Veritas Farms Signs Memorandum of Understanding With Pure Research Products, LLC to Access and Incorporate its Immune Technology in the Development of Additional Veritas Farms Products; Initiates Research Partnership

Veritas Farms Signs Memorandum of Understanding With Pure Research Products, LLC to Access and Incorporate its Immune Technology in the Development of Additional Veritas Farms Products; Initiates Research Partnership

  • October 22, 2020

Fort Lauderdale, FL, Oct. 22, 2020 (GLOBE NEWSWIRE) — via NewMediaWire — Veritas Farms, Inc. (OTCQB: VFRM) (“Veritas Farms” or the “Company”), a vertically integrated agribusiness focused on the production of full spectrum hemp oil products with naturally occurring cannabinoids, is pleased to announce that the Company has entered into a memorandum of understanding (the “MOU”) with Pure Research Products, LLC (“Pure Research”) to access and incorporate the technology used in their Del-Immune V® brand of products to develop additional Veritas Farms full spectrum hemp oil products.

Del-Immune V® and the Del-Immune line of dietary supplements use the probiotic strain Lacticaseibacillus rhamnosus (L. rhamnosus) [WF1] to boost immune function in the body. Pure Research’s proprietary formulation utilizes fragmented cells, specifically the cell wall and DNA, from the probiotic bacteria to trigger an immune modulation that boosts, strengthens, and fine-tunes the immune system. Del-Immune V® is one of the leading non-prescription cell fragment nutritional supplement supported by clinical research available in the United States.

The MOU, which was signed on October 8, 2020, establishes a partnership with Pure Research to maximize the benefits of Veritas Farms’ product line through the research, development and production of a Del-Immune V® enhanced line of full spectrum hemp oil products.

“The opportunity for Veritas Farms to develop full spectrum hemp products with clinically-supported immune-boosting biotechnology offers a new, innovative, powerful use for consumers to utilize hemp oil in their health routines,” Dr. Dan Connors, Vice President of Research and Development, stated. “The combination of Del-Immune V® and our full spectrum hemp oil products provides us with the potential to develop a diverse line of immune support products,” he concluded.

The collaboration will endeavor to research, develop, produce, and validate the efficacy of Del-Immune V® enhanced full spectrum hemp oil products. Products that are developed through the collaboration will be co-branded “Powered by Del-Immune.” The collaboration is subject to, among other matters, the negotiation and execution of a definitive collaboration agreement.

Alexander Salgado, CEO and Co-Founder, said, “We are excited to begin this research and development partnership with Pure Research Products. We strive to provide consumers with the products they need to live their healthiest lives, and now more than ever immune support is on everyone’s mind.”

“With decades of experience and research behind Del-Immune V® and our probiotic products for humans and animals, and our understanding of current scientific research and evidence of cannabinoid receptors in gut microbiota, we are confident that we will not only innovate new products in the space but lead the market,” said Dr. Liubov Sichel, CEO and Chief Scientific Officer of Pure Research.

About Veritas Farms, Inc.

Veritas Farms, Inc. (OTCQB: VFRM) is a vertically integrated agribusiness focused on producing superior quality, whole plant, full spectrum hemp oils, and extracts containing naturally occurring cannabinoids. The Company currently owns and operates a 140-acre farm and production facility in Pueblo, Colorado, and is registered with the Colorado Department of Agriculture to grow industrial hemp. The Company markets and sells products under its Veritas Farms™ brand and manufactures private label products for a number of leading distributors and retailers. 

Veritas Farms™ brand full spectrum hemp oil products include vegan capsules, tinctures, formulations for sublingual applications, and infused edibles, lotions, salves, and oral syringes in a variety of size formats and flavors. All Veritas Farms™ brand products are third-party laboratory tested for strength and purity. The Company files periodic reports with the Securities and Exchange Commission, which can be viewed at www.sec.gov.

For additional information and online product purchase, visit www.theveritasfarms.com.

About Pure Research Products, LLC

Pure Research Products, LLC was co-founded in 2002 by scientist Dr. Liubov Sichel with the intent of delivering natural immune support products based on various strains of bacteria including lacticaseibacillus rhamnosus (L. rhamnosus) which, in extracted form, is found in Del-Immune V®. Dr. Sichel developed Del-Immune V®, a fast-acting, broad-spectrum immune support supplement, based on one of the most effective microbial cell lysates used to treat a range of conditions in both humans and pets. It is the leading non-prescription cell fragment supplement backed by clinical research on the U.S. market.

Del-Immune V® is an immunomodulator that supports the immune system’s ability to help protect against all kinds of pathogens and foreign threats and provides immediate immune support. 

In addition to Del-Immune V®, Pure Research Products, offers a full line of human and pet immune support supplements. Pure Research Products, which serves customers globally, is based in Boulder, Colo., and the Del-Immune V® products are manufactured in Greenfield, Ind.

For more details on Del-Immune V ®and Pure Research Products’ full line of human and pet immune support supplements, visit: www.delimmune.com and follow @delimmunev on Facebook, Instagram and Twitter.

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Cautionary Language Concerning Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995.  All statements, other than statements of historical fact, including those with respect to the Company’s mission statement and growth strategy, are “forward-looking statements.”  Although the Company’s management believes that such forward-looking statements are reasonable, it cannot guarantee that such expectations are, or will be, correct.  These forward-looking statements involve many risks and uncertainties, which could cause the Company’s future results to differ materially from those anticipated.  Potential risks and uncertainties include, among others, general economic conditions and conditions affecting the industries in which the Company operates; the uncertainty of regulatory requirements and approvals; and the ability to obtain necessary financing on acceptable terms or at all.  Additional information regarding the factors that may cause actual results to differ materially from these forward-looking statements is available in the Company’s filings with the Securities and Exchange Commission.  The Company assumes no obligation to update any of the information contained or referenced in this press release.

