Better Living Through Well Being

The first reports of a cluster of cases of pneumonia of unknown cause in China were just over six months ago. Since then, worldwide cases of the SARS-CoV-2 (COVID-19 disease) outbreak have reached over 14 million with nearly three quarter of a million deaths. Back then none of us could have imagined how our world and our lives could be thrown into the turmoil we are in today. This viral pandemic has led not only to widespread illness and deaths, but also to economic devastation, severe day to day challenges, and long-term uncertainty for people all over the world.

World leaders are under tremendous pressure to both solve the immediate problem of this novel coronavirus pandemic, and also to keep it from happening again. This new virus has presented a global challenge to the scientific community to understand its mechanisms and expose its vulnerabilities so it can be eradicated. Increasingly, more is becoming understood but many unknowns remain. We know COVID-19 is many times more severe than seasonal flu and can kill healthy adults in addition to elderly people with existing health problems. It is transmitted quite efficiently with one infected person able to spread it to 2 or 3 others in an exponential rate of increase. Most importantly, it can be transmitted by people who are just mildly ill or even totally non symptomatic.

In the past few months, the COVID-19 pandemic has shut down a third of the global economy, triggering the largest economic shock since the Great Depression. So, what might it take for the global economy to recover and when will we be able to feel things are back to normal?

Regardless of ongoing recommendations or mandates for lockdowns, social distancing, mask wearing and hyper hygienic measures, the spread of COVID-19 is not slowing down and is actually speeding up in many countries, most of all within the United States. Learning how to live with this virus has become the new challenge, and there is still a likelihood of a second wave of infection later this year.

Many people are hoping for either a truly effective therapy or drug, or a COVID-19 vaccine to be available by early next year. Currently, universal vaccination is being promoted as the key strategy for prevention of COVID-19 and prioritized even over good nutrition, which is the natural way to maintain a healthy immune system as protection against disease.

The global scientific community used their linked information and communication technologies to sequence the genome of the novel coronavirus and made it publicly available by January 12th. Since then, researchers around the world have been sharing their findings in pursuit of a vaccine. According to the World Health Organization (WHO), there are currently 132 vaccines under preclinical investigation with 17 already subject to clinical trials, mainly in Phase 1 but some already in Phase 2, yet to enter Phase 3.

It is important to realize that not all vaccines are equally effective. A little background is helpful in this regard:

* Smallpox is the only disease known to have been completely eradicated by a vaccine, officially in 1979. Even so, one out of three people who got the vaccine had side effects bad enough to be kept from school or work for a period of time, and some suffered more serious reactions.

* Last flu season the Centers for Disease Control (CDC) found that the combination flu vaccine was only 25 percent effective for 18-49-year-olds and only 43 percent effective for those over 50.

Epidemiologists are humbled by what a tough and complicated disease the novel coronavirus is. In 2018, WHO added “Disease X” to the bottom of its list of priority diseases. This was to be a placeholder for the possibility of an unknown disease emerging for which there was no existing solution. Now we know it’s name is COVID-19.

Vaccine developers are shortening the development and approval process from a typical 5 or 6 years minimum to around 18 months using novel technology platforms, most involving some form of genetic engineering never before tested on large populations. Nucleic acid vaccines supply the body with a genetic code to get the body of the vaccinated person to become the vaccine factory, producing the antigen that is a copy of the COVID-19 spike protein. Then, assuming all goes as planned, that antigen causes the body’s immune system to attack the real virus, if and when a person becomes infected.

Vaccines which are neither proven effective or safe are already being mass manufactured in the hope that they get green-lighted after nothing more than a few months of testing, assuming there is still enough disease out there to see how they work against naturally-acquired infection. Can vaccines that are being developed within an unprecedented “warp speed” using novel technologies such as genetic engineering never before used be safe and effective?

The promise of an effective vaccine hinges on the assumption that a vaccine would generate sufficient persistent immunity. This immunity needs to come from production of enough neutralizing antibodies, or from a potent virus-specific memory T-cell response. Presently, scientists do not even know much about what happens in the body following naturally-acquired COVID-19 infection.

