Top Stories for Week of June 29, 2020

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US sees huge coronavirus resurgence; Fauci says approach to controlling pandemic “not working.”

As coronavirus cases swell across much of the US, leaders are urgently rethinking their tactics to rein in the spread, which the nation’s top infectious disease expert said on Friday were “not working.” For the first time, some governors are backpedaling on reopening their states, issuing new restrictions for parts of the economy that had resumed, says The New York Times.

Leaders in Texas and Florida abruptly set new restrictions on bars, a reversal that appeared unthinkable just days ago. And Gov. Gavin Newsom of California told rural Imperial County, where hospitals have been overwhelmed with patients, that it must reinstate a stay-at-home order, the most restrictive of requirements.

More than 45,000 new cases were reported on Friday in the US, according to a New York Times database. It was the third day in a row that the country set a daily record during the pandemic. At least six states–Florida, Idaho, Kansas, Oregon, South Carolina and Utah–hit daily highs on Friday, but even leaders outside of the new hot zones in the South and West expressed mounting anxiety.

“This is a very dangerous time,” Gov. Mike DeWine of Ohio said on Friday, as cases were trending steadily upward in his state after appearing to be under control for more than a month. “I think what is happening in Texas and Florida and several other states should be a warning to everyone.” He added, “We have to be very careful.”

The shifting assessments of the nation’s handling of the virus stretched to the highest levels of the federal government, where Dr. Anthony S. Fauci, the director of the National Institute of Allergy and Infectious Diseases, made clear that the standard approach to controlling infectious diseases–testing sick people, isolating them and tracing their contacts–was not working.

The failure, he said, was in part because some infected Americans are asymptomatic and unknowingly spreading the virus but also because some people exposed to the virus are reluctant to self-quarantine or have no place to do so. On Friday, he said officials were having “intense discussions” about a possible shift to “pool testing,” in which samples from many people are tested at once in an effort to quickly find and isolate the infected.

Even in the face of the alarming news, the White House continued to praise its own efforts.

“We have made truly remarkable progress in moving our nation forward,” Vice President Mike Pence said at what has become a rare public briefing by the coronavirus task force in Washington. “We’ve all seen the encouraging news as we open up.”

Mr. Pence did not wear a mask, although the health officials around him did. The renewed sense of urgency comes as the US confronts a new, treacherous phase of the pandemic, no longer defined by a crisis concentrated in New York City, but by rising cases in many cities and states. Infections nationwide have risen 65% over the past two weeks, including in several states that were among the first to reopen. By Saturday evening, more than 41,000 cases of the coronavirus had been announced across the US, including single-day records in Nevada, South Carolina and Florida.

Globally, more than 500,000 people have died of the SARS-CoV-2 virus as of Saturday, with 10 million cases diagnosed. More than 125,000 (25% of the global total) are reported to have died in the US, with more than 2.2 million cases (22% of the global total) diagnosed.

COVID-19 Addenda: 1) WHO says AstraZeneca, Moderna ahead in COVID-19 vaccine race; 2) $71 million going from DoD to Inovio; 3) Chinese military researchers move a new COVID vaccine candidate into human trial; 4) Coronavirus doing almost double the debt damage as financial crash; and (5) Pigs provide clues for Oxford’s COVID-19 vaccine.

AstraZeneca PLC’s (London) experimental COVID-19 vaccine is probably the world’s leading candidate and most advanced in terms of development, the World Health Organization’s (WHO) chief scientist said on Friday. The British drugmaker has already begun large-scale, mid-stage human trials of the vaccine, which was developed by researchers at University of Oxford. Last week, AstraZeneca signed its tenth supply-and-manufacturing deal.

“Certainly in terms of how advanced they are, the stage at which they are, they are I think probably the leading candidate,” WHO chief scientist Soumya said. “So it’s possible they will have results quite early.”

Swaminathan said Moderna Inc.’s (Cambridge MA) COVID-19 vaccine candidate was “not far behind” AstraZeneca’s, among more than 200 candidates, 15 of which have entered clinical trials.

“But I think AstraZeneca certainly has a more global scope at the moment in terms of where they are doing and planning their vaccine trials,” he said.

Inovio Pharmaceuticals Inc. (Plymouth meeting PA) said it has received $71 million from the US Department of Defense (DoD) to scale up production of the company’s devices that are used to administer its experimental COVID-19 vaccine into the skin. The funding from the DoD will be used to expand the manufacturing of a next-generation version of the company’s Cellectra devices. The company began developing the devices in 2019 and has already begun initial production. Cellectra is a small, hand-held device that can be stockpiled in large quantities without maintenance. Inovio said a previous version of the device has been used in clinical trials to safely dose more than 2,000 patients.

