Two studies support key role for immune system in shaping SARS-CoV-2 evolution

Two studies support key role for immune system in shaping SARS-CoV-2 evolution

  • April 8, 2021
Two studies support key role for immune system in shaping SARS-CoV-2 evolution
Colorized scanning electron micrograph of an apoptotic cell (pink) heavily infected with SARS-COV-2 virus particles (green), isolated from a patient sample. Image captured at the NIAID Integrated Research Facility (IRF) in Fort Detrick, Maryland. Credit: National Institute of Allergy and Infectious Diseases/NIH, 2020

Two studies published in the open-access journal PLOS Pathogens provide new evidence supporting an important role for the immune system in shaping the evolution of SARS-CoV-2, the virus that causes COVID-19. These findings—and the novel technology behind them—improve understanding of how new SARS-CoV-2 strains arise, which could help guide treatment and vaccination efforts.

For the first study, Rachel Eguia of Fred Hutchinson Cancer Research Center in Seattle, Washington, and colleagues sought to better understand SARS-CoV-2 by investigating a closely related virus that has circulated widely for a far longer period of time: the common-cold virus 229E.

229E and SARS-CoV-2 are both in the coronavirus family, which features a “spike protein” that enables infection of human cells. A person who is infected with 229E develops an immune response against the spike protein that protects them from reinfection, but only for a few years. Whether reinfection then occurs because the wears off or because 229E evolves to escape it has been unclear.

Eguia and colleagues addressed this question by testing the activity of serum samples collected from patients in the 1980s-90s against spike proteins from both old 229E strains and strains that evolved later on. They found that the old spike proteins were vulnerable to the older sera. However, modern spike proteins were able to evade older sera while remaining vulnerable to sera from modern patients.

This analysis suggests that modern strains of 229E have accumulated spike protein mutations that enable them to evade older sera. These findings raise the possibility that SARS-CoV-2 and other coronaviruses could undergo similar evolution, and that COVID-19 vaccines may require periodic updates to remain effective against new strains.

The authors add, “The human common-cold coronavirus evolves over the span of years to decades to erode neutralization by human polyclonal serum antibodies. This work suggests that human coronaviruses undergo significant antigenic evolution that may contribute to eventual re-infections.”

For the second study, Sung Hee Ko of the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, and colleagues developed new technology for genetic sequencing of the SARS-CoV-2 spike , enabling detection of multiple SARS-CoV-2 strains that may be present at the same time within a single infected patient.

Previous studies have used standard sequencing methods to produce a single genetic sequence from an individual patient, obscuring the potential presence of multiple SARS-CoV-2 strains. By contrast, the new technology highlights virus diversity within each patient and enables tracking of the evolution of new SARS-CoV-2 strains during acute infection.

Indeed, when the researchers applied the new method to human respiratory samples, they found new SARS-CoV-2 variants arising within the same patient over the course of acute infection. The precise mutations in these variants suggest that they arose in response to selective pressure from the immune system.

Future application of the new technology could improve understanding of how the evolution of new SARS-CoV-2 variants within a single patient impacts their outcomes. The findings also suggest that patients might see greater benefits from early treatment with capable of targeting multiple strains, than from delayed treatment with a single antiviral drug.

The authors add, “We used new technology to show that coronavirus variants with mutated spike proteins can arise early in the course of infection. Our results suggest more virus evolution in each person than previously thought, with potential implications for clinical outcomes and for the emergence of transmissible variant strains.”

Together, these two studies deepen understanding of how new SARS-CoV-2 arise in response to activity, potentially paving the way for additional research and improved treatment.


Spike proteins of SARS-CoV-2 relatives can evolve against immune responses


More information:
Ko SH, Bayat Mokhtari E, Mudvari P, Stein S, Stringham CD, Wagner D, et al. (2021) High-throughput, single-copy sequencing reveals SARS-CoV-2 spike variants coincident with mounting humoral immunity during acute COVID-19. PLoS Pathog 17(4): e1009431. doi.org/10.1371/journal.ppat.1009431

Eguia RT, Crawford KHD, Stevens-Ayers T, Kelnhofer-Millevolte L, Greninger AL, Englund JA, et al. (2021) A human coronavirus evolves antigenically to escape antibody immunity. PLoS Pathog 17(4): e1009453. doi.org/10.1371/journal.ppat.1009453

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Medolife Rx Receives Significant Purchase Order of Immunapen, Its Easy-to-Use Nutraceutical Product Designed to Increase Quality of Life and Support a Healthy Immune System

  • April 6, 2021

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BURBANK, Calif., April 06, 2021 (GLOBE NEWSWIRE) — via NewMediaWire – Medolife Rx, Inc. (“Medolife”), a global integrated bioceutical company with R&D, manufacturing, and consumer product distribution, which is a majority owned subsidiary of Quanta, Inc. (OTC PINK: QNTA), announced today that the Company has received a significant purchase order for its nutraceutical product Immunapen™, a consumer-facing product designed to increase the quality of life of users through enhancing their immune system. The order looks to propel the revenue generation side of the business, where the company sells nutraceutical and wellness products in high-impact areas such as pain management, sleep aid and immune system support.

The Immunapen™ is a natural homeopathic drug that is sold over the counter to general patient populations around the world. It is derived from the Company’s proprietary formulation found in its lead drug candidate Escozine®, which includes a small molecular peptide found in scorpions that is then polarized through a patented process. The formulation is designed to enhance the user’s immune system while providing an energy booster that increases the overall quality of life. Its new and improved pen design is easy-to-use and can be carried on the go.

The purchase order for 1,400 Immunapen™ Originals came from a pharmaceutical wholesaler based in the Republic of Armenia who will distribute the products throughout the region. This is the first purchase order from the wholesaler and the Company hopes that it will be the beginning of a strong relationship. The Company also has developed Immunapen™ Anti-Anxiety, Immunapen™ Sleep, and Immunapen™ Energy & Focus.

