Top Stories for Week of May 4, 2020

Trump’s Warp-Speed Plan aims to produce COVID-19 vaccine this year.

US President Donald Trump said on Thursday (April 30, 2020) the US plans to accelerate the development of a coronavirus vaccine, an effort that has been dubbed “Operation Warp Speed.” Trump, speaking to reporters in the Oval Office, said he is in overall charge of the project aimed at finding a vaccine for the virus as quickly as possible, according to Reuters.

“Whatever you can humanly do, we’re going to have,” he said. “I hope we’re going to have a vaccine and we’re going to fast-track it like you’ve never seen.” When asked who is in charge of “Operation Warp Speed,” Trump said, “You know who’s in charge of it? I am.” He added, “I’m the one who gets blamed.”

Government agencies and the military will team up with the private sector with the goal of having 100 million doses of the coronavirus vaccine ready by the end of 2020. Executives and other experts have previously suggested that clinical trials to guarantee a vaccine is safe and effective could take longer, at a minimum of 12 to 18 months. The Biomedical Advanced Research and Development Authority, or BARDA, recently announced nearly $1 billion in support of vaccine manufacturing efforts by Moderna Inc. and Johnson & Johnson.

Mirroring Trump’s vision, a vaccine to halt the coronavirus pandemic could be available as early as this year for vulnerable groups such as healthcare workers, even faster than initially thought, according to a key group at the heart of the global development effort. Norway’s Coalition for Epidemic Preparedness Innovations (CEPI), which is funding nine different coronavirus vaccine projects, has previously suggested a shot could be ready within 12 to 18 months, an already ambitious target.

That assessment didn’t account for the possibility of companies working closely together to accelerate the process, faster enrollment in human trials and other factors, according to Richard Hatchett, the head of the Oslo-based organization.

“These are all things we are looking at now as potential opportunities to perhaps deliver vaccines even faster than the 12 to 18 months we were discussing,” he said last Monday.

As the number of coronavirus infections globally passes 3.4 million, the pressure is growing to come up with therapies and vaccines to combat the contagion. Dozens of companies around the world are pursuing a vaccine. In addition, a University of Oxford team led by Sarah Gilbert, a professor of vaccinology, has begun trials of a potential vaccine and aims to get efficacy results as soon as September. Manufacturing is already underway. Some experts have called for caution, noting that most vaccines go through years of tests before they hit the market, and that 12 to 18 months would be extraordinarily fast. The coronavirus shots moving most rapidly are made with new technologies that have never proven useful in humans.

COVID-19 Addenda: 1) CDC reports latest coronavirus cases, deaths; 2) Amgen lobs Otezla into COVID-19 derby; 3) COVID-19 pandemic likely to last two years, report says; and 4) Arthritis drug didn’t help seriously ill COVID patients.

1) The US Centers for Disease Control and Prevention (CDC) reported there were 1,092,815 cases of the new coronavirus as of Friday (May 1, 2020), an increase of 30,369 from a day earlier, and said the number of deaths had risen by 1,877 to 64,283. The CDC’s tally of cases (https://bit.ly/348yQ0J) of COVID-19, the respiratory illness caused by the new coronavirus, was effective as of 4 p.m. ET on Friday and was released on Saturday. The CDC figures do not necessarily reflect cases reported by individual states. The tally reported over the weekend is preliminary and will be updated on Monday, May 4.

2) Following in the footsteps of other large drugmakers who have repurposed their entrenched therapies against COVID-19, Amgen Inc. (Thousand Oaks CA) has released another weapon in its arsenal that could play a more immediate role in the pandemic. Otezla–the blockbuster psoriasis drug Amgen snagged from Celgene in a $13.4 billion deal last year–will enter the clinic “in the coming weeks to be investigated as a potential immunomodulatory treatment in adult patients with the disease,” R&D chief David Reese said. The hope is that by blocking the PDE4 enzyme, the drug can help prevent the respiratory distress seen in late-stage COVID-19 patients, CEO Bob Bradway added.

