratory illness. REGN-COV2 is being tested separately for both preventing and treating COVID-19, with a late-stage prevention trial being run jointly with the National Institutes of Health. The agreement covers a fixed number of bulk lots intended to be completed in the fall of 2020, Regeneron said.

A range of 70,000 to 300,000 potential treatment doses or 420,000 to 1,300,000 prevention doses are expected to be available from these lots, with initial doses to be ready as early as end of summer. The US government would make the doses available to Americans at no cost, if Emergency Use Authorization (EUA) or product approval is granted, Regeneron said.

Biogen, Eisai complete FDA filing for Alzheimer’s disease drug aducanumab.

Biogen Inc. (Cambridge MA) said last week that it submitted an application seeking US approval of its closely watched Alzheimer’s drug, as the company aims to be the first to bring a treatment to market that can alter the course of the mind-wasting disease. The number of people in the US living with Alzheimer’s, the most common form of dementia, is expected to triple to nearly 14 million by 2050 without effective treatments, according to the US Centers for Disease Control and Prevention.

If approved, Biogen’s aducanumab would be the first treatment designed to delay progression of the fatal, memory-robbing disease. The drug has had a tumultuous journey, with promising early data raising hopes and Biogen’s share price, only to be dashed by disappointment in later trials. Biogen in October revived plans to seek approval for aducanumab based on a detailed analysis of what had seemed like less than compelling data, months after scrapping its development. The biotech company said its analysis showed patient improvements in memory and other measures of cognition and ability to function.

Wall Street analysts have been betting on aducanumab to restore Biogen’s growth prospects following a successful patent challenge to its top-selling multiple sclerosis drug Tecfidera and with looming competition for its high-priced gene therapy Spinraza weighing on its shares. However, the drug’s approval is far from guaranteed despite the desperate need for treatments. It has been at least 15 years since the Food and Drug Administration has reviewed an application for a new Alzheimer’s treatment, as drugs that were tested failed in trials.

Dr. Maria Carrillo, chief science officer at the Alzheimer’s Association advocacy organization, declined to comment on the chances of the drug winning approval, saying, “That really is up to the FDA.” She continued, “We are looking forward to that rigorous review and their decision, adding that a “drug like this that addresses the biological causes associated with Alzheimer’s dementia would be historic and no doubt impactful for the Alzheimer’s community.”

Prior to the focus on COVID-19 vaccines and treatments, the wait for aducanumab’s filing and approval was probably the most-watched saga to play out in biopharma this year, SVB Leerink analyst Marc Goodman said. The FDA now has 60 days to decide whether to accept the application for review, Biogen and partner Eisai Co. Ltd. (Tokyo) said in a joint statement. “It is unclear to us if the totality of the data support FDA approval. Just as there are signs of activity, there are inconsistencies in the data that raise questions about aducanumab’s biologic effect,” Cowen analyst Phil Nadeau said. Analysts are forecasting aducanumab sales of $673.7 million in 2022 if approved, according to Refinitiv IBES estimates.

IPO Sector: Nkarta Inc., a preclinical developer of off-the-shelf cancer therapies based on natural killer cells, raised $252 million by offering 14 million shares at $18, above the upwardly revised range of $16 to $17. The company offered 1 million more shares than anticipated. It originally planned to offer 10 million shares at $14 to $16 before increasing its proposed deal size on Thursday. At pricing, the company commands a fully diluted market cap of $584 million. South San Francisco-based Nkarta was founded in 2015 and lists on the Nasdaq under the symbol “NKTX.” Cowen, Evercore ISI, Stifel, and Mizuho acted as lead managers on the deal. Shares closed the week up 266% to $47.90.

Elsewhere, Poseida Therapeutics Inc., a Phase 2 biotech developing CAR T-cell therapies for multiple myeloma, raised $224 million by offering 14 million shares at $16, in line with the upwardly revised terms. The company originally planned to offer 10 million shares at $14 to $16 before increasing its proposed deal size on Thursday. At pricing, the company commands a fully diluted market cap of $1.0 billion. Founded in 2003, Poseida lists on the Nasdaq under the symbol “PSTX.” BofA Securities, Piper Sandler and William Blair acted as lead managers on the deal. Shares closed the week off 4% at $15.35.

Relay Therapeutics Inc., a Phase 1 biotech developing small molecule therapies for solid tumors, announced terms for its IPO on Thursday. The Cambridge, MA-based company plans to raise $250 million by offering 14.7 million shares at a price range of $16 to $18. At the midpoint of the proposed range, Relay Therapeutics would command a fully diluted market value of $1.5 billion. The company’s lead candidate RLY-1971, an inhibitor of Src homology region 2 domain-containing phosphatase-2, began a Phase 1 trial in patients with advanced solid tumors in the 1Q 2020. Relay also plans to begin a Phase 1 trial of RLY-4008, an oral small molecule inhibitor of fibroblast growth factor receptor 2 (FGFR2), in patients with advanced solid tumors having oncogenic FGFR2 alterations in the 2H 2020. Relay Therapeutics was founded in 2015 and plans to list on the Nasdaq under the symbol “RLAY.” J.P. Morgan, Goldman Sachs, Cowen and Guggenheim Securities are the joint bookrunners on the deal. It is expected to price this week.

Inventiva SA, a Phase 2 French biotech developing therapies for NASH and other diseases, raised $108 million by offering 7.5 million ADSs at $14.40, the midpoint of the revised range of $13.40 to $15.40. The company originally planned to offer the same number of ADSs at the as-converted last close of its shares on the Euronext Paris (IVA). At pricing, the company commands a fully diluted market cap of $559 million. The Daix, France-based company’s lead candidate, lanifibranor, is 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 4Q 2020. Inventiva was founded in 2011 and booked $11 million in revenue for the 12 months ended March 31, 2020. It lists on the Nasdaq under the symbol “IVA.” Jefferies, Stifel and Guggenheim are the joint bookrunners on the deal. Shares closed the week down 12% at $12.62.

GoHealth Inc., a Medicare-focused health insurance marketplace, announced terms for its IPO. The Chicago, IL-based company plans to raise $751 million by offering 39.5 million shares at a price range of $18 to $20. At the midpoint of the proposed range, GoHealth would command a fully diluted market value of $6.0 billion. 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 4 million consumer leads. GoHealth was founded in 2001 and booked $611 million in revenue for the 12 months ended March 31, 2020. It plans to list on the Nasdaq under the symbol “GOCO.” Goldman Sachs, BofA Securities and Morgan Stanley are among the joint bookrunners on the deal. It is expected to price this week.

And Oak Street Health Inc., which operates health centers that provide primary care for Medicare patients in the Midwest, filed on Friday with the SEC to raise up to $100 million in an IPO. The company employs 260 primary care provider and 54 health centers, in 13 markets across 8 states, which provided care for approximately 85,000 patients as of March 31, 2020. The Chicago, IL-based company was founded in 2012 and booked $641 million in revenue for the 12 months ended March 31, 2020. It plans to list on the NYSE under the symbol “OSH.” J.P. Morgan, Goldman Sachs, Morgan Stanley, William Blair and Piper Sandler are the joint bookrunners on the deal. No pricing terms were disclosed.

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