“Immunapen is a homeopathic solution that we are extremely proud of and prepared to produce on a mass scale as the world turns its attention to boosting the human immune system,” said Medolife CEO Dr. Arthur Mikaelian. “While we continue our clinical research efforts on Escozine as a drug therapeutic, we are also able to sell Immunapen as a nutraceutical, creating two paths for revenue generation and consumer adoption. Since the onset of the COVID-19 pandemic, we have seen a major increase in interest for immune system support in both the pharmaceutical and nutraceutical categories. After conducting significant pre-clinical research on Escozine, we verified its immune system support properties, which led us to producing this one-of-a-kind, easy-to-use product designed to support and increase quality of life in general patient populations. Although it contains some of the most expensive liquid material in the world, through our own facilities and manufacturing, we are able to produce the pens in an affordable way that makes them attractive to large distributors. We hope this is just the first of many purchase orders of the Immunapen product.”

The market for products that boost the immune system was already one of the strongest segments in functional foods and supplements. Consumers are turning to products that promise to improve their immune systems more than ever during the ongoing COVID-19 pandemic, with companies and brands around the world reporting significant sales spikes. Immune health is one of the top five reasons people take dietary supplements and global market sales of immune health supplements were valued at $14 billion in 2017 and is expected to reach $25 billion by 2025, according to a forecast by Persistence Market Research.

The Company recently announced the expansion of its first-of-its-kind scorpion reservation located in the Dominican Republic (“DR”). The facility allows the Company to safely and humanely cultivate scorpions of various types for the extraction of the peptides necessary to produce Escozine®, which is currently awaiting product registration for the treatment of the COVID-19 virus in the region, as well as its nutraceutical Immunapen™ product line.

About Medolife Rx

Medolife Rx, Inc. is a global biotechnology company with operations in clinical research, manufacturing, and consumer products. Medolife Rx was created through the merger of Medolife, a private company founded by Dr. Arthur Mikaelian who pioneered the unlaying polarization technology that makes the Company’s portfolio of pharmaceutical and nutraceutical products so effective, and Quanta, Inc., a direct-to-consumer wellness product portfolio company. The Company’s lead clinical development programs include Escozine®, a proprietary formulation consisting of small molecule peptides derived from Rhopalurus princeps scorpions, which is amplified by the Company’s polarization technology and is being researched as a treatment of various indications, including COVID-19 and cancer. The Company has completed preclinical safety and efficacy research on Escozine® and is pursuing product registration and drug approval in various countries, including the United States and throughout Latin America. 

Through its subsidiary QuantRx, Medolife manufactures and distributes consumer wellness products in high-impact consumer areas such as pain relief, beauty, and general wellness. QuantRx products are designed using Dr. Mikaelian’s polarization technology, which applies advances in quantum biology to increase the potency of active ingredients. Ultimately, Quanta’s mission is to deliver better, more effective ingredients to elevate product efficacy, reduce waste, and facilitate healthier, more sustainable consumption.

Beyond its own clinical and consumer applications, the polarization technology used by Medolife and its subsidiaries has many potential applications. From potentiating bio-ingredients, to producing more-effective carbon-trapping plants, to transformative anti-aging solutions, Medolife has the opportunity to upend how commercial and pharmaceutical products are made and increase their benefits, while decreasing their chemical concentration.

Forward-Looking Statements

Safe Harbor Statement under the U.S. Private Securities Litigation Reform Act of 1995: This release contains statements that are forward-looking in nature which express the beliefs and expectations of management including statements regarding the Company’s expected results of operations or liquidity; statements concerning projections, predictions, expectations, estimates or forecasts as to our business, financial and operational results and future economic performance; and statements of management’s goals and objectives and other similar expressions concerning matters that are not historical facts. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “estimate,” “plan,” “project,” “continuing,” “ongoing,” “expect,” “we believe,” “we intend,” “may,” “will,” “should,” “could,” and similar expressions. Such statements are based on current plans, estimates and expectations and involve a number of known and unknown risks, uncertainties and other factors that could cause the Company’s future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. These factors and additional information are discussed in the Company’s filings with the Securities and Exchange Commission and statements in this release should be evaluated in light of these important factors. Although we believe that these statements are based upon reasonable assumptions, we cannot guarantee future results. Forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.

Contacts:

Phil Sandshttps://ir.quantrx.com/818-659-8052

Kyle Portermedolife@cmwmedia.com858-264-6600

Primary Logo

Source: Quanta, Inc.

Medolife Rx Receives Significant Purchase Order of Immunapen, Its Easy-to-Use Nutraceutical Product Designed to Increase Quality of Life and Support a Healthy Immune System Other OTC:QNTA

Medolife Rx Receives Significant Purchase Order of Immunapen, Its Easy-to-Use Nutraceutical Product Designed to Increase Quality of Life and Support a Healthy Immune System Other OTC:QNTA

  • April 6, 2021

BURBANK, Calif., April 06, 2021 (GLOBE NEWSWIRE) — via NewMediaWire – Medolife Rx, Inc. (“Medolife”), a global integrated bioceutical company with R&D, manufacturing, and consumer product distribution, which is a majority owned subsidiary of Quanta, Inc. (OTC PINK: QNTA), announced today that the Company has received a significant purchase order for its nutraceutical product Immunapen™, a consumer-facing product designed to increase the quality of life of users through enhancing their immune system. The order looks to propel the revenue generation side of the business, where the company sells nutraceutical and wellness products in high-impact areas such as pain management, sleep aid and immune system support.