Much hope also hinges on the natural establishment of “herd immunity” that can occur when enough people become immune to COVID-19 to make its spread unlikely. This can occur with or without a vaccine. The more contagious a disease is, the greater the proportion of the population needing to be immune to stop its spread. The exact threshold for COVID-19 is not known. It could be as low as 60 percent or as high as 90 percent. It is possible that some communities who have had sufficient exposure to prior coronaviruses, such as the common cold and have T-cell adapted responses to them, may only need to reach 20 percent exposure to COVID-19 to achieve herd immunity.

A serology test can reveal the presence of COVID-19 antibodies in a person’s blood who has recovered from the disease. The current unknowns regarding immunity include whether or not someone who has recovered can get reinfected, how long immunity will last, and how many people will even be willing to be vaccinated for COVID-19 once a vaccination is available.

A diagnostic antigen test uses a nasal or throat swab to detect viral proteins expressed on the outer surface of the coranavirus and will be termed a positive test if these are found.

Here in the U.S., swab testing for positive presence of the SARS-CoV-2 virus responsible for the COVID-19 disease, and contact tracing for people who may have been exposed is a best hope in locating and containing the virus. There are challenges to this approach. We currently have serious infrastructure and supply chain problems to both making enough tests available and being able to get test results back quickly enough to be effective. We need to be able to scale up beyond working just at the state level to having more “interstate compacts” for shared resources such as has been done in the area around New York State. This would decrease the turnaround in getting testing results back in time to enact contact tracing in order to isolate and track the chain of transmission of the virus.

Anyone interested in volunteering for a Phase 3 clinical study to determine vaccine and monoclonal antibody efficacy studies for prevention of COVID-19 can do so on the COVID-19 Prevention Network website.

I am grateful to be in a collaborative business with many talented and skilled professionals. Additional feedback and recommendations for our services at TM Information Services are always welcome.

- Mary Michele McLaughlin

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New IHME Forecasts Show More Than 200,000 US Deaths by November 1 but High Levels of Mask Wearing Could Reduce Forecasted Deaths by Over 45,000
Seattle, Washington

In its first projections of COVID-19 deaths out to November 1, the Institute for Health Metrics and Evaluation (IHME) at the University of Washington is forecasting more than 200,000 deaths in the United States. The forecast shows 208,255 deaths (with a range of 186,087 to 244,541). Those numbers drop to 162,808 (157,217 to 171,193), if at least 95% of people wear masks in public.

"We can now see the projected trajectory of the epidemic into the fall, and many states are expected to experience significant increases in cases and deaths in September and October," said IHME Director Dr. Christopher Murray. "However, as we all have come to recognize, wearing masks can substantially reduce transmission of the virus. Mask mandates delay the need for re-imposing closures of businesses and have huge economic benefits. Moreover, those who refuse masks are putting their lives, their families, their friends, and their communities at risk."

IHME's new projections include the re-imposition of strong social distancing mandates when deaths per day reach a level of 8 per one million people, comparing that with a forecast if no action is taken, and a forecast if social distancing mandates are combined with at least 95% mask wearing in public spaces. Florida and Massachusetts 17,472 (11,275 to 32,577) and 12,906 (11,017 to 16,873), respectively, are expected to reach 8 per million deaths by November 1. The forecast for Florida, which is expected to reach 8 per million deaths on October 1, differs by 6,173 deaths if the state does not re-impose social distancing mandates. If mask wearing reaches 95%, that number drops to 9,849 (7,921 to 14,052).

The projections may increase if the current surge in infections spreads more widely in at-risk populations. Current data from states reporting the age breakdown of cases suggest that more cases are being detected in young people, who have a lower risk of death.
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Top US Scientists First To Report Data On New Biodefense Technology Proven To Eliminate Airborne Transmission Of SARS-CoV-2 To Control Spread Of COVID-19 Indoors
Houston, Texas

As evidence showing a real risk of airborne transmission of SARS-CoV-2 (Coronavirus responsible for COVID-19) continues to mount, Integrated Viral Protection (IVP) has announced the publication of a peer-reviewed paper detailing a novel biodefense indoor air protection technology. The novel, heated HVAC filter has been proven to destroy 99.8% of SARS-CoV-2, the virus responsible for COVID-19. In addition, this technology offers protection against other biological pathogens on contact using a propriety biodefense technology. The breakthrough studies were conducted at the Texas Center for Superconductivity at University of Houston (TcSUH) & Galveston National Laboratory, the nation's premier facility for biodefense research.