Coronavirus | Ayurveda supplements see sales boost despite thin research evidence on efficacy

Coronavirus | Ayurveda supplements see sales boost despite thin research evidence on efficacy

  • October 18, 2020

Companies marketing these products have capitalised on the association between COVID-19 and immunity

For a chemist shop that’s usually lined with pharmaceutical drugs, Noida-based proprietor Mahesh Agrawal prominently displays his containers of Dabur Chyawanprash. “There’s a lot of demand for them along with honey and sales have increased ever since the unlockdown began.”

Multiple grocers and stores that sell organic-labelled products say they have been seeing a sharp demand for products that are even tangentially linked to “boosting immunity”.

Amul markets turmeric-flavoured milk called Amul “Haldi Doodh,” that purports to having the “goodness of milk with the centuries old immunity boosting and healing properties of haldi”.

Rising sentiment

A July report by market research company Nielsen says chyawanprash sales have increased by 283% in June, while the sales of branded honey increased by 39%. “There is a rising sentiment towards ‘local’ with increasing support for Atma Nirbhar Bharat and Ayurveda,” the report said.

“From April-June, we saw a nearly 7-fold growth in demand [compared to last year] for Dabur Chyawanprash. Other Ayurvedic products like Ashwagandha, Dabur Giloy Ghanvati, Dabur Health Juices like Amla juice, Giloy-Neem-Tulsi Juice etc, have also reported strong growth,” Mohit Malhotra, CEO, Dabur India, told The Hindu. “People are now more inclined to prophylactic health remedies, especially immunity boosting products. This trend would sustain, going forward.”

Shoppers told The Hindu that while they didn’t believe immunity products would protect them from COVID-19, they saw it as a way to bolster their immune defences. “I regularly take chyawanprash but will never go to an Ayurveda doctor,” said Swapan Banerjee, a teacher. “These products do no harm and play a role in general good health, from my experience but aren’t substitutes for masks, social distancing, avoiding crowds and getting tested.”

Companies that have been marketing these products have capitalised on the association between COVID-19 and immunity and the government’s encouragement of Ayurveda and yoga for mild and moderate infections as well for aiding recovery post COVID-19.

An 11-member committee led by former ICMR chief recommended that in the “short term… “Guduchi(Tinospora cordifolia) aqueous extract, guduchi+pippali (Piper longum), aqueous extracts and AYUSH 64 (a drug with multiple herbs developed by the Central Council for Research in Ayurvedic Sciences) be recommended for inclusion in the standard care for mild to moderate cases of COVID-19”.

However, a perusal of the research studies listed show that none of them have been fully tested for their effectiveness in COVID management and all the evidence relies on the herbs’ effects in controlling fever in malaria and in recovery from “influenza like illnesses”.

High binding efficacy

Ashwagandha has been recommended by the committee because laboratory studies show that it “inhibited the entry” of the SARS-CoV-2 viruses into healthy cells and guduchi (Tinospora cordifolia) showed “high binding efficacy” against SARS-CoV-2 targets involved in attachment and replication of the virus, compared to Favipiravir, Lopinavir/Ritonavir.”

However unlike the latter, these haven’t been tested in controlled, comparative trials. In fact, the most recent human trials show that all of the drugs that in lab studies showed promising anti-viral activity but weren’t significantly effective in improving disease outcomes.

The viral cells, as it is now understood, infiltrate the lung cells and multiply. The SARS-CoV-2, scientists say, is particularly sneaky and the body’s immune system is frequently unable to detect these viral particles early on to neutralise them and keep them proliferating. As has been seen in instances of those suffering a severe infection, the immune system goes into an overdrive. The body is deluged by chemical messengers called cytokines that, while alerting the body’s defence cells to destroy the virus, also trigger inflammation in multiple organs. It’s to stem such over-reaction, that many a time ends up being fatal, that steroids such as dexamethason are administered.

Thus the holy grail of COVID treatment is to ensure that immune system fights the virus without going berserk.

Complex mix of herbs

In the Ayurveda system, chyawanprash is a “complex mix of herbs” and several common herbs — like turmeric, black pepper and ginger infusions contribute in varying measures to keeping the immune system in a state of preparedness against fighting pathogens, said an expert.

“Turmeric, Ashwagandha, giloy all confer varying degree of immunity and may confer varying degrees of benefit to different people, depending on their individual constitution,” said Bhavna Prasher, an Ayurveda doctor and scientist at the CSIR-Institute of Genomics and Integrative Biology.

In the modern-science view, there are two kinds of immunity: one is ‘innate’ immunity which is the first line of defence against an infection. A class of cells called “natural killer cells” and produced in the bone marrow directly attack infectious microbes. The other, a so-called adaptive immunity, where specialised cells produced in the thymus gland actively monitor — and produce antibodies that are specific to viruses and bacteria. Both systems work in tandem.

Ayurvedic literature, said Prasher, suggests that several of the herbs have been tested in immune disorders and there is evidence to show that many of them have ‘immunomodulatory’ properties, meaning they are able to either amplify or suppress immune system responses.