The Immunapen™ is a natural homeopathic drug that is sold over the counter to general patient populations around the world. It is derived from the Company’s proprietary formulation found in its lead drug candidate Escozine®, which includes a small molecular peptide found in scorpions that is then polarized through a patented process. The formulation is designed to enhance the user’s immune system while providing an energy booster that increases the overall quality of life. Its new and improved pen design is easy-to-use and can be carried on the go.

The purchase order for 1,400 Immunapen™ Originals came from a pharmaceutical wholesaler based in the Republic of Armenia who will distribute the products throughout the region. This is the first purchase order from the wholesaler and the Company hopes that it will be the beginning of a strong relationship. The Company also has developed Immunapen™ Anti-Anxiety, Immunapen™ Sleep, and Immunapen™ Energy & Focus.

“Immunapen is a homeopathic solution that we are extremely proud of and prepared to produce on a mass scale as the world turns its attention to boosting the human immune system,” said Medolife CEO Dr. Arthur Mikaelian. “While we continue our clinical research efforts on Escozine as a drug therapeutic, we are also able to sell Immunapen as a nutraceutical, creating two paths for revenue generation and consumer adoption. Since the onset of the COVID-19 pandemic, we have seen a major increase in interest for immune system support in both the pharmaceutical and nutraceutical categories. After conducting significant pre-clinical research on Escozine, we verified its immune system support properties, which led us to producing this one-of-a-kind, easy-to-use product designed to support and increase quality of life in general patient populations. Although it contains some of the most expensive liquid material in the world, through our own facilities and manufacturing, we are able to produce the pens in an affordable way that makes them attractive to large distributors. We hope this is just the first of many purchase orders of the Immunapen product.”

The market for products that boost the immune system was already one of the strongest segments in functional foods and supplements. Consumers are turning to products that promise to improve their immune systems more than ever during the ongoing COVID-19 pandemic, with companies and brands around the world reporting significant sales spikes. Immune health is one of the top five reasons people take dietary supplements and global market sales of immune health supplements were valued at $14 billion in 2017 and is expected to reach $25 billion by 2025, according to a forecast by Persistence Market Research.

The Company recently announced the expansion of its first-of-its-kind scorpion reservation located in the Dominican Republic (“DR”). The facility allows the Company to safely and humanely cultivate scorpions of various types for the extraction of the peptides necessary to produce Escozine®, which is currently awaiting product registration for the treatment of the COVID-19 virus in the region, as well as its nutraceutical Immunapen™ product line.

About Medolife Rx

Medolife Rx, Inc. is a global biotechnology company with operations in clinical research, manufacturing, and consumer products. Medolife Rx was created through the merger of Medolife, a private company founded by Dr. Arthur Mikaelian who pioneered the unlaying polarization technology that makes the Company’s portfolio of pharmaceutical and nutraceutical products so effective, and Quanta, Inc., a direct-to-consumer wellness product portfolio company. The Company’s lead clinical development programs include Escozine®, a proprietary formulation consisting of small molecule peptides derived from Rhopalurus princeps scorpions, which is amplified by the Company’s polarization technology and is being researched as a treatment of various indications, including COVID-19 and cancer. The Company has completed preclinical safety and efficacy research on Escozine® and is pursuing product registration and drug approval in various countries, including the United States and throughout Latin America. 

Through its subsidiary QuantRx, Medolife manufactures and distributes consumer wellness products in high-impact consumer areas such as pain relief, beauty, and general wellness. QuantRx products are designed using Dr. Mikaelian’s polarization technology, which applies advances in quantum biology to increase the potency of active ingredients. Ultimately, Quanta’s mission is to deliver better, more effective ingredients to elevate product efficacy, reduce waste, and facilitate healthier, more sustainable consumption.

Beyond its own clinical and consumer applications, the polarization technology used by Medolife and its subsidiaries has many potential applications. From potentiating bio-ingredients, to producing more-effective carbon-trapping plants, to transformative anti-aging solutions, Medolife has the opportunity to upend how commercial and pharmaceutical products are made and increase their benefits, while decreasing their chemical concentration.

Forward-Looking Statements

Safe Harbor Statement under the U.S. Private Securities Litigation Reform Act of 1995: This release contains statements that are forward-looking in nature which express the beliefs and expectations of management including statements regarding the Company’s expected results of operations or liquidity; statements concerning projections, predictions, expectations, estimates or forecasts as to our business, financial and operational results and future economic performance; and statements of management’s goals and objectives and other similar expressions concerning matters that are not historical facts. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “estimate,” “plan,” “project,” “continuing,” “ongoing,” “expect,” “we believe,” “we intend,” “may,” “will,” “should,” “could,” and similar expressions. Such statements are based on current plans, estimates and expectations and involve a number of known and unknown risks, uncertainties and other factors that could cause the Company’s future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. These factors and additional information are discussed in the Company’s filings with the Securities and Exchange Commission and statements in this release should be evaluated in light of these important factors. Although we believe that these statements are based upon reasonable assumptions, we cannot guarantee future results. Forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.

Contacts:

Phil Sands
https://ir.quantrx.com/
818-659-8052

Kyle Porter
medolife@cmwmedia.com
858-264-6600

GSK to support manufacture of Novavax’ COVID-19 vaccine

  • March 29, 2021

LONDON and GAITHERSBURG, Md., March 29, 2021 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, GSK and the UK Government Vaccines Taskforce announced that they have reached an agreement in principle to support manufacturing of up to 60 million doses of Novavax’ COVID-19 vaccine candidate (NVX-CoV2373) for use in the UK. GSK will provide ‘fill and finish’ manufacturing capacity at its Barnard Castle facility in the North East of England beginning as early as May 2021, with a rapid technology transfer between the two companies beginning immediately. GSK and Novavax will negotiate a final agreement to include additional terms and conditions.