A Chinese military research institute has been approved to test its second experimental coronavirus vaccine in humans, the eighth candidate in clinical trials for China as it emerges as a front-runner in the global fight against COVID-19. No vaccine has been approved for sale against the virus that has killed nearly 500,000 people, but more than a dozen candidates have entered different stages of human testing globally. The new drug is developed by the Academy of Military Science (AMS), a research institute affiliated with the People’s Liberation Army, and was approved to proceed to human trial by China’s National Medical Products Administration.

The coronavirus will push debt levels in the world’s richest nations up by almost 20 percentage points on average this year, credit rating agency Moody’s said last week, almost double the damage seen during the financial crash. Their new report looked at 14 countries from the US and Japan to Italy and Britain and assessed how coronavirus-induced economic slowdowns would scar their finances.

“We estimate that on average in this group, government debt/GDP ratios will rise by around 19 percentage points, nearly twice as much as in 2008-2009 during the Great Financial Crisis (GFC). Compared with the GFC, the rise in debt burdens will be more immediate and pervasive, reflecting the acuteness and breadth of the shock posed by the coronavirus.”

Italy, Japan and Britain are expected to suffer the biggest debt increases at around 25 percentage points of their respective GDPs, while the US, France, Spain, Canada and New Zealand will all see theirs jump roughly 20 points.

And though early human trials will soon give a more definite answer, Endpoints reports that new data from pigs suggest that two doses may be better than one for AstraZeneca PLC’s (London) and Oxford University’s COVID-19 vaccine. Researchers at Britain’s Pirbright Institute found that pigs who received an initial inoculation and then a booster dose four weeks later produced more neutralizing antibodies than their porcine counterparts, who received only a single dose. Pirbright, which works on infectious disease in animals, was working with the Jenner Institute, the Oxford group that developed the vaccine. Merck & Co., for example, in choosing its vaccine partners, said that it specifically selected a candidate that required one dose because it would be easier to distribute.

Three US governors to quarantine visitors from states where COVID-19 spiking.

New York, Connecticut and New Jersey have asked for travelers from states with high coronavirus infection rates to go into quarantine for 14 days in a bid to preserve hard-fought gains as caseloads rise elsewhere in the country.

“We now have to make sure the rates continue to drop,” New York Gov. Andrew Cuomo said last Wednesday at a briefing in New York City, joined via video by Govs. Phil Murphy of New Jersey and Ned Lamont of Connecticut, both fellow Democrats. “We also have to make sure the virus doesn’t come on a plane again.”

What was presented as a “travel advisory” that started Thursday affects three adjacent Northeastern states that managed to check the spread of the virus this spring as New York City became a hot spot for the pandemic, says the Associated Press. Travelers from more than a half-dozen states, including Florida and Texas, are currently impacted. The quarantine will last two weeks from the time of last contact within the identified state. The announcement comes as summer travel to the states’ beaches, parks and other attractions–not to mention New York City–would normally swing into high gear.

The move also marks a “gotcha” moment in the COVID-19 battle since March, when Florida Gov. Ron DeSantis and Texas Gov. Greg Abbott, both Republicans, separately issued orders requiring people flying in from the New York tri-state area, where cases were surging, to quarantine for 14 days. Now, Florida and Texas are among the struggling states being eyed warily by the three northern governors.

The states will relay the quarantine message on highways, at airports, and through websites and social media. Lamont signed an executive order on Wednesday evening requiring such messages be posted at all major points of entry into the state and at the state’s airports. He said the governors plan to also ask hotels and vacation rental companies to tell guests from affected states. Lamont’s order also allows the state’s public health commissioner to make exceptions for essential workers and for “other extraordinary circumstances” when a quarantine is not possible.

Enforcement will vary by state. The Cuomo administration said violators in New York will be subject to mandatory quarantine and face fines from $2,000 to $10,000. Violators could be discovered at business meetings or during a traffic stop, he said. It was not clear what, if any, penalties violators in New Jersey and Connecticut will face. The quarantine applies to people coming from states with a positive test rate higher than 10 per 100,000 residents on a seven-day average, or with a 10% or higher positivity rate over seven days. As of Wednesday, states over the threshold were Alabama, Arkansas, Arizona, Florida, North Carolina, South Carolina, Utah and Texas.

Dexamethasone’s swift rise as a COVID-19 treatment has US drug suppliers struggling to keep up. Hospitals in US regions hard hit by COVID-19 are ramping up use of the well-known steroid, Reuters reports. And group drug purchaser Vizient Inc. (Irving TX), which supplies meds to about half of US hospitals, confirmed that surge: It’s seen a 610% increase in calls for the steroid in hospitals across the country.

