Category Archives: Genetic Engineering

Scientists say they have managed to genetically modify mosquitoes so that they are unable to spread malaria, a disease that kills well over half a million people each year.

The changes cause mosquitoes to live shorter lives, while the parasites inside them, which cause the fatal infection, develop more slowly.

This slashes the chances of mosquitoes living long enough to carry fully grown parasites and transmit the disease to the humans they bite.

Malaria is spread by the parasite Plasmodium falciparum, which grows and reaches maturation inside the female Anopheles mosquito. The average mosquito survives on average seven to 10 days in the wild.

"Most mosquitoes never have the chance to transmit the parasite. It's only 10 per cent of the mosquitoes out there that live long enough to be able to transmit the parasite," said Professor George Christophides, of Imperial College London.

"By prolonging the developmental time that the parasite needs inside the mosquito to become infectious, this 10 per cent becomes now much smaller".

"At the same time, we managed to cut the mosquito's life a bit short. So the two things combined together now can lead to blocking malaria transmission in the field," he added.

However, the fight against malaria is far from over.

In order for the mosquitoes with modified DNA to survive and propagate widely in nature, they need to defy natural selection.

"These modifications make them weaker because they live shorter. So they will be eliminated naturally by natural selection after a few generations... unless you combine it with what we call the 'gene drive,' which will take this modification and spread it quickly through the populations," Christophides said.

Gene drive is a type of genetic engineering which favours specific hereditary characteristics to increase the likelihood that these are quickly spread through the population and passed on to the next generation, according to the Proceedings of the National Academy of Sciences (PNAS).

The researchers believe that such a "gene drive" will allow all mosquitoes to eventually carry the same modification of their DNA within a few generations.

However, it raises questions about whether massively releasing GM mosquitoes is safe for people, animals, or the environment.

For more on this story, watch the video in the media player above.

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Scientists are manipulating the DNA of mosquitoes to fight the spread of malaria - Euronews

A report published Wednesday exposes the "growing threat" of genetically engineered tree development around the world, with researchers urging a leading forest product certification body to maintain its longstanding ban on genetic modification.

"The convenience of trees that can survive glyphosate will likely result in the use of more glyphosate, more often."

"The global release of genetically engineered (GE or genetically modified) trees is closer than it has ever been," states the report, assembled by the Canadian Biotechnology Action Network (CBAN) and the Campaign to STOP GE Trees. "This advancement is a significant concern because the release of GE trees would pose serious threats to forests and other ecosystems, as well as to many local communities and Indigenous peoples. The environmental impacts could be irreversible."

The report documents the status of GE tree development worldwide to identify where the risk of GE tree use on plantations or release into the wild is most immediate. It comes ahead of the Forest Stewardship Council's (FSC) general assembly from October 9-14 in Bali, Indonesia.

The FSCa nonprofit headquartered in Germany that operates a global market-based certification program for forest productsis currently reconsidering its 27-year ban on GE trees, much to the chagrin of civil society groups around the globe.

As the report notes, the FSC and other so-called "sustainable forest management" organizations that certify products according to their own social and environmental standards are facing pressure from major corporations and university biotechnology researchers to allow GE trees in their certification programs.

Next month in Bali, FSC members will vote on two motions that, if approved, would help preserve the group's prohibition on genetic modification.

However, "if the Forest Stewardship Council decides to embrace genetic engineering, it will free the Brazilian pulp and paper company Suzano to begin planting its eucalyptus trees that are genetically engineered to tolerate glyphosate herbicides," warned Lizzie Daz of the World Rainforest Movement.

To date, the only genetically modified forest tree released commercially was a GE poplar tree in 2002 in China.

Despite opposition from nearly three dozen environmental and social justice groups in Brazil and several others across the world, the Brazilian government approved Suzano's application for a GE glyphosate-tolerant eucalyptus tree last November. As an FSC-certified company, Suzano cannot start commercial planting of its GE tree unless the FSC drops its ban on genetic modification or Suzano leaves the organization.

According to the report:

Suzano claims that this GE eucalyptus "will allow more efficient weed control with lowered chemical load and improved worker conditions." However, this promise was also made by the biotechnology industry for the use of GE herbicide-tolerant crops and it proved false. Herbicide use increased significantly with the use of GE herbicide-tolerant crops in North America and South America. Pesticide use in soybean production in Brazil increased three-fold between 2000 and 2012 after the introduction of GE (Roundup Ready) soy. Official statistics show rates of glyphosate use increased significantly in both Brazil and Argentina where glyphosate-tolerant soy is 85% and 100% of all soy grown respectively.

Glyphosate is used to clear the land of other plants in order to prepare tree plantation sites and it is also applied to new plantations in the first few years of growth. As observed with GE crops, the convenience of trees that can survive glyphosate will likely result in the use of more glyphosate, more often. In the case of eucalyptus plantations, it may also encourage ariel spraying of new plantations where direct spraying of plants on the ground is the current norm.

[...]

Glyphosate is now the most widely used herbicide ingredient in the world. Brazil's health agency, Anvisa, concluded that there are health risks for people exposed to glyphosate when it is applied to crops and stipulated a safe distance be kept from populated areas when using it. This is important because many small communities are surrounded by eucalyptus plantations, just as others are surrounded by GE glyphosate-tolerant soy monocultures. Pesticide use in Brazil with GE soy causes injury to thousands of people each year.

Contrary to claims made by agro-chemical giants, the report finds no evidence that the introduction of genetically modified trees designed to be more productive will lead to land conservation. The further expansion of tree plantationsalong with increased social conflictis the more likely outcome, the authors warn.

"Tree plantations are not forests: they do not support the same biodiversity as forest ecosystems," the report stresses. "They often deplete water resources, degrade and erode soil, and make extensive use of chemical pesticides. The ecological impacts of plantations are felt by local communities, who are often left without livelihoods, food, or water, with little recourse."