The UK Government has secured 60 million doses of the vaccine under an advance purchase agreement with Novavax. The protein antigen component of NVX-CoV2373 is also produced in the North East of England by Novavax’ manufacturing partner, FUJIFILM Diosynth Biotechnologies, at their site in Billingham, Stockton-on-Tees. 

Fill and finish, to be provided by GSK, is the completion stage of vaccine manufacturing, preparing vials of the final vaccine and packaging them for distribution and use. The GSK site at Barnard Castle, which will deliver the vaccine doses under this collaboration, is a specialised facility in GSK’s global manufacturing network, which supports production of GSK pharmaceutical and vaccine products.  

Roger Connor, President, GSK vaccines, said: “GSK is delighted to support Novavax and the UK Vaccines Taskforce with this manufacturing arrangement for the UK and our Barnard Castle facility is now undertaking the rapid preparation work required to manufacture up to 60m doses of this vaccine. We have ensured that we can deliver these volumes without impacting supply of our other vital medicines and vaccines, and without disruption to the other COVID-19 collaborations GSK is engaged in globally.”

“This partnership with GSK continues the expansion of our global supply network, which we expect to increase overall production capacity and, if approved by regulatory agencies, support access to a potentially important new vaccine against COVID-19,” said Rick Crowley, Executive Vice President and Chief Operations Officer, Novavax. “We thank the UK government’s Vaccine Taskforce for its instrumental role in ensuring the progress of our COVID-19 vaccine, from both a clinical and now manufacturing perspective, as well as GSK for making their facilities available to help fight the pandemic.”

Prime Minister Boris Johnson said: “I’m delighted by GSK’s investment, which shows the strength of UK manufacturing, and will further boost our vaccine rollout. The Vaccines Taskforce has worked hand in glove with business to successfully deliver vaccines to the whole of the UK, and this agreement will continue to support our approach. We remain on track to offer a first jab to all over 50s by 15 April, and all adults by the end of July, and I want to once again encourage everyone to come forward for a vaccine when you’re called.”

Health and Social Care Secretary Matt Hancock said: “We’ve all seen just how important onshore vaccine manufacturing capabilities are, and this fantastic deal will ensure more of these vital products can be produced here in the UK. The UK’s vaccination programme has been a national success, with over 30 million people now having received a first dose of a COVID-19 vaccine. Should the Novavax vaccine meet our medicines regulator’s high standards of safety and effectiveness, the agreement reached today will boost these efforts over the coming months.”

The Novavax vaccine candidate has demonstrated strong potential efficacy in Phase 3 clinical trials, including against the B.1.1.7 variant circulating in the UK. Submission of the vaccine for review by regulatory authorities in the UK is expected during the second quarter.  

GSK commitment to tackling COVID-19
GSK’s response to COVID-19 has been one of the broadest in the industry, with two potential treatments in addition to our vaccine candidates in development.

GSK is collaborating with several organisations around the world on COVID-19 vaccines by providing access to our adjuvant technology. Our collaboration with Canada’s Medicago, combining our pandemic adjuvant with its plant-derived vaccine candidate is in Phase 3 clinical trials, and a collaboration with French company Sanofi on an adjuvanted, protein-based vaccine candidate is in Phase 2. An earlier stage collaboration with SK Bioscience of South Korea, with funding from CEPI and the Bill and Melinda Gates Foundation, aims to develop differentiated, affordable COVID-19 vaccines for supply globally through the COVAX facility. The use of an adjuvant can be of particular importance in a pandemic since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and contributing to protecting more people.

GSK is working with German mRNA specialist, CureVac, to jointly develop next generation, multi-valent mRNA vaccines for COVID-19 with the potential to address multiple emerging variants in one vaccine. GSK will also support manufacturing of up to 100m doses of CureVac’s first generation COVID-19 vaccine at our facilities in Belgium.

GSK is also exploring potential therapeutic or treatment options for COVID-19 patients. We are collaborating with Vir Biotechnology to develop existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options for COVID-19. We recently reported that an Independent Data Monitoring Committee recommended that the Phase 3 COMET-ICE trial evaluating VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalisation be stopped for enrolment due to evidence of profound efficacy, based on an interim analysis of data from the trial. We are now seeking Emergency Use Authorization in the US and authorisations in other countries. We are also assessing whether an investigational monoclonal antibody, otilimab, can help severely ill COVID-19 patients aged over 70 who experience an overreaction of their immune system.

About GSK
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.

About NVX-CoV2373
NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax’ patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials, a trial in the U.K that demonstrated efficacy of 96.4% against the original virus strain and 89.7% overall, and the PREVENT-19 trial in the U.S. and Mexico that began in December 2020. It is also being tested in two ongoing Phase 2 studies that began in August: a Phase 2b trial in South Africa that demonstrated 48.65% efficacy against a newly emerging escape variant, and a Phase 1/2 continuation in the U.S. and Australia. NVX-CoV2373 is stored and stable at 2°- 8°C, allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in 10-dose vials.

About Matrix-M™
Novavax’ patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

About Novavax
Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company’s proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

Novavax Forward Looking Statements
Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading “Risk Factors” in the Novavax Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

GSK Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the Company’s Annual Report on Form 20-F for 2020 and any impacts of the COVID-19 pandemic.

