Top Stories for Week of September 12, 2020

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President Trump released from hospital after COVID-19 diagnosis; doctors add steroid used in treating more severe patients.

President Trump, eager to demonstrate that his coronavirus infection was a speed bump on his path to victory, last week added two more rallies to this week, one in Iowa and another Pennsylvania–in addition to his planned appearance in Florida today (Monday). The New York Times reports that recent polls seem to indicate that Mr. Trump’s personal health is not yet a central issue of the campaign–and Democrats have mostly criticized his attitude toward masks and social distancing, not his physical capacity to campaign.

Voters are far more likely to distrust his statements on matters of national well-being, including his repeated exaggerations about the pace of vaccine developments. Nonetheless, he seems to be sprinting, rather than just running, for president. On Tuesday, Mr. Trump travels to Johnstown, PA, to deliver remarks at 7 p.m., as he often has, at an airport–this one named after Democratic Congressman and power broker, John Murtha. On Wednesday, Trump–who claims to be symptom free and off all medication but has yet to say if he has tested negative for the virus–heads west for a rally at the Des Moines airport, also scheduled for 7 p.m.

Mr. Trump’s first out of town rally since falling ill will take place at an airport just outside of Orlando on Monday evening.

The invitation to these events specify, “All attendees will be given a temperature check, masks which they are instructed to wear, and access to hand sanitizer.” But in the past, such rules have been indifferently enforced. Earlier, Trump’s physician said Trump had completed his course of therapy for the novel coronavirus, had remained stable since returning to the White House and could resume public engagements on Saturday.

Dr. Sean Conley said in a memo released by the White House that Trump had responded “extremely well” to treatment without any evidence of adverse effects. Trump was hospitalized the previous Friday after he announced he had contracted the coronavirus. He returned to the White House last Monday.

“Since returning home, his physical exam has remained stable and devoid of any indications to suggest progression of illness,” Conley wrote. “Saturday will be day 10 since Thursday’s (Oct. 1) diagnosis, and…I fully anticipate the President’s safe return to public engagements at that time.”

Trump, confined to the White House with the illness that he has sought to play down, has been eager to return to the campaign trail as he trails Democratic candidate Joe Biden in national polls ahead of the Nov. 3 election. The president has been criticized both for his administration’s handling of the pandemic and for his response to his own diagnosis. Earlier on Thursday, Trump said did not believe he was contagious and was feeling good enough to resume campaign rallies.

Trump has held such rallies indoors and outdoors with thousands of people, many of whom do not wear masks, against the advice of public health professionals.

“I’d love to do a rally tonight. I wanted to do one last night,” Trump told Fox Business Network, adding that “if I’m at a rally, I stand by myself very far away from everybody.”

The White House hasn’t said when Trump last tested negative test for the virus.

Separately, according to Johns Hopkins Medical, as of Saturday, October 10, there were over 37 million COVID-19 global cases confirmed, and some 1 million deaths. Confirmed cases in the US totaled over 7.7 million with 214,000 deaths. Both of the US figures comprise 20.8% and 21.4%, respectively, of the global totals.

COVID-19 Addenda: COVID-19 is now the third leading cause of death in the US, says Scientific American. It kills more people than the flu, contrary to Trump’s claims, and also surpasses stroke, Alzheimer’s and diabetes. “It affects virtually nobody,” President Donald Trump said of the novel coronavirus on September 21–a few hours before US deaths from COVID-19 exceeded 200,000 and less than two weeks before he tested positive. Unlike the president, the numbers don’t lie.

The human toll underlying that milestone figure is a number about as big as the population of Salt Lake City or Birmingham, AL–and greater than the deaths in any US conflict except for the Civil War and World War II. The figures speak for themselves: COVID-19 became the third biggest cause of deaths in the week of March 30 to April 4, trailing heart disease and cancer. It killed more people than stroke, chronic lower respiratory disease, Alzheimer’s, diabetes, kidney disease or influenza. In that week, close to 10,000 people died of the illness caused by the coronavirus.