"In 2018, more than one thousand women from the rural Landless Workers Movement (MST) in Brazil took over a mill owned by the pulp and paper company Suzano," the report notes. "The women's key grievances included the depletion of critical freshwater resources and the contamination of water by aerial spraying of pesticides on eucalyptus plantations."

Other key findings include:

"Development of genetically engineered trees is advancing despite the serious risks to our forests and continued opposition around the world," lead author Lucy Sharratt of CBAN said in a statement. "Our report shows that genetically engineered trees are closer than ever to being released even though interest is limited to just a handful of companies and university researchers."

Nevertheless, "genetically engineered trees are not inevitable," Sharratt continued. "Even if the research is very far advanced, or even approved for planting, GE trees still might never make it to market. Genetic engineering in trees is technically challenging, extremely risky for the environment, and globally, it's very controversial."

The report also points out, however, that "just as the development of GE trees is advancing, government regulation is retreating," thereby increasing the risks that such trees will be released.

"Many national governments are reducing or removing their oversight of the field testing and commercial release of new genetically modified organisms," the authors write. "This report may be the last opportunity to get a snapshot of GE tree field testing around the world."

"The gaps in our understanding of genetic engineering, tree biology, and forest ecology conspire to build a profile of tremendous uncertainty," the report adds. "At the same time, the enormous ability of trees to spread pollen and seeds increases the reach of potential environmental and social impacts across national borders and in violation of Indigenous sovereignty."

"Genetically engineered trees would also perpetuate environmentally and socially destructive industrial plantation production that contributes to the climate crisis," the authors conclude. "Instead of moving towards a climate solution, genetically engineered trees would add unnecessary risks to forests, with possible irreversible impacts."

Originally posted here:
Experts Sound Alarm Over 'Growing Threat' of Genetically Engineered Trees - Common Dreams

Smile Coffee Werksannounced it upgraded its coffee beans toFair TradeandUSDA Organic a compliment to its plant-based, carbon neutral, and USDA-Biobased pods that are certified commercially compostable by both BPI and CMA.

The Fair Trade seal symbolizes to consumers that Smile's coffee was sourced and sold ethically, ensuring adequate working conditions and a fair deal for farmers and workers in developing countries. Fair Trade is a component of the quality of life and social justice aspects of agricultural sustainability.

The USDA Organic certification verifies the quality and production of the product itself. Organic operations must maintain or enhance soil and water quality while also conserving wetlands, woodlands, and wildlife. Synthetic fertilizers, sewage sludge, irradiation, and genetic engineering may not be used. All organic products are protected from prohibited substances and methods from the field to the point of final sale.

"Smile's committed to sustainability and convenience by finally bringing consumers what they want: a guilt-free sustainable coffee pod matched with great sustainable coffee," CEO and co-founderMichael Sands, said in the announcement.

Keurig-compatible pods are available in three flavors: Werkday (Light / Medium Roast), Woke Up (Dark Roast) and Laugh to Decaf. The pods can be bought online at Walmart, Amazon, andwww.smilecoffeewerks.com.

Read the original here:
Smile Coffee Werks upgraded its coffee beans to Fair Trade and USDA Organic - Vending Market Watch

As we know, there are three major categories of medicines according to their sources, including natural medicines, chemically synthesized drugs, and biological therapeutics.

Among them, biological therapeutics (aka. biologics) are drugs developed and manufactured through biotechnology, such genetic engineering, cell engineering, and protein engineering. Two major categories of biopharmaceuticals have been small molecule- and protein/antibody-based biologics.

Recently, fueled by the global use of mRNA-based COVID-19 vaccines and nucleic acid-based testing for the SARS-CoV-2 virus, the new wave of nucleic acid-based medicine development and production has started taking off (pdf). Furthermore, the increasing number of nucleic acid drugs approved by the U.S. Food and Drug Administration (FDA) demonstrates the potential to treat diseases by targeting the genes responsible for them.

Nucleic acid therapeutics are based on nucleic acids or closely related chemical compounds, and they are completely different from small molecule drugs and antibody drugs.

Instead of targeting protein causes of diseases, they target disease on a genetic level.

Nucleic acid drugs are currently classified into four categories, including medicines based on antisense oligonucleotides (ASOs), small interfering nucleic acids (siRNAs), microRNAs (miRNAs), and nucleic acid aptamers (aptamers).

siRNA and miRNA drugs are called RNA interference (RNAi) medicines.

ASO and siRNA drugs have been approved, and both mainly act on cytoplasmic messenger RNAs (mRNA) to achieve regulation of protein expression through base complementary recognition and inhibition of target mRNAs for the purpose of treating unmet medical needs.

According to the central dogma of molecular biology, DNA is transcribed into RNA, which is then translated into proteins. In some specific cases, RNA can be reverse transcribed into DNA. So, we can see that RNA is critical, because it determines what proteins can be expressed.

Therefore, scientists are trying to see if the process of gene expression can be regulated. That is, instead of interfering at the DNA level, scientists try to regulate the RNA, which is produced in the nucleus and then moves to the cytoplasm. The production of proteins is also carried out in the cytoplasm. If drugs can be absorbed by cells, enter the cytoplasm, and influence the process of translating RNA into proteins, then these drugs can also treat related diseases.

Nucleic acid drugs are designed around this rationale to interfere with the synthesis of disease-causing proteins to treat certain diseases.

ASO is a single-stranded oligonucleotide molecule that enters the cell and binds to the target mRNA through sequence complementation. Then, under the action of ribonuclease H1 (RNase H1), this piece of RNA will be degraded and the expression of the disease-causing proteins will be inhibited consequently.

