Top Stories for Week of August 17, 2020

      No Comments on Top Stories for Week of August 17, 2020

padrinan / Pixabay

Trump says US has deal with Moderna for 100 million doses of coronavirus vaccine.

The Trump administration last week announced that it has reached a deal with the biotechnology company Moderna Inc. (Cambridge MA) for 100 million doses of its potential coronavirus vaccine. The agreement is for about $1.5 billion, meaning the government is paying about $15 per dose, and the vaccine will then be given to patients for free, The Hill reports.

At $15, the price marks a steep discount to the $32 to $37 range CEO Stéphane Bancel has outlined for other countries inking “small orders” in the millions. Those deals, he revealed last week, had already brought in about $400 million in deposits by the end of July. Moderna shares closed the week off 7% at $69.15.

The Trump administration has made several other similar deals as it provides funding for multiple potential vaccines, with the hope of having one ready to begin distributing by the end of the year. President Trump announced the agreement from his White House press briefing as he seeks to highlight progress on a vaccine. He said he also met earlier in the day with the leaders of the Operation Warp Speed initiative aimed developing a vaccine.

Of all the potential vaccines the government is funding, Trump said there is “tremendous promise in every single one of them and we have many of them and they’re years ahead of schedule.” He added, “The military is ready to go. They’re ready to deliver a vaccine to Americans as soon as one is fully approved by the [Food and Drug Administration] and we’re moving very close to that approval.”

Some Democrats and public health experts have expressed concern about Trump pressuring the FDA to approve a vaccine too quickly, though the FDA has pledged it will follow the data.

Separately, according to Johns Hopkins Medical, as of Saturday, Aug. 15, there were over 21 million COVID-19 global cases confirmed, and some 767,000 deaths. Confirmed cases in the US totaled 5.3 million with nearly 169,000 deaths. Both of the US figures comprise 25% and 22%, respectively, of the global totals. The US population is about 4% of the global total.

COVID-19 Addenda: If the 2020 presidential election were held today, 53% of registered voters would cast their ballot for former Vice President Joe Biden, putting him 11 percentage points ahead of President Donald Trump, according to the latest PBS NewsHour/NPR/Marist poll. The poll, taken days before the Democratic National Convention, shows Biden with his widest lead yet.

In February, before Biden had taken the lead in the Democratic primaries, 50% of US voters said they would support Biden in a match-up between him and Trump, while 44% backed Trump. Among registered voters who plan to vote for Biden, 44% would do so because they genuinely like him, while 50% would vote for him because they don’t like Trump. According to the poll, 53% of US adults think Biden would handle the coronavirus pandemic better than Trump, while 37% think Trump would do a better job. Another 5% don’t think either candidate has what it takes to manage the pandemic, and 5% more weren’t sure.

Elsewhere, Dr. Anthony Fauci, the nation’s top infectious diseases expert, on Thursday cited mail-in voting as an alternative for people who didn’t want to “take the chance” of contracting the coronavirus. Fauci, in an exclusive conversation with National Geographic as part of its event, “Stopping Pandemics,” said he believed in-person voting could be safely done with proper precautions.

“For example, when you look at going to a grocery store now in many regions and counties and cities that are doing it correctly, they have ‘X’s every six or more feet. And it says, Don’t leave this spot until the person in front of you left their spot,” Fauci said. “And you can do that, if you go and wear a mask, if you observe the physical distancing, and don’t have a crowded situation, there’s no reason why you shouldn’t be able to do that.” He added, “I mean, obviously if you’re a person who is compromised physically or otherwise, you don’t want to take the chances. There’s [also] the situation of mail-in voting that has been done for years in many places. (Ref: The Hill)

The Centers for Disease Control and Prevention updated their guidance recently to suggest that people who have recovered from the virus can safely mingle with others for three months. It was a notable addition to the body of guidance from the agency, and the first acknowledgment that immunity to the virus may persist for three months. In June, a study found that antibody levels could wane over a course of two to three months in people with confirmed infections who experienced mild symptoms or no symptoms.

They drop off, but they may still be present at low levels, including below the limit of detection. The latest CDC guidance–which was tucked into public recommendations about who needs to quarantine–goes a bit further. “People who have tested positive for COVID-19 do not need to quarantine or get tested again for up to three months as long as they do not develop symptoms again,” the guidance says. (Ref: The New York Times)

BioNTech SE (Mainz DEU) executives say they’re on track to get their late-stage data on a COVID-19 vaccine–partnered with Pfizer Inc. (NYC)–into the hands of regulators as early as October. In their Q2 release last week, the biotech reported that investigators could have late-stage data as early as October, and they won’t waste time in hurrying that information over to the FDA.