“They are good at keeping the body or moving it towards a state of homeostasis — a state of internal stability that allows the body to keep itself in a state of health. However, Ayurveda is not only about these formulations and depending on the degree of sickness, there are other interventions. These are popular because they aren’t harmful and generally protective.”

Greener play areas boost children’s immune systems, research finds | Trees and forests

  • October 14, 2020

Children whose outdoor play areas were transformed from gravel yards to mini-forests showed improved immune systems within a month, research has shown.

The scientists believe this is because the children had developed significantly more diverse microbes on their skin and in their guts than the children whose playgrounds were not upgraded.

Across the western world, rates of autoimmune diseases, where the body mistakenly attacks itself, are rising. The diseases include asthma, eczema, type 1 diabetes, inflammatory bowel disease and multiple sclerosis. A leading possible explanation for this trend, called the hygiene hypothesis, is that children are being exposed to far fewer microbes than in the past. This means their immune systems are less challenged and more prone to making mistakes.

Previous studies have shown statistical associations between exposure to microbial diversity and the development of a well-functioning immune system. But this is the first study to deliberately change the children’s environment and therefore indicate a causal link.

The researchers said their experiment shows it may be possible to improve the development of the immune system with relatively simple changes to the living environments of urban children.

The study involved 75 children in two cities in Finland, a relatively small number for a trial. “But when we saw the results, we were very surprised because they were so strong,” said Prof Aki Sinkkonen, at University of Helsinki, who led the work. “Our study can pave the way for new preventive practices to cut the global epidemic of immune-mediated diseases.”

Sinkkonen said there are similar experimental studies currently taking place elsewhere but their results have not yet been published. His team has now started research to see if giving babies a boost in microbe diversity then goes on to reduce levels of autoimmune disease.

“It is wonderful forward-looking work.” said Prof Graham Rook, at University College London. “Many of the disorders that are increasing in western urbanised populations are due to failure of the mechanisms that supervise the immune system. This study shows that exposing children to a biodiverse natural environment boosts several biomarkers of the essential control mechanisms. These Finnish research groups have been leading the way in applying this understanding in a practical way.”

The research is published in the journal Science Advances and was conducted by a large team including experts in medicine, ecology and urban planning. The children were between three and five years old and spread between 10 similar daycare centres.

In four centres, turf from natural forest floors, complete with dwarf shrubs, blueberries, crowberry, and mosses, were installed in previously bare play areas. The children spent an average of 90 minutes a day outside and were encouraged to play with the plants and soil. “It was easy because [the green area] was the most exciting place in the yard,” said Sinkkonen. The cost for each green yard was around €5,000, less than the annual maintenance budgets for the yards.

Tests after 28 days showed the diversity of microbes on the children’s skin was a third higher than for those still playing in gravel yards and was significantly increased in the gut. Blood samples showed beneficial changes to a range of proteins and cells related to the immune system, including anti-inflammatory cytokine and regulatory T cells.

The researchers gave all the children the same meals each day and excluded the small number who had been given probiotic supplements by their parents. The scientists could not control the home environment but said the fact that a significant effect was seen despite variable home conditions shows the effect of the forest intervention was strong.

The researchers are also investigating whether sand pits can be inoculated with diverse microbes to boost the immune system of children in places where forest soil and plants are not available.

Prof Glenn Gibson, at the University of Reading, in the UK, and a board member of the International Scientific Association for Probiotics and Prebiotics, said: “This is an interesting study and potentially important but I do not agree that diversity is the key marker for gut health. High functionality can occur with low diversity. For instance, look at a virus that sweeps the world. Having said that, the researchers have assessed certain health biomarkers and not relied solely upon diversity as an indicator, so it is good study.”

A report in 2019 by the UK’s Royal Society for Public Health concluded that grubbing around outside is important for building a robust immune system, but that cleanliness is still vital when people are preparing and eating food.

Bioengineering technique that boosts protein production could lead to effective COVID-19 vaccine

Researchers create multi-functional nano-vaccine to prevent toxoplasmosis

  • October 14, 2020

Fighting clever parasites requires smart vaccines that can trigger critical immune responses. A University of Chicago-based research team has found a novel way to do that.

These experts, specialists in toxoplasmosis and leaders in vaccine design, have focused on one of the most frequent parasitic infections of humans.

The parasite, Toxoplasma gondii, can cause lifelong infection. It lives in the brain (and sometimes the eyes) of about 30 percent of all humans. When someone drinks contaminated water, eats infected undercooked meat or is exposed to these parasites in soil, it can result in lasting damage.

Infection from unrecognized exposure to this microscopic parasite can harm the eyes, damage the brain and, in some cases, lead to death. Toxoplasmosis, according to the CDC, is the second most frequent cause of foodborne-associated death in the United States.

These parasites tend to attack unborn babies, newborns, children and adults. While most healthy adults who are exposed to the parasite never experience any serious symptoms, dormant, unrecognized, smoldering infections can emerge years later in immune-compromised patients. There is currently no vaccine to protect people from this infection.

“We urgently need a vaccine, as well as new and better medicines, to prevent and treat this infection,” said the study’s senior author, Rima McLeod, MD, Professor of Ophthalmology and Visual Science and Pediatrics at University of Chicago and a leading authority on toxoplasmosis.

“Millions of people suffer from these infections,” McLeod said. These neglected infections are often detected too late to prevent irreversible damage, and some patients die if the infection is untreated. Until now, no vaccine has been available for humans and no known medicine in clinical use has been able to eliminate the chronic, encysted form of Toxoplasma.

