U.S. to make coronavirus strain for possible human challenge trials

U.S. 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 United States testing experimental COVID-19 vaccines from Moderna Inc (MRNA.O) and Pfizer Inc (PFE.N), according to a statement emailed to Reuters by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

U.S. 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 (AZN.L) and Johnson & Johnson (JNJ.N), 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.

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 this 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.

NIAID said it is continuing to prioritize field trials to evaluate SARS-CoV-2 vaccine candidates, but it opened the possibility to challenge trials for future generations of vaccines or treatments.

Dr. Dan Barouch, a vaccine researcher at Harvard’s Beth Israel Deaconess Medical Center in Boston, who helped design and conduct animal studies on J&J’s COVID-19 vaccine, said he is not aware of any manufacturers planning human challenge studies.

“In the setting of a pandemic that is raging, you don’t need it. You just do a trial and get a real result,” he said.

Moreover, vaccine trials would have to be done in healthy young people, said University of Maryland School of Medicine’s Dr. Kathleen Neuzil, co-leader of the Coronavirus Vaccine Prevention Network, which was formed by NIAID and is testing COVID-19 vaccines.

“A 20-year-old in a challenge study isn’t really going to give us the answer of will this vaccine keep an older person, someone with chronic kidney disease, from ending up in the hospital,” she said.

https://www.reuters.com/article/us-health-coronavirus-vaccine-challenge/exclusive-u-s-to-make-coronavirus-strain-for-possible-human-challenge-trials-idUSKCN25A1EL

Novavax to supply 60M COVID-19 vaccine doses to UK

Novavax (NASDAQ:NVAX) gains 7% premarket after signing term sheet agreement with the UK Government for the purchase of 60M doses of company’s COVID-19 vaccine, NVX-CoV2373 and a Phase 3 clinical trial to assess the efficacy of the vaccine in the UK population.

The late-stage trial expected to begin in Q3, will enroll ~9,000 adults 18-85 years of age in UK.

The company will also expand its collaboration with Fujifilm Diosynth Biotechnologies, which will manufacture the antigen component of NVX-CoV2373 from its Billingham, Stockton-on-Tees site in UK, in addition to its sites in North Carolina and Texas in U.S. The UK site is expected to produce up to 180M doses annually.

Novavax will supply vaccine doses as early as Q1 2021.

https://seekingalpha.com/news/3605584-novavax-to-supply-60m-covidminus-19-vaccine-doses-to-uk

Mesoblast rallies on advisory committee Ryoncil nod

Mesoblast Limited (NASDAQ:MESO) jumps 45% premarket on increased volume on the heels of a 9-1 vote by an FDA advisory committee backing approval of Ryoncil (remestemcel-L) (ex-vivo culture-expanded adult human mesenchymal stromal cells suspension for intravenous infusion) for the treatment of steroid-refractory acute graft-versus-host disease in pediatric patients.

The FDA’s action date is September 30.

https://seekingalpha.com/news/3605644-mesoblast-rallies-45-on-advisory-committee-ryoncil-nod

Cortexyme advancing study of lead drug in Alzheimer’s

Cortexyme (NASDAQ:CRTX) announces that it has enrolled 500 subjects in its Phase 2/3 GAIN study evaluating lead candidate atuzaginstat (COR388) in patients with mild-to-moderate Alzheimer’s disease.

An interim analysis, expected to happen before year-end, will be conducted when 300 participants reach 24 weeks of treatment. Topline results from the completed study should be available in Q4 2021.

Atuzaginstat targets toxic protease enzymes, or gingipains, produced by a bacterium called Porphyromonas gingivalis (P. gingivalis), an oral pathogen that causes gum disease. The bacterium releases gingipains when it invades the brain. Results from nerve cell cultures showed that atuzaginstat and proprietary gingipain inhibitors protected neurons infected with the bacterium from synapse loss while reducing bacterial load in infected neurons, astrocytes and microglia and protecting against deficits in other pathways impacted by the pathogen.

https://seekingalpha.com/news/3605694-cortexyme-advancing-study-of-lead-drug-in-alzheimers

Coronavirus vaccine developer CureVac raises $213 million in IPO

CureVac BV CVAC.O raised $213 million in its initial public offering (IPO) in New York on Thursday, a person familiar with the matter said, setting the stage for the first stock market debut of a company developing a promising vaccine to combat the coronavirus.

The German biotechnology firm sold 13.33 million shares at $16 apiece, the top end of its indicated price range, the source said, requesting anonymity ahead of an initial announcement. The IPO gives CureVac a valuation of about $2.8 billion.

