Top Stories for Week of October 5, 2020

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Trump hospitalized with COVID-19 diagnosis; doctors add steroid used in treating more severe patients.

As most of the world is now aware, President Donald Trump was hospitalized Friday evening after learning he had the SARS-CoV-2 virus and experiencing what aides called coughing, congestion and fever, throwing the nation’s leadership into uncertainty and destabilizing an already volatile campaign only 32 days before the election.

According to The New York Times, Mr. Trump was flown to Walter Reed National Military Medical Center after being given an experimental antibody treatment as the White House rushed to cope with a commander in chief infected by a virus that has killed more than 208,000 people in the US. Officials said he would remain in the hospital for several days and canceled upcoming campaign events.

The White House shrouded Mr. Trump’s condition in secrecy, saying little more than that he had “mild symptoms,” and officials characterized the hospital stay as a precautionary measure. But the normally voluble president remained almost entirely out of public view, skipped a telephone call with governors at the last minute and uncharacteristically stayed off Twitter nearly all day while people close to the situation said his fever and other symptoms worsened as the hours wore on.

On Sunday it was reported that Mr. Trump received 2 liters of oxygen therapy last Thursday after his oxygen saturation level temporarily dipped below 94%; still he never experienced any difficulty breathing, and dexamethasone has been added to his treatment regime, the president’s personal physician said during a Sunday morning press conference. Sean Conley, DO, backed at the briefing by a team of clinicians from Walter Reed National Military Medical Center, added that circumstances may allow the president to be released from the hospital as soon as today (Monday), according to Medscape Medical News.

Trump also received supplemental oxygen a second time on Saturday after his oxygen saturation dropped to 93%. Conley reported the president’s most recent oxygen saturation level was 98% and that his levels never dropped below 90%. In addition, “because of the timeline since his initial diagnosis,” Conley and the rest of his care team at Walter Reed initiated dexamethasone treatment on Saturday.

Initial reactions to Sunday’s update on the president’s condition included questions about the indication for starting dexamethasone. Growing evidence suggests, for example, that the steroid could help people with more severe COVID-19 illness, as previously reported by Medscape. A tweet from Eric Topol, MD, a professor of molecular medicine at Scripps Research in La Jolla, CA, and editor-in-chief of Medscape, questioned the use of dexamethasone given Trump’s brief need for oxygen therapy and raised concerns about results of a pivotal trial evaluating oxygen therapy. Two episodes of transient low oxygen saturation and the administration of oxygen therapy in two instances clarified earlier statements Conley made that the president did not require oxygen in recent days.

“I was trying to reflect the upbeat attitude of the team,” Conley told reporters when asked why he did not include the oxygen therapy in his comments during a press briefing on Saturday. “In doing so, it came off that we were trying to hide something, which is not necessarily true.”

Separately, according to Johns Hopkins Medical, as of Saturday, October 3, there were 34.7 million COVID-19 global cases confirmed, and some 1 million deaths. Confirmed cases in the US totaled over 7.4 million with 209,000 deaths. Both of the US figures comprise 21.3% and 20.9%, respectively, of the global totals.

COVID-19 Addenda: Anticipating an initial short supply of COVID-19 vaccines, a prominent scientific advisory committee recommends that the first vaccines be given to the ~15% of Americans who are at highest risk for infection or serious illness. These include primarily healthcare workers, first responders, individuals with underlying health conditions, and those older than 65 years who are living in congregate settings. Healthcare workers, for example, would be in the first of four phases of the vaccination campaign, according to the recommendations.

The panel said the second vaccination phase would include one-third of Americans: kindergarten through 12th grade teachers and staff, childcare workers, food supply and public transit workers, and others in high-risk settings, along with people of any age who have underlying conditions that put them at moderate risk for COVID-19. Just fewer than half of Americans would be in Phase 3, including young adults, children, and employees of colleges, universities, hotels and other environments that pose a moderately high risk for exposure. The final phase would cover all those who did not have access to vaccination in prior phases.

Elsewhere, a small number of infected people are the main cause of the coronavirus’s spread, according to a massive contact tracing study conducted in two Indian states. The study published in Science found that 8% of infected individuals were responsible for 60% of new infections. Meanwhile, 71% of infected individuals did not infect anybody.

“Superspreading events are the rule rather than the exception when one is looking at the spread of COVID-19, both in India and likely in all affected places,” said lead researcher Ramanan Laxminarayan, a senior research scholar at the Princeton Environmental Institute (PEI), according to a news release from Princeton.