Both siRNA and miRNAtreat diseases through RNA interference, but their molecules have different properties.

siRNAs are encoded by transposons, viruses, and heterochromatin; whereas miRNAs are encoded by their own genes.

miRNAs can regulate different genes, while siRNAs are called the silencing RNAs, as they mediate the silencing of the same or similar genes from which they originate.

miRNAs are single RNAs and have an imperfect stem-loop secondary structure.

siRNA is a class of double-stranded short RNA molecules that bind to specific Dicer enzymes to degrade one strand. Then the other strand will bind to other enzymes including Argonaute Proteins (AGO) to assemble into a RNA-induced silencing complex (RISC).

In the RISC, the single strand RNA will bind to a target mRNA through the principle of base complementary pairing. Subsequently, the target mRNA will be degraded in the RISC complex, thus blocking the expression of the target protein for the purpose of treating a disease.

This mechanism of inhibiting protein expression via siRNA is called RNA interference. The scientists that had discovered RNA interferencegene silencing by double-stranded RNAwere awarded the Nobel Prize in Physiology or Medicine in 2006.

In terms of therapeutic areas, ASO drugs are mostly developed to cure cancers, infections, as well as neurological, musculoskeletal, ocular, and endocrine diseases.

For instance, fomivirsen, manufactured by Ionis/Novartis, was the first FDA-approved ASO drug, and it is currently used as a second-line treatment for cytomegalovirus (CMV) retinitis. Second-line treatment is used after the first-line (initial) treatment for a disease or condition fails or has intolerable side effects.

Several ASO drugs are also used for treatment of certain rare diseases, including Kynamro (phosphorothioate oligonucleotide drug for the treatment of the rare disease of Homozygous familial hypercholesterolaemia [HoFH]), Exondys 51 (for the treatment of a rare disease called Duchenne muscular dystrophy [DMD]), and Spinraza (for the treatment of spinal muscular atrophy [SMA], a rare inherited disease).

Prior to the development of these medicines, these rare diseases didnt have any effective drugs for treatment.

siRNA drugs therapeutic areas include cancers, infections, as well as neurological, ocular, endocrine, gastrointestinal, cardiovascular, dermatologic, and respiratory diseases.

For instance, patisiran, produced by Alnylam/Genzyme, is the first siRNA drug, and it is used for the treatment of polyneuropathy caused by hereditary transthyretin amyloidosis (haTTR). And the worlds second siRNA drug, Givlaari, produced also by Alnylam, was designed and developed for the treatment of acute hepatic porphyria (AHP), which is a family of ultra-rare disease in adults.

The main manufacturer of ASO drugs is the California-based Ionis Pharmaceuticals. The other major ones include ProQR, Sarepta, WAVELife Sciences, Biogen, and Exicure.

The largest manufacturer of siRNA drugs is Alnylam, a Massachusetts-based biopharmaceutical company specializing in the development and manufacturing of RNA interference therapeutics. The other major producers of these medicines include Dicerna, Quark, and Arrowhead.

In terms of the current status of ASO drug development, most of the therapeutics are in the preclinical stage, with their therapeutic areas mainly focused on oncological, neurological, and muscular diseases. The second largest group of ASO drugs are still in their discovery stage, during which medicines are being designed and undergoing preliminary experiments.

The situation with siRNA drugs (pdf) is similar to that of ASO medicines, with the largest group of medicines being in the preclinical stage, and the second largest group in the discovery stage. Currently, five siRNA drugs have been approved, including patisiran, givosiran, inclisiran, lumasiran, and vutrisiran. In addition, around a dozen other drugs are in late stages of phase III clinical trials.

Therefore, in both categories, only a small percentage of drugs have already been launched.

Nucleic acid drugs are considered novel therapeutic modalities, as they have great potential to treat diseases that cannot be treated effectively in the past, such as certain cancers, and some rare diseases for which no small molecule or protein/antibody-based biologics were developed.

In comparison with small molecule drugs and antibody-based biologics, nucleic acid-based therapeutics have high specificity towards RNAs.

Furthermore, they have simple designs and rapid and cost-effective development cycles (which would later translate into lower costs for patients), as their preclinical research and development starts with gene sequence determination and reasonable designs for disease genes, the genes can be targeted and silenced, thus avoiding unnecessary development and greatly saving research and development time.

They can also quickly alter the sequence of the mRNA construct for personalized treatments or to adapt to an evolving pathogen.In addition, they have abundant targets, so they can potentially make a breakthrough for some special targets that were previously undruggable, to treat certain genetic diseases. And the RNA interference technology has already matured in terms of target selection and small RNA segment synthesis.

However, getting the small RNA segment generated is only the initial step of drug development. In order for nucleic acid drugs to be applied clinically, the next important issue is delivering the nucleic acids to target tissues and cells. Since nucleic acids are highly hydrophilic and polyvalent anionic, it is not easy for cell uptake.

The selection of different delivery mechanisms of genes or RNA agents can impact the increase or decrease the expression of proteins in a cell.

The commonly used (pdf) nucleic acid drug delivery systems include drug conjugates (such as antibody-siRNA conjugates and cholesterol-siRNA conjugates), lipid-based nanocarriers (such as stealth liposomes and lipid nanoparticles), polymeric nanocarriers (such as nanoparticles base on degradable or non-degradable polymers and dendrimers), inorganic nanocarriers (such as silica nanoparticles and metal nanoparticles), carbon-based nanoparticles, quantum dots, and natural extracellular vesicles (ECVs).

Just like almost all drugs, nucleic acid therapeutics also have side effects and risks, some of which stem from their delivery methods.

