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Monday, July 27, 2020

Mid-stage study underway on Immunic’s IMU-838 in COVID-19

The first patients have been enrolled in a Phase 2 clinical trial, IONIC, evaluating Immunic’s (NASDAQ:IMUX) oral DHODH inhibitor IMU-838 (vidofludimus calcium), combined with Roche’s (OTCQX:RHHBY) Tamiflu (oseltamivir phosphate) in COVID-19 patients.
The study will compare IMU-838 + oseltamivir to oseltamivir alone for up to 14 consecutive days. All participants will also be eligible to receive standard-of-care treatment throughout the trial.
The company is providing product for the UHCW NHS Trust-conducted trial.
The company says IMU-838 is an orally available, next-generation immune modulator that dampens the immune response by inhibiting an enzyme called dihydroorotate dehydrogenase (DHODH) that plays a key role in intracellular metabolism of activated immune cells.

AstraZeneca signs $6 bln cancer drug deal with Daiichi

AstraZeneca could pay up to $6 billion to Japan’s Daiichi Sankyo to develop and market a type of targeted cancer treatment in the second multi-billion dollar cancer drug collaboration between the two companies.
The London-listed company said on Monday it would pay Daiichi an upfront payment of $1 billion for DS-1062, a type of antibody drug conjugate (ADC). The remaining amount will be paid when regulatory and sales milestones are achieved, it said.
The drugmakers signed a near $7 billion deal last year for a breast cancer treatment, now called Enhertu, which is being tested in other tumour types too.
DS-1062 belongs to the ADC class of treatments, which link powerful cell toxins to antibodies that cling to cancer cells and spare healthy cells that are damaged during conventional chemotherapy treatments.
It targets the TROP2 protein on cancer cell surfaces – typically seen in up to 80% of patients with triple-negative breast cancer and also has been identified in a majority of non-small cell lung cancers.
AstraZeneca and Daiichi are also in talks over supply of the British company’s potential coronavirus vaccine in Japan.

Sunday, July 26, 2020

Diagnostics group Novacyt to launch more COVID-19 testing products

Clinical diagnostics company Novacyt – one of many healthcare companies whose shares have surged during the pandemic – announced on Monday more new products to test for the presence of the coronavirus.

Novacyt said it was developing a respiratory testing panel to diagnose and distinguish between the ‘A’ and ‘B’ types of influenza, the respiratory syncytial virus (RSV) and COVID-19, with the launch of this product expected in September in time for the 2020/21 flu season in the northern hemisphere.
“The immediate pipeline of new products is expected to drive incremental revenue for the company in the near-term, but Novacyt’s strengthened financial position also means we are able to redefine our R&D pipeline for the next three years, which we expect to drive significant and continued growth opportunities in the longer-term,” said Novacyt CEO Graham Mullis.

HHS Officer Reveals Functioning Blockchain Project To Track Covid-19

As hospitals adjust to the new Health and Human Services (HHS) platform called the Coronavirus Data Hub to report critical Covid-19 information, HHS Chief Information Officer José L. Arrieta confirmed that the agency is using blockchain technology to track Covid-19 hospitalization data. In an interview today, Arrieta stated how this will “allow for faster clinical trials, protect citizens and flatten the curve on this pandemic, so we can recover from this pandemic using blockchain technology, a distributed ledger technology.”
Earlier this week, Arrieta noted how HHS Protect, a platform for authenticating data, is more comprehensive than that previously provided by the CDC. “At HHS Protect, every day, every data element we receive is hashed with a time-stamped record of the parcing and curation and sharing of that data element.” Arrieta, who is well-known for championing the benefits of blockchain technology within the U.S. Government, explained blockchain will ensure the data for Covid-19 hospitalizations is accurate and traceable.
Arrieta confirmed that the blockchain system being used with HHS Protect is an enterprise version similar to those supported by the Hyperledger organization and companies such as IBM IBM -1.2%as opposed to the bitcoin or ethereum blockchains. He declined to disclose the exact name of the platform.