The release said this was the largest contract tracing study of any disease in the world. Researchers from the PEI, Johns Hopkins University, and the University of California, Berkeley, coordinated with public health officials in the two Indian states of Tamil Nadu and Andhra Pradesh. They studied 575,071 people who had been exposed to 84,965 confirmed cases of COVID-19, the release said. Young adults make up about a third of COVID-19 cases, the news release said.

The Oslo-Norway based Coalition for Epidemic Preparedness Innovations (CEPI) has established a global lab network to compare potential COVID-19 vaccines against each other, according to Reuters. The labs will evaluate early-stage data, and results from Phase 1 and 2 clinical trials–“as though vaccines are all being tested under one roof,” CEPI director of vaccine R&D Melanie Saville told Reuters.

Going forth, CEPI hopes to also include Phase 3 data. While the participating labs have yet to be announced, Saville said there will be one each in the following countries: Canada, Britain, Italy, the Netherlands, Bangladesh and India. Memorial Sloan Kettering Care Center Health Policy and Outcomes director Peter Bach wrote about the importance of a study to compare the many vaccines in development worldwide in a September STAT News op-ed. Simply comparing stand-alone trials will not do the trick, Bach argued. Trials follow different protocols, or use different reagents, Saville explained to Reuters.

“Thousands of deaths will be averted if we identify those vaccines that are more effective, even by a few percentage points,” Bach wrote.

And we won’t be buying a rapid spit test anytime soon, says The New York Times. But nose-swab versions might be on the way. For months, public health experts have been eagerly watching the companies developing spit tests for the coronavirus that could be used at home, producing results in a matter of minutes. If these rapid saliva tests worked, as many news articles have pointed out, they could greatly expand the number of people getting tested.

Some experts have even said they could perform as well as a vaccine in curbing the spread of the coronavirus and paving a path back to normalcy. But so far, the technology is not panning out as some have hoped. E25Bio Inc. (Cambridge MA) and OraSure Technologies Inc. (Bethlehem PA), two companies pursuing rapid at-home coronavirus tests, have abandoned efforts to use saliva in their products. Their tests, which detect pieces of coronavirus proteins called antigens, will for now rely on shallow nose swabs instead.

Trump up and active at Walter Reed; has received Regeneron’s antibody cocktail.

President Donald Trump was “up and active” and being closely monitored at Walter Reed National Military Medical Center, the White House physician said during a press conference Saturday morning. He was hospitalized Friday for treatment and observation after receiving a positive test early Friday for SARS-CoV-2, according to Medscape.

“He has been fever-free for more than 24 hours” and is not receiving oxygen therapy, said Sean Conley, DO.

Conley said he is “cautiously optimistic” about the president’s health status. However, a source familiar with the president’s health told the White House press pool on background that “the President’s vitals over last 24 hours were very concerning and the next 48 hours will be critical in terms of his care. We are still not on a clear path to a full recovery.” Conley also said that the president was 72 hours into his diagnosis, which contradicted earlier reports from the White House. The timeline raises the question of whether the president attended any in-person events this week while aware of his positive test status.

In a follow-up memo released after the press conference, Conley said, “This morning while summarizing the President’s health, I incorrectly used the term ‘seventy two hours’ instead of ‘day three’ and ‘forty eight hours’ instead of ‘day two’ with regards to his diagnosis and the administration of the polyclonal antibody.”

Flanked by members of the Trump’s care team on Friday, Conley noted that Trump had taken an 8 gram dose of Regeneron Pharmaceuticals Inc.’s (Tarrytown NY) antibody cocktail–the high dose that appeared to do better than the low dose in terms of batting down viral loads. Earlier last week Regeneron–led by CEO Len Schleifer and chief scientist George Yancopoulos-had stirred a mixed response with its first cut of the data on the cocktail, mainly providing proof-of-concept data for the drug without solid evidence of efficacy in easing the path of the patients with initially mild cases of COVID-19.

When asked by a reporter why the president would receive remdesivir on top of the antibody cocktail treatment, Conley replied, “He is receiving the standard of care and beyond at the moment. We are maximizing all aspects of his care and taking a multipronged approach.”

House passes $2.2 trillion Democratic coronavirus stimulus bill.

The US House of Representatives on Thursday approved a $2.2 trillion Democratic plan to provide more economic relief from the coronavirus pandemic, as a bipartisan deal continued to elude House Speaker Nancy Pelosi and the White House. Objections from top Republicans are likely to doom the House Democrats’ plan in the Senate. Senate Majority Leader Mitch McConnell has called the $2.2 trillion price tag “outlandish,” although Democrats have reduced the cost of their proposal by over a trillion dollars since May.

