Category Archives: Genetic Engineering

In May, scientists at the John Innes Centre in Norwich unveiled a new breed of biofortified tomato so rich in vitamin D that a single gram of its dried leaves could deliver an adults recommended daily amount 60 times over.

It is hoped the super crop could go some way to tackling the vitamin D deficiencies that affect a billion people worldwide and was a breakthrough only possible thanks to a scientific process known as gene editing.

From creating disease-resistant pigs, to elite wheat capable of producing high yields in tough conditions, the applications for the technology which makes precise alterations to existing genes using molecular tools appear to be vast.

And with the arrival of the Genetic Technology (Precision Breeding) Bill currently working its way through the House of Commons, it also seems the UK could be one step closer to allowing such products on shelves.

Many would welcome a relaxation of the rules around genetic engineering. It could, they say, bolster food security, combat climate change and lower food prices against the backdrop of a worsening cost of living crisis. But for others its an ill-thought out move toward deregulation that could bring disastrous consequences. So, whats the truth?

When Boris Johnson became prime minister in July 2019 he was clear on his post-Brexit plans for genetic engineering, insisting he would liberate the UKs extraordinary bioscience sector from anti-genetic modification rules. Those rules have meant a de facto ban on all types of genetic engineering in the EU since 2001, with only a single approved GM crop, an insect resistant maize, currently grown in EU fields (albeit genetically modified animal feed is in widespread use).

It had been hoped by many researchers that gene editing would face a different fate. While GM involves the insertion of foreign DNA into a plant or animal, gene editing edits existing genes and thereby creates mutations that could otherwise have occurred naturally. But in 2018, the European Court of Justice rejected the distinction, and placed gene edited organisms under the same heavy restrictions as GMOs.

With Brexit though, came an opportunity for the UK to take a different view. And it hasnt wasted any time in doing so. Gene editing is a tool that could help us tackle some of the biggest challenges we face around food security, climate change and biodiversity loss, said environment secretary George Eustice in September 2021, as he confirmed the decision to move ahead with legislation that will see genetically-edited crops able to enter the UK market for the first time if they can gain approval via the novel foods process.

Its a step in the right direction, says Johnathan Napier, a professor at Rothamsted Research. But its still quite a small step forward, he says. Its not going to transform UK agriculture or the UK food chain, which is a shame.

Having said all that, it is incredibly welcome. Its the first liberalisation of regulation around genetic technologies that the UK has seen in, well, forever. The direction of travel while we were in the EU was that the hurdles got higher and higher, and the regulatory burden got greater and greater, so to be going in the other direction is incredibly encouraging and needs to be celebrated.

The powerful tool could help create crops more resilient against extreme weather, less susceptible to disease, less reliant on fertiliser and even more nutritious, explains Napier. All which would leave UK agriculture better able to withstand some of the many shocks currently being thrown at it. Shocks that include soaring food prices.

As a relatively new addition to sciences suite of genetic engineering tools, theres currently a lack of comprehensive research to say conclusively whether gene editing can help drive down costs, but there is research on genetic modification that suggests a link. Most recently, a report by the Council for Agricultural Science & Technology (CAST) in 2021 claimed that if the US were to ban biotech crops it would raise food prices by $14bn per year, and cost the US economy up to $4.9bn. Thats based on findings that non-GMO products currently carry premiums of up to 61.8% on shelf.

But Pat Thomas, director of civil society group Beyond GM, disputes any idea that the planned relaxation of rules could ease the cost of living crisis. Its an incredibly cynical argument, she says. The fact is there are no gene edited crops ready to go in the ground right now, and the crisis were experiencing is right now. The first crops could be as long as five years away from production.

It ignores the commercial reality too, points out Paula Kover, of the University of Baths department of biology and biochemistry. The technology is expensive to develop, so companies developing them will be looking for profit, and the idea that gene edited food will necessarily be cheaper is not an obvious consequence, she says. I can think of a lot of niche markets developing for crops with extra vitamins and nutrients, and these are upscale products that will not act to give the majority of people access to cheaper food.

For government to think otherwise is just the latest example of it being completely seduced by technology as a silver bullet, believes David Rose, lead of the Change in Agriculture group at Cranfield University. Be it robots picking strawberries or super crops defying climate change, theyre looking for short-term technology fixes to solve problems, many of which they should have anticipated and had a plan for, but didnt. They think technology is going to be the cavalry that rides in and solves everything when it wont.

What it will do is pander to pressure from commercial and academic quarters, believes Thomas. On the one hand, we have a very strong biotech research establishment here and they comprise a very strong lobby, we shouldnt underestimate the influence of that. Plus, the need to strike up new trade deals outside the EU, with markets that already embrace genetic engineering such as the US, Canada, Brazil and Australia, will be weighing on the governments rush to push legislation through, in her view.

The result of these muddied and even misguided motivations is legislation that is not fit for purpose according to Rose. On one level, it lacks clarity, he says, with vaguely defined terms as to exactly what type of genetically engineered products or techniques will be allowed. Thomas even goes so far as to argue the bill is so wide in scope that it could theoretically allow for genetically modified products too (when challenged on this, Defra reiterated the legislation would only apply to genetic changes that could have occurred naturally or through traditional breeding methods).

More broadly it fails to consider the full impact of allowing gene edited foods into the food supply chain, says Rose. Thats a view that was backed up by the Regulatory Policy Committee in June, which said the governments impact assessment was weak.

In the absence of a wider government strategy to say this is the vision we have for future farming and the place of gene editing within it, then its really hard to see whether the checks and balances are in place to make sure its used in a responsible way, adds Rose. It could, for example, be used to further intensify production systems.

Thats what deeply concerns UK dairy farmer Patrick Holden, CEO of the Sustainable Food Trust. It will perpetuate the decline of agricultural biodiversity, both of plants and animals. Already the gene pool used in UK agriculture is dangerously low, he points out. Weve lost a lot of the diversity that used to characterise agriculture. That leaves crops more exposed, not less, he adds. For that reason he and others take issue with the portrayal of GE as a less invasive alternative to GMOs. Not only is the distinction meaningless to the majority of shoppers, they say, but its a mischaracterisation. In fact, in a recent interview, Michael Antoniou, a molecular geneticist at Kings College London, said: At each one of the stages of the gene editing process, you introduce unintended genetic alterations running into the hundreds of thousands. You end up with a plant that carries a high burden of unintended DNA damage with unknown downstream consequences.