“The blockchain HHS uses is not the blockchain of the anarchists and disruptors, but rather as a fresh step forward where thousands of users on the platform are accessing data sets,” stated Arrieta. According to the CIO, HHS Protect coordinates data from 6,200 hospitals across the United States, including numbers of ventilators, hospital beds, ER admittance, and discharge, lab test data across the U.S., warehouse implications, and nursing home data.
As a result of using blockchain technology with HHS Protect, the U.S. government can now, as Arrieta explained, “share with the general public how the results were generated because you have a record that is immutable.” Exactly how this would be accessed is unclear.
He added: “Science is about proving something and then sharing the steps of how you proved it. Creating time-stamps in an immutable record is truly empowering and allows for complete transparency from a data perspective.” Arrieta noted blockchain technology will enable HHS to, “allow clinical trials faster, protect citizens better, and best allow the country to recover from this pandemic.”
Asked if he believed the move of Covid-19 data from the CDC to HHS with the data protected by blockchain technology should provide more comfort to Americans about the accuracy of the data provided, Arrieta responded, “Absolutely, this is extremely important. Americans now have a public record of how the data was received with time-stamped steps where people have access to the data elements. It is important to note that the CDC, HHS, providers, and the American public are able to see the data element at the exact moment it was shared as a result of blockchain technology.”
As reported by ABC News, CDC Director Dr. Robert Redfield forcefully defended the change in a call with reporters, insisting that the federal government’s effort to create a single database run by HHS – linking an estimated 4 billion disparate data elements on everything from testing to the race and ethnicity of patients to hospital supplies and bed space — instead of through the CDC — can only help the CDC’s efforts.
According to Arrieta, for something as critical as Covid-19 data, trust and transparency is needed for data in real-time with large data sets, which the blockchain provides. “With this technology, we are able to do it and I am super excited,” says Arrieta.
While at the General Services Administration (GSA), Arrieta helped build from the ground up a blockchain working group that meets weekly and still meets every Friday. This working group, run by the the American Council for Technology and Industry Advisory Council, (ACT-IAC), a non-profit public-private partnership dedicated to improving government, has helped develop a blockchain playbook that U.S. agencies can use to in determining if blockchain should be used for a particular use case and how to implement the technology.
The group allows for an ongoing dialogue between government and industry on ways of adopting blockchain technology. From the European Union to China, the entire world increasingly seems to be increasingly seeing this technology as the next version of the World Wide Web, or Web 3.0, and is racing to adopt it.
Prior to today, there was no highly visible blockchain technology being used by the U.S. Government, causing a general concern that America was falling behind China and others in the blockchain race. However, the confirmation today of the technology’s application to Covid-19 to help reduce the rate the virus spreads, or “flatten the curve,” as it is widely described, will likely show the U.S. is turning a corner on the technology at a critical time in our history.
Arrieta, in his current role as the CIO at HHS, had previously noted, back in January, that the HHS Accelerate program, focused on using the technology to streamline and improve the procurement process, will save HHS “somewhere around $33 to $40 million” over the next five years. However, HHS Protect was an opportunity to use the technology for its true purpose, says. “The core for this technology is around sharing and transparency, using hashes and time series and being able to share the data with the integrity to allow the American public to ensure the underlying data is accurate,” he says.
According to Arrieta, blockchain will be the “anchor in the marketplace, at an individual, company, agency, and national level. The technology is transformative and how it is used takes time,” he says.. While saving taxpayer money was a good achievement with HHS Accelerate, Arrieta believes, “the use of blockchain with Covid-19 will be truly impactful in demonstrating the usefulness of this key new technology.”
https://www.forbes.com/sites/jasonbrett/2020/07/24/us-health-department-chief-discloses-functioning-blockchain-project-to-track-covid-19/#1fb8bdf11949

New Test May Show If Your Immune System Can Neutralize Coronavirus

Many of us are asking: Have I already been exposed to the coronavirus, and am I immune to further infection?
A fast, easy, and sensitive new antibody test detects the specific biomarkers of long-term immune protection against SARS-CoV-2 that can answer that question.
If Covid is here for the foreseeable future—and the waves of infections from Brazil to the US and India suggest it is—then we’re going to have to find ways to keep the economy safely going despite it.
One way is to try to understand how much of the population is immune to the virus, and how long that immunity lasts. This could help us understand both whether a vaccine might be effective in the long run, and also whether solutions such as immunity passports might be a viable option.

Unfortunately, not one test can currently give us any assurance of that. We know from related coronaviruses, such as those which cause the common cold, that immunity is often very short-lived, and people can be reinfected with the same virus.
Some studies also suggest that antibodies reduce to undetectable levels within just a few months of Covid infection, spurring the widely circulated perception in recent weeks that immunity to the disease is only temporary. The antibody tests currently being used miss this vital part of the picture.
GenScript, a leading life sciences company, has a new antibody test that could raise the standard for testing and give us clearer insights on how to fight the coronavirus. Today, in the prestigious scientific journal Nature, GenScript describes early results from the test, which targets specialized virus-thwarting antibodies known as neutralizing antibodies. The results suggest we can rethink our understanding of long term immunity to Covid, and offers hope for the effectiveness of a future vaccine.

