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AXIM® Biotechnologies Develops ELISA-Based Neutralizing Antibody Diagnostic Test for COVID-19 and Applies for Patent; Company’s Fourth COVID-19…

December 4th, 2020 12:21 am

SAN DIEGO, Dec. 03, 2020 (GLOBE NEWSWIRE) -- AXIM® Biotechnologies, Inc. (OTCQB: AXIM) (“AXIM® Biotech,” “AXIM” or the “Company”), an international healthcare solutions company targeting oncological and COVID-19 research, announced today the development and patent filing for an enzyme-linked immunosorbent assay (ELISA)-based diagnostic test (the “Test”) for the detection of SARS?CoV-2 neutralizing antibodies. This application marks AXIM’s fourth COVID-19 neutralizing antibody-focused patent application. The Company heavily focuses its resources on advancing research on what it believes will soon become the most prevalent need in the post-vaccine COVID-19 fight, the need to know levels of neutralizing antibodies in longitudinal studies of vaccine response.

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Parexel Named Best Contract Research Organization by Scrip

December 4th, 2020 12:21 am

Company recognized for innovative and effective use of real-world data and flexible trial designs Company recognized for innovative and effective use of real-world data and flexible trial designs

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Intrivo Diagnostics Inks National Distribution Agreements with Concordance Healthcare Solutions and NDC for Access Bio CareStart™ COVID-19 Tests

December 4th, 2020 12:21 am

Major supply chain agreements will ensure broad access to rapid testing solutions for patients and healthcare providers across US

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Intrivo Diagnostics Inks National Distribution Agreements with Concordance Healthcare Solutions and NDC for Access Bio CareStart™ COVID-19 Tests

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Annovis Bio to Present at the New York Academy of Sciences’ Alzheimer’s Disease Therapeutics: Alternatives to Amyloid 2020 Virtual Conference

December 4th, 2020 12:21 am

BERWYN, Pa., Dec. 03, 2020 (GLOBE NEWSWIRE) -- Annovis Bio Inc. (NYSE American: ANVS), a clinical-stage drug platform company addressing Alzheimer’s disease (AD), Parkinson’s disease (PD) and other neurodegenerative diseases, today announced its CEO, Maria Maccecchini, Ph.D., will present at the New York Academy of Sciences’ Alzheimer's Disease Therapeutics: Alternatives to Amyloid 2020 Virtual Conference on Friday, December 4, 2020.

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Akari Therapeutics Announces Publication in American Journal of Pathology Highlighting Potential of Nomacopan in Treatment of Uveitis and Retinal…

December 4th, 2020 12:21 am

NEW YORK and LONDON, Dec. 03, 2020 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where the complement and/or leukotriene systems are implicated, today announces the publication of the results of a two-year research collaboration with the University College of London (UCL) Institute of Ophthalmology. The results showed that the therapeutic intravitreal (IVT) administration of long-acting nomacopan mitigated both the severity and progress of retinal damage in two models of autoimmune uveitis, a severe inflammatory eye disease where steroids are the primary treatment option. In addition, results showed the presence of inflammatory cells expressing both complement C5 and LTB4 receptors in retinal tissue from donor patients with uveitis as compared to healthy donor eyes.

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Tauriga Sciences, Inc. Introduces its Product Line of CBD Infused Bath Bombs Under the Tauri-Gum Brand

December 4th, 2020 12:21 am

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Genmab Announces that Janssen has Submitted a Biologics License Application to U.S. FDA for Amivantamab in Non-small Cell Lung Cancer

December 4th, 2020 12:21 am

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OSE Immunotherapeutics and Nantes University Hospital Announce Initiation of a Phase 1/2 Clinical Trial to Evaluate CD28 Antagonist FR104 in Patients…

December 4th, 2020 12:21 am

NANTES, France, Dec. 03, 2020 (GLOBE NEWSWIRE) -- OSE Immunotherapeutics (ISIN: FR0012127173; Mnémo: OSE), and Nantes University Hospital (CHU de Nantes) today announced that the French National Agency for Medicines and Health Products Safety (ANSM) and the French Central Ethics Committee (CPP) approved the initiation of a Phase 1/2 trial evaluating first administration of FR104, a monoclonal antibody CD28 antagonist, in patients undergoing renal transplant. This study will be conducted as part of a collaboration agreement between OSE Immunotherapeutics and the University Hospital of Nantes.