So far, those calls haven’t been answered as often as Vizient member hospitals would like, either. They’re receiving 54% of their dexamethasone orders now, down from 97% on the day dexamethasone’s breakthrough COVID-19 data were announced, Vizient said. It doesn’t help that the stepped-up demand hit when injectable dexamethasone was already on the FDA’s shortages list. So where does that leave doctors, and more importantly, severely ill patients who are looking to the drug’s promise in severe COVID-19?

“What we’re hearing from our members right now is that they are able to treat patients who do require dexamethasone,” vice president of Vizient’s pharmaceutical solutions, Steven Lucio, said. “The concern is, can the market continue to sustain this?”

According to the FDA, injectable dexamethasone has been in low-supply since February of last year, with drugmaker AuroMedics Pharma LLC’s (Dayton NJ) doses on backorder until later this summer, and Hikma’s stores completely tapped out–both well before the COVID-19 developments.

The good news? Mylan, Somerset Pharmaceuticals and Fresenius Kabi still have doses to spare. German drugmaker Fresenius SE’s Kabi unit–the US’s biggest supplier of the steroid–was quick to voice confidence in its current dexamethasone stores and has pledged to scale up production in three US factories to meet new demand, according to Reuters.

Dexamethasone, which has been in use since the 1960s to treat inflammatory diseases and cancer, is also listed as a “high impact” drug on Vizient’s essential medicines list. This means the drug supplier can seek alternatives if its stores run dry, though it warned those alternative drugs may be less clinically desirable and more finicky to use.

Dexamethasone stole the spotlight the prior week when Oxford University researchers announced that the drug had slashed death rates in COVID-19 patients on ventilators by 35% and 20% for those on oxygen. Patients were given daily 6mg doses of dexamethasone over 10 days, delivered orally or by IV. Even with the data awaiting peer review, the drug scored a swift nod from the UK government, which authorized the drug in hospitalized COVID patients hours after the data reveal. US physicians were quick to voice skepticism though, fearing a repeat of hydroxychloroquine’s troubled rise and fall in COVID-19.

IPO Sector: Akouos Inc., a preclinical biotech developing gene therapies for inner ear disorders, raised $213 million by offering 12.5 million shares at $17, above the original range of $14 to $16. Boston, MA-based Akouos, founded in 2016, is trying to develop the first gene therapy to treat hearing loss–in particular, a form of deafness caused by mutations in a single gene. Gene-based hearing loss afflicts 300,000 people in the US each year, including more than 4,000 newborns. Its lead candidate is a treatment for a type of genetic hearing loss that afflicts about 7,000 people. The company hopes to use a small virus called adeno-associated virus, or AAV, as a vector to deliver DNA that encodes a functioning gene in target cells. These viruses don’t typically cause disease and can be customized to treat different inherited conditions. Akouos lists on the Nasdaq under the symbol “AKUS.” BofA Securities, Cowen, Piper Sandler and BTIG acted as lead managers on the deal. Shares closed the week up 29% to $22.

Elsewhere, Fusion Pharmaceuticals Inc., a Phase 1 biotech developing radiopharmaceuticals for solid tumors, raised $213 million by offering 12.5 million shares at $17, above the range of $14 to $16. At pricing, the company commands a fully diluted market cap of $774 million (+25% vs. original terms). Hamilton, Canada-based Fusion’s pipeline contains lead candidate FPI-1434, which is designed to target and deliver an alpha emitting isotope to cancer cells expressing the insulin-like growth factor 1 receptor (IGF-1R), a receptor that is overexpressed on many tumor types. The company is currently conducting a Phase 1 trial for solid tumors expressing IGF-1R and plans to report initial data approximately three to six months after it resumes clinical activities due to disruptions caused by COVID-19. Fusion Pharmaceuticals was founded in 2014 and lists on the Nasdaq under the symbol “FUSN.” Morgan Stanley, Jefferies and Cowen are the joint bookrunners on the deal. Shares closed the week unchanged at $17.

Renalytix AI PLC, which is commercializing AI-powered diagnostic tests for kidney disease, filed with the SEC to raise up to $86 million in an IPO in the US. Renaytix AI is a $374 million company with investor interest focused on its KidneyIntelX, the company’s diagnostic platform which uses artificial intelligence (AI) algorithms to digest data inputs–blood-based biomarkers, inherited genetics, electronic health records, etc.–and generate a unique patient risk score for people with chronic kidney disease (CKD). The pre-revenue company is currently listed in London on the AIM under the ticker “RENX;” it closed Wednesday with a market cap of £303 million ($377 million). The Cardiff, UK-based company was founded in 2018 and plans to list on the Nasdaq under the symbol “RNLX.” J.P. Morgan and Stifel are the joint bookrunners on the deal. No pricing terms were disclosed.