The government has not looked at the long-term effects of deregulation and liberalisation, sums up Thomas. Its looked at what the impact might be on researchers but not on natural or organic food businesses, the environment or farming. This bill is a free-for-all and unworkable at almost every level.

Given the long and controversial history of genetic engineering in this country its no surprise perhaps that the Genetic Technology Bill, which could see gene edited crops cultivated in UK fields in as little as two years, has reignited passionate views.

For Holden it is a disaster waiting to happen. The complexity of the genome is beyond the ken of the most sophisticated plant breeders in the world and yet with their arrogance and hubris they think they can redesign plants and animals to suit our purposes, he says. The arrogance of the science community is breathtaking and yet another manifestation of the way in which policy and science in agriculture has departed from the wisdom of the farming community that understand agriculture from the ground up, he says.

But for Cathie Martin, professor of plant sciences at the John Innes Centre, whose team were behind the gene edited vitamin D-rich tomatoes, that isnt fair.

Were proper scientists, and we dont want to produce something thats dangerous or rule the world, she laughs. Yes, the Genetic Technology Bill may have been drafted a little hastily, she accepts, and isnt highly defined but it will be the role of regulatory authorities such as Defra and the FSA to ensure that no unintended product gains approval. And they will judge that on a scientific basis, not on the basis of campaigners, or NGOs claims that its GM coming through in a different guise. They will do it on the basis of whether theres a risk to either the environment or food safety.

Even though the genetic mutation that allows tomatoes to produce extra vitamin D could have arisen naturally, the gene edited crop will be subject to the same stringent novel foods process that the likes of insect proteins or CBD are faced with, for example.

For Martin and many other scientists, the benefits outweigh the risks. Its a bit like Frankenstein, she adds. The worry is a monster will be created that we wont be able to control. But with plenty of regulatory mechanisms in place to prevent that happening, she and others insist, thats simply science fiction.

Though the leaves of tomato plants naturally produce vitamin D at very low levels, scientists at Norwichs John Innes Centre found that by turning off a specific molecule in the plants genome they could not only dramatically boost levels of production of the sunshine vitamin in the plants leaves, but also in the fruit itself.

The leaves could be used to create vegan vitamin D3 supplements, or for food fortification, say scientists.

Porcine reproductive and respiratory syndrome (PRRS) costs European pig producers nearly 1.5bn a year. But by deleting a small section of DNA that leaves pigs vulnerable to the disease, scientists at the University of Edinburghs Roslin Institute in 2018 created a GE breed with natural immunity.

As one researcher put it: The resulting pig is still 100% pig or 99.9999999% of a pig. The only thing missing is susceptibility to PRRS.

In September 2021, Rothamsted Research was granted permission by Defra to run field trials for its strain of GE low-acrylamide wheat.

The wheat has been edited to reduce levels of the naturally occurring amino acid asparagine, which is converted into acrylamide when bread containing the grain is baked or toasted.

In April, planting began on a field trial of both GE and GM barley that is hoped could reduce reliance of the crop on chemical fertilisers.

The gene edited variant has been altered to suppress the way in which it reacts with soil fungi. Scientists hope to create barley that more efficiently absorbs water from the soil, water that contains nitrogen and phosphorus two nutrients currently supplied often via synthetic fertilisers.

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Can gene editing ease the cost of living crisis? - The Grocer

These trees once ruled the canopies of much of Appalachia, with billions of mature American chestnut trees that towered in leafy forests from Maine to Mississippi. But around the beginning of the 20th century, an exotic fungus nearly drove the tree out of existence. Today, they still sprout in the wild but rarely reach maturity. Outside of growers orchards, scientists say, the tree is functionally extinct.

[Kyra] LoPiccolo and other researchers at SUNY ESF are growing American chestnut trees in the fields of Syracuse that can withstand that infection: Half of the nuts produced with the genetically engineered pollen will carry DNA meant to fight the blight. The researchers are now ready to sow the seeds in the wild, pushing to become the first in the United States to use genetic engineering to bring a forest tree back to its former glory.

But first, the project is seeking approval not only from three federal agencies but also from chestnut aficionados concerned about altering the genome of a beloved tree.

Anne Petermann, executive director of Global Justice Ecology Project, which helped organize the campaign against Darling 58, is worried the project will lead to morecommercial use of transgenic trees, to produce paper and lumber. She noted biotech firms hoping to make greater use of genetically modified organisms have helped fund SUNY ESFs work.

There are studies coming out weekly that show just how much we dont know about forest ecosystems, she said.

This is an excerpt. Read the original post here

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Gene editing could revive the American chestnut tree and help fight climate change but familiar anti-biotechonology activist critics will have none...

Teresa Martin| Columnist

Thethylacine, aka the Tasmanian tiger,more properly, Thylacinus cynocephalus. Meet this creature of myth and reality, a sad tale of human destruction and most recently of human hubris, all under the guise of technology power.

Thylacinus cynocephalusonce lived across Australia, New Guinea, and Tasmania. This meat-eating marsupial looked a bit like a brindled dog with an oversized head as reflected in the translation of its scientific name, which roughly means pouched dog with wolf head. They appear in fossils and in aboriginal rock paintings, representing thousands of years on the planet. At some point, the population retreated primarily to Tasmania, but well into modern humanitys lifeline thylacines roamed across dry forests, wetlandsand grasslands.

Their short soft brown fur carried distinct stripes across their backs and down their long tails. They weighed in at about 60 pounds imagine something like a striped brown Labrador retriever with a pouch for baby thylacines. They were shy around humans and often surrendered without a struggle. We know this because in 1924 settlers brought sheep to Tasmania and forever altered the ecosystem. The Van Diemans Land company set a bounty on thylacines in 1830 and by 1910 they were essentially gone. In 1936 the last known thylacine died in captivity and they were officially declared extinct in 1986.