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Issuance of a 4th tranche of €1.5 million of notes convertible into new shares

December 4th, 2020 12:21 am

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Tauriga Sciences Inc. Fully Repays and Retires $88,333.00 Face Value 8.00% Convertible Debenture Issued on May 18, 2020

December 4th, 2020 12:21 am

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Catalyst Biosciences Hosting Research & Development Call on Systemic Complement Regulator Programs

December 4th, 2020 12:21 am

SOUTH SAN FRANCISCO, Calif., Dec. 03, 2020 (GLOBE NEWSWIRE) -- Catalyst Biosciences, Inc. (NASDAQ: CBIO) today announced that it will host a research and development call on the Company’s systemic complement regulator programs on Monday, December 14, 2020 at 12:00 pm Eastern Time.

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Indus Holdings, Inc. Announces Updated Fourth Quarter Guidance

December 4th, 2020 12:21 am

SALINAS, Calif., Dec. 03, 2020 (GLOBE NEWSWIRE) -- Indus Holdings, Inc. ("Indus” or the “Company”) (CSE:INDS; OTCQX: INDXF), a leading, vertically-integrated, California-focused cannabis company, announces updated guidance for the fourth quarter ending December 31, 2020. All figures stated are in US Dollars.

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ERYTECH Announces Conference Webcast to Discuss Results from Eryaspase Phase 2 Trial in Acute Lymphoblastic Leukemia to be Presented at the American…

December 4th, 2020 12:21 am

Webcast scheduled for Monday, December 7 at 4:00 pm CET/10:00 am ET Webcast scheduled for Monday, December 7 at 4:00 pm CET/10:00 am ET

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ERYTECH Announces Conference Webcast to Discuss Results from Eryaspase Phase 2 Trial in Acute Lymphoblastic Leukemia to be Presented at the American...

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BioCryst Announces FDA Approval of ORLADEYO™ (berotralstat), First Oral, Once-daily Therapy to Prevent Attacks in Hereditary Angioedema Patients

December 4th, 2020 12:21 am

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BioCryst Announces FDA Approval of ORLADEYO™ (berotralstat), First Oral, Once-daily Therapy to Prevent Attacks in Hereditary Angioedema Patients

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Recover your immune system through the holidays – Action News Now

December 4th, 2020 12:19 am

CHICO, Calif. -- It's the holiday season, and this Thanksgiving, most people engaged in activities that can lower immunity, like eating a lot of sugar, drinking alcohol in excess, in addition to experiencing increased stress due to the holidays.

Dr. Rand McClain, an expert in restorative and regenerative health and the Chief Medical Officer of LCR Health, shows us how Thanksgiving traditions and habits could be harmful to our immune systems and what we can do to get our immune systems back on track and stay healthy.

Here are a few of his suggestions:

1) Adequate sleep Aim for regular sleep 7 9 hours nightly and during roughly the sameperiod (ex. 11p 7a each night rather than at varying times, especially as occurs with"shift work").

2) Daily exercise Anything is better than nothing but ideally a minimum of 30 minutes, 3times per week of effort that amounts to brisk walking. 5 6 times per week would beeven better, and efforts of an hour each time would be even better. However, morethan that is not necessarily better.

3) Proper nutrition This includes staying hydrated, eating a balanced array of whole, non-processed foods, and spending the time to find what diet works best for you (one dietdoes not fit all). In addition, avoid overeating. Most people eat more than is necessaryfor good immune health. Keep sufficient fiber in the diet to maintain regular bowelmovements and a healthy gut microbiome now considered a major factor inmaintaining healthy immune function.

4) Modulate and avoid excess stress Breathing exercises and other methods (eg,meditation and yoga) of reducing stress (and excess cortisol levels) can help keep theimmune system functioning at its best.

5) Avoid excess alcohol consumption and smoking both known to have negative effectson immune function.

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Vaccines against the coronavirus will have side effects and thats a good thing – PBS NewsHour

December 4th, 2020 12:19 am

In 2021 hundreds of millions of people will be vaccinated against SARS-CoV-2. The success of that COVID-19 vaccination campaign will heavily depend on public trust that the vaccines are not only effective, but also safe. To build that trust, the medical and scientific communities have a responsibility to engage in difficult discussions with the public about the significant fraction of people who will experience temporary side effects from these vaccines.

I am an immunologist who studies the fundamentals of immune responses to vaccination, so part of that responsibility falls on me.