3) The coronavirus pandemic is likely to last as long as two years and won’t be controlled until about two-thirds of the world’s population is immune, a group of experts said in a report. Because of its ability to spread from people who don’t appear to be ill, the virus may be harder to control than influenza, the cause of most pandemics in recent history, according to the report from the Center for Infectious Disease Research and Policy at the University of Minnesota. People may actually be at their most infectious before symptoms appear, according to the report. After locking down billions of people around the world to minimize its spread, governments are now cautiously allowing businesses and public places to reopen. Yet the coronavirus pandemic is likely to continue in waves that could last beyond 2022, the authors said.

4) And the drug, sarilumab, sold as Kevzara, didn’t show benefits to patients who were hospitalized but not on ventilators. The study will continue with critically ill patients. Doctors around the world, trying to save seriously ill coronavirus patients, have been dosing them with rheumatoid arthritis drugs that can squelch immune responses. The theory was that many were dying because their immune systems went into overdrive, creating a fatal storm that attacked their lungs. But now, preliminary results on treatments with one of these drugs, sarilumab, marketed as Kevzara and made by NY-based Regeneron Pharmaceuticals Inc. and Paris based Sanofi SA, indicate that it does not help patients who are hospitalized but not using ventilators.

FDA authorizes Gilead’s remdesivir drug as emergency treatment for COVID-19.

Gilead Sciences Inc.’s (Foster City CA) antiviral drug has been cleared by US regulators for emergency use in COVID-19 patients. The drug, remdesivir, has shown positive results in helping hospitalized patients recover more quickly.

The Food and Drug Administration cleared the drug under an emergency use authorization, a step by which the agency can bring products to market without full data on their safety and efficacy, says Bloomberg News. The company has faced questions from investors about how it plans to make money on the drug. FDA Commissioner Stephen Hahn, speaking with Trump at the White House Friday, said the drug was being cleared for emergency use in hospitalized patients.

A US-led study released last week showed that patients who got the drug recovered in an average of 11 days, while those who get a placebo recovered in 15 days. An effective therapy against the viral infection is seen as a key bridge between the ongoing outbreak and longer-term efforts to either stamp out the virus or come up with an effective vaccine. Those measures are all considered crucial by government and health officials to fully reopening the economy and ending social distancing.

Gilead said earlier last week it has about 50,000 courses of the drug ready to distribute. The company has been in talks with the FDA about how the drug will be used, and said it expects the antiviral medication to be a backbone of therapy as well as proof that other drugs can target the virus. It’s also examining how to increase manufacturing of the drug. It’s also started to face questions about how, or if, it will make money on the product. After reporting quarterly earnings on Thursday, financial analysts on a call with the company asked what its long-term plans were for the drug after it dispenses an early round of the treatment for free.

“There has been no other time like this in the history of the planet,” CEO Daniel O’Day said. “There is no rule book out there, other than that we need to be thoughtful about how we can make sure we provide access of our medicines to patients around the globe and do that in a sustainable way for the company [and]its shareholders.”

AstraZeneca sprints ahead in COVID-19 vaccine race with UK’s Oxford University pact.

AstraZeneca PLC (London) entered into an agreement for the global development and distribution of the University of Oxford’s potential recombinant adenovirus vaccine aimed at preventing COVID-19 infection from SARS-CoV-2, the parties announced Thursday. As part of the deal, the UK drugmaker would also be responsible for worldwide manufacturing of the vaccine, called ChAdOx1 nCoV-19.

A week prior, the first two patients were dosed in Phase 1 studies of the vaccine, which uses a viral vector containing the genetic material of SARS-CoV-2 spike protein, with results potentially available next month, before advancing into late-stage trials by the middle of the year. Labiotech.eu reports that one volunteer was injected with the coronavirus vaccine and another with a control vaccine in a Phase 1 trial that aims to recruit over 1,000 participants. The trial is expected to conclude in May 2021, and the first results could be available in up to six months. Recently, University of Oxford researchers said that large-scale production capacity was being put in place on an “at risk” basis, with a target to produce a million doses as early as September.

On Thursday, AstraZeneca CEO Pascal Soriot suggested that results over the next few months will show whether ChAdOx1 nCoV-19 will be effective or not.

“By June, July, we will already have a very good idea of the direction of travel in terms of its potential efficacy,” Soriot remarked, adding “we’ll continue working with the Oxford Vaccine Unit to bring it to patients and to regulatory authorities first of all as soon as possible.”