But this summer a company named Colossal announced a partnership with an Australian lab. The goal? To de-extinct the thyacine.

It seems that a large donor gave 10 years of funding to establish the TIGRR lab TIGRR stands for Thylacine Integrated Genomic Restoration Research lab whose mission is to develop technologies for marsupial conservation and restoration. Colossal Bioscience (https://colossal.com/) says it brings that tech.

The company self-describes itself as the de-extinction company … a breakthrough bioscience and genetic engineering company that builds radical new technologies to advance the field of genomics. You might remember the company name as one attached to an effort to resurrect the woolly mammoth. Although frozen mammoth carcasses have yielded DNA for genetic engineering, it isnt quite clear that this large furred creature of the ice age could thrive in our 21st-century de-forested and heating climate.

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In contrast, the company says the thylacine's environment remains largely the same as it was at the time of its slaughter,making it an excellent candidate for restoration and re-wilding. It says it will use CRISPR genetic engineering and nine almost simple steps to undo the past.

According to an article by Andrew Pask of the University of Melbourne published on Phys.org (https://phys.org/news/2022-03-australia-extinct-thylacine.html) last March, steps 1 and 2 are already complete. The team says it has the full thylacine genome in hand; a genome basically provides a DNA recipe for an organism. It also has the full genome for a close living relative, in this case, the dunnart, also known as the marsupial mouse. Researchers will use dunnartDNA as a starting template.

The third step, now underway, aligns the two different genomes and identifies every point of variance, creating a master plan for DNA modification. Step 4 gathers dunnart STEM cells, steps 5-7 develop the assistive reproductive techniques to create and implant embryos into the host mother, and steps 8 and 9 sort out how a tiny marsupial baby, once born, can be nourished into a living thylacine.

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Remember, marsupials arrive in the world far smaller and less developed than mammals and the pouch provides a sort of external gestation period which explains how a smaller animal could potentially birth a much larger one.

This all sounds sort of sci-fi and gee-whiz! A whole whoosh of euphoria over how mankind can undo mankinds mistakes, restore the ecosystem, and revive the planet gushes forth in each announcement. But is playing a god of resurrection really any better than playing the god of death?

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As a species, our destruction of other species either directly or through wanton disregard for the ecosystem and environment has marked our travel through time. Some argue we represent the worst invasive species ever, wiping out all in our path. This is decidedly not good, and yet as a species, we seem unable to change. Right now, the global collective of homo sapiens seems bent on erasing the great rainforests, with their diversity and still-unknown depths, not to mention altering the base climate of our world and disrupting pretty much every other living organism. Yet, at the same time, we seem to think tech can Band-Aid it all.

Sorry, mom, I broke the vase. But dont worry, I have magic glue to put it back together again!

Marvel fans might recognize the same ethical question in the fictional storyline of the Blip/Snap, when Thanos snapped his fingers while wielding the Infinity Stones and blipped a random half of all living things in the universe out of existenceonly to have it made right five years later by Bruce Banner reversing the blip with Infinity Stones recovered from a different timeline. Are we both Thanos and Bruce Banner rolled into one?

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Tech always brings with it a whole host of deeper questions, questions of ethics and value and hubris. Just because we can, should we? Can we do anything because godlike we believe we can reverse it? And if we do reverse it, what unintended consequences emerge?

We killed the passenger pigeon, the great auk, the dodo, the eastern moa, the blue walleye, the silver trout, the Bali tiger, the golden toad and the thylacine. The list goes on, at a length that should leave us chilled and resolved to change our ways. Instead, we seem to focus on finding tech to clean up after us. The thylacine may well deserve its rebirth but make no mistake, technology does not make us a hero nor redeem prior actions. So as you marvel at the potential of tech resurrection, dont forget to look into our historical mirror at the same time.

Teresa Martin of Eastham lives, breathes and writes about the intersection of technology, business and humanity.

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Other columns by Teresa Martin:

Who knew shrimp shells could make this building material 40% stronger?

Dodd's decision: 'When it comes to privacy, no one can remain complacent'

The Power of Pup is far more satisfying than artificial intelligence

Link:
Colossal to de-extinct the Tasmanian tiger. Is it a safe thing to do? - Cape Cod Times

Opinions expressed by Entrepreneur contributors are their own.

Nanotechnology refers to the scientific study, research and reengineering of the properties of atoms and molecules. There's a great deal of controversy around this science, as it is intended to reshape the building blocks of matter. Like with all growing fields, there are costs and benefits, and due to its infinitely broad usage for applications, nanotech will impact our daily life in a profound way we have only started to see.

Introduced to the world in 1959 by physicist Richard Feynman, nanotechnology was conceptualized as synthesis through the reconstitution of atoms and molecules.

Over the past decade-and-a-half, nanotech has been one of the globe's fastest-growing industries, evolving each year significantly with great new applications. We've seen incredible innovation in energy, robotics, agriculture, health, computation, military intelligence and manufacturing. Those are just a small sampling of the sectors in which nanotech has been a great leader in advancement.

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Through particle rescaling and manipulation, nanotech creates chemical bonds that are sometimes hundreds of times more potent than steel. These bonds increase a material's surface area, allowing for more atoms to interact with it, making the material more robust, more conductive and more malleable than its natural-sized counterparts. How the particles are manipulated affects how dense or light, big or small, visible or transparent, reflective or absorptive to waves a nanotech product is. The objects of particle manipulation are referred to as nanomaterials.

Nanomaterials are classified into two main categories: naturally occurring (such as blood hemoglobin) and artificially developed (such as quantum dots). Of the artificially generated nanomaterials, there are four common types: carbon-based, metal-based, dendrimers and nanocomposites. While carbon-based and metal-based nanomaterials are formed through the chemical manipulation of elements to derive micro-matter constructs, dendrimers either expand outwardly from a strong core or inwardly from a solid outer shell, and nanocomposites combine different nanomaterials and larger-scale high-volume materials. To be considered a nanomaterial, the engineering must operate within the parameters of a nanoscale's nanometer, which translates to a billionth of a meter.