Simply put, receiving these vaccines will likely make a whole lot of people feel crappy for a few days. Thats probably a good thing, and its a far better prospect than long-term illness or death.

In 1989, immunologist Charles Janeway published an article summarizing the state of the field of immunology. Until that point, immunologists had accepted that immune responses were initiated when encountering something foreign bacteria, viruses, and parasites that was non-self.

Janeway suspected that there was more to the story, and famously laid out what he referred to as the immunologists dirty little secret: Your immune system doesnt just respond just to foreign things. It responds to foreign things that it perceives to be dangerous.

Now, 30 years later, immunologists know that your immune system uses a complex set of sensors to understand not only whether or not something is foreign, but also what kind of threat, if any, a microbe might pose. It can tell the difference between viruses like SARS-CoV-2 and parasites, like tapeworms, and activate specialized arms of your immune system to deal with those specific threats accordingly. It can even monitor the level of tissue damage caused by an invader, and ramp up your immune response to match.

Sensing the type of threat posed by a microbe, and the level of intensity of that threat, allows your immune system to select the right set of responses, wield them precisely, and avoid the very real danger of immune overreaction.

Vaccines work by introducing a safe version of a pathogen to a patients immune system. Your immune system remembers its past encounters and responds more efficiently if it sees the same pathogen again. However, it generates memory only if the vaccine packs enough danger signals to kick off a solid immune response.

As a result, your immune systems need to sense danger before responding is at once extremely important (imagine if it started attacking the thousands of species of friendly bacteria in your gut!) and highly problematic. The requirement for danger means that your immune system is programmed not to respond unless a clear threat is identified. It also means that if Im developing a vaccine, I have to convince your immune system that the vaccine itself is a threat worth taking seriously.

This can be accomplished in a number of ways. One is to inject a weakened what immunologists call attenuated or even killed version of a pathogen. This approach has the benefit of looking almost identical to the real pathogen, triggering many of the same danger signals and often resulting in strong, long-term immunity, as is seen in polio vaccination. It can also be risky if you havent weakened the pathogen enough and roll out the vaccine too fast, there is a possibility of unintentionally infecting a large number of vaccine recipients. In addition to this unacceptable human cost, the resulting loss of trust in vaccines could lead to additional suffering as fewer people take other, safer vaccines.

A safer approach is to use individual components of the pathogen, harmless by themselves but capable of training your immune system to recognize the real thing. However, these pieces of the pathogen dont often contain the danger signals necessary to stimulate a strong memory response. As a result, they need to be supplemented with synthetic danger signals, which immunologists refer to as adjuvants.

To make vaccines more effective, whole labs have been dedicated to the testing and development of new adjuvants. All are designed with the same basic purpose to kick the immune system into action in a way that maximizes the effectiveness and longevity of the response. In doing so, we maximize the number of people that will benefit from the vaccine and the length of time those people are protected.

To do this, we take advantage of the same sensors that your immune system uses to sense damage in an active infection. That means that while they will stimulate an effective immune response, they will do so by producing temporary inflammatory effects. At a cellular level, the vaccine triggers inflammation at the injection site. Blood vessels in the area become a little more leaky to help recruit immune cells into the muscle tissue, causing the area to become red and swell. All of this kicks off a full-blown immune response in a lymph node somewhere nearby that will play out over the course of weeks.

In terms of symptoms, this can result in redness and swelling at the injection site, stiffness and soreness in the muscle, tenderness and swelling of the local lymph nodes and, if the vaccine is potent enough, even fever (and that associated generally crappy feeling).

This is the balance of vaccine design maximizing protection and benefits while minimizing their uncomfortable, but necessary, side effects. Thats not to say that serious side effects dont occur they do but they are exceedingly rare. Two of the most discussed serious side effects, anaphalaxis (a severe allergic reaction) and Guillain-Barr Syndrome (nerve damage due to inflammation), occur at a frequency of less than 1 in 500,000 doses.

Early data suggest that the mRNA vaccines in development against SARS-CoV-2 are highly effective upwards of 90%. That means they are capable of stimulating robust immune responses, complete with sufficient danger signaling, in greater than nine out of 10 patients. Thats a high number under any circumstances, and suggests that these vaccines are potent.

So lets be clear here. You should expect to feel sore at the injection site the day after you get vaccinated. You should expect some redness and swelling, and you might even expect to feel generally run down for a day or two post-vaccination. All of these things are normal, anticipated and even intended.