“I am incredibly proud of our team, who has worked tirelessly to initiate our BNT162 Phase 2b/3 trial in record time and put us in a position to seek regulatory review as early as October of this year, if our trials are successful,” said Ugur Sahin, BioNTech’s CEO and co-founder.

Those comments back up comments from Pfizer CEO Albert Bourla, who recently noted that they’ll know in October if the vaccine works.

And NIH Director Francis Collins has opted out of any wager that the FDA will authorize a COVID-19 vaccine in October, Endpoints reports. The discussion came up last week during a call with reporters because some states and local governments have been told by the CDC to have vaccination plans ready to go by Oct. 1. Pharma executives, most notably from Pfizer Inc. (NYC) and BioNTech SE (Mainz DEU), have raised hopes about a licensure during that month; President Donald Trump last week sounded an optimistic note about having a vaccine on the market “right around” Election Day on Nov. 3–or possibly before.

But the way Collins sees it, in order for an emergency use authorization to be granted in October, one of the ongoing Phase 3 trials would have to enroll at “just absolute record speed” and show the vaccine 100% effective so safety and efficacy can be evaluated based on a smaller population.

“I would not expect to see, on the basis of what we know scientifically, that we would be at the point where the FDA could make such a judgment until considerably later than October 1st,” he said.

Russia approves COVID-19 candidate before completing clinical trials; many of their own doctors wary of getting the shot.

A majority of Russian doctors would not feel comfortable being injected with Russia’s new COVID-19 vaccine due to the lack of sufficient data about it and its super-fast approval, a survey of more than 3,000 medical professionals showed on Friday. Russia has said that the world’s first vaccine for the novel coronavirus will be rolled out by the end of this month, with doctors among those set to be administered with it on a voluntary basis, Reuters reports.

The vaccine, called “Sputnik V” in homage to the world’s first satellite launched by the Soviet Union in 1957, has yet to complete its final trials and some scientists said they fear Moscow may be putting national prestige before safety. A survey of 3,040 doctors and health specialists, conducted by the “Doctor’s Handbook” mobile application and quoted on Friday by the RBC daily, showed 52% were not ready to be vaccinated, while 24.5% said they would agree to be given the vaccine.

Just a fifth of respondents said they would recommend the vaccine to patients, colleagues or friends. Their misgivings are shared by some Russians who say they are too scared to try the vaccine, while others agree with their government that skepticism expressed by foreign experts is driven by jealousy. The Russian vaccine’s approval comes before trials that would normally involve thousands of participants, commonly known as Phase 3. Such trials are usually considered essential precursors for a vaccine to secure regulatory approval.

Russian President Vladimir Putin has said the vaccine, developed by Moscow’s Gamaleya Institute, was safe and that it had been administered to one of his daughters. Health Minister Mikhail Murashko rejected safety concerns aired by some experts over Moscow’s rapid approval of the drug as “groundless.”

US government begins preparing for COVID-19 “challenge” trials.

US government scientists have begun efforts to manufacture a strain of the novel coronavirus that could be used in human “challenge” trials of vaccines, a controversial type of study in which healthy volunteers would be vaccinated and then intentionally infected with the virus, Reuters has learned.

The work is preliminary and such trials would not replace large-scale, Phase 3 trials such as those now under way in the US testing experimental COVID-19 vaccines from Moderna Inc. (Cambridge MA) and Pfizer Inc. (NYC), according to a statement emailed to Reuters by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. US officials organizing the fight against the pandemic have been under pressure from advocacy groups such as 1 Day Sooner and others that see challenge trials as a way to speed up tests of a COVID-19 vaccine. Most vaccine trials rely on inadvertent infection, which can take time to occur.

Some drugmakers, including AstraZeneca PLC (London) and Johnson & Johnson (New Brunswick NJ), have said they would consider human challenge trials to test COVID-19 vaccines if needed.

“Should there be a need for human challenge studies to fully assess candidate vaccines or therapeutics for SARS-CoV-2, NIAID has begun investigations of the technical and ethical considerations of conducting human challenge studies,” the agency statement said.

That includes efforts to manufacture a suitable SARS-CoV-2 strain, draft a clinical protocol and identify resources that would be required to conduct such studies. Small challenge studies would be done in small isolation units to control the virus. Larger challenge studies involving 100 people or so would have to be done in multiple locations, adding months of preparations to coordinate the studies. Such trials are typically done when a virus is not widely circulating, which is not the case with COVID-19. Many scientists consider human challenge trials of the novel coronavirus unethical because there are no “rescue therapies” for those who fall ill.