The first of its kind results confirmed this breakthrough technology to be 99.8% effective at killing the SARS-CoV-2 and 99.9% effective at killing anthrax spores in a single pass, making this technology protective against other potentially dangerous bio pathogens. The scientific research behind this biodefense indoor air protection technology has been published in the highly respected, multi-disciplinary journal Materials Today Physics.

Replicative studies on the biodefense filter system recently validated original findings from the Galveston National Laboratory, this time with the addition of non-ozone producing UVC-light. Even though a 270-fold higher concentration of aerosolized SARS-CoV-2 (coronavirus) was used in these experiments, the biosampler was unable to detect any active virus, proving an enhanced first pass kill of 99.999% by this novel biodefense filter.

"We now know that SARS-CoV-2 is an airborne pathogen, capable of traveling through the air at greater distances than first thought. The virus can survive for hours, suspended in the air, resulting in COVID-19 spread through the air we breathe, necessitating the urgent need for an indoor air protection system," says Dr. Faisal Cheema, Associate Professor of Biomedical and Clinical Sciences at University of Houston College of Medicine. According to Dr. Cheema, "This novel biodefense indoor air protection technology -- endorsed by leading national and international scientists including Massachusetts Institute of Technology (MIT), Argonne National Laboratory amongst others -- offers the first in line prevention against environmentally mediated transmission of airborne SARS-CoV-2 and will be on the forefront of the armamentarium of technologies available to combat current COVID-19 pandemic and any future airborne biothreats indoors."
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Aegis Living Debuts New COVID-Era Future for Senior Assisted Living
Bellevue, Washington

Aegis Living, a national leader in assisted living and memory care, unveiled a series of company-wide commitments for advancing resident care, safety and wellness during the COVID-19 era. The comprehensive commitments -- which are debuted in a short, animated video -- span all aspects of the organization from leadership to operations, research, resident care and more.

"Families are facing unprecedented challenges as they work to care for their loved ones during this uncertain time," said Kris Engskov, Aegis Living President. "Our number one priority is to apply our 23 years of experience and deep clinical expertise to continue to innovate well ahead of this virus to ensure we are the safest place for our seniors and also a place where they can thrive – physically, mentally and emotionally – now and well into the future."

Aegis Living commitments were driven by insights and experience gleaned over the past four months navigating the pandemic, coupled with medical expertise and direct feedback from residents, families and staff.

At the center of these new advancements is building the most qualified team to drive this work forward. Appointed as Infection Control & Safety Officer, Tom Laborde has a 22-year tenure at Aegis, most recently as their Chief Operating Officer. In his new position, Laborde will work closely with Aegis' senior management team to assess, develop and implement new infection control technologies and measures across all of Aegis' properties.
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Northeast-Based Design Firm Launches New Enterprise To Redesign Companies' Workspaces Post-COVID-19
Brooklyn, New York

COVID-19 has had a tremendous impact on the way people work, and therefore has consequences for the ways companies need to look at workspaces and how employees work in them. Northeast-based design firm Stewart-Schäfer, a multidisciplinary architecture and interior design studio led by James Veal and Christine Stucker, announces the launch of a second enterprise to address office health and safety issues and create sustainable solutions for the future. DistanceDesigns will provide services and resources to create agile workspaces that help prevent disease spread and promote health, while also increasing creativity and productivity through data-driven design. In a recent survey, they found more than 69 percent of respondents would like to see design changes in their offices beyond health and safety measures. Pioneering the design-led concept of agile working, DistanceDesigns' goal is to create lower density hybrid workspaces that are optimized for specific tasks, empowering employees to work where, when and how they choose and enhance their performance and do their best work.

