Top Stories for Week of September 14, 2020

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After a shocking clinical trial halt, AstraZeneca gets approval to keep dosing its Oxford COVID19 vaccine, but only in the UK.

The University of Oxford said it was moving ahead in the United Kingdom with trials of a coronavirus vaccine it developed in partnership with the pharmaceutical company AstraZeneca PLC (London), after passing a safety review that was prompted when a participant in the United Kingdom appeared to have developed a serious neurological condition.

The trials were placed on hold a week ago, as researchers investigated whether the vaccine may have been the cause. A safety panel reviewed the findings and notified the government’s Medicines Health Regulatory Authority, which then confirmed it was safe to restart the trials in Britain. A statement from the university on Saturday did not mention the prospects for trials that have been suspended in India, Brazil, South Africa and the US, according to The New York Times. The statement also did not offer any clarity about the patient’s condition.

“We cannot disclose medical information about the illness for reasons of participant confidentiality,” the statement said. A statement from AstraZeneca added that the relevant information would be shared with “all trial investigators and participants” and would also “be disclosed on global clinical registries, according to the regulatory standards.”

To date, roughly 18,000 individuals worldwide have already received this particular vaccine. AstraZeneca is one of just three companies with vaccines in late-stage clinical trials in the US. While late-stage trials are designed to test whether vaccines are indeed safe across large populations, the university said it anticipated that some participants would experience adverse effects.

“In large trials such as this, it is expected that some participants will become unwell and every case must be carefully evaluated to ensure careful assessment of safety,” it said in a statement.

Scientists largely praised AstraZeneca’s decision to pause trials and defer to a thorough review by an independent board of experts. The suspension appeared to be the second time that AstraZeneca has halted vaccine trials because of questions surrounding severe neurological symptoms in recipients.

Separately, according to Johns Hopkins Medical, as of Saturday, Sept. 5, there were over 28.6 million COVID-19 global cases confirmed, and nearly 913,000 deaths. Confirmed cases in the US totaled 6.5 million with over 193,000 deaths. Both of the US figures comprise 23% and 21%, respectively, of the global totals.

COVID-19 Addenda: Political appointees at the Department of Health and Human Services have repeatedly asked the Centers for Disease Control and Prevention to revise, delay and even scuttle reports on the coronavirus that they believed were unflattering to President Trump. Current and former senior health officials with direct knowledge of phone calls, emails and other communication between the agencies confirmed on Saturday a report in Politico late Friday that the CDC’s public Morbidity and Mortality Weekly Reports have been targeted by senior officials in the Health and Human Services’ communications office.

The reports, which one former top health official called the “holiest of the holy” in agency literature, are written largely for scientists and public health experts, to update them on trends in infectious diseases, not only the coronavirus but also other outbreaks around the country. They are guarded so closely by agency staff that political appointees only see them just before they are published. Inside the CDC, employees expressed outrage and demoralization on Saturday over the reports of interference. (Ref: The New York Times)

Elsewhere, the public is deeply skeptical about any coronavirus vaccine approved before the November election, and only 42% would be willing to get a vaccine in that scenario, according to a new poll. The results of the poll by Kaiser Family Foundation (KFF) Health Tracking reveal widespread concern that the Trump administration will bring pressure on drug regulators to approve a vaccine before the election without ensuring it is safe and effective.

Six of 10 adults said they were worried the Food and Drug Administration will rush to allow a vaccine because of political pressure. The concern is held by 85% of Democrats, 35% of Republicans and 61% of independent voters. Resistance to taking the vaccine is strong among all groups, with 60% of Republicans saying they would not want to be inoculated if a vaccine were available before the Nov. 3 election. Among Democrats, 46% would decline the vaccine. The wariness may reflect the ongoing political jockeying over a vaccine, and it may also be influenced by strains of general anti-vaccine sentiment in the populace. The Trump administration has suggested a vaccine could be ready by November.

The Sturgis Motorcycle Rally led to significant spread of the novel coronavirus in the event’s home state of South Dakota and in other parts of the US, a team of researchers said in a newly released study that is disputed by state officials. The report from San Diego State University’s Center for Health Economics & Policy Studies used anonymized cellphone location data and virus case counts to analyze the impact of the 460,000-person event that took place last month, believed to be one of the largest events held during the pandemic.