The House vote was 214-207. No Republican voted for the Democratic plan, although 18 Democrats voted no, many of them moderates from swing districts who have been urging Pelosi to bring a bipartisan proposal to the House floor. “Today’s package is another partisan exercise that will never become law,” Representative Abigail Spanberger, one of the Democrats who voted no, said. Republican President Donald Trump’s negotiating team has suggested a $1.6 trillion response, and the White House on Thursday dismissed Democrats’ $2.2 trillion plan as not serious.

Pelosi and Treasury Secretary Steven Mnuchin talked every day last week, including a 50-minute phone call Thursday, in an effort to negotiate a bipartisan aid package to respond to the economic fallout from a pandemic that has killed more than 208,000 Americans and thrown millions out of work. Congress and the White House approved more than $3 trillion worth of coronavirus relief measures earlier this year, but Mnuchin, as well as members of Congress from both parties, have argued more stimulus is needed. Asked if there would be a resolution to her negotiations with the administration on Thursday evening, Pelosi told reporters, “No.” She gave no details of their talks but said: “Even if we came to some agreement, nothing is agreed to until everything is agreed to. It’s the language.”

In the absence of a deal with the White House, and with lawmakers preparing to leave Washington for the remaining weeks of the 2020 presidential and congressional campaign, the Democratic-majority House went ahead and passed the Democrats’ proposal.

“Frankly if we had reached a bipartisan agreement…we wouldn’t have this bill on the floor,” House Majority Leader Steny Hoyer said. “But we also want to let the American people know where we stand.”

Lawmakers and securities analysts viewed talks as a last-gasp effort to secure relief ahead of the Nov. 3 election for tens of millions of Americans and businesses including US airlines, which have begun furloughing over 32,000 workers. (Ref: Reuters)

IPO Sector: Included among recent SEC filings for initial public offerings, Auna SAA, a Peruvian healthcare plan provider and hospital operator, registered up to $100 million in an initial public offering. It plans to dual-list ADSs on the NYSE and common stock on the Lima Stock Exchange (BVL). The company was originally founded in 1989 as Oncosalud, a healthcare coverage provider selling prepaid plans for cancer prevention and detection. Auna now operates seven general hospitals, three specialized oncology hospitals, and ten clinics throughout Peru and Colombia, while also continuing to provide oncology healthcare plans. The Lima, Peru-based company booked $372 million in revenue for the 12 months ended June 30, 2020, and plans to list on the NYSE under the symbol “AUNA.” Morgan Stanley and Goldman Sachs are the joint bookrunners on the deal. No pricing terms were disclosed.

Elsewhere, Processa Pharmaceuticals Inc., which is developing an analog therapy for necrotic skin disease, announced the pricing of an underwritten IPO of 4.8 million shares of common stock for a price to the public of $4.00 per share. Gross proceeds to the Hanover MD-based company are expected to be approximately $19.2 million. Processa Pharmaceuticals was founded in 2011 and lists on the Nasdaq under the symbol “PCSA.” Craig-Hallum Capital Group and The Benchmark Company are the joint bookrunners on the deal. Shares closed the week down 5 cents at $3.95.

Pulmonx Inc., which makes minimally invasive systems to treat severe emphysema, priced its upsized IPO of 10 million common shares at $19.00 per share, higher than the already raised price range of $17-$18 for gross proceeds of $190 million. The Redwood City, CA-based company had previously filed to offer 6.7 million shares at a range of $14 to $16. Pulmonx’s Zephyr Valve, a severe emphysema treatment device, received pre-market approval in 2018 and is now commercially available in more than 25 countries, with over 80,000 valves used to treat more than 20,000 patients through June 30, 2020. Pulmonx was founded in 1995 and booked $32 million in sales for the 12 months ended June 30, 2020. It lists on the Nasdaq under the symbol “LUNG.” BofA Securities, Morgan Stanley and Stifel were among the joint bookrunners on the deal. Shares more than doubled over the week to $41.90.

Aziyo Biologics Inc., which makes regenerative medical products for various tissue types, announced terms for its IPO. The Silver Spring, MD-based company plans to raise $50 million by offering 2.9 million shares at a price range of $16 to $18. At the midpoint of the proposed range, Aziyo Biologics would command 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 plans to list on the Nasdaq under the symbol “AZYO.” Piper Sandler, Cowen, Cantor Fitzgerald and Trust Securities are the joint bookrunners on the deal. It is expected to price on Wednesday, Oct. 7.