The common adverse drug reactions (ADRs) of FDA-approved ASO drugs include injection site reactions (e.g. swelling), headache, pyrexia, fever, respiratory infection, cough, vomiting, and nausea (pdf). Individual ASO drugs have their own respective side effects. For instance, fomivirsen can potentially increase intraocular pressure and ocular infection. Pegaptanib can cause conjunctival hemorrhage, corneal edema, visual disturbance, and vitreous floaters. The ADRs of mipomersen (Kynamro) resemble flu symptoms. Nusinersen can cause fatigue and thrombocytopenia. And inotersen can also cause contact dermatitis.

Users of ASO drugs should also be aware of hepatotoxicity, kidney toxicity, and hypersensitive reactions (pdf).

Inotersen (Tegsedi) even carries black box warnings, which are required by the FDA for medications that carry serious safety risks, against its severe side effects, including thrombocytopenia, glomerulonephritis, and renal toxicity. Furthermore, users of inotersen are warned against possible reduced serum vitamin A, stroke, and cervicocephalic arterial dissection.

Side effects of siRNA drugs are similar to those of ASO drugs, including nausea, injection site reactions, heart block, vertigo, blurred vision, liver failure, kidney dysfunction, muscle spasms, fatigue, abdominal pain, and the potentially life-threatening anaphylaxis.

Specifically, during clinical trials of givosiran, one siRNA drug, 15 percent of subjects reported alanine aminotransferase (ALT) elevations three times above the normal range, and 15 percent reported elevated serum creatinine levels and reductions in estimated Glomerular Filtration Rate (eGFR), both signs of poor kidney function. Therefore, liver and kidney toxicity was reported during these clinical trials.

The use of siRNA drugs by pregnant mothers may entail risks for their unborn children. So far, although data on using givosiran, patisiran, and lumasiran have not been reported, certain ADRs of these drugs can serve as warning signs for use during pregnancy. For instance, patients using patisiran (Onpattro) will experience a reduction in their vitamin A levels. Vitamin A is essential for the unborn babys developing organs such as eyes and bones, as well asits circulatory, respiratory, and central nervous systems. Also, givosiran is shown to cause unfavorable developmental effects on animals. Furthermore, inclisiran therapy is not recommended for pregnant mothers, as it may harm the fetus.

In order for nucleic acid drugs to be effective, their design and development need to overcome a number of challenges, such as nuclease degradation, short half-life, immune recognition in circulation, accumulation in target tissues, transmembrane transport, and endosomal escape. Although nuclease stability and avoidance of immune recognition can be greatly reduced by combining chemical modifications, other problems remain to be solved.

Since carrier systems can greatly solve the problems that cannot be solved by chemical modifications and enhance the effectiveness and safety of nucleic acid drug therapeutics, these carrier systems are considered by many as the most important for development and overcoming the aforementioned challenges.

Currently, siRNA drug development faces several challenges (pdf), such as efficacy in siRNA delivery, safety, biocompatibility/biodegradability, and issues of their production, standardization, and approval as multi-component systems.

For example, in the case of lipid nanoparticles (LNPs; one type of lipid-based nanocarriers), only 1 to 2 percent of the internalized siRNAs are released into the cytoplasm. Therefore, research should be focusing on making nanoparticles capable of increasing the release of siRNAs.

However, it should also be noted that the safety, biodistribution, biokinetics, clearance or accumulation of LNPs in different tissues and organs are not well characterized for different types of LNPs. Therefore, the side effects or adverse reactions triggered by this delivery system should also be carefully studied.

The unprecedented global usage of mRNA vaccines under the context of pandemic has given a very unusual momentum to drive more RNA-based therapeutic development. However, clear and calm minds are still needed to see the challenges and explore the safety and risks issues comprehensively and longitudinally for any newly designed RNA-based therapeutic drugs.

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COVID mRNA Jabs and Testing Kicked Off This Industry of Drug Development: Here's What You Need to Know - The Epoch Times

BUFFALO, N.Y., Oct. 03, 2022 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. XXII, a leading agricultural biotechnology company dedicated to improving health with reduced nicotine tobacco, hemp/cannabis, and hops advanced plant technologies, today announced that the Company has added Creager Mercantile as a distribution partner to expand availability and support for its VLN reduced nicotine content cigarette products in the state of Colorado.

Operating since 1958, Creager is a well-known wholesale supplier fora wide array of cigarette retailers including hospital gift shops, gas stations, and tobacco shops across the state. The company supports more than1,000stores across numerous specialty and retail store brands. Combined with 22nd Century's previously announced partnership with Eagle Rock Distributing Company, the Company now has access to thousands of potential retail sites across the state that could be serviced by its VLN distribution partners.

22nd Century Group's proprietary VLN cigarettes smoke, smell, and taste like a cigarette but contain approximately 95% less nicotine than conventional cigarettes, a level shown to be non-addictive. As noted on the packaging, VLN is the only cigarette in the world purposefully designed to "Help You Smoke Less."

"We are excited to work with 22nd Century Group to make VLN available to adult smokers in Colorado who are looking for a new way to cut their ties to nicotine," said Chip Creager, President of Creager Mercantile. "Creager supports a diverse array of specialty stores, often advising retailers on the best new products to add to their shelves. We believe that VLN's uniqueness as the first and only cigarette designed specifically to help smokers smoke less makes it an important and attractive product for adult smokers, and we will be actively working with our retail partners to launch VLN to their stores in the coming months."

"Creager opens up an entire additional channel of specialty retail and tobacco suppliers across the state of Colorado, and its direct role in product recommendations and store support make it an ideal partner for 22nd Century's VLN rollout," said John J. Miller, president of 22nd Century's Tobacco Business. "We look forward to working directly with Creager to place VLN on as many shelves as possible, making our important new product broadly available in as many locations as possible where traditional combustible cigarettes are sold."

More information about Creager can be found online at https://creagermerc.com/.