In an article published in the journal Scientific Reports (Nature), the research team unveiled a clever “immunosense” approach – the use of Self-Assembling Protein Nanoparticles (SAPNs). These have been engineered to boost each component of the immune system.

The goal is to protect humans from this common, harmful and sometimes lethal parasite.”Engineering and characterization of a novel Self Assembling Protein for Toxoplasma peptide vaccine in HLA-A*11:01, HLA-A*02:01 and HLA-B*07:02 transgenic mice” was published online on October 12, 2020.

The team used cell-based and murine models. These mouse models have human immune-response genes to mimic how people can fight the infection. The SAPN scaffold serves as a stimulus, boosting the innate immune response and delivering components of the vaccine to relevant target cells.

“Especially important,” McLeod said, “these novel SAPNs have been engineered to have the size, shape and ability to produce immune responses against Toxoplasma gondii. This triggers a protective effect.”

The team’s approach has been quickly adopted by other investigators. There is ongoing work to immunize against herpetic eye disease, SARS-CoV-2 (COVID19), HIV, malaria and influenza viruses.

The researchers found that their SAPN scaffold can fold reliably into a stable shape. As the immune system perceives it as a foreign invader stimulating a protective immune response, the scaffold can incorporate components that stimulate an immune response against the genetic variants of the parasite.

This can be tailored for people of differing genetic backgrounds. The vaccine becomes a multisystem targeting weapon. The researchers named their new weapon “ToxAll.” They describe it as a “multi-epitope, multi-functional, toxoplasmosis nano-vaccine.”

It contains crucial immunity-stimulating components, mixed with an adjuvant, known as GLA-SE, that appears to be powerful and safe in humans. This type of vaccine, with components from plasmodia, has already been tested in primates for malaria, and is moving into the clinic.

Prior infections with T.gondii before pregnancy can protect a pregnant woman from passing the infection to her unborn child. But when a mother first acquires the infection during pregnancy – before her body can mount an immune response – the parasite can cause significant harm to the unborn child.

The investigators first created a live, attenuated vaccine that can protect mice against toxoplasmosis. Prior natural infection of humans can confer protection, and live vaccines could protect mice. These live vaccines, however, can have safety concerns.

ToxAll was created as a synthetic vaccine that could stimulate danger signals, alerting the immune system to focus on foreign invaders. A crucial part of the process is to create a design with the right properties, assembling particles into predictable shapes that resemble viruses, then enabling the fragments of components of the parasite to educate the “adaptive memory” of the immune system. This creates a long-lasting immune response, including antibodies and protective T lymphocytes.

Protection with the full SAPN, at this point, is not yet available, “but is under development with promising results,” McLeod said. The team is working to expand the use of additional fragments of the parasite. They hope to create a next generation vaccine that could provide lasting immunity against toxoplasmosis – one that could offer a novel, safe, synthetic vaccine to prevent this disease.

The next step is to develop vaccines as part of a “toolbox” that also includes new medicines and novel use of older medicines for prevention and treatment of toxoplasmosis. The team has applied their clinical and laboratory experiences to understand the infection and devise ways to prevent it, using immunology, genetics, bioinformatics and systems biology to develop and enhance the vaccine and make certain it can help humans worldwide.

We now think we are reaching the next stage. Our toolbox could be developed to prevent and treat human T. gondii and P. falciparum infections. This approach for vaccines can generate innate immunity, cell-mediated adaptive immunity, and host-neutralizing antibodies that are critical to protect against different pathogens.”


Rima McLeod, MD, Study Senior Author and Professor, Department of Ophthalmology and Visual Science and Pediatrics, Leading Authority on Toxoplasmosis, University of Chicago

Source:

Journal reference:

Bissati, K. E., et al. (2020) Engineering and characterization of a novel Self Assembling Protein for Toxoplasma peptide vaccine in HLA-A*11:01, HLA-A*02:01 and HLA-B*07:02 transgenic mice. Scientific Reports. doi.org/10.1038/s41598-020-73210-0.

Combination therapy boosts the immune system's appetite for cancer

Cancer-killing T cells release chemicals to direct swarms towards tumors

  • October 14, 2020

When immune system T cells find and recognize a target, they release chemicals to attract more T cells which then swarm to help subdue the threat, shows a new study published today in eLife.

The discovery of this swarming behavior, and the chemical attractants that immune cells use to direct swarms towards tumors, could one day help scientists develop new cancer therapies that boost the immune system. This is particularly important for solid tumors, which so far have been less responsive to current immunotherapies than cancers affecting blood cells.

Scientists have previously thought that cancer-killing T cells identified tumors by randomly searching for them or by following the chemical trails laid by other intermediary immune cells. We wanted to investigate this further to see if it’s true, or whether T cells locate tumours via another mechanism.”


Jorge Luis Galeano Niño, lead author, PhD graduate at UNSW Sydney

Using 3D tumor models grown in the laboratory and in mouse models, the team showed that cancer-killing T cells can home-in on tumor cells independently of intermediary immune cells. When the T cells find and recognise a tumor, they release chemical signals, which then attract more T cells that sense the signals through a receptor called CCR5, and cause a swarm. “These cells coordinate their migration in a process reminiscent of the swarming observed in some insects and another type of immune cell called neutrophils, which help the body respond to injury and pathogens,” Galeano Niño says.

After confirming their results using computer modelling, the team genetically engineered human cells called chimeric antigen receptor (CAR)-T cells and showed they also swarm toward a 3D glioblastoma tumor grown in the laboratory.