Novavax enquires:

Investor enquiries:
Novavax, Inc.
Erika Schultz | 240-268-2022
[email protected]

Solebury Trout
Jennifer Porcelli | 617-974-8659
[email protected]

Media enquiries:
Amy Speak | 617-420-2461
Laura Keenan | 410-419-5755
[email protected]

GSK enquiries:




Media enquiries:

Simon Steel

+44 (0) 20 8047 5502

(London)


Simon Moore

+44 (0) 20 8047 5502

(London)


Kristen Neese

+1 804 217 8147

(Philadelphia)


Kathleen Quinn

+1 202 603 5003

(Washington DC)





Analyst/Investor enquiries:

James Dodwell

+44 (0) 20 8047 2406

(London)


Sonya Ghobrial

+44 (0) 7392 784784

(Consumer)


Jeff McLaughlin

+1 215 751 7002

(Philadelphia)


Frannie DeFranco

+1 215 751 4855

(Philadelphia)

SOURCE Novavax, Inc.

Related Links

http://www.novavax.com

support your immune system with vitamin C-rich soup

support your immune system with vitamin C-rich soup

  • March 29, 2021

The light broth is perfect for cool evenings and the wontons are stuffed with spiced pumpkin for a dose of vitamins A and C to strengthen your immune system (because colds aren’t just for winter). On average, wonton wrappers contain an impressive 10 grams of protein while the mushrooms contain fibre, making it the perfect supper that supports both sleep and muscle recovery. So you can tackle tomorrow’s workout, no matter the weather. 

PUMPKIN WONTON TORTELLINI & PORCINI SOUP

Cooking time: approximately 1 hour 

INGREDIENTS:

For the tortellini:

1 small pumpkin or squash

Olive oil

Small bunch of thyme, woody stems removed

1 tsp cinnamon

1 tsp ground nutmeg

Zest of one lemon

100g smoked ricotta crumbled – optional

Wonton wrappers

Semolina for dusting

For the broth:

Couple of spring onions, chopped

Handful of dried porcini mushrooms

1 glass of sherry

500ml stock (chicken or vegetable)

Squeeze of honey

Salt and pepper

Sage leaves 

METHOD:

  1. Heat the oven to 200c. 
  2. Roughly slice up the squash removing the seeds, but you can keep the skin on. 
  3. Place on an oven tray and drizzle with olive oil, sprinkle with thyme and season. 
  4. Place in the oven and roast for about 30 – 40 mins till soft and starting to caramelise.
  5. Take out the oven and scrape the soft insides into a bowl, discard the skins.
  6. Add the cinnamon, nutmeg, lemon zest, season and mash together, taste.
  7. Arrange the wonton wrappers in front of you and spoon a teaspoon amount onto the wrapper (then place a cube of the smoked ricotta on top if using).
  8. Fold into tortellini (this make take a couple of goes!). 
  9. Dust a tray with semolina and leave the tortellini on top whilst you make the broth. (They will keep in the fridge covered for a good day or so).
  10. To make the broth heat a little oil in a pan and add the spring onions, add the stock, sherry and porcini mushrooms and simmer for about 15 mins, season and add a squeeze of honey.
  11. To make the sage leaves simply heat a little oil in a pan and add the sage leaves for about 20 seconds, remove and drain on kitchen paper.
  12. When ready to serve bring a pan of salted water to the boil and drop in your wontons, simmer for about 3 – 4 minutes and remove and distribute between bowls. Spoon the broth over the top and finish with the crispy sage leaves. 

Want more simple and nutritious recipes? Follow @StrongWomenUK on Instagram for the latest workouts, delicious recipes and motivation from your favourite fitness experts.

Plant-based RG-I ingredient may support immune function, modulate the microbiota: Study

Plant-based RG-I ingredient may support immune function, modulate the microbiota: Study

  • March 25, 2021

Data published in Nutrients​ indicated that RG-I from bell pepper and carrot offered similar immune- and microbiota modulatory potential in vitro, while a proof-of-concept trial in humans showed that RG-I from bell pepper (bpRG-I) was well tolerated and enhanced innate immune responsiveness.

“RG-I enriched extracts prime innate immune responses and display a dual mode of action by exerting (1) an immunomodulatory effect on phagocytosis, a biomarker previously shown in some studies with ginseng-PS to be associated with protective effects against respiratory infections, and (2) a microbiota modulatory effect, with concomitant enhanced production of SCFA [short chain fatty acids],” ​wrote the researchers.

BeniCaros

The ingredients are being developed and commercialized by Netherlands-based NutriLeads. The privately held company was founded in 2012 and is and backed by investors including Icos Capital, Goeie Grutten, DSM Venturing, Oost NL, SHIFT Invest and Thuja Capital.

The company’s lead ingredient, BeniCaros, is extracted from carrot pomace, which itself is a side stream from carrot juice production. This ingredient is expected to be available in the US for the formulation of dietary supplements and functional foods in the second half of 2021.

Commenting on the publication and the expected impact of the findings, Ruud Albers, PhD, CEO of NutriLeads, said: “We are delighted to share these new data, demonstrating the immunomodulatory effects of plant-based RG-I, which have the potential to bring health benefits to us all. We are particularly pleased that we can successfully derive RG-I from sustainable and widely available sources.

Scientific Paper by NutriLeads Shows That Its Plant-based RG-I Food Ingredients Support Immune Function and Modulate the Microbiota

Scientific Paper by NutriLeads Shows That Its Plant-based RG-I Food Ingredients Support Immune Function and Modulate the Microbiota

  • March 25, 2021

WAGENINGEN, The Netherlands–()–Dutch health ingredients innovator, NutriLeads, announces the first peer-reviewed publication of data proving the immune modulating properties of its proprietary pectin-derived rhamnogalacturonan-I (RG-I) polysaccharides in the journal Nutrients.[2]

RG-I are natural, plant-derived compounds (polysaccharides), that interact with the gut bacteria (microbiota) and the host innate immune system. In selected traditional plant extracts, such pectic polysaccharides have previously been shown to have immunostimulatory effects. However, these traditional remedies are often expensive, derived from non-renewable sources, and could face regulatory challenges.