22nd Century Group's decision to launch in Colorado follows the exceptional pilot results in Chicago and the Company's plans to have distribution and retail partnerships in place to support the expanding availability of VLN to adult smokers across the country. The Chicago pilot demonstrated that in-store outreach was highly effective, and once adult smokers had tried VLN, the vast majority were quick to recommend VLN to other adult smokers. Specialty distribution such as Creager, which supports additional functions such as merchandising and product advice, expands the awareness of VLN's highly differentiated value proposition in key retail channels.

About 22nd Century Group, Inc.22nd Century Group, Inc. (Nasdaq:XXII) is a leading agricultural biotechnology company focused on tobacco harm reduction, reduced nicotine tobacco and improving health and wellness through plant science. With dozens of patents allowing it to control nicotine biosynthesis in the tobacco plant, the Company has developed proprietary reduced nicotine content (RNC) tobacco plants and cigarettes, which have become the cornerstone of theFDA's Comprehensive Planto address the widespread death and disease caused by smoking. The Company received the first and only FDA MRTP authorization of a combustible cigarette in December 2021. In tobacco, hemp/cannabis, and hop plants, 22nd Century uses modern plant breeding technologies, including genetic engineering, gene-editing, and molecular breeding to deliver solutions for the life science and consumer products industries by creating new, proprietary plants with optimized alkaloid and flavonoid profiles as well as improved yields and valuable agronomic traits.

Learn more atxxiicentury.com, on Twitter, onLinkedIn, and on YouTube.

Learn more about VLNattryvln.com.

Cautionary Note Regarding Forward-Looking StatementsExcept for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. Forward-looking statements typically contain terms such as "anticipate," "believe," "consider," "continue," "could," "estimate," "expect," "explore," "foresee," "goal," "guidance," "intend," "likely," "may," "plan," "potential," "predict," "preliminary," "probable," "project," "promising," "seek," "should," "will," "would," and similar expressions. Actual results might differ materially from those explicit or implicit in forward-looking statements. Important factors that could cause actual results to differ materially are set forth in "Risk Factors" in the Company's Annual Report on Form 10-K filed on March 1, 2022, and in the Company's Quarterly Report filed on August 9, 2022. All information provided in this release is as of the date hereof, and the Company assumes no obligation to and does not intend to update these forward-looking statements, except as required by law.

Investor Relations & Media ContactMei Kuo22nd Century Group, Inc.Director, Communications & Investor Relationsmkuo@xxiicentury.com

Darrow Associates Investor RelationsMatt KrepsT: 214-597-8200mkreps@darrowir.com

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22nd Century Group (Nasdaq: XXII) Expands VLN Distributor Network with the Addition of Specialty Distrib - Benzinga

University of Idaho researchers are introducing genes from a plant in the nightshade family into potatoes, seeking to develop spuds that resist harmful nematodes. The plant, called litchi tomato, has natural resistance to several species of cyst and root-knot nematodes.

Thats an unusual trait to have such broad resistance, said Allan Caplan, associate professor in U of Is Department of Plant Sciences who is involved in the project.

Nematode cysts can remain viable in fields for more than a decade, and they can be found down to 3 feet deep in soil.U of I researchers led by nematologist and plant pathologist Louise-Marie Dandurand have worked for several years studying a range of possibilities for using litchi tomato as a tool to avert nematode-related yield losses in potatoes. Litchi tomato has been planted as a trap crop in the program to eradicate pale cyst nematode (PCN), which is quarantined in a small area of eastern Idaho. When planted in fields infested with PCN, litchi tomato stimulates cysts to hatch in the absence of a viable host, causing them to starve.

Dandurand also has a post-doctoral researcher seeking to identify chemicals in litchi tomato that harm or kill nematodes. Thechemicals that prove effectivecould be refined and applied directly to fields as a pesticide.

Caplan and Fangming Xiao, professor in the Department of Plant Sciences, have been working to identify the genes in litchi tomato that are specifically expressed when nematodes attack the plant.

We found at least 277 genes that got turned on, Caplan said. We think not all of them are necessary. We have to make educated guesses of which to try first, and its really a matter of trial and error. Were pretty certain some of these are going to have a big effect but we cant say with certainty which ones theyre going to be.

They turned over some of the genes they suspect may be directly involved in killing nematodes to Joseph Kuhl, associate professor in the Department of Plant Sciences, who used biotechnology to introduce them into a red-skinned potato variety, Desiree, last summer. Desiree was chosen because its relatively easy to transform through genetic modification.

If we see resistance in Desiree then well make the effort to put it in russets, Caplan said.

Xiao created some biotech potatoes using litchi tomato genes last fall, and Caplan is set to introduce additional litchi tomato genes into potatoes this summer. All their growing, infecting and analysis is taking place in closed growth chambers.

Byfirst using genetic engineering to find the pathway through which litchi tomato protects itself, Caplan believes researchers may later be able to change gene expression to protect potatoes from nematodes through laboratory methods that arent considered to be genetic modifications.

For more information:Louise-Marie DandurandUniversity of Idaho Tel.: +1 208-885-6080lmd@uidaho.edu

See original here:
Researchers are seeking to develop spuds that resist harmful nematodes - FreshPlaza.com

The prospect of creating life in the laboratory is as fascinating as it is terrifying. Will we really be able to modify the genetic code of a living creature to mold it to our design? Will we be able to assemble different bits of living creatures to create a new one?

A few years back, J. Craig Venter announced the creation of a living, self-reproducing bacterial cell with a DNA sequence produced in the laboratory. According to Laurie Garretts 2013 article for Foreign Affairs about this experiment, the creature moved, ate, breathed, and replicated itself. Garrett quotes from an older interview with Venter from 2009: Theres not a single aspect of human life that doesnt have the potential to be totally transformed by these technologies in the future.