"We solve problems through design. We believe that instead of simply reacting to the crisis by adding policies and procedures and placing desks six feet apart, there is a real opportunity to redesign the space and foster long-term productivity and creativity through activity-based spaces," said Veal. "We want to bring together health and safety with the psychology of cultural change."

Veal and Stucker bring decades of high-profile commercial and retail design experience, where they designed for the customer in mind, to respond to the immediate need for workplaces in transition. Now they apply this model to the modern workspace and design around the employee, the tasks they accomplish, and how they interact with their work environment to increase their productivity and ensure health and safety measures. DistanceDesigns' proprietary model can be found in a detailed white paper on their website, DistanceDesigns.com.
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Farmer sentiment rebounds amidst ongoing COVID-19 concerns
West Lafayette, Indiana

Farmer sentiment improved in June for the second month in a row, rebounding from sharp declines that took place in both March and April, according to the Purdue University/CME Group Ag Economy Barometer. The index was up 14 points from May to a reading of 117. The Ag Economy Barometer is based on responses from 400 U.S. agricultural producers with this month's survey conducted from June 22-26, 2020.

Ag producers became more optimistic about both their current and future farming operations compared to a month earlier. The Index of Current Conditions rose 19 percent from May to a reading of 99, and the Index of Future Expectations climbed 12 percent from May to a reading of 126. Over the last two months, farmers' perspective regarding making large investments in their farming operations improved markedly. The Farm Capital Investment Index recovered to a reading of 60 in June, compared to just 50 a month earlier and a reading of 38 in April. Although much improved since bottoming out in April, the recovery still left the Farm Capital Investment Index 12 points below the 2020 high established in February, before coronavirus impacted markets.

"This month's survey was conducted after the USDA announced details regarding the Coronavirus Food Assistance Program (CFAP)," said James Mintert, the barometer's principal investigator and director of Purdue University's Center for Commercial Agriculture. "A more favorable spring planting season combined with assistance from CFAP help explain this month's improvement in farmer sentiment, yet a majority of producers believe additional economic assistance will be needed in 2020."

Despite their concerns, when asked about the impact of the virus on their farms' profitability, 64 percent of respondents indicated they were "very worried" or "fairly worried", down from 71 percent in May. The June survey provided the first opportunity to survey farmers after details about the CFAP were made available. Sixty percent of surveyed farmers indicated that CFAP "somewhat" (53 percent) or "completely" (7 percent) relieved their concerns about the impact of the virus on their 2020 farm income while just over one-fourth of respondents (26 percent) responded "not at all." However, 64 percent of farmers surveyed indicated they think it will be necessary for Congress to pass another bill to provide more economic assistance to U.S. farmers.
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Regeneron Announces Start of REGN-COV2 Phase 3 COVID-19 Prevention Trial in Collaboration with National Institute of Allergy and Infectious Diseases
Tarrytown, New York

Regeneron Pharmaceuticals, Inc. has announced the initiation of late-stage clinical trials evaluating REGN-COV2, Regeneron's investigational double antibody cocktail for the treatment and prevention of COVID-19. A Phase 3 trial will evaluate REGN-COV2's ability to prevent infection among uninfected people who have had close exposure to a COVID-19 patient (such as the patient's housemate), and is being run jointly with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). REGN-COV2 has also moved into the Phase 2/3 portion of two adaptive Phase 1/2/3 trials testing the cocktail's ability to treat hospitalized and non-hospitalized (or "ambulatory") patients with COVID-19.

This clinical progress follows a positive review from the Independent Data Monitoring Committee of REGN-COV2 Phase 1 safety results in an initial cohort of 30 hospitalized and non-hospitalized patients with COVID-19.

The Phase 3 prevention trial is being conducted at approximately 100 sites and is expected to enroll 2,000 patients in the U.S.; the trial will assess SARS-CoV-2 infection status. The two Phase 2/3 treatment trials in hospitalized (estimated enrollment =1,850) and non-hospitalized (estimated enrollment =1,050) patients are planned to be conducted at approximately 150 sites in the U.S., Brazil, Mexico and Chile, and will evaluate virologic and clinical endpoints, with preliminary data expected later this summer. All trials are adaptively-designed, and the ultimate numbers of patients enrolled will depend on trial progress and insights from Phase 2 studies.