Elsewhere, when the Trump administration suspended federal funding in 2019 for most new scientific research projects involving fetal tissue derived from abortions, officials argued that whatever the scientific benefits, there was a pressing moral imperative to find alternative research methods.

“Promoting the dignity of human life from conception to natural death is one of the very top priorities of President Trump’s administration,” the Department of Health and Human Services said in a statement released at the time.

Yet the treatment for COVID-19 received by Mr. Trump–a cocktail of monoclonal antibodies he described as a “cure” in a celebratory video posted on Twitter–was developed using human cells derived from a fetus aborted decades ago, says The New York Times. Remdesivir, an antiviral drug that the president received late last week, was also developed with those cell lines. At least two companies racing to create a vaccine against the coronavirus, Moderna and AstraZeneca, are also relying on the cells. Johnson & Johnson is testing its vaccine in another so-called cell line originally produced from fetal tissue.

Dr. Anthony Fauci offered a grim image of the coronavirus pandemic, telling students last week that between 300,000 and 400,000 people could die from the disease in the US. Speaking at a virtual event hosted by American University last Tuesday, the White House coronavirus specialist said: ”If we don’t do what we need to in the fall and winter, we could have 300,000-400,000 COVID-19 deaths,” according to excerpts tweeted by the school. More than 200,000 people have died from the disease in the US, and over 7 million have been diagnosed with it, Politico notes.

University of Washington study found in August that as many as 300,000 people could die of the disease by Dec. 1. Fauci added that a vaccine likely won’t be widely available until next summer or fall. That timeline is in line with a prediction by CDC Director Robert Redfield, who warned that it would take about six to nine months to vaccinate the public once a vaccine is approved. Fauci, the director of the National Institute of Allergy and Infectious Diseases, also said last Monday that normal life may not resume until the end of 2021 due to the challenges of distributing the vaccine.

The US Centers for Disease Control and Prevention (CDC) said COVID-19 can spread through virus lingering in the air, sometimes for hours, acknowledging concerns widely voiced by public health experts about airborne transmission of the virus. The updated CDC guidance comes weeks after the agency published–and then took down–a similar warning, sparking debate over how the virus spreads. In last week’s guidance, the CDC said there was evidence that people with COVID-19 possibly infected others who were more than six feet away, within enclosed spaces with poor ventilation.

Under such circumstances, CDC said scientists believe the amount of infectious, smaller droplets and particles, or aerosols, produced by the people with COVID-19 become concentrated enough to spread the virus. The CDC has long warned of transmission through small droplets that shoot through the air and generally fall to the ground, which resulted in the six-feet social distancing rule. Aerosol droplets are much smaller still, and can remain suspended in the air, like smoke.

Gilead Sciences’ remdesivir reduces death risk in COVID-19 patients on oxygen.

Final data from Gilead Sciences Inc.’s (Foster City CA) antiviral drug remdesivir showed the treatment cut COVID-19 recovery time by five days compared with patients who got a placebo, one day faster than indicated in preliminary data, the company and researchers said on Thursday. In patients who were on oxygen when they first got the drug, remdesivir–sold under the brand Veklury–reduced recovery time by seven days compared with placebo after 29 days, according to the 1,062-patient study, published in the New England Journal of Medicine.

The final study looked at data at 29 days of treatment, versus a preliminary study released in May that reported results after 15 days, according to Reuters. Gilead’s drug was among the first to be used as a treatment for the novel coronavirus and was one of the drugs recently used to treat US President Donald Trump. Remdesivir received emergency use authorization from the US Food and Drug Administration on May 1 and has since been authorized for use in several other countries. Results of the overall study suggested the drug may reduce mortality, but the benefit was not statistically significant.

In a separate analysis looking just at patients who received oxygen, however, the drug appeared to reduce the risk of death by 72% at day 15, and 70% by day 29. With this analysis, “we now have data suggesting that giving remdesivir to patients on oxygen may significantly reduce their chances of death compared to other subgroups,” Dr. Andre Kalil, an infectious disease expert at the University of Nebraska Medical Center and the study’s principal investigator, said in a press release.

