Inovio to start coronavirus vaccine safety test in Philly, Kansas City

A second U.S. company is poised to begin a small safety test of a vaccine against the new coronavirus.

Inovio Pharmaceuticals said Monday that it has Food and Drug Administration permission for the study in 40 healthy volunteers in Philadelphia and Kansas City, Mo.

The study is a first step to see if the vaccine appears safe enough for larger tests needed to prove whether it will protect. Even if the research goes well, it is expected to take over a year before any vaccine could be widely available.

Last month, the first safety test in people of a different vaccine candidate began in Seattle. It was developed by the National Institutes of Health and Moderna Inc.

Numerous other research groups are attempting to make vaccines against COVID-19 using a variety of different methods in hopes at least one will offer protection.
https://www.inquirer.com/health/coronavirus/coronavirus-covid-19-vaccine-testing-philadelphia-kansas-city-20200406.html

CytoDyn to supply leronlimab to UK COVID-19 patients

CytoDyn (OTCQB:CYDY) is collaborating with the U.K.’s Department of Health to provide emergency access to leronlimab, an investigational medicine for COVID-19.

The submission to Medicines and Healthcare Products Regulatory Agency (MHRA) is expected soon to include clinical trial sites in the U.K.

U.K. representatives are coordinating with CytoDyn’s international clinical research organization, Amarex Clinical Research, to prepare the requisite clinical agreements and to prepare for timely delivery of leronlimab.

The FDA has cleared the Company to initiate a Phase 2b/3 clinical trial COVID-19 patients for which enrollment is now underway.

https://seekingalpha.com/news/3558860-cytodyn-to-supply-leronlimab-to-uk-covidminus-19-patients

‘U.S. is past the peak, economy to reopen shortly’ – JPMorgan

Sounding more bullish about the outlook than anyone out there, JPMorgan says the U.S. passed its peak in new cases three or four days ago, and expects a limited reopening of the economy in one-to-two weeks.

Noting global stocks down about 35% on average, they are overweight equities. While acknowledging the horrendous near-term economic hit, the team says investors will be focusing on 2021, and even 2022.

As for winners going forward, they note every recession accelerates pre-existing trends – in this case things like working from home and online retail.

Some related ETFs: USA, CRF, SCHX, ZF, VV, FEX, JKD, SFY, EEH, EQL, IWL, GSEW

https://seekingalpha.com/news/3558890-u-s-is-past-peak-economy-to-reopen-shortly-jpmorgan

Chester County is first in PA to initiate COVID-19 antibody testing

Officials in Chester County, Pennsylvania announced a plan to undertake antibody testing of priority individuals who are currently performing essential functions in the fight against COVID-19. This is the first in the Commonwealth to undertake such a test.
“We have just received a shipment of 10,000 blood test kits and are expecting a second shipment of 10,000 more next week. These kits will be administered to priority individuals – emergency responders, healthcare workers and staff at long-term care facilities throughout Chester County, to determine those who have developed coronavirus antibodies, with or without symptoms,” said Chester County Commissioners’ Chair Marian Moskowitz.
When a person gets infected by a particular germ, the body starts making specially designed proteins called antibodies to fight the infection. After the person recovers, those antibodies float in survivors’ blood — specifically plasma, the liquid part of blood – for months, even years.
The tests are just another weapon in the county’s arsenal to fight the coronavirus.
“This test is supplemental to the coronavirus testing that we have already been doing and will continue to do,” said Jeanne Casner, Chester County Health Department Director. “It is not a replacement test for confirming cases.
The county purchased the antibody test kits from Advaite, a Chester County-based company. Test results are available within 15 minutes.
The first level priority testing will begin this week.
Chester County Commissioner Michelle Kichline said, “As we review the results of the antibody blood tests, we will work with first responders, hospitals and long-term care facilities to determine how the results can best be used to manage this crisis. It is our intention to continue sourcing more of the blood test kits. The more we have, the more people we can test to get a fuller picture of how many have had COVID-19 in Chester County, either knowingly or unknowingly.”
Officials say the antibody test will not require the use of personal protection equipment required by first responders, healthcare workers and staff at long-term care facilities.
To date, three Chester County residents have died from the virus. A total of 304 cases have been confirmed in the county.
https://6abc.com/health/chester-co-to-initiate-covid-19-antibody-testing-for-essential-workers/6081721