While the data arent finalized, more than 2% of the Moderna vaccine recipients experienced what they categorized as severe temporary side effects such as fatigue and headache. The percentage of people who experience any side effects will be higher. These are signs that the vaccine is doing what it was designed to do train your immune system to respond against something it might otherwise ignore so that youll be protected later. It does not mean that the vaccine gave you COVID-19.

It all comes down to this: Some time in the coming months, you will be given a simple choice to protect yourself, your loved ones and your community from a highly transmissible and deadly disease that results in long-term health consequences for a significant number of otherwise healthy people. It may cost you a few days of feeling sick. Please choose wisely.

This article is republished from The Conversation under a Creative Commons license. Read the original article.

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Anatomy of a vaccine: What it takes to create a safe, effective COVID shot – University of California

December 4th, 2020 12:19 am

Shawn stepped into the UCLA Vine Street Clinic in Hollywood with confidence. He offered up his arm. The UCLA doctor injected him. It took seconds; there was barely a sting.

Twenty-four hours after the first of two shots, given 28 days apart, he suffered the headaches and fatigue associated with a milder case of COVID-19. But Shawn remained calm, resolved to honor the memory of his mother, a nurse who had died in May 2020 from an unrelated cause.

The 57-year-old nonprofit worker had been thinking about the challenges of COVID-19 for a long time, and he decided to go through the lengthy consent process for the medical trial. It gave me something to do with my anger that was so much better than yelling at someone for not wearing a mask, he says. And [at UCLA] I felt I was in good hands.

Shawn is one of many volunteers who have stepped up to participate in medical trials at UCLA, which is part of a global network thats determined to help find a vaccine against the novel coronavirus.

The stakes are huge. More than 250,000 Americans have already died, and there have been more than 1 million deaths around the world. Economies have been brought to their knees, social tensions have disrupted communities and emotional maladies are on the rise.

In response, doctors and scientists have been challenged to be resilient and ingenious. Theyre taking an array of different approaches, knowing that public confidence in vaccines hangs in the balance.

In addition, it has been a challenge to create a vaccine in such a short amount of time similar efforts have taken five to 10 years. Pharmaceutical giant Pfizer and biotech firm Moderna have both reported remarkable progress, announcing in November that their vaccine candidates were more than 90% effective. All of which has raised questions about the next steps, such as how the vaccines will be distributed.

I dont want to make a vaccine to protect against mild disease, says Dr. Marcus Horwitz, distinguished professor of medicine and microbiology, immunology and molecular genetics at the David Geffen School of Medicine at UCLA. I want to protect people who are going to get severe disease.

Horwitz has already developed vaccines against the bacteria behind tuberculosis, anthrax and the tick-borne disease tularemia, but he has never tried to create a vaccine against a virus. When faced with a worldwide pandemic, we thought we might be able to make a contribution, he says.

Vaccines work by training the immune system to recognize and fight disease-causing pathogens, such as viruses or bacteria. Doctors introduce the bodys immune system to antigens, which are molecules from the virus or bacteria, and the immune system responds by making proteins called antibodies and immunity-building T cells, which both neutralize the pathogen.

The delivery of these antigens requires a delicate calculus: It must provoke the immune system, but not go so far as to make the patient ill. You need a vector that will wake up the immune system of the host, but not cause any further harm, Horwitz says.

The vaccine approach by Horwitz and his team, including lead investigator Qingmei Jia, is a medical outlier: They adapted an existing antibacterial platform to build protection against SARS-CoV-2, the virus that causes COVID-19. The team has shown that their vaccine candidate protects hamsters, which develop severe disease in a way similar to humans.

Some of the potential vaccines for SARS-CoV-2 use a weakened form of an adenovirus, which causes the common cold, to deliver the S protein that is found on the surface of the SARS-CoV-2 virus. Horwitzs vaccine stands out from the pack because it uses a weakened bacterium to deliver two SARS-CoV-2 proteins, the M and N proteins.

That difference could have a tremendous impact. Billions of COVID-19 vaccine doses are needed, and bacteria, unlike viruses, are easy and cheap to produce and transportable.

The success of a COVID-19 vaccine also depends on the immune system, which can be less robust in older people.