Soriot indicated that the partnership is looking to produce 100 million doses of ChAdOx1 nCoV-19 by the end of the year and prioritize supply in the UK. The executive explained that AstraZeneca plans to rely on contract manufacturing organizations and other partners, while boosting its own production capacity. Soriot added that under the deal with the University of Oxford and the UK government, “for the period of the pandemic we will be supplying the vaccine at cost.”

Researchers at the University of Oxford are currently collaborating with a number of manufacturing partners around the world, including three in the UK, two in Europe, one in India and one in China. Last week, the Serum Institute of India said it plans to start production of ChAdOx1 nCoV-19 in the next two to three weeks, with the aim to initially produce five million doses per month.

The Swiss pharmaceutical company Idorsia Pharmaceuticals Ltd. (Allschwil) has announced that its drug candidate daridorexant significantly improved sleep onset, sleep quality, and daytime functioning of insomnia patients in a pivotal Phase 3 trial. The trial recruited 930 adult patients with insomnia, Labiotech reports. The company used a technique called polysomnography to measure the time taken to fall asleep and sleep maintenance–the study’s primary endpoint.

The study also addressed a secondary endpoint of total sleep and daytime performance, measured using patient questionnaires and sleep diaries. In analyses carried out at one and three months post-treatment, daridorexant significantly improved sleep onset and maintenance. The patients also reported increased overall sleep time and improved daytime performance. This came with neither a rebound after the treatment regimen ended nor a next morning “hangover” effect, often seen with many sleeping medications, such as benzodiazepines.

The company aims to present its full results at upcoming congresses and in peer-reviewed publications. “The results of this pivotal study are truly remarkable for the consistency of the benefit in sleep measures. Moreover, this is the first study to demonstrate an insomnia product can improve how the patient feels during the day,” said Guy Braunstein, Head of Global Clinical Development at Idorsia.

The company’s drug candidate daridorexant has been under development for insomnia since the late 1990’s, and was formerly known as nemorexant. It works by blocking the action of orexin, a neuropeptide that regulates wakefulness, thereby turning down overactive wakefulness seen in insomnia patients. This differs from the mechanism of action of most sleep medications, which act through broad sedation of the brain, leaving patients with a next-day “hangover.”

This news represents a huge step forward for Idorsia, which was created just three years ago following Johnson & Johnson’s acquisition of Actelion. The findings have already pushed Idorsia’s share price up by almost 14% and have been hailed as a wake-up call for competitors in the insomnia field, which is generally seen as underserved.

IPO Sector: Lyra Therapeutics Inc., a biotech company developing a new way to treat the persistently runny nose, has raised $56 million in its initial public offering. Late Thursday, Lyra offered 3.5 million shares priced at $16 apiece, which was the high end of its projected $14 to $16 price range. Watertown, MA-based Lyra is developing technology that precisely delivers a drug for ear, nose, and throat (ENT) conditions and sustains that delivery for months. Lyra accomplishes this via an implantable device that has “shape memory,” meaning it is designed to adapt to the anatomy of the nasal passages. The device also uses a mesh scaffold that maximizes the surface area for the drug, along with a polymer complex that customizes the rate at which a drug is released, according to Lyra’s IPO filing.

The company’s lead research program, LYR-120, is being developed to treat chronic rhinosinusitis, a condition in which sinus inflammation leads to pain, increased drainage, and obstruction of the nasal passages. Patients who suffer from chronic rhinosinusitis can find relief from nasal irrigation or allergy medications. If they don’t work, patients can also opt for sinus surgery. LYR-120 administers mometasone furoate, a steroid that is the active pharmaceutical ingredient in several allergy and asthma medications. The Lyra device can be implanted during a brief visit to a physician’s office. The company says that its technology can extend the delivery of mometasone furoate for up to six months. A Phase 2 test of LYR-120 is underway.

Lyra Therapeutics was founded in 2005 and lists on the Nasdaq under the symbol “LYRA.” BofA Securities, Jefferies and William Blair are the joint bookrunners on the deal. Shares closed the week up 16% at $18.56. (Ref: Xconomy)

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