Top Stories for Week of July 27, 2020

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California, Florida report record numbers of daily COVID-19 deaths; CDC says rates likely 10 times higher than reported.

The US came just shy of breaking its single-day record for new coronavirus cases, adding more than 73,400 on Friday, the second-highest daily total, and signaling that infection rates show no signs of slowing. The single-day record, set on July 16, is 75,697 cases. Since June 24, the seven-day average has more than doubled, from 31,402 to more than 66,100 on Friday.

Friday was also the fourth consecutive day with more than 1,100 deaths reported. As the number of cases has continued to climb, so has the number of hospitalizations, which had skimmed its own record in recent days. On Friday, the number of people known to be hospitalized with the coronavirus in the US was 59,670, according to the COVID Tracking Project, a few hundred short of the record of 59,940 reported by the database on April 15.

The national number of hospitalizations dipped briefly below 28,000 in mid-June. Since then, the situation has worsened across a number of states. California and Florida reported record numbers of daily coronavirus fatalities Thursday, as the total number of infections in the US surpassed four million.

California’s 157 deaths last Wednesday continued a week of coronavirus records in the state that had once been considered a COVID success story, according to The Hill. Gov. Gavin Newsom (D) on Wednesday said 12,807 new coronavirus infections had been reported statewide in 24 hours, a record high.

Thursday brought another day of more than 12,000 new infections reported, though the daily numbers reported Thursday were slightly less than Wednesday. The 14-day statewide rate of positive tests has crept up slightly, and is now 7.6%. It’s a far cry from the nearly 50% positivity rate in early April, but still up from the lowest rate of about 4% at the end of the same month.

Cases began rising after Newsom lifted the stay-at-home order and let the state’s individual counties reopen businesses in May. In many instances, experts said, that flexibility likely allowed local governments to rush ahead and reopen before they were ready. Newsom has been re-imposing some of the restrictions, and has shut down all indoor non-essential businesses in most of the state. Still, it will take weeks before that impact is seen on cases, hospitalizations and deaths.

Florida Gov. Ron DeSantis (R) on Thursday continued to downplay the severity of the state’s COVID-19 outbreak, even as health officials reported a record 173 new deaths among Florida residents.  The 173 new COVID-19 deaths increased the state’s cumulative total to 5,518. In the past seven days, Florida has confirmed just under 1,000 resident deaths related to COVID-19. DeSantis on Thursday said he would not consider imposing a statewide mask requirement, even though many cities, towns and counties statewide have done so.

Meanwhile, between late March and mid-May, it’s probable that 10 times more coronavirus infections occurred than the number of cases that were reported during that time, according to a new study by the CDC’s COVID-19 Response Team. Published last week in the journal JAMA Internal Medicine, the study looked for antibodies in 10 locations across the US. In San Francisco, 1% of samples had antibodies in late April, as compared with nearly 7% in New York City, which was collected in late March. “It is likely that greater than 10 times more SARS-CoV-2 infections occurred than the number of reported COVID-19 cases; most persons in each site, however, likely had no detectable SARS-CoV-2 antibodies,” the authors wrote.

According to Johns Hopkins Medical, as of Saturday, July 25, there were nearly 16 million COVID-19 global cases confirmed, and over 641,000 deaths. Confirmed cases in the US totaled 4.1 million with nearly 146,000 deaths. Both of the US figures continue to comprise 26% and 23%, respectively, of the global totals.

COVID-19 Addenda: 1) HCQ study “fully irresponsible;” 2) Self-swab COVID-19 home testing found comparable; 3) COVID antibodies fade rapidly, raising risk of lost immunity; 4) American officials accuse two Chinese hackers of trying to steal coronavirus data; and (5) Even mild obesity raises severe COVID-19 risks.

The March 2020 paper that set off months of debates about whether hydroxychloroquine is effective in treating COVID-19 has “gross methodological shortcomings” that “do not justify the far-reaching conclusions about the efficacy of hydroxychloroquine in COVID-19,” according to a review  commissioned by the journal that published the original work.

“[The study] suffers from major methodological shortcomings which make it nearly if not completely uninformative,” Frits Rosendaal of Leiden University Medical Center in the Netherlands wrote in the review. “Hence, the tone of the report, in presenting this as evidence of an effect of hydroxychloroquine and even recommending its use, is not only unfounded, but, given the desperate demand for a treatment of COVID-19, coupled with the potentially serious side-effects of hydroxychloroquine, fully irresponsible.” (Ref: Journal of The International Society of Antimicrobial Chemotherapy)

Symptomatic people seeking COVID-19 testing can effectively swab themselves at home, suggests a new study, which found that the results of such testing were comparable to those involving traditional nasopharyngeal swabbing by clinicians. Home swab testing was 80% sensitive and 98% specific for detecting SARS-CoV-2 compared with testing administered by clinicians.