CAR-T cells are currently being used to treat certain types of blood cancer. But the new findings suggest that it might also be possible to train these cells to attack solid tumors.

“Although this is fundamental research and at an early stage, the swarming mechanism could be exploited in the future to target CAR-T cells to solid tumors, potentially leading to enhanced immunotherapies that are more effective at infiltrating and destroying these types of tumors,” says senior author Maté Biro, EMBL Australia Group Leader at the Single Molecule Science node, UNSW.

“It will also be important to determine whether silencing the swarming mechanism could be beneficial in dampening overzealous T-cell responses following transplant surgery, in autoimmune conditions, or associated with viral infections,” he adds.

Source:

Journal reference:

Galeano Niño, J.L., et al. (2020) Cytotoxic T Cells swarm by homotypic chemokine signalling. eLife. doi.org/10.7554/eLife.56554.

New immuno-oncology combo attacks glioblastoma in mice and paves path to human trials

New immuno-oncology combo attacks glioblastoma in mice and paves path to human trials

  • October 7, 2020

The aggressive brain cancer glioblastoma is infamously “cold” when it comes to immunotherapy, meaning it typically doesn’t respond to immune-boosting therapies because of immune-suppressing molecules in its environment.

A team led by University Hospital Zurich and the University of Zurich engineered a protein-based drug that fuses immune-stimulating cytokines with antibodies that specifically target glioblastoma. The drug slowed tumor growth in mouse models of the disease and boosted the ability of immune cells to reach patients’ brain tumors in a small, ongoing clinical trial, they reported in Science Translational Medicine.

“Glioblastoma is considered an immunological ‘desert,’” the researchers wrote in the study. “Proinflammatory cytokines are ‘master regulators’ of the immune system that can turn tumors from cold to hot.” But unmodified cytokines are too toxic for patients to tolerate, necessitating new approaches to selecting and engineering them for safety and efficacy, they added.

RELATED: New insights into cancer cell escape mechanisms could boost immuno-oncology treatments

The Swiss scientists tested three different cytokines in combination with antibodies targeting glioblastoma: IL-2, IL-12 and TNF. They found that antibodies fused to IL-12 or TNF and given to mice intravenously accumulated in glioblastoma tumors, slowing their growth. Two out of five of the animals tested were cured, they reported.

To determine whether the anti-tumor response lasted, the team implanted glioblastoma tumors into the mice 180 days after the initial treatment. Without further treatment, the mice remained protected.

The researchers tested the TNF immunocytokine treatment in three glioblastoma patients. The treatment was safe and resulted in a larger infiltration of immune cells into the tumor environment. Two of the patients remained stable at six months, and the study is currently recruiting additional patients.

This is one of several new immuno-oncology approaches being tested in glioblastoma, and it’s not the first to focus on pro-inflammatory cytokines. Last year, scientists from Brigham and Women’s Hospital and the Dana-Farber Cancer Institute announced they saw early signs of efficacy in a trial of an IL-12 gene therapy in combination with Ziopharm’s oral drug veledimex in glioblastoma.

Cedars-Sinai researchers are using a polymer-based delivery vehicle to deliver drugs that block the immune checkpoints CTLA-4 and PD-1 into the brain. They showed in mice that the treatment was able to cross the blood-brain barrier and boost the infiltration of cancer-killing immune cells to tumors.

The Swiss team noted that the ongoing clinical trial of their TNF immunocytokine drug only tests one dose, and additional studies will be needed to fully understand the safety and efficacy of the treatment. They are also starting to examine combining the fused drug with other therapies, including medicines that target VEGF, a protein that promotes blood growth to tumors and has been fingered as a major factor in glioblastoma.

Designing a universal flu vaccine by refocusing the immune system

Designing a universal flu vaccine by refocusing the immune system

  • October 7, 2020

A universal flu vaccine that can protect people against any influenza strain is considered a holy grail of flu research because it could spare scientists from the often inaccurate process of predicting the circulating strains each year and redesigning the vaccine to match them.

Now, a group of researchers at the Massachusetts Institute of Technology, the Ragon Institute and Bristol Myers Squibb has shed light on a possible strategy for developing a universal flu vaccine by targeting a more stable region of the influenza virus that’s normally not targeted by the immune system.

In mice, a vaccine that uses nanoparticles to carry flu proteins triggered an antibody response to the desired segment of the virus, suggesting the vaccine could be broadly effective against any flu strain. The team reported the findings in the journal Cell Systems.

“The reason we’re excited about this work is that it is a small step toward developing a flu shot that you just take once, or a few times, and the resulting antibody response is likely to protect against seasonal flu strains and pandemic strains as well,” Arup Chakraborty, Ph.D., the study’s senior author, said in a statement

Influenza virus coats itself with a protein called hemagglutinin (HA), which is crucial for its ability to infect human cells. HA consists of two parts: a globular head region and a stem or stalk region. The head region often mutates and varies across different strains of influenza viruses. In contrast, the stem or stalk region rarely mutates, making it a great target for a universal vaccine.

However, the immune system is almost always drawn to the highly variable head region, producing antibodies that can only recognize a few virus subtypes rather than what are known as broadly neutralizing antibodies.

In the new study, the researchers used computational modeling to determine why the immune system is inclined to target the HA head, and then to find ways to refocus the immune response to the stem.

RELATED: French biotech Osivax nabs funding boost for universal flu, coronavirus vaccine work

It’s been shown that the head region is much more accessible than the stem, so the researchers hypothesized the surface geometry of the virus could be key to its ability to hide the stem from antibodies.