Regeneron requests emergency use approval from FDA for antibody treatment given to Trump.

Regeneron Pharmaceuticals Inc. (Tarrytown NY) said that it submitted a request to the FDA seeking emergency-use authorization for its REGN-COV2 investigational antibody treatment for COVID-19. The therapy is a combination of two monoclonal antibodies, REGN10933 and REGN10987, and was designed to block infectivity of SARS-CoV-2.

FirstWord Pharma noted that the disclosure came the same day that Eli Lilly announced that it submitted an EUA request to the FDA for its neutralizing IgG1 monoclonal antibody LY-CoV555 for use in higher-risk patients who have been recently diagnosed with mild-to-moderate COVID-19. According to Regeneron, if the EUA is granted, the US government has committed to making REGN-COV2 available to the American people at no cost and would be responsible for its distribution. The company noted that currently there are doses available for approximately 50,000 patients, while it expects to have doses available for 300,000 patients in total “within the next few months.”

Regeneron reported early study results last month showing that the addition of REGN-COV2 to standard-of-care reduced viral load as well as the time to symptom alleviation in non-hospitalized patients with COVID-19. Meanwhile, the company recently confirmed that a single 8-gr dose of REGN-COV2 was given to President Donald Trump following a compassionate-use request from his doctors as part of a treatment regimen that also included Gilead Sciences Inc.’ (Foster City CA) antiviral Veklury (remdesivir) and the steroid dexamethasone.

Following treatment and amid his ongoing recovery from COVID-19, Trump claimed that REGN-COV2 was “the key” to his positive outcome. “I want everybody to be given the same treatment as your president,” he remarked, adding that “I think we’re going to work it so you’re going to get [REGN-COV2 and LY-CoV555] and you’re going to get them free,” with distribution handled by the military.

In addition, Trump’s doctor said that a recent blood test showed that the president had detectable levels of SARS CoV-2 antibodies, which had not been present in a test prior to receiving REGN-COV2. Regeneron noted that it is not possible for the blood test to distinguish between antibodies made by Trump himself and those from REGN-COV2. However, company spokeswoman Alexandra Bowie said that given the volume of antibodies delivered in REGN-COV2, and the timing of the tests, “it is likely that the second test is detecting REGN-COV2 antibodies.” Regeneron shares closed the week up 7% at $602.07.

IPO Sector: Included among recent SEC filings for initial public offerings, Atea Pharmaceuticals Inc., a clinical stage biotech developing therapies for COVID-19 and other viral infections, registered up to $100 million worth of common stock. Atea 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. The Boston, MA-based company was founded in 2014 and plans to list on the Nasdaq under the symbol “AVIR.” J.P. Morgan, Morgan Stanley, Evercore ISI and William Blair are the joint bookrunners on the deal. No pricing terms were disclosed.

Elsewhere, Vivos Therapeutics Inc., which is developing medical devices for sleep disordered breathing, registered up to $20 million in an IPO. The Highlands Ranch, CO-based company plans to raise $20 million by offering 3.3 million shares at a price range of $5 to $7. At the midpoint of the proposed range, Vivos Therapeutics would command a fully diluted market value of $107 million. Vivos is focused on the development and commercialization of a clinically effective non-surgical, non-invasive, non-pharmaceutical, and low-cost solution for sleep disordered breathing, including mild-to-moderate obstructive sleep apnea (OSA). Its treatment, the Vivos System, involves specially designed and customized oral appliances and treatment protocols. Its patented oral appliances have proven effective in over 15,000 patients treated worldwide by more than 1,200 trained dentists. Vivos was founded in 2007 and booked $13 million in sales for the 12 months ended June 30, 2020. It plans to list on the Nasdaq under the symbol “VVOS.” Roth Capital is the sole bookrunner on the deal.