Biodesix Inc., which provides diagnostic tests and services for lung disease and other unmet needs, registered up to $75 million in an IPO. 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 and diagnostic services. 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. It plans to list on the Nasdaq under the symbol “BDSX.” Morgan Stanley, William Blair, Canaccord Genuity and BTIG are the bookrunners on the deal. No pricing terms were disclosed.

Foghorn Therapeutics Inc., a preclinical biotech developing gene therapies for hematologic cancers and solid tumors, registered up to $100 million in an IPO. Foghorn is developing a new class of medicines targeting genetically determined dependencies within the chromatin regulatory system through its proprietary Gene Traffic Control platform. The company’s two most advanced candidates are FHD-286, a selective allosteric ATPase inhibitor, and FHD-609, a protein degrader. The candidates are being developed for hematologic cancers and solid tumors, and the company plans to file INDs for FHD-286 and FHD-609 in the 4Q20 and 1H21, respectively. The Cambridge, MA-based company was founded in 2015 and plans to list on the Nasdaq under the symbol “FHTX.” Goldman Sachs, Morgan Stanley, Cowen and Wedbush PacGrow are joint bookrunners on the deal. No pricing terms were disclosed.

PaxMedica Inc., a Phase 2 biotech developing therapies for neurodevelopmental disorders, revised the terms of its upcoming IPO. The Woodcliff Lake, NJ-based micro-cap now plans to raise $15 million by offering 2.6 million shares at a price range of $5.50 to $6.50. The company is also offering 2.0 million warrants, exercisable at the IPO price. Each share is being sold with three-quarters of a warrant. The company had previously filed to offer 2.5 million shares of common stock at a range of $5.50 to $6.50. At the midpoint of the range, PaxMedica will raise 5% more in proceeds than previously anticipated. 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.

Orphazyme A/S, a Danish late-stage biotech developing protein therapies for rare neurodegenerative diseases, raised $84 million by offering 7.6 million ADS equivalents at $11, below the as-converted last close of its shares on the Nasdaq Copenhagen (ORPHA). At pricing, the company raised 16% less in proceeds than anticipated. The Copenhagen-based company is developing heat shock proteins to develop novel therapies for neurodegenerative orphan diseases. The company submitted an NDA for product candidate arimoclomol with the FDA for Niemann-Pick disease Type C (NPC) in July 2020, and it plans to submit a marketing authorization application to the EMA in the 2H20. In its Phase 2/3 trial of arimoclomol in NPC, the company observed evidence of slowing of disease progression. Orphazyme was founded in 2009 and lists on the Nasdaq under the symbol “ORPH.” BofA Securities, Cowen and Guggenheim Securities were the joint bookrunners on the deal. Shares closed the week off 2% at $10.81.

C4 Therapeutics Inc., a preclinical biotech developing small molecule protein degraders to treat cancer, priced 9.6 million shares at $19 million apiece, netting $182.4 million. The proceeds will be used to push the company’s first protein degradation candidates into the clinic, according to an S-1/A filing. The Watertown, MA-based company had planned to raise $150 million by offering 8.8 million shares at a price range of $16 to $18. C4 has four preclinical programs for its small molecule protein degraders. The company expects to submit an IND for its lead candidate in the fourth quarter of 2020 and begin a first-in-human Phase 1/2 clinical trial in the first half of 2021. C4 Therapeutics was founded in 2015 and lists on the Nasdaq under the symbol “CCCC.” Jefferies, Evercore ISI, BMO Capital Markets and UBS Investment Bank acted as the joint bookrunners on the deal. Shares closed the week up 34% at $25.49.

And Oncorus Inc., a Phase 1 biotech developing oncolytic virus therapies for solid tumors, raised $87 million by offering 5.8 million shares at $15, within the range of $14 to $16. The company’s pipeline contains lead candidate ONCR-177, an intratumorally administered viral immunotherapy based on its oncolytic HSV-1 platform. Oncorus has initiated and begun dosing patients in a Phase 1 trial of ONCR-177 for solid tumors, including breast cancers and cutaneous tumors, with preliminary data expected from the 2H21 through the 2H22. Oncorus was founded in 2015 and lists on the Nasdaq under the symbol “ONCR.” Jefferies, Evercore ISI and Piper Sandler are the joint bookrunners on the deal. Shares closed the week up 7% at $16.

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