Gottlieb: FDA needs to up pace on COVID-19 drugs

Scott Gottlieb has called on the FDA to deploy regulatory tactics honed on rare and deadly cancers to help get a treatment for COVID-19 to market by the summer. Gottlieb thinks the industry needs to hit that timeline if the U.S. is to both restart its economy and avoid a new epidemic in the fall.
With even the most optimistic forecasts suggesting limited availability of vaccines this year, drugs are the best hope of fighting back against SARS-CoV-2 in the near term. Recognizing that, Gottlieb, a former commissioner of the FDA, wants government and industry to go all in on getting a therapeutic to market by the summer.
Writing in The Wall Street Journal, Gottlieb sketched out how the FDA could use approaches such as real-time reviews, which enable the regulatory evaluation of data from ongoing clinical trials, to cut the time it takes to get drugs against COVID-19 to patients.

The FDA has honed these approaches in recent years to accelerate the development of treatments for rare diseases, meaning it has the tools in place to speed COVID-19 drugs to market. However, the FDA may also need a clear signal of political support for the use of the tools.
“FDA’s senior career scientists need the firm backing of political leadership to apply these and similar scientific approaches to COVID-19,” Gottlieb wrote.
Gottlieb sees two pools of products that could, with the benefit of a regulatory fast track, come to market in the summer. Gilead’s remdesivir is leading one of the pools, which consists of repurposed antivirals. Remdesivir has shown potential in preclinical studies and compassionate use cases and is at the head of the race to market.
Yet, Gottlieb’s op-ed spends more time discussing the antibodies in development. Those assets are less advanced than remdesivir, with Regeneron aiming to be in humans in June, but as an established approach to treating and preventing infectious diseases antibodies are seen as a very promising way of getting a handle on COVID-19.
The timing of the first approvals matters. As Gottlieb notes, while a combination of the current social distancing efforts and higher temperatures could see COVID-19 cases slump over the summer, people will remain concerned about a resurgence in the fall. An effective drug could help change that, enabling the U.S. economy to get back into gear without risking a second epidemic.
With Kevin Warsh, a former Federal Reserve governor, estimating the availability of a drug against COVID-19 could restore $1 trillion in economic activity, Gottlieb wants government and industry to do whatever it takes to get such a medicine to market.
“It’s time to place some firm bets and put resources behind these experimental treatments,” Gottlieb said.

https://www.fiercebiotech.com/biotech/ex-fda-chief-says-regulator-needs-to-up-pace-covid-19-drugs

Arrested, Jailed For Violating Coronavirus Stay-At-Home Mandates

Local police in the U.S. are arresting people who fail to comply with social distancing and stay-at-home orders. The American Civil Liberties Union cautions against this practice, saying jail time is potentially more dangerous, as it could expose detainees to COVID-19 and may disproportionately affect minority communities that are already highly policed.

• A 25-year-old man was arrested and charged with a misdemeanor on Saturday in Cincinnati for allegedly violating the governor’s “stay-at-home” order after posting a video on Instagram Live showing an outdoors gathering, which he narrates, saying: “We don’t give a [expletive] about coronavirus.”
• In nearby Toledo, two people were separately arrested Sunday: one for allegedly failing to disperse from a gathering of 20-plus people; the other arrest was a woman apparently among a group of 50, but “the circumstances surrounding the arrest or the reason for the crowd were not immediately available,” according to TV station 13ABC.
• Eight abortion protesters (who were originally part of a 50-person group) in Charlotte, North Carolina were arrested outside A Preferred Women’s Health Center after refusing to comply with officers orders to disperse, Charlotte’s 3 WBTV.