In this recent publication, NutriLeads shows that RG-I can be extracted from affordable and renewable crops, namely carrots and bell peppers, and even obtained from side streams of crop processing, allowing for sustainable and scalable production. RG-I from both carrot and bell pepper showed immune stimulating and microbiota modulating activity in vitro. Furthermore, bell pepper RG-I was shown to enhance innate immune responsiveness in a proof-of-concept trial in humans.

Commenting on the publication and the expected impact of the findings, Ruud Albers, PhD, CEO of NutriLeads, said: “We are delighted to share these new data, demonstrating the immunomodulatory effects of plant-based RG-I, which have the potential to bring health benefits to us all. We are particularly pleased that we can successfully derive RG-I from sustainable and widely available sources.

“Due to the pandemic, immune health is even higher on the agenda than ever before, and we believe that this research shows that dietary supplementation with RG-I from specific food crops is ideally suited to support immune function and modulate the microbiota. We are well advanced with generating additional evidence showing the immune benefits of carrot-derived RG-I and are working together with Food and Food Supplement companies to deliver these benefits to consumers in the second half of 2021.”

Demand for food supplements and food and beverage products with immune health properties has been growing sharply in recent years. The global immune health supplements market alone was estimated to be worth USD 16.32 billion in 2019 and is expected to reach USD 29.40 billion by 2027.[3] In addition, recent research shows that 64% of respondents will aim to improve their immunity in the next 12 months.[4]

NutriLeads’ lead ingredient, BeniCaros, extracted from carrot pomace (a side stream from carrot juice production), has been developed to support immune function. This ingredient is expected to be available in the US for the formulation of dietary supplements and functional foods in the second half of 2021.

References

1. Innova Consumer Survey 2020 – https://www.prnewswire.com/il/news-releases/innova-identifies-top-10-food-and-beverage-trends-to-accelerate-innovation-in-2021-301155638.html

2. Early access article available at: https://www.mdpi.com/2072-6643/13/3/963

3. https://www.globenewswire.com/news-release/2020/10/27/2115103/0/en/Immune-Health-Supplements-Market-Worth-USD-29-40-Billion-at-7-4-CAGR-Rapid-Changes-in-Lifestyles-to-Bolster-Growth-says-Fortune-Business-Insights.html

4. FMCG Gurus, Top Ten Trends for 2021, Dec 2020. https://fmcggurus.com/webinar-top-ten-trends-2021/

– ENDS –

Notes to Editors:

About NutriLeads

NutriLeads, established in 2012, is a Health Ingredients Innovator advancing nutrition to strengthen human health. Based on our proprietary RG-I platform, we are developing a portfolio of sustainable and 100% natural, plant-based ingredients that are clinically proven to support human physiology and modulate the gut microbiome.

NutriLeads takes all its proprietary ingredients through clinical trials to demonstrate their positive effect on human health (e.g. immune health, gut health and metabolic health), gains regulatory approval for market access, commissions production, and then partners with companies that incorporate the ingredients into their finished (food) products to bring the benefits to consumers.

The Company’s lead RG-I-based ingredient, BeniCaros, supports immune function. The ingredient, which is extracted from carrots, is expected to be available in the US for the formulation of dietary supplements and functional foods in the second half of 2021.

NutriLeads is privately held and backed by investors including Icos Capital, Goeie Grutten, DSM Venturing, Oost NL, SHIFT Invest and Thuja Capital. It has also received non-dilutive funding from various regional, national and European grants, including Eurostars, EFRO and SME instrument.

The Company is headquartered in Wageningen, the Netherlands, a world-renowned centre for nutrition and health research and development, also known as the ‘Foodvalley’.

For more information, please visit the website: www.nutrileads.com

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Immune Support: Beyond Supplements | WholeFoods Magazine

  • March 19, 2021

Awareness of the benefits of immune-supporting nutrients has grown significantly over the past 12 months, but supplements are just one of the tools consumers can turn to help safeguard their wellbeing. Here, we take a wider look at the immune category.

 

Functional Foods & Beverages

When it comes to immune health, promoting fruit and vegetable intake is an important start. Beyond the nutrient-rich basics, there are plenty of foods imbued with immune-supporting ingredients that can offer an additional assist. We’ve discussed many of the all-star nutrients in earlier installments of this four-part series (part 1, part 2, part 3), including vitamins C and D, zinc, and elderberry. Those nutrients are available in non-supplement forms, including in beverages, like one from Uncle Matt’s: The company makes an Organic Ultimate Immune juice that contains orange juice, elderberry, 300% RDA vitamin C, 50% RDA Vitamin D, and 25% RDA zinc. The drink is certified glyphosate residue free.

Remedy Organics also offers an elderberry-based beverage—the company’s Berry Immunity drink contains elderberry, echinacea, lion’s mane, and prebiotics. It also contains camu-camu, a fruit that grows in the Peruvian Amazon, Brazil, Colombia, and Bolivia. Camu-camu contains vitamin A in the form of beta-carotene, carotenoids including lutein and zeaxanthin, and high amounts of vitamin C—100g of camu-camu delivers 2,145mg of vitamin C, or 3,575% of the daily value (1). It has a higher concentration of vitamin C than lemons or oranges, making it a potent source of this all-important vitamin.

Bragg, too, has created blends that can help customers support their health, while providing the comfort of familiarity. The company offers Organic Apple Cider Vinegar Refreshers in Ginger Lemon Honey and Honey Green Tea. Ginger, lemon, and honey is a classic combination—in part 3 of this series, we covered how it soothes sore throats, boosts the immune response, and helps reduce inflammation. The caffeine-free Honey Green Tea drink combines immune-boosting honey and green tea antioxidants. Bragg states on its website that the company’s apple cider vinegar is a prebiotic, for added benefits.