iTeos Therapeutics Inc., a Phase 1/2 oncology biotech, filed with the SEC to raise up to $100 million in an IPO. The company’s lead candidate EOS-850, a highly selective small molecule antagonist of the adenosine A2a receptor (A2AR), is in an open-label Phase 1/2 clinical trial in adult patients with advanced solid tumors, with initial data expected in the 1H 2021. Lead antibody candidate is EOS-448 which binds to an immune cell protein receptor called TIGIT, a checkpoint with roles in both inhibitory and stimulatory pathways in the immune system. A Phase 1/2a study was recently launched with preliminary data expected in H1 2021. The Cambridge, MA-based company was founded in 2019 and plans to list on the Nasdaq under the symbol “ITOS.” J.P. Morgan, SVB Leerink and Piper Sandler are the joint bookrunners on the deal. No pricing terms were disclosed.

Relay Therapeutics Inc., a Phase 1 biotech developing small molecule therapies for solid tumors, filed with the SEC to raise up to $200 million in an IPO. The company’s lead candidate RLY-1971, an inhibitor of Src homology region 2 domain-containing phosphatase-2 (SHP2), began a Phase 1 trial in patients with advanced solid tumors in the 1Q 2020. Relay is also planning 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. The Cambridge, MA-based company was founded in 2015 and plans to list on the Nasdaq under the symbol “RLAY.” J.P. Morgan, Goldman Sachs, Cowen and Guggenheim are the joint bookrunners on the deal. No pricing terms were disclosed.

Greenwich LifeSciences Inc., a Phase 3 biotech developing immunotherapies for breast cancer, announced terms for its IPO. The Stafford, TX-based company plans to raise $21 million by offering 2.7 million shares (63% insider) at a price range of $7.50 to $8.50. At the midpoint of the proposed range, Greenwich LifeSciences would command a fully diluted market value of $106 million. The company is developing GP2, an immunotherapy designed to prevent the recurrence of breast cancer following surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2/neu protein. In a Phase 2b clinical trial completed in 2018, no recurrences were observed in the HER2/neu 3+ adjuvant setting after median 5 years of follow-up, if the patient received the 6 primary intradermal injections over the first 6 months. The company is planning to commence a Phase 3 trial in 2020. Greenwich LifeSciences was founded in 2006 and plans to list on the Nasdaq under the symbol “GLSI.” Aegis Capital Corp. is the sole bookrunner on the deal.

Kiromic BioPharma Inc., a preclinical biotech developing immunotherapies for blood cancers and solid tumors, announced terms for its IPO on Friday. The Houston, TX-based company plans to raise $25 million by offering 1.9 million shares at a price range of $12 to $14. At the midpoint of the proposed range, Kiromic BioPharma would command a fully diluted market value of $119 million. Kiromic’s pipeline consists of four early-stage product candidates targeting blood cancers and solid tumors. Kiromic utilizes its proprietary target discovery platform, Diamond, to identify new cancer immunological targets for T cells and B cells. The company is also developing a non-viral gene editing mechanism, called ABBIE (A Binding-Based Integrase Enzyme), for delivering its product candidates. Kiromic BioPharma was founded in 2006 and plans to list on the NYSE American under the symbol “KRBP.” ThinkEquity is the sole bookrunner on the deal.

ACell Inc., which makes medical devices for wounds and soft tissue surgical defects, filed on Friday with the SEC to raise up to $86 million in an IPO. The company’s urinary bladder matrix (UBM) product is designed to help manage the healing and scarring of traumatic, surgical and chronic wounds, burns, hernias and other ailments which require soft tissue reinforcement. ACell markets and sells directly to hospitals as well as to group purchasing organizations, integrated delivery networks, and government facilities such as the Department of Veterans Affairs and Department of Defense medical facilities. The Columbia, MD-based company was founded in 1999 and booked $100 million in sales for the 12 months ended March 31, 2020. It plans to list on the Nasdaq under the symbol “ACLL.” UBS Investment Bank, Barclays, RBC Capital Markets and SunTrust Robinson Humphrey are the joint bookrunners on the deal. No pricing terms were disclosed.

And PolyPid Ltd., a Phase 3 biotech developing extended-release drugs to prevent surgical site infections, raised $60 million by offering 3.8 million shares at $16, within the range of $15 to $17. The company offered 625,000 more shares than anticipated. Insiders indicated on $27 million of the IPO. At pricing, the company commands a fully diluted market value of $319 million. PolyPid’s lead candidate D-PLEX100 is currently in a Phase 3 trial for bone surgical site infections (SSIs) and the company is planning to initiate a Phase 3 trial for abdominal SSIs set to begin in the 3Q 2020. The Petah Tikva, Israel-based company was founded in 2008 and lists on the Nasdaq under the symbol “PYPD.” Barclays and BMO Capital Markets acted as lead managers on the deal. Shares closed the week up 19% at $19.

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