"We are running simultaneous adaptive trials in order to move as quickly as possible to provide a potential solution to prevent and treat COVID-19 infections, even in the midst of an ongoing global pandemic," said George D. Yancopoulos, M.D., Ph.D., Co-Founder, President and Chief Scientific Officer of Regeneron. "We are pleased to collaborate with NIAID to study REGN-COV2 in our quest to further prevent the spread of the virus with an anti-viral antibody cocktail that could be available much sooner than a vaccine."
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In Fight Against COVID-19, CSL Behring Begins Trial to Evaluate Monoclonal Antibody (CSL312) for Respiratory Distress
King of Prussia, Pennsylvania

Global biotherapeutics leader CSL Behring has announced that the first patient has been enrolled in its Phase 2 study to assess the safety and efficacy of CSL312 (garadacimab, Factor XIIa antagonist monoclonal antibody) to treat patients suffering from severe respiratory distress, a leading cause of death in patients with COVID-19 related pneumonia. In this multicenter, double-blind, placebo-controlled study, approximately 124 adult patients testing positive for the SARS CoV-2 infection will be randomized to receive either CSL312 or placebo, in addition to standard of care (SOC) treatment. The primary endpoint being the incidence of tracheal intubation or death. "The greatest clinical challenge in treating patients with severe COVID-19 and improving outcomes has been our ability to manage the serious respiratory complications associated with the disease," said Lars Groenke, R&D Lead, Respiratory Therapeutic Area, CSL Behring. "Our hope with CSL312 is to be able to prevent the progression of COVID-19, improve patient outcomes, and provide physicians with an effective tool in the fight against this deadly virus." Currently, CSL Behring is evaluating five approaches across its plasma fractionation and recombinant and antibody strategic scientific platforms to preventing and treating COVID-19.
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Affinity discovers potent SARS-CoV-2 antibodies
Melbourne, Australia

Melbourne-based Affinity Biosciences Pty Ltd (Affinity), a privately held company focused on antibody discovery for cancer therapeutics, has announced the discovery of potent antibodies with therapeutic potential against COVID-19.

In March, Affinity commenced screening its proprietary library of one hundred billion human antibodies to discover those that might neutralise SARS-CoV-2, the virus that causes COVID-19. After discovering a number of candidate antibodies that block the virus spike protein from binding to its human receptor, Affinity engaged The Peter Doherty Institute for Infection and Immunity (Doherty Institute) in April to conduct testing using the virus in the laboratory. The Doherty Institute has confirmed that Affinity's antibodies can completely neutralise the infectivity of SARS-CoV-2 at a single digit microgram/ml concentration in a five-day virus neutralisation assay. The antibodies have high affinity for the SARS-CoV-2 spike protein at around 20 picomolar, driven by an exceptionally slow off-rate, a measure of how long the antibody remains bound to its target.

"Our antibodies latch onto the virus spike protein and block its activity," said Affinity CEO, Dr Peter Smith. "These antibodies may be protective in humans by preventing the virus from gaining a foothold in healthy people exposed to the virus, and may be useful in arresting the progress of the virus in an infected person by blocking its ability to infect new cells and replicate."

A highly effective therapy would allow faster resumption of normal life by reducing the threat of infected individuals needing hospitalization.
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Johns Hopkins Reports Promising Clinical Data in COVID-19 ARDS Treated with Cellenkos' Cord Blood T-Regulatory Cells
Houston, Texas

Physician-investigators at Johns Hopkins University Hospital report on the promising data of treatment of COVID-19 induced acute respiratory distress syndrome with allogeneic, cord blood derived T-regulatory (Treg) cell therapy (manufactured by Cellenkos), published in peer reviewed journal of Annals of Internal Medicine. Both patients were critically ill and intubated (one on ECMO). Both had failed Tociluzimab (Actemra, Roche) and had multiorgan failure. Patients received cell therapy under FDA Emergency Use IND for up to 3 doses. Clinical improvement was evident within 48 hours of first infusion and correlated with concurrent dampening of the cytokine storm as demonstrated by a rapid decline in peripheral biomarkers including lactate, C-reactive protein, and Ferritin as well as decreased blood levels of inflammatory cytokines including IL-6, IFN? and TNFa .