Also benefitting from familiarity, the tea category contains opportunities for customers to get some herbal immune support into their daily routines. The immune category particularly lends itself to this format, as so many immune boosters are herbal. Offer options like Yogi Tea’s immune support line, which includes Echinacea Immune Support and Elderberry Lemon Balm Immune + Stress tea. The company offers Sweet Grapefruit Everyday tea, which includes astragalus root, tulsi leaf, acerola fruit, cinnamon, and, of course, grapefruit, along with hibiscus. For an extra boost, sweeten the tea with local honey, which can benefit the immune system beyond just helping with allergies.

Also offering tulsi, Organic India has Tulsi Original and Tulsi Turmeric Ginger. Tulsi, the company says, is an immunomodulator shown to reinforce and support the immune system.

And perhaps less familiar to some, foods made with chicory root deliver inulin, a prebiotic that can provide digestive support and more. Upwards of 70% of the immune system is in the gut, and maintaining digestive health is key to maintaining immune health. Studies from Beneo show the immune potential of its Orafti branded inulin. One randomized, parallel, double-blind, placebo-controlled study was performed on 219 children aged 3 to 6 (2). The relative abundance of Bifidobacterium and Lactobacillus bacteria increased in the trial group, and the number of fever and sinusitis episodes were significantly lower, although rates and durations of infectious episodes did not differ significantly between the two groups. The researchers noted, “Large conclusive studies are thus justified to examine in further detail…whether the moderate, but significant effects seen in this study can be interpreted as signs of this beneficial immune-modulatory effect.”

 

Shots

The latest innovation in health and wellness is shots. Not the vaccination kind, but the drinkable kind. We can drop in on Bragg again, for their Carrot Ginger ACV shot—the company states that it contains vitamin A, which is involved in the creation of B- and T-cells (for a cheat sheet on different types of cells, see part 1 of this series) (3). Vitamin A is also a useful immune system regulator—a deficiency leads to increased levels of pro-inflammatory cytokines.

Remedy Organics makes a whole line of immune support shots, with added benefits such as energy support. These shots contain ingredients we’ve discussed before—elderberry, ginger, vitamins C and D—but they also contain ingredients such as cayenne, which has been shown at low doses to beneficially influence gastrointestinal permeability and absorption and changes in gastrointestinal microflora, along with other gastrointestinal benefits (4).

For something trendy that boasts benefits, customers may be interested in Lumen’s Hemp Shots—offered in Immune, Vitamin D & Zinc, and Gut Well, all of the shots contain 1,750mg of hemp seed oil. Hemp seeds are a source of omega-3 fatty acids, which, besides their heart- and brain-health benefits, may have an effect on immune health. A study published in Lipids in 2003 explains that the matter is more complicated than “omega-6 is bad, omega-3 is good” (5). The author’s point: Balance is vital. For those who don’t eat enough fish, hemp seeds can be a useful way to up their omega-3 intake, and pairing it with immune-support ingredients can make this a go-to for customers looking for a wellness boost. (If you’re curious about omega-3’s other benefits, watch Dr. Alex Richardson’s talk in the Naturally Informed event Mental Wellness: Mastering the Market, available at www.NaturallyInformed.net.)

Buried Treasure offers a liquid version of many of the nutrients we’ve discussed as well, including a whole food complex Adult’s Daily Immune Wellness product and a D3 formula offering 5,000IU of this all-important nutrient.

There are also companies looking to improve bioavailability within the wellness shots arena. Vive Organic offers a line of Immunity Boost shots, including one with cayenne and one with elderberry. Their base mix includes turmeric and black pepper, a scientifically supported combination. Curcumin (a component of turmeric) is known for its anti-inflammatory effects, and a 2007 study notes that “curcumin has been shown in the last two decades to be a potent immunomodulatory agent that can modulate the activation of T cells, B cells, macrophages, neutrophils, natural killer cells, and dendritic cells. Curcumin can also downregulate the expression of various proinflammatory cytokines…curcumin at low doses can also enhance antibody responses” (6). Black pepper, on the other hand, doesn’t necessarily have major immune health benefits—but it contains a compound called piperine, which aids absorption of curcumin and other compounds, increasing bioavailability (7).

Quicksilver Scientific is improving bioavailability via liposomal technology. Liposomes are phospholipid bilayer structures—effectively, spheres made up of two layers of fat (8). These structures can contain a water-based solution, and can travel through the body to their target without breaking down; upon making contact with the target cells, the lipid bilayer breaks down, releasing its contents into the cell (8). This can increase absorption. Quicksilver offers a range of products, including several immune-support products, all made with liposomal technology.

NutraBio Immune For Optimal Immune System Support

NutraBio Immune For Optimal Immune System Support

  • March 18, 2021

Maximize your health and wellness with this top tier immune supplement.

Product Overview

As these winter months start to fade and the warmer ones move in, we’ll be outside more, basking in the sun after our forced hibernation for many months. While we all pay close attention to our health during these bitter, nasty months, it would be a mistake to let our guard down just because its warmer. Our immune systems are essential in keeping us running as efficiently as possible and we all know a minor setback or illness can throw our busy routine out of whack. NutraBio Immune is a great supplement to help maximize your health and support your wellness so you never let your guard down.

A powerful supplement like Immune is not only an immune booster but works to promote and support other vital functions in your body. Everything from your digestion process to bone and joint health are enhanced because they play into your overall health. While catching a cold may force you to stay out of the gym for a day or two, the larger benefits to a supplement like Immune go far beyond helping your sniffles.