This is a problem that has driven Song Li, chair of the bioengineering department at the UCLA Samueli School of Engineering, who has focused his career on cell and tissue engineering. Adapting a concept from cancer immunotherapy, Li is developing a biomaterial vaccine booster using artificial cells that could improve the immune systems ability to generate long-term protection.

When the immune system encounters a destructive pathogen, it produces cells that are designed to attack the invader. A small number of those cells, called T memory stem cells, can stay in the system for years ready for a future invasion. Unfortunately, our ability to produce T memory stem cells declines as we get older. Li hopes his booster, in combination with a vaccine, can help fragile immune systems effectively fight against the SARS-CoV-2 virus.

My goal at the outset was to help the elderly population, Li says. But it could be useful for any person whose immune system needs help generating protection from the virus.

Another UCLA team led by Bogdan Pasaniuc, Dr. Manish Butte and Dr. Daniel Geschwind, the Gordon and Virginia MacDonald Distinguished Professor of Human Genetics at the Geffen School of Medicine is trying to find out why the virus significantly impacts some, but leaves others relatively unscathed.

We know age is a major factor, but we see older people who get infected and do quite well, Geschwind says. We have a limited ability to predict how sick someone will get. His team hopes that studying whole-genome sequences from thousands of COVID-19 patients will reveal hidden factors that make some more vulnerable than others. The research could help identify people who are at higher risk for infection as well as develop new treatment and prevention strategies.

Dr. Brigitte Gomperts, professor of pediatrics and pulmonary medicine and a member of the UCLA Broad Stem Cell Research Center, is studying how COVID-19 affects lung tissue. By using stem cellderived clusters of lung cells, known as organoids, she can rapidly screen thousands of prospective treatments. Because the organoids are grown from human cells and reflect the cell types and architecture of the lungs, they can offer insights into how the virus infects and damages the organ.

At UCLA medical centers around Los Angeles County, physicians are ensuring that their medical trials include diverse groups of people and women of all ages.

COVID-19 has hit the African American and Latino communities particularly hard, says Dr. Jesse Clark, associate professor-in-residence in the department of medicine at the Geffen School of Medicine. We have to make sure that any vaccine has been determined to be safe and effective in all populations that will receive it.

COVID-19 has hit the African American and Latino communities particularly hard. We have to make sure that any vaccine has been determined to be safe and effective in all populations that will receive it.

Dr. Jesse Clark, associate professor-in-residence in the department of medicine at the David Geffen School of Medicine at UCLA

Clark is medical director of the UCLA Vine Street Clinic, which is involved in the Moderna clinical trial. Notably, Modernas vaccine works differently from a typical vaccine, because it doesnt contain the virus at all. Instead, it uses messenger RNA, or mRNA, which uses the bodys genetic code to produce antibodies against the virus.

CNN mentioned that the vaccine trials were having trouble finding minorities to participate, says Roderick, a 37-year-old IT manager and father of two, who is participating in the Moderna trial. Being Black and Mexican, and knowing how hard my demographic has been hit, I just went ahead and signed up online. Its worth doing to help out.

Meanwhile, Dr. Katya Corado, an infectious disease specialist at Harbor-UCLA Medical Center in Torrance, has been enrolling patients in a phase 3 clinical trial of an adenovirus vector vaccine thats under development by the University of Oxford and the biopharmaceutical company AstraZeneca.

All vaccines undergo three phases of clinical trials, according to rules set by the Food and Drug Administration. Phase 1, which involves 20 to 100 volunteers, tests the safety and dosage of the vaccine. Phase 2 tests the drugs efficacy and side effects among several hundred participants, and phase 3 gathers more information about a vaccines safety and effectiveness by studying thousands of volunteers.

In the phase 3 trial, we focus on studying how effective the vaccine is in populations that need it most, Corado says.

Clark and Corado are both hopeful that their work can protect the most vulnerable, which includes people over 65, patients with chronic conditions, those facing economic disadvantages and essential workers.

Inoculations have eradicated past epidemics, such as smallpox. But public faith in vaccines has wavered, especially when a now-disproven report in 1998 suggested that the measles, mumps and rubella vaccine was linked to autism spectrum disorder. That has led to U.S. outbreaks of measles, which had been previously eliminated. So scientists recognize the importance of getting the COVID-19 vaccine right.

There are other factors to consider as well. Vaccine distribution will be high on the agenda of the incoming White House administration, but if supply is limited, the Centers for Disease Control and Prevention recommends prioritizing certain groups, such as medical workers.