Neutralizing a pathogen

When a virus infects our body, our immune system kicks into action to combat it in a number of ways. One part of that immune response involves antibodies, the tiny proteins which recognize a virus and stick to it. But not all antibodies are made equal.
“When you have a virus, you generate all these antibodies, but only a small fraction bind to the virus in a way that prevents it from infecting a cell,” GenScript’s Eric Wang explains. “Those are the neutralizing antibodies.”
Neutralizing antibodies make up less than 1% of the total antibodies measured by current commercial tests, and Wang says they’re being missed. That means we could be underestimating just how many people are already protected against reinfection with the virus.
Neutralizing antibodies are not sufficient in all cases. But based on the body’s response to other viruses, neutralizing antibodies are a good indicator of protective immunity in most patients who have recovered from a disease.
“All the antibody tests at the moment look at total antibodies, and these can reduce significantly just a few months after a patient recovers from Covid,” says Wang. “But as long as you have a small amount of neutralizing antibody, the patient may still be immune to the virus.”
Recent studies have indicated that total antibodies, including neutralizing antibodies, do indeed reduce in both asymptomatic and symptomatic Covid survivors. A UK team suggested last week that this seemingly transient immune response, which included a reduction in neutralizing antibodies, might well be linked to the severity of the initial illness.
However, a study led by Dr. Lin-fa Wang, Director of the Duke-NUS’ Emerging Infectious Diseases program, suggests that we might rethink what this means for long-term immunity to Covid.
The research shows GenScript’s novel, specific, and more sensitive antibody test could detect significant levels of neutralizing antibodies, even in patients who show low levels of antibodies overall. This effect was confirmed across patient cohorts in two different countries: Singapore and China.
Another promising finding was gleaned from the blood serum of patients previously infected with the SARS virus of 2003, which still had detectable neutralizing antibodies 17 years after recovery, indicating the potential for long-term protection against a similar virus.

Introducing the first SARS-CoV-2 Neutralization Test

According to GenScript, the cPass test, or SARS-CoV-2 Surrogate Virus Neutralization Test (sVNT), is safer, faster, easier, and more sensitive than traditional virus or cell-based tests with comparable specificity. It’s under review by FDA, but it already has CE-IVD clearance in Europe, and received provisional authorization for clinical use in Singapore.
David Martz, Vice President of new product development in GenScript’s Life Science Group, said, “this paper demonstrates that sVNT can detect neutralizing antibodies, better known as a biomarker of immunity, with 95-100% sensitivity and  99.93% specificity.  Additionally, this new method also provides the means for standardized testing.”
So how does it work?
“It uses a different principle,” says Wang. “We don’t detect the antibody itself, but instead we check the blood for anything which blocks the binding of the virus [spike protein] to the hACE2 receptor on human cells. It’s a functional assay that specifically looks for the neutralizing antibody.”
At the moment, the company can’t say for sure that this test—even if it detects neutralizing antibodies—guarantees immunity against reinfection with Covid. That still requires further research. However, the test could offer a vital step when trying to figure out our current levels of herd immunity, for example, or whether that’s even achievable without a vaccine. When a vaccine does come along, it can also help show whether it is effective.
“We need something to test whether the people who receive vaccinations generate neutralizing antibodies,” Wang explains. “And not just any antibody. It has to be the neutralizing antibody.”
It’s neutralizing antibodies that will offer long term protection against Covid, stopping the disease before it can take hold.

The plaguing mysteries of Covid

A recent study from Spain published in the Lancet found that 5% of the population carried antibodies for Covid. The study was carried out using non-specific antibody tests, which is useful in measuring how much the virus had spread through the Spanish population. But no conclusions can be drawn on potential herd immunity among those already exposed.
“Imagine if scientists had access to the cPass test. Not only they would have been able to accurately determine the total level of neutralizing antibodies but also use this test to assess herd immunity,” added Martz. “We are very excited to see how this will shed new light on the current plaguing mysteries of Covid.”
Covid is still an enigma in many ways, and it is still unclear how long immunity to the virus will last. However, neutralizing antibodies are a pretty good indicator of  immunity, and improved antibody tests provide us with a far more detailed understanding of the effects the virus is having on the population as a whole, helping us in the continued fight against the pandemic.