“As we continue to see a large number of cases across the US, timely testing needs to be a priority,” senior study author Helen Y. Chu, MD, MPH, told Medscape Medical News.

Home testing could also supplement traditional types of testing.

“At-home self-collected swabs provide a way for individuals to get tested quickly and accurately without needing to leave their home and potentially expose other individuals,” added Chu, a professor of medicine in the Division of Allergy and Infectious Diseases at the University of Washington School of Medicine in Seattle.

The findings were published online July 22 in a research letter in JAMA Network Open.

Recovering from COVID-19 may not offer much lasting protection from future infections for those with only mild cases, according to a report that suggests caution regarding so-called herd immunity as well as the durability of vaccines.

The correspondence in the New England Journal of Medicine outlined research on antibodies taken from the blood of 34 patients who had recovered after suffering mainly mild symptoms that didn’t require intensive care. Just two needed supplemental oxygen and received an HIV medication, and none were on a ventilator or getting Gilead Sciences Inc.’s (Foster City CA) remdesivir. The first analysis was done on antibodies taken an average of 37 days after symptoms began, with a second after about 86 days, or less than three months. The researchers found that antibody levels fell quickly, with a half-life of about 73 days between the two time frames.

The US Justice Department last week accused a pair of Chinese hackers of targeting vaccine development on behalf of the country’s intelligence service, says The New York Times. DOJ officials called the suspects a blended threat who sometimes worked on behalf of China’s spy services and sometimes worked to enrich themselves. The officials said that an indictment secured against them earlier this month and unsealed last week was the first to target such a threat.

The hacking was part of a broader, years-long campaign of cybertheft by the pair aimed at an array of industries. American government officials said that at the behest of China’s spy service, the two hackers shifted their focus this year to trying to acquire vaccine research and other information about the pandemic. The accusations also came days after the US and allied countries accused Russia of trying to steal information on vaccine development.

And people with a body mass index of 30 kg/m2 or above are at significantly increased risk for severe COVID-19, while a BMI of 35 and higher dramatically increases the risk for death, new research suggests. The data, from nearly 500 patients hospitalized with COVID-19 in March and April 2020, were published in the European Journal of Endocrinology. The data support the recent change by the Centers for Disease Control and Prevention to lower the cutoff for categorizing a person at increased risk from COVID-19 from a BMI of 40 down to 30. However, in the United Kingdom, the National Health Service still lists only a BMI of 40 or above as placing a person at “moderate risk (clinically vulnerable).”

Fauci says COVID-19 vaccine “probably won’t be widely available until several months into 2021.”

A COVID-19 vaccine likely won’t be “widely available” in the US until “several months” into next year, Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said Friday.

“I think as we get into 2021, several months in, that you would have [a] vaccine that would be widely available to people in the US,” Fauci told the Washington Post’s Bob Costa during a Post Live event.

It was a clear acknowledgment that approval, manufacturing and distribution of a vaccine would take months, even if one is found to work by the end of this year.

“The key word there, Bob, is widely available,” Fauci said.

Fauci noted that some companies have claimed they could have a vaccine available before the end of the year.

“I’m a little skeptical about that, but, you know, anything is possible,” he told the Post. “It is likely that in the beginning of next year we would have tens of millions of doses available,” he added. “The companies who are involved in making these vaccines, many of which the federal government is in deep collaboration with, promised that as we get into 2021, there will be hundreds of millions of doses. And then maybe sometime thereafter, billions of doses.”

Fauci also said that as many people as possible should get vaccinated for influenza this year, since the pandemic will complicate flu season. Fauci’s assessment comes after the US hit a sobering four million cases of COVID-19. And as the rising daily rate of confirmed cases and hospitalizations suggest the virus is far from under control, medical experts are urging political leaders to shut down the country and start over to contain the pandemic. Coronavirus is set to become a leading cause of death in the US, Centers for Disease Control and Prevention mortality statisticians told CNN Thursday.

Early data show AstraZeneca/Oxford COVID-19 vaccine prompts dual immune response.