Also, some vaccines currently in development need to be stored in ultra-cold conditions. For example, Pfizers vaccine must be stored at minus 70 degrees Celsius, while Modernas vaccine must be kept at minus 20 degrees Celsius the temperature of a regular freezer. These factors will affect how the vaccines are distributed.

Some lawmakers have advocated letting the virus run its course in the hopes of achieving herd immunity, which is when enough people have become immune to an infectious disease, either through being infected or vaccination. Since the COVID-19 vaccine is still pending, a majority of people will need to be infected in order to achieve herd immunity and that comes at a terrible cost.

According to Dr. Robert Kim-Farley, professor-in-residence of epidemiology at the UCLA Fielding School of Public Health, up to 2 million Americans would have to die before the country reached herd immunity.

He argues that vaccines work, even if they are not perfectly safe or perfectly effective, as proven by the near-eradication of polio. But approving vaccines prematurely to buckle under the pressure of politics or profit could cause a terrible backlash against being vaccinated, which could lead to future outbreaks.

We want to make sure we are not cutting corners, Kim-Farley says, that we are getting the best vaccine that has the highest efficacy, the longest duration, the fewest number of side effects [with] the fewest number of doses.

This is a very high-stakes game, and its important to get it right, without recalls or playing into the [anti-vaccination] narrative. What still concerns me is the equitable distribution of vaccines to make sure that countries that are not as wealthy as us have access to these life-saving vaccines. We are all members of one global community.

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For the Biome makes leap from skin to immune health – NutraIngredients-usa.com

December 4th, 2020 12:19 am

The new collection includes Immune Therapy, Stress Therapy, and Gut Therapy that synergistically nourish the gut microbiome, nervous system, gut-lung axis, and gut-brain axis.

The formulations are the culmination of immune research and over four decades of experience from Co-Founder Paul Schulick. As the companys formulator, Schulick launched For The Biome after parting ways with New Chapter, a company he founded in 1982 which was later acquired by Procter & Gamble in 2012.

We identify For The Biome as a wellness company and although we launched with skincare, my intention has always been to expand into ingestibles. We like to say that you have to treat as a whole to heal as a whole so its only natural that we offer products designed for internal and topical use. The choice to move into immunity was simply nature calling. It was an opportunity to make a contribution, which is what I am here to do, said Schulick.

The master herbalist explained that the products target specific biomarkers to bring an exhausted or overactive immune system back to balance.

We looked at a panel of cytokines, both pro and anti-inflammatory, and a window of immediate effects and response to the exposure of the products. We wanted to see the acute effects and what was moving the needle, said Schulick.Examples of the biomarkers include IL-1B, IL-Ra., IL-2, CD69, CD25, and G-CSF, which help modulate inflammation, signal an immune response, and support renewal. We also looked at the CAP-e antioxidative capacity for the product, or its ability to get into the cells and protect them from the inside out.

Schulick said the Immune Therapy and Stress Therapy are both backed by clinical studies and the probiotic strains in Gut Therapy are backed by several clinical studies as well, adding, We invest heavily to conduct ongoing research and will share this with our customers as it breaks.

In-vitro testing suggests that Immune Therapy balances immunomodulating markers within 2 hours as it coats the mouth and gut microbiome with a protective liquid infusion.

Stress Therapy is a restorative infusion that delivers stress relief by soothing the immune system, nervous system, and supporting the gut microbiome.

The company said Gut Therapy is a first-to-the-world fermentate featuring clinically studied prebiotics, postbiotics, para-probiotics, and live probiotics that support a resilient gut microbiome and its connection to immune, respiratory, and emotional health.

We select the most healing and restorative prebiotic, whole-food, and certified organic botanicals for the digestive system (eg., flax, chaga, aloe, and moringa) and then utilize the power of fermentation to further amplify their benefits. This is no ordinary fermentation process. It is a dual-stage process using the yeast Saccharomyces cerevisiae and two of the most researched probiotic strains from Lactobacillus and Bifidobacteria genera, GG and BR03. These strains produce many important immunologically active peptides also known as postbiotics.

Schulick added that Gut Therapy then completes the formulation with a therapeutically validated, live dose of Lactobacillus plantarum DR7, a probiotic with multiple positive effects on immunity (NK cell upregulation, respiratory protection), stress response (cortisol, serotonin) and cognition (enhanced learning and social emotional reasoning).