Health officials had expressed concerns about the rally, which, the researchers noted, “represents a situation where many of the ‘worst case scenarios’ for superspreading occurred simultaneously.” Those included the event being prolonged over 10 days, attracting a significant out-of-town population and involving attendees clustered together, with few wearing masks. The consequences were “substantial,” the researchers concluded. By analyzing the parts of the country that had the highest number of Sturgis attendees and changes in coronavirus trends after its conclusion, they estimated 266,796 cases could be linked to the rally.

Inovio Pharmaceuticals Inc. (Plymouth Meeting PA) said that Thermo Fisher Scientific Inc. (Waltham MA) would manufacture the drug developer’s experimental coronavirus vaccine, as it looks to boost the supply ahead of large trials this month. The company said it plans to have 100 million doses of its vaccine, INO-4800, in 2021 through its third-party manufacturers. Inovio is in the race to develop a vaccine for the coronavirus pandemic that has killed over 913,000 people globally.

The vaccine was found to be safe in early-stage studies and a larger study is expected to begin later this month, subject to the US Food and Drug Administration’s clearance. The development timeline lags those of rivals such as Moderna Inc., Pfizer Inc. and AstraZeneca PLC, which have begun late-stage studies of their coronavirus vaccine candidates. Thermo Fisher joins other manufacturers such as Richter-Helm BioLogics and Ology Biosciences in making Inovio’s experimental vaccine.

And after immune modulators and antibodies, blood thinners are the next class of drugs to be put through a Phase 3 trial organized under the NIH’s ACTIV initiative. Three different anticoagulants have been named for the master protocol: heparin, aspirin and apixaban. Informed by studies suggesting that many patients who died from COVID-19 had formed unusual blood clots throughout their bodies–including in their smallest blood vessels–the NIH wants to see which therapies are the most effective at preventing or reducing clotting and thus improving outcomes for patients.

Agency chief, Francis Collins, said, “There is currently no standard of care for anticoagulation in hospitalized COVID-19 patients, and there is a desperate need for clinical evidence to guide practice. Conducting trials using multiple existing networks of research sites provides the scale and speed that will get us answers faster.”

For the inpatient trial, patients will be given either a low dose or a high dose of heparin.

Trump admits he deliberately downplayed deadly coronavirus; says goal was to diminish panic.

In a series of on-the-record interviews with The Washington Post’s Bob Woodward, President Donald Trump struck a very different tone about the disease, says Politico. Trump acknowledged the “deadly” nature of the coronavirus earlier this year in the series of recorded interviews with Woodward, even as Trump publicly sought to dismiss the disease’s threat to Americans.

Recounting a conversation with Chinese President Xi Jinping, Trump told Woodward on Feb. 7 that the coronavirus is “more deadly than your, you know, your–even your strenuous flus.” He added, “This is more deadly. This is five per–you know, this is 5% versus 1% and less than 1%, you know. So, this is deadly stuff.” Woodward conducted 18 on-the-record interviews with the president between last December and July to gather material for the veteran journalist’s forthcoming book on the Trump White House.

Excerpts of those conversations were published last Wednesday by the Post, including an exchange between Trump and Woodward in which the president revealed he was eager to downplay the coronavirus outbreak so as not to alarm Americans.

“I wanted to always play it down. I still like playing it down,” Trump said on March 19. “Because I don’t want to create a panic.”

Trump later defended himself during a White House briefing, emphasizing the notion that he was trying to prevent panic. He called Woodward’s account “just another political hit job,” and said he was acting in the country’s best interest, even calling himself “a cheerleader for this country.”

He continued, “We had to show calm. The last thing we can show is panic or excitement or fear or anything else. We had to take care of the situation we were given.”

When asked why he didn’t take more preemptive measures based on his understanding of the virus before the disease spread in the US, Trump said: “You didn’t really think it was going to be to the point where it was.” But Trump acknowledged to Woodward in February how easily transmissible and deadly the disease was.

When asked if he felt the outcome of the pandemic could have been different had he been more forthcoming to the American people, Trump said his response showed leadership. He declined to take responsibility for not reducing the nearly 200,000 deaths from the disease in the US, claiming millions more would have died had he not shut down the country to foreign visitors.

“We have to show leadership,” Trump said. “And leadership is all about confidence. And confidence is confidence in our country.”

On Wednesday night, in an interview with Sean Hannity on Fox News, the president again said that his actions saved many lives, and he praised his administration’s handling of the pandemic.

“We could’ve lost 2 million, 2.5 million, maybe even more than that if we did it a different way, and we’ve done a really good job,” Trump said.

