Inovio COVID-19 vaccine shows 94% response rate in early-stage study

Inovio Pharmaceuticals (NASDAQ:INO) announces preliminary data from a Phase 1 clinical trial evaluating COVID-19 DNA vaccine candidate INO-4800 in 40 healthy adult volunteers aged 18 – 50.

Each participant received 1 mg or 2 mg doses four weeks apart, each administered with the company’s Cellectra 2000 device.

94% (n=34/36) showed overall immunological responses based on data assessing humoral (binding and neutralizing) and T cell immune responses. Three participants were excluded from the immune analyses due to testing positive for COVID-19 antibodies at study entry and one discontinued for reasons unrelated to safety or tolerability.

The full dataset will be submitted for publication.

It has expanded the Phase 1 study to include older participants.

The company says INO-4800, selected to participate in an Operation Warp Speed-connected non-human primate challenge study, is the only nucleic acid-based vaccine that is room temperature-stable and does not need to be frozen during storage or transport.

A Phase 2/3 trial should launch this summer.

Shares down 10% premarket on robust volume in what looks like “sell on the news” behavior considering the stock’s 107% rally since June 22.

https://seekingalpha.com/news/3587278-inovio-covidminus-19-vaccine-shows-94-response-rate-in-early-stage-study

BioNTech bull rings the register after big run

“The risk/reward for BioNTech (NASDAQ:BNTX) has become less attractive,” says HC Wainwright’s Raghuram Selvaraju, downgrading to Neutral from Buy.

He notes many open questions remain on the company’s mRNA-based Covid-19 vaccine. Among them: The strength and duration of neutralizing antibodies and T cell responses that may be generated in human trials, and whether long-term protection is effective.

At last night’s close, the company is worth $15B – less than Moderna’s $24B, but still a bit perky for Selvaraju.

https://seekingalpha.com/news/3587274-biontech-bull-rings-register-after-big-run

These high-end NYC hotels not changing sheets, wiping down surfaces

Some high-end Manhattan hotels aren’t thoroughly cleaning rooms between guests amid the coronavirus pandemic, a new report found.

Three different Midtown hotels didn’t even bother to change pillowcases or wipe down commonly used surfaces, according to an investigation by Inside Edition set to air Monday night.

Producers with the TV program booked rooms at each of the hotels and used a washable spray to apply an Inside Edition logo — only visible under UV light — to the pillows, bed sheets and bath towels.

They also doused commonly touched surfaces, like the TV remote, thermostat and desk with a special washable gel.

The next day, using a new reservation under a different name, they checked-in to the same room to see if the linens had been changed and surfaces wiped down.

At the Hyatt Place Times Square, the logo was still visible on the bedsheets and pillowcase under UV light — indicating they hadn’t been replaced, the report found.

While the desk had been wiped down and the towel replaced, the gel was visible on the remote control when placed under UV light.

A few blocks away at the Hampton Inn Times Square Central, the sheets and a pillowcase weren’t changed either and neither the remote control nor thermostat were wiped down, according to the report.

At the Trump International Hotel overlooking Central Park, the sheets and towels were changed. But the pillowcase wasn’t and the desk and the remote control weren’t wiped down.

A Hyatt spokesperson told the program they were “deeply concerned” about the situation.

“We are working with the hotel’s owner to ensure the hotel is implementing proper cleaning protocols that are consistent with Hyatt’s commitment to cleanliness for the safety and wellbeing of our guests,” the statement said.

A spokesperson for Hampton Inn said it had conducted an investigation of their own and found that “our housekeeping team relied on a visual inspection of the room’s cleanliness to determine which areas received attention, deviating from our protocols.”

“This is a violation of our standards to thoroughly clean each room,” the statement said. “Both our housekeeping team and management apologize for this mistake and we are retraining our team members to reinforce our procedures.”

A rep for the Trump International Hotel denied Inside Edition’s findings.