These technologies refer to the world of synthetic biology, the ability to construct living creatures from the assembly of different parts in a sort of Lego world of the living. Playing the game of life is no longer the stuff of sci-fi stories. If you need further proof, I refer you to the Big Think video featuring Nobel Prize-winner Jennifer Doudna (as well as a recent interview), exploring the universe of CRISPR technology the good and the bad of it. Also, check out the excellent Netflix documentary series Unnatural Selection.

The question, as this technology evolves, becomes one of regulation and control. As Richard Lewontin asked in his essay on synthetic biology for The New York Review of Books, In cases where there is a conflict between the immediate and the long-range consequences or between the public and private good, how can that conflict be resolved?

The difference between the gothic speculations of Mary Shelleys Frankenstein and todays reality is twofold: First, we are building these creatures fiction is now real. Second, money plays a huge role in it. There is great financial gain in genetic engineering, an industry that according to estimates offered by Drew Endy from Stanford Universitys bioengineering department, contributes two percent of the U.S. economy and is growing at a pace of 12 percent each year.

The problem, as Lewontin reminds us, is that we often cannot rely on those who pursue invention for profit or for military interests to have the publics best interest in mind. So, as we create new lifeforms for different purposes, who will control them? The stockholders of biotech companies? The government? How will we reach a consensus on such a divisive topic that has clear global reach?

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The stakes are so high, and discussion must be brought into the open. There are great possibilities and great dangers. There is money to be made and cures to be found. There are horrible weapons and potential environmental chaos, too. The biosphere is a complex network of unpredictable interactions and responses that affect us and every other voiceless creature on this planet. Collectively as the human species, we must have some control over where all this is going. But how?

The opinions of scientists matter, of course. Corporate accountability and manufacturer liability are certainly reasonable. And there also should be democratic participation and transparency. We are all stakeholders in this debate.

All sorts of questions come into the open, questions that we should already be thinking about very seriously. Years have passed since this started, and there hasnt been much progress on addressing those questions. Synthetic creations such as genetically modified organisms (GMOs) are widely available, and a growing number of people are eating them. As far as science is concerned, there is no reason for us not to. (It is telling that so much conflict goes into the commercial labeling of such products, so that people actually know what they are consuming.)

How could we enforce the full public participation? How can we guarantee that different sectors of the population in this and other countries know enough about the various issues to reach a well-informed opinion? Some of the issues involved are extremely technical, and even the experts disagree on the details, as is the case with most cutting-edge research. How can we guarantee that government legislators are free of party bias or lobbying influences as they decide how to rule on the matter? Will the health and social benefits from the technology outpace its potential dangers?

Governments will face internal conflict, as they need to protect their citizens, defending them from any enemy that might use synthetic bioweapons. They may, of course, manufacture the weapons as well, perhaps mirroring the nuclear dtente policy of Mutually Assured Destruction: If you attack me, I attack you, and we both die. Very safe policy indeed, and very morally advanced.

If such technologies are used in wars or terrorist attacks, how efficiently will we be able to isolate from them? Judging from the responses to the COVID pandemic, government efficiency leaves much to be desired. Unless you plant your own organic garden and live in some sort of ecologically insulated bubble, synthetic biology will be knocking at your door. The question, then, is whether it will usher in a new era for humanity, or end up as the latest example of a promising technology that is used to inflict pain and destruction. Such technologies have emerged from physics (nuclear bombs) and from chemistry (poison gas). Now that its biologys turn, hopefully our past experiences have made us wiser.Hopefully we know better, now.

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Synthetic biology has the power to cure and kill. How will we use it? - Big Think

The NationalBioengineeredFood Disclosure Standard(NBFDS) which narrowlydefines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in nature kind of shot in the middle and missed every constituency,"observes Nate Ensrud, VP, US technical services, certification, and food safety solutionsatFoodChain ID, which helps firms to comply with the standard.

For some stakeholders in the natural foods industry, he says,it missed the mark,both in scope (the definition fails to capture thousands of products that have been produced with genetic engineering) and application (many objected to bioengineered vs GMO as the chosen terminology and the option to use digital disclosures on food labels).

For other stakeholders who believeslapping a blanket statement about bioengineering (which has thousands of different applications) on a jar of pasta sauce is about as useful as saying 'science was used to make this product," the NBFDS in its current form is just acostlybureaucratic headachewithout any obvious consumer benefit.

A major sticking point is the definitionof bioengineered, which excludes meat and dairy from animals fed GM feed, incidental additives, and highly refined oils and sweeteners made from GM crops such as soybean oil and high fructose corn syrup if they contain no detectable modified DNA.

Gene-edited foods, in turn, occupy something of a grey area. They may not contain detectable genetic material that has been modified through traditional rDNA techniques, but how easy is it for a third party to determine if gene-edited material meets the definition ofcannot be created through conventional breeding or found in nature?

Back in the day, says Ensrud, We were mostly talking about a series of crops that very obviously had genes inserted to express different traits.

"But since then, theres been a substantial proliferation of gene-edited products, products made using synthetic biology and so on, and while the [alternative meat, egg, and dairy]movement used to be pretty aligned, this is not the case anymore [as anyone following the social media debate about whether 'biotech' companies should be allowed to exhibit at Natural Products Expo West can see].

For example, under the NBFDS, firms deployingsynthetic biologyto re-tool the DNA of microbes to produce everything from flavors, sweeteners, and colors to animal-free collagen, egg, or dairy proteins are not required to label their ingredients as 'bioengineered' if there is no detectable level of the genetically modified host micro-organism in the final product.

This means that milk, ice cream, or cream cheese containing Perfect Days animal-free whey protein, which is expressed by a genetically engineered strain of fungi in a fermentation tank; or beverages containing Cargills EverSweet Reb M sweetener, made by GM bakers yeast, will not trigger a bioengineered label, if no GM material is detectable in the final ingredient.