They modeled a process called antibody affinity maturation, in which antibody-producing B cells gradually evolve, leaving only those that can bind tightly to the HA protein. “As time goes on, after infection, the antibodies get better and better at targeting this particular antigen,” Chakraborty explained.

In a typical flu vaccine, the body doesn’t favor B cells that bind to the HA stem because they can’t reach and bind to their targets as easily as their counterparts that target the HA head, the researchers found.

The researchers also used the model to simulate the maturation process of a nanoparticle universal vaccine developed at the National Institutes of Health (NIH), which is already being tested in a clinical trial. As the HA stem proteins in that shot are more loosely spaced, they become more accessible to antibodies and therefore eventually survive the maturation process, the simulations found.

RELATED: A universal flu vaccine from llamas?

Because previous immunization or infection could leave behind memory B cells that can immediately launch an attack once the same target shows up, it could be difficult for a universal vaccine using components from the same strain of virus to overcome existing immunity.

Using mice with human immune cells, the researchers tested whether vaccination with HA-like proteins from one flu strain could induce broadly neutralizing antibodies. They first immunized the animals against the 2009 H1N1 pandemic strain, which according to the researchers has “reset” much of the human B-cell memory population and remains a major immunodominant antigen in current memory recall responses in humans. Then they used a nanoparticle vaccine of the HA stem protein from a different H1N1 strain. They found that this approach was much more effective at inducing broadly neutralizing antibodies than other methods they tried.

Outside of HA, scientists have also been looking at antibodies against neuraminidase, which is also targeted by Roche’s popular flu drug Tamiflu. A neuraminidase-inhibiting antibody that scientists from the Icahn School of Medicine at Mount Sinai, the Washington University School of Medicine and Scripps Research isolated from a flu patient was found to protect mice from all 12 strains of influenza virus tested.

Researchers at the NIH’s National Institute of Allergy and Infectious Diseases found an antibody they developed to recognize HA stem was also able to inhibit neuraminidase. Combining that antibody with Tamiflu helped mice survive a lethal viral challenge.

Chakraborty and colleagues believe their findings suggest sequential exposure to variants of an immunodominant antigen can refocus the immune system’s attention onto the conserved HA stem region as a universal vaccine target.

Australian scientists develop a nasal spray that could stop SARS-CoV-2 infection

Australian scientists develop a nasal spray that could stop SARS-CoV-2 infection

  • September 30, 2020

As the coronavirus disease (COVID-19), caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), continues to wreak havoc globally, scientists race to develop an effective medicine or vaccine to fight the infection. With more than 33.5 million people infected since the pandemic started in December 2019, finding a treatment for those infected is crucial to stemming its spread.

Now, a biotech company in Australia, Ena Respiratory, said that a nasal spray it is developing might help boost the human immune system to fight flu and common colds, significantly reduced the growth of the coronavirus in a recent study in animals.

The potential nasal spray may not only help treat COVID-19 but also prevent it.

The nasal spray

The novel product, called INNA-051, is being developed by Ena Respiratory, and laboratory experiments have shown that it reduced viral replication by as much as 96 percent in the animal study. Spearheaded by Public Health England’s (PHE) Deputy Director, Professor Miles Carroll, the new study described the potential treatment and has been published in the open-source preprint server bioRxiv*.

Used as a nasal spray, it aims to boost the natural immune system of the body to fight common colds and flu. It works by triggering the innate immune system, which is the body’s first line of defense against infection from a pathogen. When the drug has enhanced the immune system, it also prevented the infection and replication of SARS-CoV-2 in the laboratory.

Clinical observations. (a) Schematic of experimental design. Ferrets received INNA-051 and PBS treatments 4 days and 1 day prior to challenge with 5.0 x 106 pfu/ml SARS-CoV-2. Nasal wash and throat swabs were collected at days 1, 3, 5, 7, 10 & 12 post challenge (p.c.) for all treatment groups and control group. Scheduled culls were performed for 6/24 ferrets on day 3 p.c. and 18/24 ferrets on days 12-14 p.c. (b) Temperatures were measured twice daily (approximately 8 hours apart), using implanted temperature/ID chips. Mean temperatures +/- standard error of the mean (SEM) are displayed. Temperature dip post SARS-CoV-2 challenge (*) was attributed to sedation. (b) Weight was recorded daily and percentage change from the ferret weight prior to treatment plotted. Mean percentage weight change +/- SEM are displayed.

Clinical observations. (a) Schematic of experimental design. Ferrets received INNA-051 and PBS treatments 4 days and 1 day prior to challenge with 5.0 x 106 pfu/ml SARS-CoV-2. Nasal wash and throat swabs were collected at days 1, 3, 5, 7, 10 & 12 post challenge (p.c.) for all treatment groups and control group. Scheduled culls were performed for 6/24 ferrets on day 3 p.c. and 18/24 ferrets on days 12-14 p.c. (b) Temperatures were measured twice daily (approximately 8 hours apart), using implanted temperature/ID chips. Mean temperatures +/- standard error of the mean (SEM) are displayed. Temperature dip post SARS-CoV-2 challenge (*) was attributed to sedation. (b) Weight was recorded daily and percentage change from the ferret weight prior to treatment plotted. Mean percentage weight change +/- SEM are displayed.

The study

Respiratory tract diseases, including those that cause flu, common colds, and the coronavirus infection, represent major ongoing global health threats. These viruses have caused outbreaks to pandemics, endangering the lives of those who are at higher risk, such as children, older adults, and those who are immunocompromised.