Nanotechnology is already widely present in our daily life. You may not realize it, but it is in everything from textiles to food packaging to transportation. For example, in recent years, nanotech has been used to create lightweight road, sea, air and space vehicles. In the medical sector, nanotech has allowed for better imaging tools, diagnostic technology and even within medicine itself, including delivering antigens to compromised cells while avoiding healthy cells. And how was that accomplished? The answer might seem like it's out of the pages of sci-fi-- but it's happening today.

Nanobots are nanoscopic machines programmed to deliver a specific task. They've been functional on both bioorganic matter and inorganic matter and have been central in many of today's significant advancements in virology, clean energy, water filtration and 3D printing. Nanobots can deliver medicine, move as a unit to improve the source collection of wind and solar resources, clean contaminated water and link together to replicate a 3D object and enact the point of its function.

Currently, nanotech is researching several world-changing initiatives. Self-repair of structural surfaces is now in the testing phase. This could be revolutionary for transportation infrastructure, allowing nanotech to bind to damaged roads, bridges and railways to correct structural issues and material deficits.

Synthesis of enzymes is also in the works, as is synthetic ethanol. A finite resource naturally derived from fossils, ethanol has various uses, from fuel to household cleaning products to acting as a binding agent for personal care products.

Robust rechargeable industrial battery systems are another avenue of exploration for which nanotech actively seeks real-world testing. Imagine the generation of an infinite amount of electricity. This may soon be possible through nanobots deployed as self-adaptive sensors, working in tandem with nanomaterials fabricated into self-servicing generators capable of powering cities with environment-friendly energy.

Another investigational innovation is replacing computer microchips with nanochips capable of fitting your computer and phone's entire memory on infinitesimal storage units. Since nanotransistors already exist and have been commercially operating since 2014, we may not be so far off from this development.

Gene-sequencing and genetic engineering are incorporating nanotech in illness eradication and the study of tissue-and-organ regeneration. While this is one of the farthest from practical implementations of nanotech's practical applications, it poses significant promise. We've poised to eventually engineer sequencing at the gene level to help eliminate hereditary illnesses and replace the sequences with positive characteristics and traits.

While it can be argued that the future of nanotech is happening now, we have barely scratched the surface. For example, the meeting of nanotechnology with self-realizing AI has long been theorized for its potential benefits in predicting, resolving and managing environmental crises and space exploration through analyzing universal patterns and behaviors. Though still far away, the applications to make climate concerns a thing of the past or develop new climate systems on otherwise inhabitable planets are pretty plausible.

Projected to reach $33.63 billion by 2030, from its current $1.76 billion market size value, nanotech is well on its way to trending as one of the current fastest-growing sciences, not just due to its percentage increase, but in its continued collaboration with industries across the board, and sharing budget of their market share. Future applications are genuinely limitless through nanotechnology, and living during this age of exploration is exciting.

Related: Think Big With a Nanotechnology Business

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The Future of Nanotech, the World's Tiniest Industry - Entrepreneur

What could be more natural than organically grown Golden Promise barley, used to make craft-brewed pale ale?

As one artisan brewer boasts:

The Golden Promise malt, showcased in this pale ale, is an early-maturing spring barley from Scotland. It has a very clean sweetness and a prominent biscuity flavour that is perfect for UK-style pale ales with their rich and malty flavour profiles.

Only hang on a minute.

Golden Promise was produced in 1965 by irradiating barley seeds with gamma rays from Cobalt 60 isotopes provided by the Harwell Atomic Energy Research Establishment to a profit-seeking plant breeding firm.

It was one of the first fruits of this new high-tech approach to scrambling the genomes of plants by busting their DNA in random ways in the hope of haphazardly generating valuable new forms of variation. Known as mutation breeding, some 2500 crop varieties have been bred in this way.

And yet Golden Promise is considered natural none the less. Indeed, it is a favourite crop among organic farmers.

By contrast, consider the case of genetically modified Bt maize.

This maize variety has never been near a nuclear plant but has had placed within it an entirely natural gene derived from an entirely naturally occurring bacteria called Bacillus thuringiensis indeed a bacterium that has itself been used as a crop protection product by organic farmers since the 1930s.

Bt insect resistance is a technology that reduces the need for man-made chemical sprays, relying instead on proteins made within organisms arguably a far more natural product, therefore, and certainly in any normal definition of the word organic.

Yet organic farmers reject this crop variety as unnatural, even though it uses the same protein molecules as their own sprays, because they say it is not natural for a plant to contain a bacterial gene.

Actually, thats not true. We now know that there is horizontal gene transfer between plants and bacteria, quite naturally, in the wild.

For example, the sweet potato contains a number of genes that were transferred naturally from Agrobacterium sometime during the last few million years. God in this case had played God.

But this was not known at the time the organic movement set up their rules, and they decided that a line has been crossed by genetic engineering that was not crossed by using the bacterium as a pesticide or by irradiating barley with gamma rays. And they have chosen not to change their rules since it became known.

So what are the criteria by which we decide when something has become unnatural.

The word natural is the single biggest selling point on any food item in a grocery store. Its widely used and there are absolutely no rules about when you can or cannot use it.

But what does it mean in the context of food?

Does it mean made by a natural, biological process within a living wild organism and untouched thereafter in which case almost nothing qualifies?

Does it mean organic? That is to say, farmed but without chemical fertiliser? In which case its a very arbitrary definition.

Does it mean healthy? That is to say low-carb, low-fat, low-sugar or something? In which case you have to face the fact that lots of natural things are bad for you deadly nightshade, destroying angel mushrooms etc.

Does it mean ethical? That is to say produced without exploiting somebody or some animal? Well, why is that natural? A pigeon shot by a farmer is surely natural meat but it would hardly get the RSPCAs approval.

Does it mean sustainable? That is to say, needing the least land and resources? Well, the best way to use the least land, water and other imports is probably to farm as intensively as possible.

The fact is, there is no single common definition or understanding of the term natural, a conclusion also reached by the Nuffield Council on Bioethics in a 2015analysis paperentitledIdeas about naturalness in public and political debates about science, technology and medicine.

Indeed, the Nuffield report found that the diversity and ambiguity of ideas associated with naturalness mean that people end up speaking at cross-purposes, or talking past one another using identical terms with different meanings and thereby fail to fully understand one another.