However, burgers containing Motif FoodWorks 'meaty' animal-free heme protein myoglobin which is also made in a fermentation tank using a pichia pastoris yeast strain probably will trigger a bioengineered disclosure under the NBFDS, as trace amounts of the host microbe may be in the final product, says the company.

But even for exactly the same ingredient - myoglobin - no two companies producing this via fermentation are necessarily subject to the same labeling requirements when it comes to bioengineered food, saysBelgian startup Paleo, which has engineered a strain of pichia pastoristo express myoglobin in an extra-cellular fashion (it's secreted outside the cell).

This means its easier to separate myoglobin from the yeast cells during downstream processing and purification, such that Paleo'smyoglobin would not trigger bioengineered labeling in the US and would not be subject to EU GMO regulations, argues co-founder Hermes Sanctorum.

"Weve tested our heme proteins through PCR and there is no recombinant DNA whatsoever in our products.

The difficulty for companies trying to navigate this minefield is that the NBFDS doesn't really talk much about microbes"or much less explain how you label them with the exception of something like certain probiotics where genetically engineered bacteria might be the end product itself [rather than a production platform for something else], notes Ensrud.

To further complicate matters, he says:Then theres a really vague section of the of NBFDS that says if a company has actual knowledge its using something bioengineered, even if a food is not on the BE list, it is supposed to make a disclosure, which feels like a throwaway line, but how do you determine that?

He adds:We don't know a lot about how this will be enforced because the USDA has been clear that they're not going to be proactively enforcing this, but will be reliant on complaints. And so far, we havent seen very many well-structured complaints that can help us say, these are the areas that companies are going to challenge, and I don't know that it's going to be one of the first areas people think about because microbes are not included in the list of bioengineered foods.

(FoodNavigator-USA has asked USDA how manywritten complaints have been filed with the AMS Administrator alleging violations of the NBFDS and will update this article when we hear back.)

The detectability factor makes practical sense, argue many stakeholders: if there's noGMOactually in the food, why should you have to label it?

But for organizations such as the Non-GMO Project that take issue withgenetic engineering in the food supply chain per se, whether there's actually any 'modified genetic material' left in soybean oil or a natural flavor is hardly the point, notes Ensrud.

Their goal is to establish a GMO-free supply chain, and so the gap between their definition of what should be labeled GMO and the NBFDS is an ocean wide.

Having said that, the Non-GMO Project has arguably gained traction as a result of all this confusion, given that foods without bioengineered labels are not necessarily Non-GMO given the narrow scope of the federal law, prompting shoppers that care about avoiding genetic engineering to seek outthe butterfly logo while shopping if they want to be sure.

So what about disclosure options, which like everything else in theNBFDS, have generated a lot of controversy? The standardpermits multiple options:

Aspects of the digital disclosure options have just been successfully challenged in a lawsuitbrought by the Center for Food Safety and others, with a court sending USDA back to the drawing board to make revisions consistent with Congressional requirements around consumer access.

So what does this mean for companies currently using the QR code or text message option? According to Ensrud, We did see some companies choose to use the QR code, but not a large majority by any means. The ones that were choosing QR codes told us they liked the flexibility, as perhaps they were still trying to remove some bioengineered foods from their supply chain and would move from having to disclose to not having to disclose, which would require a change in labels, which can be costly and laborious.

The opposite is also possible. If a company has to make an emergency shift from a non-GMO source to a GMO source for an ingredient [not that unusual given current supply chain volatility], it would likely change the labeling requirements. For companies that have less settled supply chains, this change in requirements could make things more difficult.

Sam Jockel, a senior associate at law firm Alston & Bird, noted that There is still an opportunity for either USDA or the plaintiffs in this case to appeal theruling, which I am watching for.

According to George Kimbrell, legal director at the Center for Food Safety, which filed the lawsuit challenging many aspects of the NBFDS, The Court did not set a deadline, but under law agencies cannot unduly delay such action and must complete it in a reasonable time.

Should the order ultimately stand, said Jockel,it appears that USDA would have discretion in terms of timing as the court did not set any deadlines for USDA to conduct its post-remand proceedings.

For those who think this means that the QR code will go away, added Jockel, The statute passed by Congress requires an electronic/digital link disclosure as one of the options along with the text and symbol, so the QR code option is not going away.

The Consumer Brands Association said it is still reviewing the court order, but added:"We plan to stay engaged during the forthcoming rulemaking and legal process, especially considering the potential impact on the companies using QR codes or texts. Consumer Brands will also continue supporting the valuable role digital disclosures play in boosting consumer transparency through programs like SmartLabel.

Jockel also noted that the scope of the products that require mandatory disclosure is actually subject to change.

Companies will want to watch for any updates to thelist of BE Foodsas AMS is required to review and consider updates on an annual basis. As the judges order put it in reference to the agencys regular updates to the List of BE Foods, AMS did not ignore the likelihood of progress. As evidence of that, the agency is currently proposing to expand the list to include insect-resistant sugarcane.

Greg Jaffe, biotechnology project director at the Center for Science in the Public Interest (CSPI), told us that an informal surveyconducted in his local Giant grocery store earlier in the year found that almost no companies use the symbol on the package with most seeming to opt for the bioengineered food or contains a bioengineered food ingredient option, although several brands had adopted QR codes.

My informal survey also found many foods disclose even though they probably only have highly refined ingredients, so companies are clearly erring on the side of giving more information to the consumer than might be required.

So has the law helped consumers make informed choices? Or are blanket references to bioengineered foods just wallpaper to busy shoppers?

I think that the law has provided consumers who want to know this information, more information than they would receive without the law, said Jaffe, who described it as a step in the right direction in terms of transparency, in part because companies were not providing this information voluntarily anywhere for the consumer who wanted it.