• Nine people have been arrested in Hawaii for violation of stay-at-home orders, which can result in up to one year of jail time and a fine of no more than $5,000, according to local news site West Hawaii Today.
• A paddleboarder in Malibu, California was arrested on Thursday after allegedly ignoring lifeguards’ requests to come ashore on a closed beach, paddleboarding for at least 30 minutes, according to the LA Times.
• In Lancaster County, Pennsylvania, two people drinking alcohol on the street who allegedly refused to comply with officers’ orders to disperse were arrested for violating the state’s stay-at-home order, which carries a $200 fine, and alcohol charges, according to LancasterOnline.
• Though social distancing-related arrests is a new and relatively rare practice with little data, the ACLU is concerned: “This will be enforced disproportionately in black and brown communities because that’s where the police already are,” Carl Takei, Senior Attorney at the ACLU who focuses on police practices, told Forbes.“The good news is that many jurisdictions have stated they are not using arrests as the primary means of enforcing these orders. Arresting people for violating a public health order is something that actually harms public health.”

Key Background: With the exception of Arkansas, Iowa, Nebraska, North Dakota, Oklahoma, South Carolina, South Dakota, Utah and Wyoming, all states have mandated stay-at-home orders for all non-essential outings and non-essential workers. (The holdouts’ republican governors have defended their decisions with belief in small government and personal responsibility, says the New York Times.)
The broad call for social distancing has also highlighted the economic challenges to following safe social distancing guidelines: Wealthy individuals with homes in suburbs can work comfortably from home, while this is virtually impossible for people who live in poverty, with cramped, crowded and uncomfortable spaces, according to Johns Hopkins’ Coronavirus Resource Center.
“Staying at home is a privilege. Social distancing is a privilege,” writes New York Times’ opinion columnist Charles M. Blow. “People can’t empathize with what it truly means to be poor in this country, to live in a too-small space with too many people, to not have enough money to buy food for a long duration or anywhere to store it if they did.”
https://www.forbes.com/sites/alexandrasternlicht/2020/04/06/arrested-for-violating-coronavirus-stay-at-home-mandates-police-are-jailing-alleged-scofflaws/#7f17aece68a4

Xerox Will Mass Produce Disposable Ventilators In Partnership With Vortran

Xerox will mass-produce disposable ventilators in partnership with Vortran Medical Technology in the fight against coronavirus.
The copier giant plans to help Vortran, a small medical-device manufacturer, scale production of its GO2Vent ventilator and related airway pressure monitor, APM-Plus, from approximately 15,000 before the crisis and 40,000 ventilators in April to between 150,000 and 200,000 a month by June. Their goal is to eventually produce as many as 1 million of these ventilators for both the U.S. and global markets.
The GO2Vent, which is disposable and costs approximately $120, is not a replacement for ventilators used in ICUs for the most critically ill patients, but rather a device that can be used for lower- and medium-risk patients to free up those devices for the patients who most need them. The device is gas-operated and can be operated on a compressor, oxygen or air for up to 30 days.
“It is very simple in terms of design and use at emergency response centers and in hospital settings, and it can be manufactured at hyper-scale,” Xerox chief technology officer Naresh Shanker told Forbes.

Shanker said that Xerox CEO John Visentin had pulled together a team of scientists, researchers and engineers in March to figure out how the company could help during the coronavirus crisis. So when Vortran reached out looking to scale up its production, Shanker said, it was a good fit.
Xerox plans to manufacture the devices at its factory outside of Rochester, N.Y., where the company was founded. Vortran will continue to make the ventilators at its facility in Sacramento, California. “We are mobilizing a team to scale out the production lines,” Shanker said. “We are in the process of sorting out materials, ramping up the labor, molding and tooling. We are ramping up everything.”

The partnership is just the latest corporate effort to temporarily up to crank up production to solve the ventilator shortage, following earlier partnerships by Ford and GE Healthcare, and by General Motors and Ventec.
https://www.forbes.com/sites/amyfeldman/2020/04/06/xerox-will-mass-produce-disposable-ventilators-in-partnership-with-vortran-to-fight-coronavirus/#32129d61205a