The damaging recordings come in the final weeks of a general election campaign which has seen the coronavirus emerge as the most important issue to voters, and as the White House is already deflecting reports of Trump disparaging the US military and America’s war dead.

EU choses Pfizer/BioNTech for 200 million-dose vaccine supply deal.

Pfizer Inc. (NYC) and BioNTech SE (Mainz DEU) announced that they concluded exploratory talks with the European Commission for a proposed supply of 200 million doses of their investigational mRNA-based vaccine candidate against SARS-CoV-2, with an option to buy a further 100 million doses. The companies noted that deliveries of BNT162b2, which they say is on track to be filed for approval as soon as October, would start by the end of 2020, subject to clinical results and regulatory clearance.

Albert Bourla, CEO at Pfizer, remarked “we have activated our supply chain, most importantly our site in Belgium, and are starting to manufacture so that our vaccine would be available as soon as possible.” Doses for Europe would also be produced at BioNTech’s German manufacturing sites, says FirstWord Pharma. The companies said they will now enter into contract negotiations with the European Commission, which has so far only signed one advance purchase deal for a COVID-19 vaccine, agreeing last month to secure up to 400 million doses of AstraZeneca and the University of Oxford’s AZD1222 candidate.

Aside from these latest exploratory talks with Pfizer and BioNTech, EU officials have also held discussions with Moderna, Sanofi and partner GlaxoSmithKline, Johnson & Johnson and CureVac. According to Pfizer and BioNTech, the proposed supply deal with the EU would represent the largest initial order of their vaccine to date. In July, the US government agreed to pay almost $2 billion for an initial order of 100 million doses of BNT162b2, with the possibility of acquiring up to 500 million more. The companies also agreed to supply 120 million doses to Japan, while the UK also recently struck a deal for 30 million doses.

A late-stage study is currently evaluating BNT162b2 at a dosage of 30 mcg as part of a two-dose regimen in up to 30,000 participants aged 18 to 85 years. Enrollment has so far exceeded 25,000 people with a second dose under way, the companies said, adding that they have already produced sufficient vaccine quantities for the trial and have started to manufacture and stockpile their pandemic supply as well.

IPO Sector: Included among recent SEC filings for initial public offerings, Codiak BioSciences Inc., an early stage biotech developing exosome therapeutics for various diseases, registered up to $100 million worth of common stock. The company previously filed to raise $86 million in April 2019 but withdrew the following July. 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. The Cambridge, MA-based company 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. No pricing terms were disclosed.

Elsewhere, Immunome Inc., a preclinical biotech developing antibody therapies for cancer and infectious diseases, registered up to $30 million in an IPO. The company is developing first-in-class antibody therapeutics based on its proprietary human memory B cell platform. The company’s lead discovery program, IMM-ONC-01, is focused on interleukin-38, a small protein which appears to function as a novel immune checkpoint inhibitor. Immunome expects to file an IND for IMM-ONC-01 in the 2H21 upon successful completion of its preclinical evaluation. The Exton, PA-based company was founded in 2006 and plans to list on the Nasdaq under the symbol “IMNM.” Ladenburg Thalmann and Chardan Capital Markets are joint bookrunners. No pricing terms were disclosed.

Oncorus Inc., a Phase 1 biotech developing oncolytic virus therapies for solid tumors, registered up to $86 million in an IPO. 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. The Cambridge, MA-based company was founded in 2015 and plans to list on the Nasdaq under the symbol “ONCR.” Jefferies, Evercore ISI and Piper Sandler are the joint bookrunners. No pricing terms were disclosed.

And Dyne Therapeutics Inc., a preclinical biotech developing oligonucleotide therapies for rare muscular diseases, announced terms for its IPO. The Waltham, MA-based company plans to raise $175 million by offering 10.3 million shares at a price range of $16 to $18. At the midpoint of the proposed range, Dyne Therapeutics would command a fully diluted market value of $782 million. The company is using its proprietary FORCE platform to develop a pipeline of programs to address genetically-driven muscle diseases with high unmet need. This includes candidates for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD), and facioscapulohumeral dystrophy (FSHD). Dyne expects to submit INDs for candidates in its DM1, DMD, and FSHD programs between the 4Q21 and 4Q22. Dyne Therapeutics was founded in 2017 and plans to list on the Nasdaq under the symbol “DYN.” J.P. Morgan, Jefferies, Piper Sandler and Stifel are the joint bookrunners on the deal. It is expected to price this week.

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