He added:I dont think many consumers look for this information or make purchasing choices based on it. With that said, for many consumers, knowing that there is transparency and information is available is important (i.e. knowing that information that some people might want is not hidden or inaccessible).

Asked about the growing number of ingredients produced by genetically engineered microbes, he said:Many ingredients made with engineered organisms also will not require disclosure, but I think it is important that those companies are transparent and provide information to consumers about the origin of the ingredients in their products, whether or not it has to be disclosed as bioengineered.

Being transparent with consumers will build trust, educate consumers about the use of biotechnology in foods, and allow for consumer choice.

Further reading:

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SPECIAL REPORT: Bioengineered food labeling: 'They kind of shot in the middle and missed every constituency' - FoodNavigator-USA.com

An incredibly old way of making drugs is now an incredible new way to make drugs. Scientists have genetically reengineered a yeast fermentation process in order to produce chemotherapeutics instead of beer.

Vinblastine is the most complex compound produced with engineered yeast so far, the researchers say. Its naturally occurring ingredients are normally harvested from an endangered plant in Madagascar, and the chemotherapeutic is on the World Health Organization's essential medications list. Synthetic production of vinblastine could eliminate supply problems, lower costs, and save lives.

Getting it right took 7 years.

"It's like getting an orchestra to play in tune, because all of those steps have to work together in order to get to that final product," said article co-author Jay Keasling, PhD. "If you feed yeast sugar, it produces beer and wine. In this case, we've replaced the ethanol pathway with pathways to produce these natural products."

Genetically engineered yeast (along with E coli) is a key microorganism used in biopharmaceutical production. Yeast has been redesigned to produce other naturally occurring compounds, such as cannabinoids and the antimalarial drug artemisinin. The process involves removing a sequence of biochemical reactions, or metabolic pathway, from a plant cell and reconstructing it inside a yeast cell.

Vinblastine is part of a family of more than 3000 plant-produced molecules called monoterpene indole alkaloids (MIAs), several of which have been approved by the US Food and Drug Administration as therapeutics. Each MIA comes from a different plant, some of which are rare or in danger of extinction from overharvesting, according to Keasling.

"Engineering a yeast to produce these molecules would enable their production in a simple platform, fermentation, rather than having to grow individual plants or harvest them from the wild," explained Keasling. "We've essentially co-opted this age-old method for producing beer and wine to produce these other important products."

The international team of researchers, led by the Technical University of Denmark in Kongens Lyngby, Denmark, wanted to prove that they could synthetically manufacture all kinds of MIAs, so they started with the most complex one they knew of: vinblastine.

Vinblastine has something like 30,000 genes. The researchers first had to identify a 31-step sequence. It is the longest biosynthetic pathway ever removed from a plant and inserted into a microbe, according to the researchers.

Until now, vinblastine could only be produced by using two active ingredients, vindoline and catharanthine, harvested from the leaves of the Madagascar periwinkle plant. It can take more than 4000 pounds of dried leaves to produce a single gram of vinblastine. Supply delays resulted in an international shortage of the drug from the summer of 2019 until 2021.

Although the researchers couldn't produce vinblastine directly in yeast, they succeeded in genetically engineering yeast to produce vindoline and catharanthine. These compounds were then purified and coupled chemically to form vinblastine.

Reconstructing vinblastine's metabolic pathway required 56 genetic edits, according to the researchers. Biochemical reactions that occur at each step along the pathway require enzymes so the researchers had to ensure that enzymes were produced in the correct amount.

"You can't have one step working significantly better than all the other steps, or one step that doesn't work very well at all," said Keasling. The enzymes also depend on other factors, such as vitamins and minerals, which also had to be inserted into the sequence.

The researchers produced only a very small amount of vinblastine, but the technique opens the door for production of numerous other naturally occurring compounds, including an antiaddiction molecule that's expensive to manufacture because it's produced by plants in small quantities.

"This molecule we chose is kind of like a holy grail. It's a big molecule, it's really challenging to produce in any other way," Keasling said. "And so, if we can do this molecule, that means that the other ones are definitely doable."

Funding for the research was provided by the National Institutes of Health, the European Research Council, the Wellcome Trust, the Open Philanthropy/Silicon Valley Community Foundation, the Weston Havens Foundation, and the Centre for Trophoblast Research.

Nature. Published August 31, 2022. Full text

For more news, follow Medscape on Facebook, Twitter, Instagram, and YouTube.

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Yeast-Fermented Chemo: Now We Can Brew Anything - Medscape

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This week, we share the second part of a recorded discussion hosted by the Civil Liberties Defense Center. CLDC has been at the forefront of anti-repression legal work for decades now, working on many of the Green Scare cases, in which the FBI infamously hounded and smashed radical environmental organizing between 2000 and 2008. In this discussion, Chava and Lauren speak with Letha, a long-time supporter for Marius Mason, who is the last remaining Green Scare prisoner. Marius is a former Bloomington resident whose public organizing and clandestine acts of sabotage in the 1990s presaged many of the ecological concerns which have now become global issues as we face climate catastrophe. Marius was harshly sentenced to almost 23 years in prison for acts of sabotage against logging, highway construction, water privatization schemes, and corporate genetic engineering. He came out as a trans man while inside and is being held at the federal prison in Connecticut.

Thanks to theCLDCfor organizing this important discussion and for all their work.

You can find out more about how to support Marius here:https://supportmariusmason.org/

Here are some of our favorite previous episodes about Marius:

Last Weeks Episode: https://www.kitelineradio.org/podcast/321-marius-mason-the-last-green-scare-prisoner/

8 | Dear Marius

45 | Ongoing Support for Marius Mason and His Family

150 | Be Like Water: J11 Reflections on Marius Mason’s Journey Through Federal Prison

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September 23, 2022: The Integrity of Marius Mason WFHB - WFHB News