CureVac is researching how to use messenger RNA to treat a series of diseases, including the coronavirus. It is an experimental approach that has also been adopted by some of its peers, including Moderna (MRNA.O) and BioNTech SE (22UAy.F).

By using messenger RNA, researchers hope they can compel a patient’s own body to create proteins that can play an important role in combating disease.

In June, the German government took a 23% stake in CureVac for about $343 million, a sign that it views the company’s research to be strategically important to its national interests. In July, GlaxoSmithKline Plc (GSK.L) and the Qatar Investment Authority bought a stake in the company.

The Tuebingen-based company, which is also backed by Microsoft Corp (MSFT.O) founder and billionaire Bill Gates, secured a 75 million euro ($85 million) loan from the European Investment Bank last month.

Beyond the coronavirus, CureVac is also researching therapies to fight cancer, rabies, and other illnesses. SAP SE (SAPG.DE) co-founder Dietmar Hopp owns a controlling stake in CureVac and is expected to hold a little less than 50% after the listing, according to a company filing.

Bank of America, Jefferies, and Credit Suisse are lead underwriters on the IPO. CureVac shares are due to start trading on Nasdaq on Friday under the symbol ‘CVAC’.

https://www.reuters.com/article/us-curevac-ipo/coronavirus-vaccine-developer-curevac-raises-213-million-in-ipo-source-idUSKCN25A043

U.S. health official says approval of COVID vaccines unlikely before November

Any potential COVID-19 vaccine backed by the Trump administration’s “Operation Warp Speed” program is unlikely to receive a green light from regulators any earlier than November or December, given the time needed for a large-scale clinical trial, the National Institutes of Health director said on Thursday.

In a call with reporters, Francis Collins said he thinks testing a vaccine in at least 10,000 people could potentially give enough evidence of safety and efficacy to clear it for wider use. U.S. late-stage vaccine trials launched so far aim to recruit up to 30,000 people.

“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,” Collins said, referring to the U.S. Food and Drug Administration. “Maybe November or December would be my best bet.”

He added that he is confident that at least one of the six vaccines funded by the initiative will be shown to be safe and effective by the end of the year.

President Donald Trump said last week it was possible the United States would have a coronavirus vaccine before the Nov. 3 election, a more optimistic forecast on timing than anything suggested by his own White House health experts.

Collins expects that the first tens of millions of doses of vaccine produced in the United States will be allocated to those most in need, such as patients at higher risk of complications or front line healthcare workers.

The U.S. government has helped finance the development of several vaccines and therapies through the program aimed at accelerating access to medicines to fight COVID-19.

U.S. public health officials last month charged a group of independent scientists and ethicists with developing guidelines to determine who should get the first doses of a vaccine, once one becomes available.

https://www.reuters.com/article/us-health-coronavirus-vaccine/top-u-s-health-official-says-approval-of-covid-vaccines-unlikely-before-november-idUSKCN2592YS

Calif. court: Amazon liable for injuries from defective products

Amazon.com can be held liable like other traditional retailers for injuries from defective products sold via its sprawling e-commerce marketplace, a California state appeals court ruled on Thursday.

The decision overturned a San Diego Superior Court ruling that the world’s biggest online retailer was shielded from liability because it acted as a service provider, which is not subject to California product liability law.

In addition to selling its own inventory, Amazon allows third-party vendors to list products for sale on its website. Such vendors may store their products in Amazon’s warehouses or ship them directly to customers.

The appeals court found that Amazon played a pivotal role in every step of plaintiff Angela Bolger’s purchase of a replacement laptop battery from Amazon third-party seller Lenoge Technology HK Ltd, which was operating under the fictitious name “E-Life.” Bolger alleged that the battery burst into flames while she balanced the laptop on her thighs, resulting in severe burns to her arms, legs and feet.

“Whatever term we use to describe Amazon’s role, be it ‘retailer,’ ‘distributor,’ or merely ‘facilitator,’ it was pivotal in bringing the product here to the consumer,” the appeals court held.

Amazon has faced multiple lawsuits seeking to hold it responsible for damage or injuries caused by defective products sold by third parties, including ones based overseas in China, with most courts concluding it is not a “seller” under various states’ product liability laws. But a few rulings have gone the other way and have allowed Amazon to be sued.

Both Pennsylvania’s and Ohio’s top courts are currently considering the issue, and federal appeals courts are weighing cases under California and Texas law.

The case decided on Thursday drew friend-of-the-court briefs from plaintiff lawyer groups and corporate groups.

The ruling comes as California lawmakers weigh legislation that would put Amazon and other operators of online marketplaces on equal footing under the state’s strict liability law.

https://www.marketscreener.com/news/California-court-rules-Amazon-is-liable-for-injuries-from-defective-products–31116480/