“Following an internal review, we have concluded that the claims made by Inside Edition are categorically false,” the spokesperson said.

“Trump International Hotel & Tower New York is one of the premier luxury hotels anywhere in the world and has received countless accolades, including the Forbes Five-Star award for the past 13 years, for its consistently impeccable service.”

https://nypost.com/2020/06/29/high-end-nyc-hotels-not-sanitizing-rooms-changing-sheets/

Spraying ethanol on nanofiber masks makes them reusable

As the COVID-19 pandemic spreads around the world, masks have become an essential personal hygiene product as the first line of defense to protect one’s respiratory system against the viruses and germs that spread through droplets in the air. It’s a waste to dispose the masks after single use but troubling to reuse them. In light of this, a Korea-Japan research team recently released findings that compare and analyze the performance and functional differences of the filters used in masks after they are cleaned with ethanol.

Professor Hyung Joon Cha and doctoral candidates Jaeyun Lee and Yeonsu Jeong of the Department of Chemical Engineering at POSTECH and Professor Ick-Soo Kim and doctoral candidates Sana Ullah and Azeem Ullah of Shinshu University in Japan have been jointly analyzing the filtration efficiency, airflow rate, surface and morphological properties of the mask filters after they undergo cleaning treatments.

The research team verified the results using two types of cleaning procedures: First one was spraying 75% ethanol on the mask filter then air drying it, second was to saturate the filter in a 75% ethanol solution then air drying it.

A study of the melt-blown filters commonly used in N95 masks and the nanofiber filters produced by electrospinning found that just by spraying ethanol three or more times on the two materials or dipping them in the ethanol solution for more than five minutes effectively inhibit pathogens that can remain inside the mask filter.

The filtration efficiency of both materials in its first usage was measured at 95% and above, indicating that the wearer’s respiratory system is effectively protected. It was also confirmed that surface of both materials do not allow water to adhere well, sufficiently hindering wetting by moisture or saliva (droplets).

However, the filtration efficiency of the melt-blown filter decreased by up to 64% when cleaned with ethanol solution and reused. On the other hand, the filtration efficiency of nanofiber filters when reused 10 times through ethanol spray cleaning or immersion in ethanol solution for 24 hours maintained nearly consistent high filtration efficiency.

The joint research team attributed this difference to the decrease in static electricity in the filters after cleaning. Melt-blown filters rely in part on the electrostatic effect of the surface when filtering particles. However, nanofiber does not rely on static electricity but filters according to the morphological properties and pore size of the surface, and is not deformed by ethanol.

Moreover, nanofiber filters have better breathability because they have much higher heat and carbon dioxide emission capabilities compared to the melt-blown filters. Biosafety tests using human skin and vascular cells also confirmed no cytotoxicity.

In summary, both mask filters have similar filtration performance in its initial use, but only nanofiber filters can be reused multiple times through a simple ethanol cleaning process.

POSTECH Professor Hyung Joon Cha explained the significance of the research by commenting, “This research is an experiment that has verified the biosafety of nanofiber masks – which have recently become a hot issue – and their ability to maintain filtration efficiency after cleaning.”

In addition, Professor Ick-Soo Kim of Shinshu University added, “I hope the nanofiber masks will help everyone as a means of preventing contagion in the possible second or third wave of COVID-19.

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These research findings were recently published online in the international journal ACS Applied Nano Materials published by the American Chemical Society.

https://www.eurekalert.org/pub_releases/2020-06/puos-set062820.php

Pilot study suggests Parkinson’s disease progression can be slowed

Deep Brain Stimulation (DBS) implanted in early stage Parkinson’s disease decreases the risk of disease progression and the need to prescribe multiple drugs to patients simultaneously, according to a five-year outcomes study of 30 patients released in the July 2020, issue of Neurology®, the medical journal of the American Academy of Neurology.

The journal released a Classification of Evidence statement along with the study stating that it provides “Class II evidence that DBS implanted in early stage Parkinson disease decreases the risk of disease progression and polypharmacy compared to optimal medical therapy alone.”