"We are excited by these early data in very sick patients suffering from COVID-19 ARDS. We recognize that there are several factors at play but believe that the temporal relationship between Treg infusions and patient recovery cannot be ignored," said Dr. Douglas Gladstone, principal investigator at Johns Hopkins. "We look forward to evaluating this promising therapy in the FDA-approved randomized, double-blinded, placebo-controlled clinical trial of cryopreserved, allogeneic, off-the-shelf, cord blood derived T-regulatory cells (CK0802) in intubated patients suffering from COVID-19 ARDS. Planned correlative assays during this trial will provide insights into the mechanism of action of CK0802 and its relation to clinical outcomes."

The multicenter clinical trial is set to launch in Q3 2020, with patients assigned to treatment with multiple doses of CK0802 or placebo, with two co-primary outcomes of safety (no severe toxicity) and efficacy (alive and extubated at day 28). CK0802 will be manufactured by Cellenkos and shipped to the clinical site to be infused at the patient's bedside.

"We are very encouraged by these early clinical observations and remain fully committed to bring forward this promising, potentially life-saving therapy into market. We believe that our product will materially change the fatal outcome of COVID-19, allowing for the needed (necessary) time to develop an effective COVID-19 vaccine," said Tara Sadeghi, VP, Clinical Operations at Cellenkos. "Our company-owned clean room facility allows us to have full control of the manufacturing processes, supply chain, and distribution logistics. We are confident that we can deliver on this multicenter clinical trial."
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Regenerative Medicine Company Identifies Mechanism Responsible for Blocking COVID19-Like Lung Inflammation
Houston, Texas

FibroGenesis, a regenerative medicine company, has announced identification of molecular mechanisms associated with the potent reduction of lung inflammation previously reported by the Company in an animal model of COVID-19 lung failure.

The Company disclosed data demonstrating that administration of PneumoBlast resulted in dramatic alterations of immunological signaling molecules called "cytokines". The studies showed that PneumoBlast reduced concentrations of the inflammatory cytokines interleukin-1 beta, interleukin-6, interleukin-8, interleukin-17, interleukin-18, and Tumor Necrosis Factor alpha, TNFa. Supporting the inflammation-inhibiting properties of PneumoBlast, Company scientists observed an increase in anti-inflammatory cytokines interleukin-4, interleukin-10, interleukin-13 and interleukin-35, as well as regeneration-associated cytokines FGF-2 and HGF-1. The cytokines found to be manipulated by PneumoBlast are known to be associated with survival and recuperation from COVID-19.
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Entera Health Announces Approval of COVID-19 Clinical Trial using EnteraGam
Ankeny, Iowa

Entera Health, in cooperation with Lemus Buhils, has received IRB approval to conduct a clinical trial in Barcelona Spain using EnteraGam to manage the symptoms associated with COVID-19 infections. The trial titled "Randomized Open-Label Clinical Study Evaluating the Impact of EnteraGam, a Nutritional Intervention containing Bovine Plasma-Derived Immunoglobulin CoNcentrate, on Clinical Outcomes In People with COVID-19 (Spanish PICNIC Study)" will investigate the use of EnteraGam to manage inflammation and symptom severity in patients with mild-to-moderate SARS-CoV-2 infections.

The Spanish PICNIC Study is a randomized open-label clinical trial which aims to enroll 420 subjects with SARS-CoV-2 infection. Patients will be randomized in a 2:1 ratio to receive EnteraGam in addition to standard of care, or standard of care alone. Patients enrolled in this trial will have mild-to-moderate symptom severity, including respiratory distress such as coughing and shortness of breath, but will not require invasive mechanical ventilation or management in the intensive care unit. The primary endpoints of the trial are the change in plasma IL-6 levels between entry and Week 2, and the percentage of patients with disease progression by Week 2. A number of secondary endpoints will focus on specific COVID-19 associated symptoms, including diarrhea, and other markers of gut associated inflammation and permeability.
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