The report warned thateffective communication on the ethics of science, technology, and medicine may be hindered, rather than helped, by appeals to naturalness.

In a series of recommendations, the Nuffield report advised organisations and individuals contributing to public and political debates about science and technology, including policy-makers, politicians and journalists, to avoid using the terms natural, unnatural and nature without conveying the values or beliefs that underlie them.

The report also warned that manufacturers and advertisers of food and health products should be cautious about describing a product as natural given the ambiguity of this term and that it is unlawful to mislead consumers.

Since the terms natural and organic appear to have become synonymous and even more widely used in food marketing and advertising since the Nuffield Council on Bioethics produced its report, I will simply conclude with the thoughts of evolutionary biologist Richard Dawkins in an open letter to the Prince of Wales some years ago:

Agriculture has always been unnatural. Our species began to depart from our natural hunter-gatherer lifestyle as recently as 10,000 years ago too short to measure on the evolutionary timescale. Wheat, be it ever so wholemeal and stoneground, is not a natural food for Homo sapiens. Nor is milk, except for children. Almost every morsel of our food is genetically modified admittedly by artificial selection not artificial mutation, but the end result is the same. A wheat grain is a genetically modified grass seed, just as a Pekinese is a genetically modified wolf. Playing God? Weve been playing god for centuries!

Matt Ridley is a member of the Science for Sustainable Agriculture advisory group. He is the author of numerous books on science. He has been a journalist and a businessman and served for nine years on the House of Lords. He lives on a farm in Northumberland. Follow him on Twitter@mattwridley

A version of this article was originally posted at Science for Sustainable Agriculture and is reposted here with permission. Find Science for Sustainable Agriculture on Twitter @SciSustAg

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Viewpoint: The 'natural food' sham 'Effective communication on the ethics of science may be hindered by appeals to naturalness' - Genetic Literacy...

In Japan, Toray Industries, Inc., says it has developed the worlds first 100% bio-based adipic acid, a raw material for nylon 66 (polyamide 66), from sugars derived from inedible biomass. This achievement came from using a proprietary synthesis technique combining the companys microbial fermentation technology and chemical purification technology that harnesses separation membranes.

The company has started to scale up its capabilities in this area. It will test polymerization of nylon 66, develop production technology, conduct market research, and take steps to commercialize applications for this bio-based adipic acid by around 2030.

Nylon 66 has been used for many years in fibers, resins, and other applications due to its exceptionally durable, strong, and rigid properties. Pressures to develop eco-friendly nylon 66 have risen in recent years amid a growing awareness of the need to realize a sustainable society. One challenge is that conventional chemical synthesis for producing adipic acid, the raw material of nylon 66, generates a greenhouse gas called dinitrogen monoxide.

Toray was the first in the world to discover microorganisms that produce an adipic acid intermediate from sugars. The company reconfigured metabolic pathways within microorganisms to enhance production efficiency by applying genetic engineering technology, which artificially recombines genes to streamline synthesis in microorganisms. It also employed bioinformatics technologies to design optimal microbial fermentation pathways for synthesis. Quantity of the intermediate synthesized by microorganisms has increased more than 1,000-fold since the initial discovery, and the efficiency of synthesis has improved dramatically.

Toray is using reverse osmosis separation membranes to concentrate the intermediate in the purification process. This approach is more energy efficient than other methods that do not use these membranes. This bio-adipic acid production technique is free of dinitrogen monoxide emissions, unlike the manufacturing processes for petroleum-derived adipic acid, and is expected to help combat global warming.

Tags: Adipic acid, Inc., Japan, Toray Industries

Category: Fuels

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Toray says it has developed the worlds first 100% bio-based adipic acid - Biofuels Digest

"The laboratory house mouse has maintained a standard 40-chromosome karyotypeor the full picture of an organism's chromosomesafter more than 100 years of artificial breeding," said Li Zhikun, a researcher at CAS's Institute of Zoology.

"Over longer time scales, however, karyotype changes caused by chromosome rearrangements are common. Rodents have 3.2 to 3.5 rearrangements per million years, whereas primates have 1.6," added Li, co-first author of the study.

The mouse, known as Xiao Zhu, or "Little Bamboo," was the world's first mammal with fully reprogrammed genes, according to the South China Morning Post.

The study claims to have provided important insight into how chromosomal rearrangements may affect evolution by showing that chromosome-level engineering is possible in mammals and by effectively deriving a laboratory house mouse with a novel and sustainable karyotype.

According to Li, such small changes can have a big impact. Humans and gorillas are separated by 1.6 changes in primates. Gorillas have two distinct chromosomes, whereas humans have two fused chromosomes, and a translocation between ancestor human chromosomes resulted in two distinct chromosomes in gorillas.

Individually, fusions or translocations can result in missing or extra chromosomes, as well as diseases like childhood leukemia.

While the chromosomes' consistent reliability is useful for understanding how things work on a short time scale, Li believes that the ability to engineer changes could inform genetic understanding over millennia, including how to correct misaligned or malformed chromosomes.

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Chinese scientists claim to have engineered the world's first mouse with fully reprogrammed genes - Interesting Engineering

DetailsCategory: DNA RNA and CellsPublished on Saturday, 27 August 2022 11:16Hits: 666

Investigational New Drug Application for CNTY-101, a CAR-iNK product candidate targeting CD19 for B-cell malignancies, cleared by FDA

First cell product candidate engineered with six precision gene edits including a CD19-CAR, Allo-Evasiontechnology, IL-15 cytokine support and a safety switch

Phase 1 ELiPSE-1 trial evaluating CNTY-101 in relapsed or refractory CD19 positive B-cell malignancies anticipated to begin in 2H22

PHILADELPHIA, PA, USA I August 25, 2022 I Century Therapeutics, Inc., (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology, announced today that the company has been notified by the U.S. Food and Drug Administration (FDA) that the Companys ELiPSE-1 clinical study may proceed to assess CNTY-101 in patients with relapsed or refractory CD19 positive B-cell malignancies. CNTY-101 is the first allogeneic cell therapy product candidate engineered with four powerful and complementary functionalities, including a CD19 CAR for tumor targeting, IL-15 support for enhanced persistence, Allo-Evasiontechnology to prevent host rejection and enhance persistence and a safety switch to provide the option to eliminate the drug product if ever necessary. CNTY-101 is manufactured from a clonal iPSC master cell bank that yields homogeneous product, in which all infused cells have the intended modifications.