Japanese government to urge more telecommuting as coronavirus cases soar

Japan’s economy minister says the government will urge businesses to aim for 70% telecommuting and enhance other social distancing measures amid a rise in coronavirus cases among workers, some infected during after-work socialising.
Though Japan has largely avoided the mass infections that have killed tens of thousands overseas, a record surge in cases during the past week in Tokyo and other major urban areas has experts worried the country face a second wave.
Economy Minister Yasutoshi Nishimura late on Sunday called on business leaders to enhance anti-virus measures such as encouraging the level of telecommuting achieved during Japan’s state of emergency this year.
Tokyo last week reported a daily record of 366 cases, with 239 on Sunday. The southern city of Fukuoka reported a record 90 cases on Sunday, along with rising numbers in Osaka.
“At one point, commuter numbers were down by 70 to 80%, but now it’s only about 30%,” Nishimura said. “We really don’t want to backtrack on this, so we have to explore new ways of working and keep telecommuting high.”
He also called on companies to avoid large gatherings and to urge staggered shifts.
Nishimura said last week that concern was rising about clusters, specifically those involving host and hostess bars as well as others connected to workplaces and after-work socialising.
Though the number of serious cases remains relatively small, the government is also concerned about a rise in infections among people in their 40s and 50s.
The rate of telecommuting has lagged in Japan because of a paper-driven culture and technological shortcomings, experts say.
The central government remains determined to restart economic activity and last week launched a domestic travel campaign in the face of widespread criticism.
But Tokyo was omitted from the plan and Tokyo governor Yuriko Koike called on the city’s residents to stay home during a four-day weekend starting Thursday.
More than 30,000 people in Japan have been infected and nearly 1,000 have died.

CDC Director Says School Reopening ‘Important for Our Public Health’

July 26, 2020

With the new school year looming, the US Centers for Disease Control and Prevention has issued expanded guidelines on school reopenings that stress the importance of putting children back into the classroom.
“It is critically important for our public health to open schools this fall,” CDC Director Dr. Robert R. Redfield said in a statement. “I know this has been a difficult time for our Nation’s families. School closures have disrupted normal ways of life for children and parents, and they have had negative health consequences on our youth. CDC is prepared to work with K-12 schools to safely reopen while protecting the most vulnerable.”
The new CDC information provides online tools to help parents decide whether to send their children back to school and resources for school administrators, such as protocols to follow if a student or teacher tests positive for COVID-19 and advice on how strictly measures such as face masks should be enforced based on the level of community transmission.
Though putting children back in the classroom is emphasized, the CDC said that in the case of “substantial, uncontrolled transmission” of COVID-19, a school system should consult with local authorities on whether to reopen and might want to consider virtual learning.
Whether to reopen in-class education has become a crucial question in many communities. Many large school systems, such as Los Angeles, San Diego and Atlanta, have decided to start the year with distance learnings.
The CDC said more than a week ago that it would expand on the school reopening guidance offered in May. President Donald Trump had complained that the May guidance, which stressed social distancing and closure of communal school spaces like cafeterias, was too strict.
In a post titled “The Importance of Reopening America’s Schools This Fall,” the CDC said infected children are less likely to suffer severe symptoms if they catch the virus.
“The best available evidence indicates that COVID-19 poses relatively low risks to school-aged children. Children appear to be at lower risk for contracting COVID-19 compared to adults,” the CDC said. “No studies are conclusive, but the available evidence provides reason to believe that in-person schooling is in the best interest of students. …”
Schools help the growth of “the whole child,” the CDC said, and often provide nutrition and socialization children don’t receive at home.
“At the same time, the harms attributed to closed schools on the social, emotional, and behavioral health, economic well-being, and academic achievement of children, in both the short- and long-term, are well-known and significant,” the CDC said. “Further, the lack of in-person educational options disproportionately harms low-income and minority children and those living with disabilities.”
The guidelines for school leaders stress the need for social distancing and sanitation and suggest children be placed in pods, with the same teacher with the same group of children. Entry and exit into the school could be done in phases and outdoor spaces utilized.
The guidelines do not call for routine screening of students.
Sources
CDC. CDC releases new resources and tools to support opening schools
CDC. “School Decision-Making Tool for Parents, Caregivers, and Guardians”
CDC. “Preparing K-12 School Administrators for a Safe Return to School in Fall 2020”
CDC. “The Importance of Reopening America’s Schools this Fall”