“Parkinson’s is relentless. There’s nothing that slows down its progression. With this pilot study, we’ve shown that if DBS is implanted early it’s likely to decrease the risk of progression, and if this is borne out in our larger study it would be a landmark achievement in the field of Parkinson’s disease,” said senior author David Charles, MD, professor and vice-chair of Neurology at Vanderbilt University Medical Center (VUMC).

The FDA has approved VUMC to lead a 130-patient, multi-site double-blinded randomized clinical trial of DBS for early stage Parkinson’s; if results of the pilot trial are replicated in that larger study, DBS will become the first therapy proven to slow the progression of any element of Parkinson’s.

Parkinson’s is a long-term neurodegenerative disorder most obviously characterized by tremor, rigidity, slow movement (bradykinesia) and difficulty with balance and walking.

As of 2016, some 6.2 million people worldwide were living with Parkinson’s. According to the Parkinson’s Foundation, as many as 60,000 Americans are diagnosed each year with the disease.

Early stage Parkinson’s disease is defined as within four years of disease onset.

From 2006 to 2009, the investigators enrolled 30 patients, all of whom received optimum drug therapy, with a random half additionally receiving DBS, which is often characterized as a pacemaker for the brain.

The DBS surgery uses a pair of ultra-thin electrodes surgically implanted deep into the brain to deliver electric pulses to the subthalamic nucleus, a small cluster of neurons. As with a heart pacemaker, the electric pulses are supplied by a battery implanted under the skin near the collarbone.

After five years, the patients who received optimal drug therapy only but not surgery in early-stage Parkinson’s had five-fold greater odds of experiencing worsening of their rest tremor, a hallmark of this disease, as compared to patients who received early DBS in addition to drug therapy.

In other five-year outcomes from the study, the DBS patients required considerably less of the medication used to manage symptoms of Parkinson’s.

“Patients who were randomized to receive early optimal drug therapy had 15-fold greater odds of needing multiple types of Parkinson’s disease medications,” said project leader Mallory Hacker, PhD, MSCI, assistant professor of Neurology at VUMC.

In a marked but uncertain trend falling just short of statistical significance, Parkinson’s patients randomized to receive drugs alone were more than twice as likely to have worse motor symptoms than patients who received early DBS.

“What this pilot study is most clearly telling us is that the new FDA-approved Phase III study must be done to definitively determine whether DBS slows the progress of Parkinson’s disease when implanted in the very earliest stages,” Charles said.

“While this is an incredibly exciting finding, patients and physicians should not change clinical practice at this time,” he added.

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Hacker and Charles were joined by Peter Konrad, MD, PhD, nine other investigators from VUMC, and one investigator from Walter Reed National Military Center.

The study was funded by the National Institutes of Health (TR000445, EB006136), the Michael J. Fox Foundation for Parkinson’s Research, and Medtronic, Inc., the manufacturer of the DBS system.

https://www.eurekalert.org/pub_releases/2020-06/vumc-pss062620.php

Labs warn COVID-19 testing demand will top capacity soon as new hotspots emerge

• With the spike in coronavirus cases in Southern and Western states, commercial laboratories say they do not have the capacity to keep up with growing demand for their testing services and predict longer turnaround times for results over the coming weeks.
• The American Clinical Laboratory Association, which represents LabCorp, Quest Diagnostics and other labs, said Saturday its members have seen a steady increase in the volume of COVID-19 test orders recently, specifically calling out the fact that critical testing materials are in short supply.
• Quest on Thursday issued its own warning that despite the rapid expansion of its testing capacity, demand has been growing faster. In particular, the lab giant noted that orders for molecular diagnostic services have increased by about 50% over the past three weeks.

U.S. commercial labs had made “significant strides” during the coronavirus pandemic by expanding testing capacity from about 100,000 tests per day in early April to more than 300,000 currently, according to ACLA.