This IND clearance is a significant milestone for Century as we execute on our vision to merge two disruptive platforms, precision gene editing and the powerful potential of iPSCs, to potentially move the allogeneic cell therapy field forward, and continue on our path to becoming a leader in the space, said Lalo Flores, Chief Executive Officer, Century Therapeutics. We believe that CNTY-101, our first and wholly owned product candidate, will be the most technically advanced and differentiated CD19-targeted cell product when it enters the clinic, which is anticipated to occur later this year. We look forward to assessing the potential of Allo-Evasionto prevent immunological rejection and enhance persistence of multiple dosing of CNTY-101 regimens with the aim to increase the proportion of patients that achieve durable responses.

CNTY-101 is the first allogeneic cell product candidate with six genetic modifications incorporated using sequential rounds of CRISPR-mediated homologous recombination and repair that has received IND clearance by the FDA, said Luis Borges, Chief Scientific Officer, Century Therapeutics. We believe CNTY-101 will demonstrate the power of Centurys iPSC technology and cell engineering technology platforms. This accomplishment is a testament to the expertise and dedication of our team as we continue to make progress developing our pipeline of iPSC-derived NK and T cell product candidates.

The Phase 1 trial, ELiPSE-1 (NCT05336409), is intended to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of CNTY-101 in patients with relapsed or refractory CD19-positive B-cell malignancies. All patients will receive an initial standard dose of conditioning chemotherapy consisting of cyclophosphamide (300 mg/m2) and fludarabine (30mg/m2) for 3 days. Schedule A of the trial includes a single-dose escalation of CNTY-101 and subcutaneous IL-2. Schedule B will evaluate a three-dose schedule per cycle of CNTY-101. Patients who demonstrate a clinical benefit are eligible for additional cycles of treatment with or without additional lymphodepletion pending FDA consent. We anticipate initiation of the Phase 1 trial later this year.

About Allo-Evasion

Centurys proprietary Allo-Evasiontechnology is used to engineer cell therapy product candidates with the potential to evade identification by the host immune system so they can be dosed multiple times without rejection, enabling increased persistence of the cells during the treatment period and potentially leading to deeper and more durable responses. More specifically, Allo-Evasion1.0 technology incorporates three gene edits designed to avoid recognition by patient/host CD8+ T cells, CD4+ T cells and NK cells. Knockout of beta-2-microglobulin or 2m, designed to prevent CD8+ T cell recognition, knock-out of the Class II Major Histocompatibility Complex Transactivator, or CIITA, designed to prevent CD4+ T cell recognition, and knock-in of the HLA-E gene, designed to enable higher expression of the HLA-E protein to prevent killing of CNTY-101 cells by host NK cells. Allo-Evasiontechnology may allow the implementation of more flexible and effective repeat dosing protocols for off-the-shelf product candidates.

About CNTY-101

CNTY-101 is an investigational off-the-shelf cancer immunotherapy product candidate that utilizes iPSC-derived natural killer (NK) cells with a CD19-directed chimeric antigen receptor (CAR) and includes Centurys core Allo-Evasionedits designed to overcome the three major pathways of host versus graft rejection - CD8+ T cells, CD4+ T cells and NK cells. In addition, the product candidate is engineered to express IL-15 to provide homeostatic cytokine support, which has been shown pre-clinically to improve functionality and persistence. Further, to potentially improve safety, the iNK cells were engineered with an EGFR safety switch, and proof-of-concept studies have demonstrated that the cells can be quickly eliminated by the administration of cetuximab, an antibody against EGFR approved by the U.S. Food and Drug Administration (FDA) for certain cancers. Initiation of the Phase 1, ELiPSE-1 trial in relapsed or refractory CD19-positive B-cell malignancies in multiple centers in the United States is anticipated to begin in the second half of 2022.

About Century Therapeutics

Century Therapeutics, Inc. (NASDAQ: IPSC) is harnessing the power of adult stem cells to develop curative cell therapy products for cancer that we believe will allow us to overcome the limitations of first-generation cell therapies. Our genetically engineered, iPSC-derived iNK and iT cell product candidates are designed to specifically target hematologic and solid tumor cancers. We are leveraging our expertise in cellular reprogramming, genetic engineering, and manufacturing to develop therapies with the potential to overcome many of the challenges inherent to cell therapy and provide a significant advantage over existing cell therapy technologies. We believe our commitment to developing off-the-shelf cell therapies will expand patient access and provide an unparalleled opportunity to advance the course of cancer care. For more information on Century Therapeutics please visithttps://www.centurytx.com/.

SOURCE: Century Therapeutics

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Century Therapeutics Receives Study May Proceed Notification from FDA for CNTY-101, the First Allogeneic Cell Therapy Product Candidate Engineered to...

Part 1 of the new Climate Tech Weekly series, "What Would Dolly Parton Do? 9 to 5 in the Climate Tech Sector"

Before we dive in, I need to say thank you so much to everyone who responded to my call for climate tech startups with influential women steering the ship. I received so many messages I literally had to create a new folder in my inbox to keep everything organized a.k.a. Please be patient with me about my response time!

Welcome to the first article in our brand new series, "What Would Dolly Parton Do? 9 To 5 In the Climate Tech Sector." First up is Living Carbon, a synthetic biotechnology company based in Hayward, California.

One sunny Friday, I walked into an unassuming building and was met by a woman with a glowing smile Living Carbon CEO and co-founder Maddie Hall. She instantly set the tone of the tour as informative yet conversational, cracking jokes and sipping seltzer throughout our afternoon together.

So what does a synthetic biotech company do? Hall breaks it down for me: It all comes down to trees. As we walked through the lab and growing center, Hall explained that Living Carbon starts with the seedlings of hybrid poplar trees and genetically alters the seeds.