Earlier last week, Johan Van Hoof, global vaccines chief for J&J, said in an interview with Reuters that the preparations for such trials are under way across the world, and the company is following those preparations. Van Hoof said such trials would offer a testing option in case the virus stops circulating widely, but the company would only move forward with such trials if the ethical issues are resolved and an effective treatment is available. Dr. Anna Durbin, a vaccine researcher at the Johns Hopkins Bloomberg School of Public Health, who has run a dozen challenge studies, estimates it could take nine to 12 months to set up a human challenge trial, and another six months to coordinate testing across multiple testing sites.

IPO Sector: Nano-X Imaging Ltd., which claims to be developing affordable medical imaging systems, announced terms for its IPO on Friday. The Neve Ilan, Israel-based company plans to raise $100 million by offering 5.9 million shares at a price range of $16 to $18. Certain insiders and other investors intend to purchase $80 million worth of shares in the offering. At the midpoint of the proposed range, Nano-X Imaging would command a fully diluted market value of $793 million. The company is developing lower cost medical imaging technology which it believes can achieve the same functionality as legacy X-ray imaging. Nano-X’s Nanox System is comprised of its Nanox.ARC hardware, which uses a microelectromechanical system semiconductor cathode as opposed to X-ray analog cathodes, and its cloud-based imaging software Nanox.CLOUD. Nano-X Imaging was founded in 2012 and plans to list on the Nasdaq under the symbol “NNOX.” Cantor Fitzgerald, Oppenheimer and Berenberg are among the joint bookrunners on the deal. It’s expected to price this week.

Elsewhere, Inhibrx Inc., a Phase 1 biotech using protein engineering to develop targeted therapies for cancer and rare diseases, announced terms for its IPO on Wednesday. The company previously filed to raise $75 million in June 2019 and withdrew the following November. The La Jolla, CA-based company plans to raise $102 million by offering 6 million shares at a price range of $16 to $18. At the midpoint of the proposed range, Inhibrx would command a fully diluted market value of $620 million. The company’s lead candidate INBRX-109, is a tetravalent death receptor 5, or DR5, agonist being evaluated in patients diagnosed with chondrosarcoma and mesothelioma, two difficult-to-treat cancers. INBRX-109 is currently in a Phase 1 trial and has enrolled 75 patients to date. Inhibrx was founded in 2017 and booked $6 million in revenue for the 12 months ended June 30, 2020. It plans to list on the Nasdaq under the symbol “INBX.” Jefferies, Evercore ISI and Credit Suisse are the joint bookrunners on the deal. It is expected to price this week.

Harmony Biosciences Holdings Inc., a commercial stage biotech developing therapies for narcolepsy and other CNS disorders, announced terms for its IPO. The Plymouth Meeting, PA-based company plans to raise $100 million by offering 4.7 million shares at a price range of $20 to $23. At the midpoint of the proposed range, Harmony Biosciences would command a fully diluted market value of $1.4 billion. The company’s sole marketed product, WAKIX (pitolisant), was approved for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019. The company expects to initiate a Phase 3 trial for EDS and cataplexy in pediatric patients in the 2H21. It also plans to begin Phase 2 trials for EDS and other key symptoms in patients with Prader-Willi Syndrome in the 2H20 and in adult patients with myotonic dystrophy in the 1H21. Harmony Biosciences was founded in 2017 and booked $64 million in net product revenue for the 12 months ended June 30, 2020. It plans to list on the Nasdaq under the symbol “HRMY.” Goldman Sachs, Jefferies and Piper Sandler are the joint bookrunners on the deal. It is expected to price this week.

And CureVac AG, a German Phase 1 biotech developing an mRNA vaccine for SARS-CoV-2, raised $213 million by offering 13.3 million shares at $16, the high end of the range of $14 to $16. The company, with a $2.8 billion market cap, soared 249% on its first day of trading, the highest jump of any IPO since 2005. With a portfolio of mRNA-based therapies and vaccines, the company developing a COVID-19 vaccine and has a Phase 1 candidate, which competes with other more advanced clinical candidates from large pharmas like AstraZeneca PLC. The Tübingen, Germany-based 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. CureVac was founded in 2000 and booked $20 million in revenue for the 12 months ended March 31, 2020. CureVac lists on the Nasdaq under the symbol “CVAC.” BofA Securities, Jefferies and Credit Suisse were among the lead managers on the deal. Shares closed the week 349% at $55.90.

Print Friendly, PDF & Email