But newly emerging hotspots like Arizona, California and Texas are putting a strain on labs and an already limited supply of testing materials, the group said.

While labs nationwide are trying to increase capacity by purchasing more testing machines and attempting to secure additional test materials from suppliers, ACLA President Julie Khani cautioned, “the reality of this ongoing global pandemic is that testing supplies are limited” and “every country across the globe is in need of essential testing supplies, like pipettes and reagents, and that demand is likely to increase in the coming months.”

Khani said ACLA has been in talks with the Trump administration and supply chain partners about the challenges labs face as they try to increase their level of respective COVID-19 testing abilities to meet the anticipated increase in U.S. demand for tests over the coming weeks.

In the absence of a solution, Khani warned that significant demand “will likely exceed” labs’ testing capacities and “could extend turnaround times for test results.”

For its part, Quest’s statement on Thursday described the U.S. coronavirus outbreak as an “evolving” situation that is putting a “strain” on the company’s COVID-19 testing resources.

“Today, we have the capacity to perform approximately 110,000 of these tests a day (770,000 a week). Despite the rapid expansion of our testing capacity, demand for testing has been growing faster,” according to Quest.

Currently, Quest’s average turnaround time for test results are one day for hospital patients, pre-operative patients in acute care settings, and symptomatic healthcare workers, and two to three days for all other patient populations. However, the company warned that “given increased demand, we expect average turnaround times near term to extend in excess of 3 days.”

Nonetheless, Quest said it is taking actions to try to increase COVID-19 testing scale, with the goal of being able to perform 150,000 tests per day. Toward that end, the company is installing additional testing platforms in its network of U.S. labs and said it is collaborating with independent labs who currently have underused capacity.

Quest’s rival LabCorp was not immediately available for comment on its testing capacity amid reports of demand increasing across the country.

https://www.healthcaredive.com/news/labs-warn-covid-19-testing-demand-will-top-capacity-hotspots-new-surge/580730/

Novavax Analyst Says COVID-19 Vaccine Could Net $400M In Yearly Sales

Novavax, Inc. NVAX 8.04% shares are on a dream run this year amid catalysts including its COVID-19 vaccine program.

The Novavax Analyst: Vernon Bernardino reiterated a top pick Buy rating on Novavax and raised the price target from $50 to $101.

The Novavax Thesis: Novavax’s COVID-19 vaccine candidate NVX-CoV2373 is likely a sustainable long-term market opportunity, Bernardino said in a Monday note. (See his track record here.)

H.C. Wainwright held a virtual fireside chat with Novavax executives Thursday.

The $388 million in CEPI funding for Novavax de-risks clinical development of the vaccine candidate, the analyst said.

Novavax is capable of being a robust competitor against larger vaccine makers, likely helping it realize over $400 million in annual sales of NVX-CoV2373, he said.

Discussions with former U.S. Health and Human Services and BARDA official Kevin Gilligan increased Bernardino’s positive view on Novavax’s prospects for realizing a near-term lucrative market opportunity as well as sustained commercial opportunity, the analyst said.

“Gilligan concluded that multiple therapeutic approaches, including antiviral and antibiotic strategies, would be important for a near-term response to the pandemic.”

Gilligan said it’s likely that booster vaccinations, new vaccines against mutated SARS-CoV-2 and antiviral and antibody therapies will be needed to prepare for future pandemics, the analyst said.

Matrix-M and vaccine adjuvants in general are underappreciated, Gilligan told H.C. Wainwright.

“In a situation where a significant percentage of the world’s 7B+ population may need to be vaccinated, the potential of adjuvants to boost vaccine efficacy, and thus, be dose-sparing could be important if not enough CoV vaccine is available for global distribution.”

https://www.benzinga.com/analyst-ratings/analyst-color/20/06/16428790/novavax-analyst-says-covid-19-vaccine-could-net-400m-in-yearly-sales