"We start with these undifferentiated plant cells, or the plant version of stem cells, and we go through this process called particle bombardment where we use a combination of helium, gold particles and a vacuum. We also do gene editing with CRISPR [a technology often used to edit genes]."

Living Carbon grows the seedlings from a few cells on a petri dish to fledging trees, and are in the process of building a specific greenhouse for the plants once they grow to a certain height; for now, the trees are housed in a special room with specifically designed LED lights.

Living Carbon then sells the trees to landowners seeking to transform their own properties to more productive systems. Additionally, Living Carbon sells credits to carbon credit buyers Ill expand on that aspect of the company later on.

Once transferred from the lab to the earth, the real fun begins. As the trees grow and live, they accumulate highly concentrated amounts of nickel from the soil and capture higher than normal amounts of carbon from the atmosphere once planted in the ground.

Nickel is a natural component of soil, but when too much has built up due to industrial processes, it can actually inhibit natural growth.

What makes these trees stand apart from the multitudes of tree planting campaigns around the world is the genetic engineering that increases their effectiveness for eliminating hazardous materials from the natural world and higher growth rate.

Lounging in the conference room, appropriately decorated with wall art depicting branches in a forest, Hall and I discuss Living Carbons inception and creation.

Before Living Carbon, Hall worked at venture capital firm Y Combinator on special projects focusing on the future of artificial intelligence (AI). As she learned about the technology of the future via her clients, her own passion to make an impact began to bloom.

"Were already working on something that is decades in the future and what the world will sort of look like. You start to think a lot more about existential threats to humanity, and climate is one of them. So I did a deep dive looking for something similar to AI but for climate change."

And her path became clear: plant biotechnology. "You have all of these really brilliant tenured researchers who have spent most of their lives working on crops or sometimes even chemicals, but you go into plant biotech because you really like plants." So Hall, alongside her co-founder, Patrick Mellor, decided to provide a third option for these singular minds: A private company that supports both lab and field research and implementation for multiple species of trees.

Hall counts herself among those who really like plants. Since childhood, the CEO explained her whole world has been influenced by greenery via her family, saying, "My grandmother was on the board of the arboretum in Seattle for 50 years as a volunteering memberand my other grandma was a librarian who studied plants and birds and my mom did flowers."

When I asked Hall to describe her experience as a female founder in Silicon Valley a space famously oversaturated with male CEOs she dropped the jovial tone.

"Neither [my grandmother or mother] had the chance to start a company. So I feel like [Living Carbon] is the company that I would have wanted all of the women in my family who came before me to also have the opportunity to start."

And it's not just a family legacy Hall considers when evaluating her role as CEO. She describes the implications of starting a business in her late 20s, acknowledging that if she wanted to become a mother, the time for Living Carbon was now or never. And this dilemma, she elaborates, of family versus work is a decision frequently weighed by women that men in her position dont tend to consider.

Furthermore, Hall describes her hesitancy to engage in PR for Living Carbon until multiple clients were booked, saying, "I wanted us to have scientific credibility because I saw so many hit pieces on female founders coming out and Im like, I know at least 20 male founders who had done the same things but didnt get an entire article."

I recently wrote about Frontier, a new philanthropic advance market commitment (AMC) that finances early-stage climate tech companies with the potential to invigorate a carbon capture and credit market. In June, Living Carbon was announced as one of six companies chosen to receive money from the AMC, allowing the company to sell carbon credits created with the carbon sequestered from the atmosphere via the trees planted.

With this new funding, Living Carbon will continue to scale up. When I asked if the public would be able to pick up one of these super trees from their local Lowes sometime in the near future, the answer was a firm no. Hall made it clear that Living Carbon wants to make a massive impact, saying, "If were at Home Depot or Lowes, it's one person planting a tree, but what we want is to be working on a massive scale." That massive scale is more to the tune of planting thousands of trees where an old mine used to be, rehabilitating the soil and habitat. And isnt that, after all, the reason why trees exist in the first place?

So there you have it, folks. The first official entry in the series "What Would Dolly Parton Do? 9 To 5 in the Climate Tech Sector." And dont worry. Ill let Dolly play me out(skip to one minute in to get to the actual song).

"You better get to livin"

Some quotes in this article were altered for clarity or length.

[Want more great insight on technologies and trends accelerating the clean economy? Subscribe to our free Climate Tech Weekly newsletter. ]

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Living Carbon: The startup setting down roots from 9 to 5 | Greenbiz - GreenBiz

GAITHERSBURG, Md., Aug. 26, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) has granted expanded conditional marketing authorization (CMA) for Nuvaxovid (NVX-CoV2373) COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged 12 through 17.

"As we start to prepare for a potential fall surge, we are pleased to offer the first protein-based COVID-19 vaccine to adolescents aged 12 through 17 in the U.K.," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We believe that our vaccine, developed using an innovative approach to traditional technology, may help increase adolescent vaccination rates."

The expanded CMA was based on data from the ongoing pediatric expansionof the Phase 3 PREVENT-19 trial of 2,247 adolescents aged 12 through 17 years across 73 sites in the U.S., to evaluate the safety, effectiveness (immunogenicity), and efficacy of Nuvaxovid. In the pediatric expansion, Nuvaxovid achieved its primary effectiveness endpoint and demonstrated 80% clinical efficacy overall at a time when the Delta variant was the predominant circulating SARS-CoV-2 strain in the U.S.

Preliminary safety data from the pediatric expansion showed the vaccine to be generally well-tolerated. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups, and not considered related to the vaccine. Local and systemic reactogenicity was generally lower than or similar to adults, after the first and second dose. The most common adverse reactions observed were injection site tenderness/pain, headache, myalgia, fatigue, and malaise. There was no increase in reactogenicity in younger (12 to <15 years old) adolescents compared to older (15 to <18 years old) adolescents. No new safety signal was observed through the placebo-controlled portion of the pediatric expansion.

The next step for the vaccine is a policy recommendation for use from the UK Joint Committee on Vaccination and Immunisation (JCVI). Doses of Nuvaxovid will be made available for use in adolescents based on the JCVI's recommendation.

In the 12 through 17 year-old population, the Novavax COVID-19 vaccine has been granted authorization in the U.S., India, the European Union, Australia, Japan, Thailand, and New Zealand, and is actively under review in other markets.