The SARS-CoV-2 infection is actively spreading worldwide, and it spreads quickly from one person to another through close contact and respiratory droplets. One of the biggest threats of the current pandemic is that several people infected with the virus are asymptomatic, which means that they do not know that they carry the virus. As a result, they are called silent spreaders.

The research team from the National Infection Service, Public Health England (PHE) wanted to develop the nasal spray to prevent the replication of the virus in the nasal area, the most common point of entry of the virus.

To test the nasal spray, the team obtained nasal wash and throat swab samples four days before the viral challenge. Upon analyzing the viral RNA in nasal wash samples, the team confirmed infection in all treatment groups, with lower viral RNA levels seen in the INNA-051 treatment.

The team has found that prophylactic intra-nasal administration of INNA-051 in the SARS-CoV-2 ferret infection model has reduced levels of viral RNA in the nose and threat.

“The results of our study support clinical development of a therapy based on prophylactic TLR2/6 innate immune activation in the URT to reduce SARS-CoV-2 transmission and provide protection against COVID-19,” the team wrote in the paper.

Further, the research team added that the prophylactic approach is important to people at a high risk of community transmission or development of the severe disease from COVID-19, such as older adults, people with comorbidities, and those who are immunocompromised.

“We’ve been amazed by just how effective our treatment has been. By boosting the natural immune response of the ferrets with our treatment, we’ve seen a rapid eradication of the virus,” Christophe Demaison, the Ena Respiratory Managing Director, said.


“If humans respond similarly, the benefits of treatment are two-fold. Individuals exposed to the virus would most likely rapidly eliminate it, with the treatment ensuring that the disease does not progress beyond mild symptoms. This is particularly relevant to vulnerable members of the community. In addition, the rapidity of this response means that the infected individuals are unlikely to pass it on, meaning a swift halt to community transmission,” he added.

*Important Notice

bioRxiv publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information.

Source:

Journal reference:

Researchers discover new type of antigen-presenting immune cell

Novel nasal treatment could protect people from COVID-19

  • September 30, 2020

A novel nasal treatment developed to boost the natural human immune system to fight common colds and flu, has proved remarkably successful in reducing COVID-19 viral replication test results, released today, reveal.

The novel product, INNA-051, being developed by Australian biotech company, Ena Respiratory, reduced viral replication by up to 96 percent in a gold-standard animal study led by Public Health England’s (PHE) Deputy Director, Professor Miles Carroll and now published on biomedical pre-publication research site, bioRxiv.

The INNA-051 compound works by stimulating the innate immune system, the first line of defence against the invasion of pathogens into the body. By boosting the immune response in this way with INNA-051 prior to infection, the ability of the COVID-19 virus to infect the animals and replicate was dramatically reduced the PHE study showed. The study provides evidence that INNA-051 can be used as a stand-alone method of antiviral preventative therapy, complementary to vaccine programs.

We’ve been amazed with just how effective our treatment has been. By boosting the natural immune response of the ferrets with our treatment, we’ve seen a rapid eradication of the virus. If humans respond in a similar way, the benefits of treatment are two-fold. Individuals exposed to the virus would most likely rapidly eliminate it, with the treatment ensuring that the disease does not progress beyond mild symptoms. This is particularly relevant to vulnerable members of the community. In addition, the rapidity of this response means that the infected individuals are unlikely to pass it on, meaning a swift halt to community transmission.”


Ena Respiratory Managing Director, Dr Christophe Demaison

Ena Respiratory has raised AU$11.7m from Australian investors and, subject to successful toxicity studies and regulatory approval, the company could be ready to test INNA-051 in human trials in less than four months.

Investment and support in developing the novel therapy has been led from the Australian Medical Research Commercialisation Fund (MRCF), Australia’s largest life science investment fund managed by Brandon Capital, with co-investment from university commercialization fund Uniseed. The company is urgently seeking additional funding to accelerate the nasal spray’s clinical development and global distribution.

Dr Chris Nave, CEO of the MRCF and co-founder of Brandon Capital, says these extremely promising results means INNA-051 is an exciting frontrunner in the battle to beat COVID-19. “We are doing all we can to support Ena Respiratory and its quest to secure additional investment to accelerate the development and testing of the therapy in humans. While a vaccine is ultimately the key solution to combating COVID-19, governments need to be developing different treatment approaches to ensure they have a range of options, in the event that a vaccine proves elusive or takes longer to develop.”

INNA-051 is a synthetic small molecule and would be self-administered via an easy-to-use nasal spray, taken once or twice a week, with the treatment taking almost immediate effect. If human trials are successful and, given the unprecedented need for drugs to combat COVID-19, this prophylactic immune modulation therapy could be rapidly manufactured at scale and be available for use soon.

“This is a significant development as the world races to find a solution to halt COVID-19 transmission and infection of at risk-populations,” says Professor Roberto Solari a respiratory specialist, advisor to Ena Respiratory and visiting Professor at Imperial College London. “Most exciting is the ability of INNA-051 to significantly reduce virus levels in the nose and throat, giving hope that this therapy could reduce COVID-19 transmission by infected people, especially those who may be presymptomatic or asymptomatic and thus unaware they are infectious,” Professor Solari says.

INNA-051 offers real hope to those in the frontline fight against COVID-19, says Dr Chris Smith, Ena Respiratory Board Director, and Senior Investment Manager at Brandon Capital. “The treatment offers significant potential to protect the most vulnerable, including those with pre-existing respiratory conditions and the elderly, where vaccines can be less effective.”