Praxis Precision Medicines Inc., a Phase 2 biotech developing therapies for CNS disorders using genetic insights, announced terms for its IPO on Friday. The Cambridge, MA-based company plans to raise $126 million by offering 7.4 million shares at a price range of $16 to $18. At the midpoint of the proposed range, Praxis Precision Medicines would command a fully diluted market value of $643 million. The company’s pipeline contains its most advanced candidates, PRAX-114 and PRAX-944, which are in Phase 2 development for major depressive disorder/perimenopausal depression and essential tremor, respectively. The company plans to initiate a Phase 2/3 trial for PRAX-114 in the US and Australia in the 4Q20, with topline data expected in the 2H21. Praxis Precision Medicines was founded in 2015 and plans to list on the Nasdaq under the symbol “PRAX.” Cowen, Evercore ISI and Piper Sandler are the joint bookrunners on the deal.

Shattuck Labs Inc., a Phase 1 biotech developing novel dual-sided fusion protein therapies for cancer, raised $202 million by offering 11.9 million shares at $17, above the range of $14 to $16. The company offered 1.9 million more shares than anticipated. At pricing, the company raised 35% more in proceeds than expected. The company’s lead candidate, SL-172154, is designed to simultaneously inhibit the CD47/SIRPa checkpoint and activate the CD40 costimulatory receptor. The company is currently conducting a Phase 1 trial of SL-172154 for ovarian cancer, with initial data expected in the 2H21. Austin, TX-based Shattuck Labs was founded in 2016 and lists on the Nasdaq under the symbol “STTK.” Citi, Cowen and Evercore ISI acted as joint bookrunners on the deal. Shares closed the week up 14% at $19.35.

Spruce Biosciences Inc., a Phase 2 biotech developing a novel therapy for rare endocrine disorders, raised $90 million by offering 6 million shares at $15, within the range of $14 to $16. The company offered 1 million more shares than anticipated. At pricing, the company raised 20% more in proceeds than expected. The company’s lead candidate, tildacerfont, is being developed for classic congenital adrenal hyperplasia (CAH). The company has initiated a Phase 2b trial in adult patients with classic CAH with poor disease control and anticipates topline results in the 4Q21 or the 1Q22. It has also initiated a second Phase 2b trial in adult patients with classic CAH with good disease control and anticipates topline results in the 1H22. Spruce Biosciences was founded in 2014 and lists on the Nasdaq under the symbol “SPRB.” Cowen, SVB Leerink, Credit Suisse and RBC Capital Markets acted as joint bookrunners on the deal. Shares closed the week up 30% at $17.

Kiromic BioPharma Inc., a preclinical biotech developing immunotherapies for blood cancers and solid tumors, lowered the proposed deal size for its upcoming IPO. The Houston, TX-based company now plans to raise $15 million by offering 1.2 million shares at a price range of $12 to $14. The company had previously filed to offer 1.9 million shares at the same range. At the revised deal size, Kiromic BioPharma will raise 40% less in proceeds than previously anticipated to command a market value of $95 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 and Paulson Investment are the bookrunners on the deal.

Codiak BioSciences Inc., an early-stage biotech developing exosome therapeutics for various diseases, announced terms for its IPO. The Cambridge, MA-based company plans to raise $83 million by offering 5.5 million shares at a price range of $14 to $16. At the midpoint of the proposed range, Codiak BioSciences would command a fully diluted market value of $309 million. The company’s lead program, exoSTING, is an exosome therapeutic candidate engineered with its engEx Platform. The company is developing exoSTING for the treatment of multiple solid tumors. Codiak believes exoSTING has demonstrated encouraging preclinical activity, and it expects to initiate a Phase 1/2 trial in the 2H20, with preliminary data expected by mid-2021. Codiak BioSciences was founded in 2015 and booked $1 million in collaboration revenue for the 12 months ended June 30, 2020. It plans to list on the Nasdaq under the symbol “CDAK.” Goldman Sachs, Evercore ISI, William Blair and Wedbush PacGrow are the joint bookrunners on the deal.