The MHRA previously granted CMA for Nuvaxovid in adults aged 18 and older in February 2022. The vaccine is given as a primary vaccination in two doses administered 21 days apart. Novavax filed for expanded CMA for use as a booster in adults aged 18 and over in June 2022.

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. If you are concerned about an adverse event, it should be reported on a Yellow Card. Reporting forms and information can be found at https://coronavirus-yellowcard.mhra.gov.uk/or search for MHRA Yellow Card in the Google Play or Apple App Store. When reporting please include the vaccine brand and batch/Lot number if available.

Trade Name in the U.S.The trade name Nuvaxovid has not yet been approved by the U.S. Food and Drug Administration.

Important Safety Information: UK

For more information on Nuvaxovid, including the Summary of Product Characteristics with Package Leaflet, adverse event reporting instructions, or to request additional information, please visit the following websites:

About Nuvaxovid (NVX-CoV2373)Nuvaxovid (NVX-CoV2373) is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. The vaccine was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Nuvaxovid contains purified protein antigen and can neither replicate, nor can it cause COVID-19.

Nuvaxovid is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2- 8 Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations.

Novavax has established partnerships for the manufacture, commercialization, and distribution of Nuvaxovid worldwide. Existing authorizations leverage Novavax' manufacturing partnership with Serum Institute of India, the world's largest vaccine manufacturer by volume. They will later be supplemented with data from additional manufacturing sites throughout Novavax' global supply chain.

About the Novavax COVID-19 vaccine (NVX-CoV2373) Phase 3 TrialsThe Novavax COVID-19 vaccine (NVX-CoV2373) continues being evaluated in two pivotal Phase 3 trials.

PREVENT-19 (thePRE-fusion protein subunitVaccineEfficacyNovavaxTrial | COVID-19) is a 2:1 randomized, placebo-controlled, observer-blinded trial to evaluate the efficacy, safety and immunogenicity of the Novavax COVID-19 vaccine with Matrix-M adjuvant in 29,960 participants 18 years of age and over in 119 locations inthe U.S.andMexico. The primary endpoint for PREVENT-19 was the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least seven days after the second dose in serologically negative (to SARS-CoV-2) adult participants at baseline. The statistical success criterion included a lower bound of 95% CI >30%. A secondary endpoint was the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Both endpoints were assessed at least seven days after the second study vaccination in volunteers who had not been previously infected with SARS-CoV-2. In the trial, the Novavax COVID-19 vaccine achieved 90.4% efficacy overall. It was generally well-tolerated and elicited a robust antibody response after the second dose in both studies. Full results of the trial were published in theNew England Journal of Medicine(NEJM).

The pediatric expansion of PREVENT-19 is a 2:1 randomized, placebo-controlled, observer-blinded trial to evaluate the safety, effectiveness, and efficacy of the Novavax COVID-19 vaccine with Matrix-M adjuvant in 2,247 adolescent participants 12 to 17 years of age in 73 locations in the United States, compared with placebo. In the pediatric trial, the vaccine achieved its primary effectiveness endpoint (non-inferiority of the neutralizing antibody response compared to young adult participants 18 through 25 years of age from PREVENT-19) and demonstrated 80% efficacy overall at a time when the Delta variant of concern was the predominant circulating strain in the U.S.Additionally, immune responses were about two-to-three-fold higher in adolescents than in adults against all variants studied.

Additionally, a trial conducted in the U.K. with 14,039 participants aged 18 years and over was designed as a randomized, placebo-controlled, observer-blinded study and achieved overall efficacy of 89.7%. The primary endpoint was based on the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least seven days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline. Full results of the trial were published inNEJM.

About Matrix-M AdjuvantNovavax' 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 NovavaxNovavax, 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 harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. The Novavax COVID-19 vaccine, has received authorization from multiple regulatory authorities globally, including the U.S., EC and the WHO. The vaccine is currently under review by multiple regulatory agencies worldwide, including for additional indications and populations such as adolescents and as a booster. In addition to its COVID-19 vaccine, Novavax is also currently evaluating a COVID-seasonal influenza combination vaccine candidate in a Phase 1/2 clinical trial, which combines NVX-CoV2373 and NanoFlu*, its quadrivalent influenza investigational vaccine candidate, and is also evaluating an Omicron strain-based vaccine (NVX-CoV2515) as well as a bivalent format Omicron-based / original strain-based vaccine. These 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, visitwww.novavax.comand connect with us on LinkedIn.

*NanoFlu identifies a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine candidate produced by Novavax. This investigational candidate was evaluated during a controlled phase 3 trial conducted during the 2019-2020 influenza season.

Forward-Looking StatementsStatements herein relating to the future of Novavax, its operating plans and prospects, its partnerships, the potential for subsequent orders from the U.S. government for additional doses of NVX-CoV2373 and other potential formulations, the timing of clinical trial results, the ongoing development of NVX-CoV2373, including an Omicron strain based vaccine and bivalent Omicron-based / original strain based vaccine, a COVID-seasonal influenza investigational vaccine candidate, the scope, timing and outcome of future regulatory filings and actions, including Novavax' plans to supplement existing authorizations with data from the additional manufacturing sites in Novavax' global supply chain, additional worldwide authorizations of NVX-CoV2373 for use in adults and adolescents, and as a booster, the potential impact and reach of Novavax and NVX-CoV2373 in addressing vaccine access, controlling the pandemic and protecting populations, the efficacy, safety and intended utilization of NVX-CoV2373, and the expected administration of NVX-CoV2373 are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; unanticipated challenges or delays in conducting clinical trials; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax' Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent Quarterly Reports on Form 10-Q, 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 http://www.sec.gov and http://www.novavax.com, 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.

Contacts:

InvestorsErika Schultz | 240-268-2022[emailprotected]

MediaAli Chartan or Giovanna Chandler | 202-709-5563[emailprotected]

SOURCE Novavax, Inc.

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Novavax Nuvaxovid COVID-19 Vaccine Granted Expanded Conditional Marketing Authorization in the United Kingdom for Use in Adolescents Aged 12 Through...