When formulating these products, I referenced groundbreaking research that focused on advancements in immune support around the world. This research, coupled with my passion for herbalism, guided me as I chose plants, mushrooms, and probiotics renowned for their ability to support a wiser immune response.

Schulick told NutraIngredients-USA that his goal was to source the best possible forms of these components and introduce some of them for the first time to North America. One of the most remarkable is the herb Cistus incanus, popular in the Mediterranean, and known for its remarkable restorative and protective abilities. Its featured in Immune Therapy because of its notable ability to signal immune response and recovery. Whats more is that, while this ingredient is phenomenal on its own, its even more effective when paired with symbiotic nutrients. We saw increased activity of Cistus incanus when we paired it with vitamin C-rich black currant leaves and rose hips, and birch-grown chaga with betulinic acid. All three of our formulas deliver these kinds of extraordinary synergies.

Schulick said identifying the ingredients is the easier part. Getting the level of efficacy and quality that meets our standards is another story.

For the most part, this has always been the case, COVID or not. Certainly, this period of time during COVID has made that more difficult and weve had to search around the world two or three times, sometimes, to find what we needed. We then independently test and confirm for levels of active compounds to deliver what we are seeking.

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ASU receives $12.5M subcontract to better understand COVID-19 immune response and improve patient outcomes – ASU Now

December 4th, 2020 12:19 am

December 2, 2020

Arizona State University has been awarded a $12.5 million multiyear subcontract from the Frederick National Laboratory for Cancer Research (FNL), operated by Leidos Biomedical Research on behalf of the National Cancer Institute, to join the NCIs Serological Sciences Network (SeroNet), the nations largest coordinated effort to study peoples immune response to COVID-19.

SeroNet was enacted as a result of $306 million in emergency supplemental funding from the U.S. Congress for the NCI to study serological sciences related to COVID-19.

ASU is one of just four Capacity Building Centers (CBCs) selected nationally for SeroNet. The goal is to develop high performance serological tests to determine a persons previous exposure to SARS-CoV-2. The network aims to combat the ongoing COVID-19 pandemic by improving the ability to test for an antibody response to infection, especially among diverse and underserved populations, and to accelerate the development of treatments and vaccines aimed at preventing COVID-19 and improving patient outcomes.

This award will now establish Arizona State University as the most comprehensive COVID testing research center in the Southwest, and is a testament to our commitment and scientific capabilities to be offered the opportunity to join SeroNet and to provide a critical service to our community and nation, said ASU Biodesign Institute Executive Director Dr. Joshua LaBaer. It builds upon the great successes of our innovative antibody testing platform, robust biomarker discovery and diagnostic assay development capabilities; our extensive experience at successfully completing large federal contracts, grants and FDA emergency use authorizations; and our response to this pandemic through large-scale PCR-based SARS-CoV-2 testing of saliva samples.

According to ASU Biodesign Institute Executive Director Dr. Joshua LaBaer, ASU hopes to develop a simple, FDA-approved COVID-19 antibody test to detect for previous SARS-CoV-2 exposure and to better understand a persons immune response to COVID-19.

The NCI, FNL and ASU were able to pivot to support COVID-19 research because of their deep experience in virology and immunology research, including research on viruses that cause cancer, such as HPV, and experience in immunotherapy.

In March, LaBaer, a medical oncologist by training who co-discovered breast cancer biomarkers included in a CLIA-approved breast cancer test with colleague Dr. Karen Anderson, shifted his laboratory to become a CLIA-certified clinical laboratory to fully support COVID-19 testing.

In May 2020, LaBaer and Vel Murugan, an ASU associate research professor and co-principal investigator on the SeroNet CBC subcontract, created the first saliva-based COVID-19 test in the Western United States.

To date, ASU has provided more than 300,000 free saliva tests to the general public, first responders, doctors, nurses and medical personnel, and the entire ASU community to help Arizona in the response to keep individuals safe and healthy during the pandemic.

As part of the national SeroNet, ASUs interdisciplinary team of expert scientists and researchers at the Biodesign Institute, led by LaBaer, will establish the ASU Biodesign Capacity Building Center (ABCBC). Other key individuals involved in this project are Ji Qiu, Jin Park, Femina Rauf, Lusheng Song, Mitch Magee and Michael Fiacco.