INNA-051 was in development before the outbreak of COVID-19 to promote resistance towards broader respiratory viral epidemics. Unlike vaccines which are targeted to a specific strain, INNA-051, is designed to be effective for all types of respiratory infections.

“Our nasal treatment has amazing potential for combating COVID-19 and future pandemics,” continues Dr Smith. We know that vaccinations are often the most attractive approach in combating respiratory virus epidemics, but this method often comes with challenges as vaccines trigger a specific response in the adaptive immune system which might not be effective against future mutations of a virus. INNA-051 utilizes the non-specific innate immune response meaning it is effective against a broad spectrum of viruses.”

“As an original investor alongside Uniseed, the MRCF saw great potential in INNA-051, before the COVID-19 era, to manage respiratory viral outbreaks, exactly like we are currently experiencing, although our initial focus was against influenza,” Dr Nave continues.  “We are now thrilled to be able to redirect the effort toward the fight against COVID-19. The treatment has significant potential, not only against this pandemic but also to play a key role in future viral respiratory outbreaks.”

The authors of the study include scientists from Public Health England (PHE), Ena Respiratory, and leading Australian research organisations, the Hunter Medical Research Institute, Newcastle and the University of Melbourne.

These are very exciting results and demonstrate the potential clinical utility of the Ena drug in the treatment of COVID-19 which will likely require multiple treatment approaches. It also underlines the value of facilitating early-stage commercialization of research, which can go on to create a global impact.”


Dr Peter Devine, CEO, Uniseed

Download an animation that explains how the treatment works here: https://innavac.box.com/s/x88k1wecf7qyowci332ar97avivsrnpx

Source:

Journal reference:

Proud, P.C., et al. (2020) Prophylactic intranasal administration of a TLR2 agonist reduces upper respiratory tract viral shedding in a SARS-CoV-2 challenge ferret model. bioRxiv. doi.org/10.1101/2020.09.25.309914.

Children’s immune systems respond differently to Covid-19 than those of adults, research suggests

Children’s immune systems respond differently to Covid-19 than those of adults, research suggests

  • September 24, 2020



Marelize Wilke
|
Health24

  • Our immune systems have innate and adaptive responses, which include the production of antibodies
  • Researchers have found that children’s immune systems respond differently to Covid-19 than adults
  • This might affect the way vaccines and treatments are targeted in the future

Early in the Covid-19 outbreak, evidence showed that children are likely to experience milder Covid-19 symptoms than adults.

A study published in Science Translational Medicine is the first to compare the immune responses of children and adults. This new research detected some key differences to explain the phenomenon.

What did the research entail?

For the research, scientists from the Albert Einstein College of Medicine, Children’s Hospital at Montefiore and Yale University investigated cases of 60 adult Covid-19 patients and 65 child patients (all younger than 24 years) between 13 March and 17 May 2020.

The scientists tested the patients’ blood for several types of immune cells, antibody responses and cytokines produced by immune cells.

The children’s immune responses looked significantly better than those of the adults. Twenty-two adults needed ventilation, in comparison with only five children, and 17 adults died compared to just two of the paediatric patients.

“Our findings suggest that children with Covid-19 do better than adults because their stronger innate immunity protects them against SARS-CoV-2, the novel coronavirus that causes the disease,” said co-senior author Dr Betsy Herold, chief of infectious diseases and vice chair for research in the department of paediatrics at Einstein and CHAM.

What are the differences in the immune systems?

The authors explain the difference between our innate and adaptive immune systems. The innate immune system is responsible for fighting any invasive viruses or bacteria immediately, while the adaptive immune system builds up a long-term memory of pathogens and functions.

According to the authors, it seems like the innate immune systems of children are more robust than those of adults and thus protect them against the dire respiratory outcomes of Covid-19 – which may lead to death in severe adult cases.

One cytokine in particular, known as IL-17A, was found at much higher levels in paediatric patients than in adults, the researchers said. This may be an important protective mechanism against severe Covid-19.

Both children and adults with Covid-19 develop a level of antibodies, including spike-protein antibodies that fight the SARS-CoV-2 spike protein, as well as neutralising antibodies that try to block the virus from latching on to cells.

The researchers found that the levels of neutralising antibodies were higher in adults who died or required breathing assistance while in hospital.

“These results suggest that the more severe Covid-19 disease seen in adults is not caused by a failure of their adaptive immunity to mount T-cell or antibody responses,” said Dr K. Herold from Yale School of Medicine, who co-authored the study. “Rather, adult patients respond to coronavirus infection with an over-vigorous adaptive immune response that may promote the inflammation associated with ARDS.” 

How does this research benefit future Covid-19 treatment?

The findings of this study could be important for Covid-19 therapies and vaccines, said Dr Betsy Herold.

“Our adult Covid-19 patients who fared poorly had high levels of neutralising antibodies, suggesting that convalescent plasma, which is rich in neutralising antibodies, may not help adults who have already developed signs of ARDS. By contrast, therapies that boost innate immune responses early in the course of the disease may be especially beneficial,” she stated.

Many of the vaccine candidates for SARS-CoV-2 are currently focusing on boosting neutral antibody levels, but with these insights, it may be vital to look at other ways to boost immunity, such as focusing on the innate immune response.

READ | Immune system markers could predict severity of Covid-19

SEE | Striking pics show exactly how Covid-19 infects the lungs

Image credit: Getty Images

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