A coronavirus vaccine the University of Oxford is developing with AstraZeneca PLC (London) showed promising results in early human testing, and is now set to move into larger trials that are likely to be decisive on how effective they truly are. But the results weren’t enough to convince the market, Bloomberg reports. AstraZeneca fell 9% over the week to $55.80 from a record high in New York trading on concerns over whether its vaccine can match the progress seen in programs from Pfizer Inc. and BioNTech SE, as well as Moderna Inc.

“In the competitive context they fail to impress,” said Bernstein analysts led by Ronny Gal.

The vaccine increased levels of both protective neutralizing antibodies and immune T-cells that target the virus, according to the study organizers. The results, published last week in The Lancet medical journal, are a key milestone for one of the fastest-moving vaccine projects globally.

“Our hope is that we can actually start delivering a vaccine before the end of the year,” AstraZeneca CEO Pascal Soriot said. “We’re working as quickly as we can but of course there are things you cannot control.”

Exacerbating market concerns, The Lancet medical journal publication came just an hour after Pfizer and BioNTech had announced early positive data from their COVID-19 vaccine trial in Germany, which builds upon promising results from their program earlier this month. Sarah Gilbert, a vaccinologist who leads the work at Oxford, said 18-to-55 year-olds and people over 55 in the UK trial are already being given two doses of the vaccine candidate. The larger US trial due to start in a few weeks will also likely test two doses, she said.

“We don’t know where we need to get to with the immune response,” Gilbert said. “Nobody knows how strong it needs to be.” The best strategy, she said, is to go for a strong immune response to determine efficacy, she added. “If it turns out to be too much, that’s fine,” Gilbert added. “We may be able to take it back to one dose at least for the younger adults. The testers are also looking at different dose levels” to determine the best way forward, she said.

A positive outcome had been widely expected after reports last week lifted AstraZeneca’s stock, with the vaccine already in more advanced trials. Researchers plan to prioritize testing a two-dose regimen, rather than a single shot, dampening some of the enthusiasm over the vaccine.

“The market should be extremely gratified that we have several vaccine candidates that are making good progress,” Lancet Editor Richard Horton said in a Bloomberg interview.

Although stimulating production of neutralizing antibodies doesn’t prove a vaccine will be effective, it’s considered an important early step in testing. Results from testing in animals had already shown the Oxford-AstraZeneca shot provoked an immune response. Most of the participants in the study received a single dose of vaccine. Astra will prioritize a two-shot regimen in future testing, said Adrian Hill, head of Oxford’s Jenner Institute. A single dose of Oxford vaccine resulted in a four-fold increase in antibodies to the virus’s spike protein in 95% of participants one month after injection, AstraZeneca said.

IPO Sector: CureVac AG, a Phase 1 biotech developing mRNA-based cancer therapies and vaccines, filed on Friday with the SEC to raise up to $100 million in an initial public offering. The company’s pipeline contains lead candidates CV8102, which is currently in a Phase 1 trial for solid tumors, and CV7202, which is currently in a Phase 1 trial for potential vaccination against rabies. The company is also advancing its mRNA vaccine program against coronavirus (SARS-CoV-2), for which it initiated a Phase 1 trial in healthy volunteers in June 2020, with results expected in the 4Q20. The Tübingen, Germany-based company was founded in 2000 and booked $20 million in revenue for the 12 months ended March 31, 2020. It plans to list on the Nasdaq under the symbol “CVAC.” BofA Securities, Jefferies, Credit Suisse, and Kempen are the joint bookrunners on the deal. No pricing terms were disclosed.

Elsewhere, Inozyme Pharma Inc., a preclinical biotech developing protein therapies for rare calcification diseases, raised $112 million by offering 7 million shares at $16, in line with the upwardly revised terms. It originally filed to offer 5 million shares at a range of $14 to $16, before increasing its proposed deal size on Thursday morning. At pricing, the company commands a fully diluted market cap of $386 million. South Boston, MA-based Inozyme Pharma was founded in 2015 lists on the Nasdaq under the symbol “INZY.” BofA Securities, Cowen and Piper Sandler are the joint bookrunners on the deal. Shares closed the week up 10% at $17.54.