NutraBio Immune

Shop at NutraBio

NutraBio is a high-quality sports supplement company creating top tier products for athletes everywhere. Their mission is clear: maximize the health and wellness of all consumers by bringing advanced nutrition products with science-backed research to enhance training and performance while aiding in an overall better quality of life. They are a standout in the industry for clean and effective products with no artificial fillers or excipients and stand by their goal of being honest and transparent with their labels.

strong man

NutraBio Immune Highlights

NutraBio Immune is the perfect supplement to help tackle your health and wellness needs. Those with a stronger immune system will be able to stay healthy every day, as well as alleviate that stress that seems to hurt your fitness and gains. What Immune can do is work to maximize your health and support your wellness by supporting your immune system, digestion process, bone and joint health, and overall health support to keep you firing at all times.

 

With 9 clean and effective ingredients, you can be sure that NutraBio provides transparency in their labels. Immune is non-GMO, gluten-free, and lactose-free with zero secret or proprietary blends. Everything you need and want to know is on the label. For those looking for the best immune supplement to help with their overall health, Immune is clean, effective, and perfect for you.

immune

Ingredients

Vitamin C: Boosts immune response and works to assist other bodily functions (1).

Epicor: Epicor is the whole food ingredient that supports your immune system as well as provide prebiotic benefits to support the digestion process of your food.

Grape Seed Standardized Extract: This ingredient provides antioxidant benefits and can help prevent free radical damage.

Ginger Root Extract: Supports the immune system and joints in hard-training athletes as well as older adults (2).

Vitamin D3: A vitamin that works alongside GRE in supporting bone health and a healthy heart.

N-Acetyl-Cysteine: NAC is a derivative of the amino acid L-cysteine which supports respiratory and immune health.

Zinc: Zinc is a well-known essential mineral that supports immune cells, metabolism, nerve function and skin health (3).

Selenium: Supports the immune system and thyroid health (4).

Copper: Copper is an essential mineral that supports nerve cells and is involved in the production of red blood cells.

NutraBio Immune Label

Price & Effectiveness

NutraBio Immune offers amazing benefits in supporting your health and wellness to keep your training and performance at an all-time high and your gains never stopping. With 30 servings per container, each serving size of 3 capsules will pump you with these clean and effective ingredients to boost your overall health.

 

Pros: Clean and effective ingredients matched by a transparent and honest label. Will support daily health and wellness with a well-researched and advanced formula. From a reputable and honest company in NutraBio.

Cons: Three capsules for a serving size is a lot for some.

Price: $39.99

Featured Athlete

Shane Burgos

Shane Burgos is a Professional UFC Featherweight and NutraBio athlete who uses their products to enhance all of his training and performance needs. His amateur record stood at 7-0, giving him the chance to compete with the best at the UFC level. Once going pro, his winning streak continued, winning 7 consecutive fights, all being either by knockout or submission. Five of those fights were won in the first round. As a serious athlete who knows what it takes to keep his body in the utmost shape to compete with the best in the world, Burgos relies on NutraBio for all his supplementation needs to keep him going strong under the bright lights in the cage.

Overall Value

NutraBio Immune is a great supplement designed to support your immune system, as well as help with a host of other vital bodily functions to keep you running and operating at maximum capacity. An advanced formula with clean and effective ingredients, NutraBio has created a supplement that is honest and transparent, so you know exactly what you are putting in your body. What you are really getting is a high-quality immune support supplement with the ability to enhance other vital functions created from clean ingredients from a reputable company. Try NutraBio Immune today and work to give your immune system that much needed support.

Try NutraBio Immune Today

Generation Iron may receive commissions on purchases made through our links. See our disclosure page for more information.

Let us know what you think in the comments below. Also, be sure to follow Generation Iron on Facebook, Twitter, and Instagram. 

*Images courtesy of NutraBio and Envato

References

  1. Carr, Anitra C.; Maggini, Silvia (2017). “Vitamin C and Immune Function”. (source) Vitamin C and Immune Function – PubMed (nih.gov)
  2. National Center for Complementary and Integrative Health. “Ginger”. (source) Ginger | NCCIH (nih.gov)
  3. Brandao-Neto, Jose; Stefan, Vivian; Mendonca, Berenice B.; Bloise, Walter; et al. (1995). “The essential role of zinc in growth”. (source) The essential role of zinc in growth – ScienceDirect
  4. Kohrle, Josef (2015). “Selenium and the thyroid”. (source) Selenium and the thyroid : Current Opinion in Endocrinology, Diabetes and Obesity (lww.com)

Surging demand for immune support creates opportunities for new ingredients

Surging demand for immune support creates opportunities for new ingredients

  • March 18, 2021

The immune health category has a lot of established ingredients like vitamins C & D, zinc, elderberry, echinacea, astragalus, and branded ingredients like Wellmune and EpiCor, but the overall percentage of the population searching for immune support has grown significantly, Sid Shastri, Director of Marketing for Kaneka Probiotics, told NutraIngredients-USA.

“After the pandemic hit in 2020, 54% of the global population has spent time learning about immune ingredients and procedures*,”​ said Shastri.   “So, while there are an increased number of branded offerings in this category, the massive public interest in the whole category will create opportunities for many innovative products.”

No longer a seasonal category

The expanded consumer base walks hand-in-hand with a shift in buying habits for immune products: The pandemic kept immune health front-of-mind at all times, shifting the category away from seasonal to constant. Many stakeholders think that this will continue, at least for several years.

Moving forward we do expect the trend of consuming immune health ingredients to be utilized year-round,” ​said Dr Shintaro Ichikawa, Director Technical Affairs, Kyowa Hakko USA. “According to NBJ report, around half of immune supplement users in the US are taking immune supplement daily, higher than those that use supplements occasionally.

“As we begin to gather back with friends and family and travel consumers will use and carry supplements with them on a regular basis,” ​added Dr Ichikawa. “In fact, one of our claims for IMMUSE is that is provide year-round immune support.”

capsimmunesystem.org