InMed Pharmaceuticals Inc., a clinical stage biotech developing cannabinoid-based products, announced terms for its IPO. The Vancouver, Canada-based company plans to raise $10 million by offering 2.4 million shares at $4.13, above the last close of its shares on the OTCQX (IMLFF) and the Toronto Stock Exchange (IN). The company is also offering warrants to purchase 2.4 million shares of common stock at an assumed exercise price of $4.13. At the proposed price, InMed Pharmaceuticals would command a market value of $32 million. InMed Pharmaceuticals is developing an API using a synthetic cannabinoid named cannabinol, or CBN, and plans to develop its two products INM-755 for rare skin disease Epidermolysis Bullosa (EB) and INM-088 for glaucoma. INM-755 is currently in a Phase 1 trial in The Netherlands. InMed Pharmaceuticals was founded in 2014 and plans to list on the Nasdaq under the symbol “INM.” Roth Capital is the sole bookrunner on the deal.

Spinal Elements Holdings Inc., which develops medical devices for minimally invasive spinal surgery procedures, announced terms for its IPO. The Carlsbad, CA-based company plans to raise $108 million by offering 7.7 million shares at a price range of $13 to $15. The company plans to raise an additional $84 million in a concurrent private placement to Kohlberg & Company. At the midpoint of the proposed range, Spinal Elements Holdings would command a fully diluted market value of $382 million. Spinal Elements offers a comprehensive product portfolio that can address approximately 95% of spinal surgery procedures performed worldwide as of 2018. Its systems, products, and technologies cover a wide variety of spine disorders, including degenerative conditions, deformities, and trauma. Spinal Elements was founded in 2003 and booked $93 million in sales for the 12 months ended June 30, 2020. It plans to list on the Nasdaq under the symbol “SPEL.” Credit Suisse, Baird, Stifel, Truist Securities and BTIG are the bookrunners on the deal. It is expected to price on Wednesday, October 14, 2020.

Kronos Bio Inc., a Phase 2 biotech developing kinase inhibitors for leukemia and solid tumors, raised $250 million by offering 13.2 million shares at $19, above the range of $16 to $18. The company originally planned to offer 10.3 million shares at the same range before revising its terms on Thursday morning. At pricing, the company raised 12% more in proceeds than anticipated. The company’s lead candidate, entospletinib (ENTO), is an orally administered, selective spleen tyrosine kinase inhibitor that has been tested in 148 acute myeloid leukemia (AML) patients. Based on clinical results in a biomarker-defined subset of patients and subject to discussions with regulatory agencies planned for the 1H21, the company plans to initiate a registrational Phase 2/3 trial in 2021, with data readout expected in 2023. San Mateo, CA-based Kronos Bio was founded in 2017 and lists on the Nasdaq under the symbol “KRON.” Goldman Sachs, Jefferies, Cowen and Piper Sandler are the joint bookrunners on the deal. Shares closed the week up 42% at $27.07.

Aziyo Biologics Inc., which makes regenerative medical products for various tissue types, raised $50 million by offering 2.9 million shares at $17, within the range of $16 to $18. Insiders have indicated an interest in purchasing up to $20 million of the offering. At pricing, the Silver Spring, MD-based company commands a fully diluted market value of $177 million. Through its proprietary tissue processing platforms, the company has developed a portfolio of advanced regenerative medical products designed to be similar to natural biological material. Its core products are designed to address the implantable electronic device/cardiovascular, orthopedic/spinal repair, and soft tissue reconstruction markets. Aziyo Biologics was founded in 2015 and booked $42 million in revenue for the 12 months ended June 30, 2020. It lists on the Nasdaq under the symbol “AZYO.” Piper Sandler, Cowen, Cantor Fitzgerald and Trust Securities are the joint bookrunners on the deal. Shares closed the week down 20% at $13.54.

And Galecto Inc., a Phase 2 biotech developing therapeutics for fibrosis and fibrotic related diseases, registered up to $100 million in an IPO. 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 plans to list on the Nasdaq under the symbol “GLTO.” BofA Securities, SVB Leerink and Credit Suisse are the joint bookrunners on the deal. No pricing terms were disclosed.

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