Annexon Inc., a Phase 1 biotech developing therapies for rare autoimmune diseases, raised $251 million by offering 14.8 million shares at $17, above the narrowed range of $15 to $16. It originally planned to offer 10 million shares at a range of $14 to $16, before increasing its proposed deal size on Thursday morning. At pricing, the company commands a fully diluted market value of $640 million. South San Francisco-based Annexon was founded in 2011 and lists on the Nasdaq under the symbol “ANNX.” J.P. Morgan, BofA Securities, and Cowen acted as lead managers on the deal. Shares closed the week up 4% at $17.76.

iTeos Therapeutics Inc., a Phase 1/2 immuno-oncology biotech developing therapies for various cancers, raised $201 million by offering 10.6 million shares at $19, above the range of $16 to $18. At pricing, iTeos commands a fully diluted market cap of $681 million. iTeos is a biotech that focuses on immuno-oncology therapies with a pipeline that features two clinical-stage programs, both of which aim to find ways around the limitations of PD-1 and CTLA-4 treatments. The first targets the adenosine A2 pathway by blocking the A2A receptor, in theory preventing tumors from using this mechanism for evasion. The second targets TIGIT ligands on tumor cells, which stop T and NK cells from recognizing the cancer. Cambridge, MA-based iTeos lists on the Nasdaq under the symbol “ITOS.” J.P. Morgan, SVB Leerink and Piper Sandler acted as lead managers on the deal. Shares closed the week up 5 cents at $19.05.

Nurix Therapeutics Inc., a preclinical biotech developing small molecule therapies for cancer, raised $209 million by offering 11 million shares at $19, above the narrowed range of $17 to $18. The San Francisco based company originally planned to offer 8.8 million shares at a range of $16 to $18. At pricing, the company commands a fully diluted market value of $754 million. Nurix had been a relatively low-profile, preclinical cancer biotech before quietly striking deals with Gilead and Sanofi within the span of a few months. The biotech is a player in the protein degradation field, which has shown promise in oncology, and is notable for its BTK program and research into the biology of E3 ligases. Nurix Therapeutics lists on the Nasdaq under the symbol “NRIX.” J.P. Morgan, Piper Sandler, and Stifel acted as lead managers on the deal. Shares closed the week up 1 cent at $19.01.

PaxMedica Inc., a Phase 2 biotech developing therapies for neurodevelopmental disorders, announced terms for its IPO. The Woodcliff Lake, NJ-based company plans to raise $15 million by offering 2.5 million shares at a price range of $5.50 to $6.50. At the midpoint of the proposed range, PaxMedica would command a fully diluted market value of $64 million. The company’s lead candidate PAX-101, an intravenous formulation of suramin, is currently in a Phase 2b clinical trial at six sites in South Africa for the treatment of autism spectrum disorder (ADS), which affects more than 3.5 million Americans. PaxMedica was founded in 2018 and plans to list on the Nasdaq under the symbol “PXMD.” The Benchmark Company is the sole bookrunner on the deal.

Inhibikase Therapeutics Inc., a clinical stage biotech developing therapies for Parkinson’s and related disorders, filed on Thursday with the SEC to raise up to $18 million in an IPO. The company’s pipeline contains lead candidate IkT-148009, a c-Abl protein kinase inhibitor being developed for Parkinson’s disease (PD) and related disorders that arise inside and outside of the brain. The company has filed two INDs for IkT-148009, one for PD and one for the treatment of PD-related gastrointestinal complications, and it expects to commence the first dosing of PD patients shortly after the conclusion of the offering. The Atlanta, GA-based company was founded in 2008 and booked $1 million in grant revenue for the 12 months ended March 31, 2020. It plans to list on the Nasdaq under the symbol “IKT.” ThinkEquity is the sole bookrunner on the deal. No pricing terms were disclosed.

And AlloVir Inc., a Phase 2 biotech developing allogeneic T cell therapies for viral diseases, announced terms for its IPO on Thursday. The Cambridge, MA-based company plans to raise $251 million by offering 14.8 million shares at a price range of $16 to $18. At the midpoint of the proposed range, AlloVir would command a fully diluted market value of $1.0 billion. The company’s pipeline contains lead candidate Viralym-M, a multi-virus-specific T cell therapy targeting five viruses. The company is initially focusing on immunocompromised allogeneic hematopoietic stem cell transplant (HSCT) and solid organ transplant patients who are at high risk for life-threatening viral infections from the five viruses targeted by Viralym-M. AlloVir recently reported positive data from its completed Phase 2 trial. AlloVir was founded in 2013 and plans to list on the Nasdaq under the symbol “ALVR.” Morgan Stanley, J.P. Morgan, SVB Leerink and Piper Sandler are the joint bookrunners on the deal. It is expected to price this week.

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