Through this latest project, we hope to develop a simple, FDA-approved COVID-19 antibody test to detect for previous SARS-CoV-2 exposure and to better understand a persons immune response to COVID-19, said LaBaer. We ultimately want to develop a test for any exposures people may have had to all known human coronaviruses and other respiratory pathogens in order to improve patient outcomes.

The core of the technology builds upon a novel ASU platform (called MISPA) that uses rapid DNA sequencing to monitor many patients immune responses to multiple viral proteins simultaneously, via a molecular barcoding. ASU has tested the platform on cancer subtypes caused by HPV. Now, they want to adapt the same technology for understanding COVID-19.

This system exploits the power of DNA next-generation sequencing (NGS) technology to quantify COVID virus antigens and their interactions with antibodies produced in the body to fight the infection, said Murugan. With this assay, we 'barcode' individual proteins called antigens within the virus with unique DNA sequences that interact in solution with patient serum, followed by quantification of the antibody-bound barcodes by NGS.

Unlike current commercially available serological tests, the MISPA-based test is designed to be quantitative about the strength of the immune response while providing information about responses to multiple proteins and eventually, multiple viruses simultaneously. In addition, because individual reactions can also be indexed (or barcoded) in parallel, thousands of patient samples can be combined, and all the results determined in a single NGS run (many barcoded patients versus many barcoded proteins).

MISPA will also be deployed through a similar high-throughput, fully automated test that can process thousands of samples per day as we have successfully demonstrated from our COVID-19 saliva test, said Murugan.

Initial tests will rely on a testing pool of individuals who have recovered from the infection. Potential sites for serological tests include: ValleyWise, Midwestern/Abrazo hospital networks, Dignity Health hospital network, Columbia University, Colorado River Indian Tribal community through their tribal government, ASU students and population, other universities in Arizona and essential infrastructure partners.

Should the test validation and FDA EUA become approved, testing will expand to essential infrastructure employees, health care professionals and residents in long-term care facilities or other congregate living settings, including prisons and shelters. Community surveillance for asymptomatic population will be conducted at a lower priority when needed.

The lessons learned from ASUs role in SeroNet research could be applied immediately to the COVID-19 pandemic crisis and may prove valuable to public health beyond the pandemic.

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ASU receives $12.5M subcontract to better understand COVID-19 immune response and improve patient outcomes - ASU Now

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Stronger early immune reaction might make COVID worse – Futurity: Research News

December 4th, 2020 12:19 am

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While having a robust immune response to coronavirus infection may sound helpful, a new study shows the opposite may be true.

To better understand how variations in early host immune responses affect disease outcomes, researchers at the Tulane National Primate Research Center followed the course of disease in the four weeks following COVID-19 infection in non-human primates.

They discovered robust early immune responses to the virus and a recruitment of immune cells from the blood to the lungs. They also found that certain cytokinei.e., cell-signaling proteins that help to regulate pro- and anti-inflammatory responsesmay prove helpful in predicting disease outcomes.

These results suggest that in these early weeks post-infection, the stronger the initial host immune response, the worse the disease outcome, says Monica Vaccari, associate professor of microbiology and immunology at the Center and lead author of the study in Nature Communications.

Vaccari explains that while the body mounts a pro-inflammatory innate immune response as a first line of defense to protect against the spread of infection and heal damaged tissue, it is a dysregulated or over-reactive immune response that can cause severe damage. Too much inflammation in the lungs, for example, can result in decreased oxygen.

A pro-inflammatory response is usually our bodys first line of defense, and it can be a very helpful mechanism. But what were seeing with coronavirus infection is that somewhere down the line, there is uncontrolled inflammation. We want to know when and why this happens, Vaccari says.

Understanding what happens in the immune system during this short period following infection will be essential in developing effective therapeutics against COVID-19. While immune functions can be modulated, scientists want to avoid turning off immune responses that may be critical to fighting infection.

One of the most vexing aspects of the novel coronavirus is the broad spectrum of disease outcomes associated with it. A disease that causes few or mild symptoms for most also has the capacity to cause severe and lasting damage or death for others.

While scientists and clinicians have long suspected that it is the hostor person that acquires the diseasethat dictates disease severity, they have not known which specific individual immune markers are harmful and which are protective, particularly in the earliest stages of disease.

This new study identified variations in early host immune responses that may be predictive of COVID-19 disease severity.

Source: Tulane University

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Stronger early immune reaction might make COVID worse - Futurity: Research News

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