Category Archives: Genetic Engineering

By Anne Petermann

On August 18, 2020, the U.S. Department of Agriculture (USDA) published a petition by researchers at the State University of New York College of Environmental Science and Forestry (ESF) seeking federal approval to release their genetically engineered (GE) Darling 58 (D58) American chestnut tree into U.S. forests. Researchers claim the transgenic D58 tree will resist the fungal blight that, coupled with rampant overlogging, decimated the American chestnut population in the early 20th century. In fact, the GE American chestnut is a Trojan horse meant to open the doors to commercial GE trees designed for industrial plantations.

The D58 would be the first GE forest tree approved in the U.S. and the first GMO intended to spread in the wild. (GE canola plants were discovered in the wild in 2010 but that was unplanned.) "This is a project to rapidly domesticate a wild species through genetic engineering and accelerated breeding, and then to put it back into ecosystems to form self-perpetuating populationsan intentional evolutionary intervention that has never been attempted before with any species," explain scientists at the Center for Food Safety (CFS) and International Center for Technology Assessment (ICTA), which are nonprofits based in Washington, D.C.

"The Southern U.S. is global ground zero for the forest products industry and we see genetically engineered chestnut trees as this industry's sneaky way of opening the floodgates for 'frankentrees' that will harm forests, biodiversity and local communities across the region," explains Scot Quaranda of Dogwood Alliance, a nonprofit based in North Carolina that works to protect Southern U.S. forests. "Our natural forests that support wildlife and the economic sovereignty of rural communities will rapidly be replaced with tree plantations for wood pellets, paper and more, leaving environmental and climate injustice in their wake."

The GE American chestnut faces an uphill battle due to decades of opposition to GE trees by Indigenous peoples, scientists, students, activists, foresters and others, including a GE tree ban by the Forest Stewardship Council and a United Nations decision that warns countries of the dangers of GE trees and urges use of the precautionary principle while addressing the issue.

By October 19, 2020, the close of the public comment period on the petition, 109 organizations, representing millions of members, plus an additional 123,426 individuals had registered their opposition to the D58. The next step is the creation of a draft Environmental Impact Statement (EIS) by the USDA recommending action on the petition. The American Chestnut Foundation (TACF) estimates this could take up to a year to complete. Following this, another public comment period will be undertaken to review the draft EIS, after which the agency will develop a final EIS with a decision on the petition.

While American chestnut trees are known to live hundreds of years, D58 trees have only been growing since 2017, calling into question the ESF petition assertion that "Darling 58 has been studied in detail and no plant pest or environmental risks have been observed."

In a report on the GE American chestnut she co-wrote, Dr. Rachel Smolker from Biofuelwatch explains, "Given the long lifespan of trees and varying environmental conditions they face, we cannot extrapolate from tests done on very young trees under controlled lab and field conditions. How GE trees might behave in the diverse and changing context of natural forests over long periods of time is unknown and likely to remain unknown even after they are released."

Scientists at CFS and ICTA warn of problems with the D58 safety studies, writing, "Given the young age of Darling 58 trees and corresponding dearth of tissue samples, conclusions from most of the animal experiments described in the Petition are too preliminary to depend upon."

In studying ESF's assessment of the impacts of inserting the blight-resistant oxalate oxidase (OxO) transgene into the chestnut genome, both CFS and ICTA further point out that some D58 studies did not, in fact, use material from transgenic D58 trees, rendering them invalid. "Petitioners did experiments to study how bumblebees might be affected by Darling 58, but did not have enough Darling 58 pollen for the experiments so used non-transgenic pollen instead, to which they added purified OxO from barley seeds. Other important initial studies on animals reported in the Petition are of limited use because they involved feeding leaves from the Darling 4 instead of Darling 58 even though Darling 4 has much lower levels of OxO in leaves again invalidating the conclusions for risk assessments." The Darling 4 was an earlier version of the American chestnut genetically engineered with the OxO transgene.

While researchers have argued that a strict regulatory process will ensure the safety of the D58 GE tree, a 2019 report by the National Academies of Sciences, Engineering, and Medicine titled, "Forest Health and Biotechnology: Possibilities and Considerations," raises flags: "Forest health is not accounted for in the regulations for the use of biotechnology or for other approaches to mitigating forest tree insect pests or pathogens. There are no specific regulations or policies that those agencies apply to biotech trees."

Proponents argue that there can be no downside to releasing a tree engineered to resist an introduced blight. But like fire suppression, which has led to devastating wildfires due to an unnatural buildup of flammable materials in the forest, the future impacts of even a well-meaning action can become catastrophic, especially in combination with the unpredictable effects of climate change and extreme weather. Yet, researchers are engineering trees with the conviction that because they can, they should.

In her book Can Science Make Sense of Life?, Dr. Sheila Jasanoff, Pforzheimer Professor of Science and Technology Studies at the Harvard Kennedy School, explains the implications of this arrogance. "For life scientists and their enthusiastic promoters, the arc of the technologically possible, often coincident with the promise of financial gain, increasingly defines the boundaries of the morally permissible."

Researcher William Powell, whose GE American chestnut research has received both financial and technical support from companies with a vested interest in the approval of the GE American chestnutincluding Monsanto, ArborGen and Duke Energydefends his approach. In an article in the Conversation, Powell says, "One of the key advantages of genetic engineering is that it's far less disruptive to the original chestnut genomeand thus to its ecologically important characteristics. The trees remain more true to form with less chance of unforeseen and unwanted side effects. Once these genes are inserted, they become a normal part of the tree's genome and are inherited just like any other gene."

However, in a briefing paper published by the Federation of German Scientists, Dr. Ricarda Steinbrecher, a molecular geneticist, and Antje Lorch, a biologist, counter that the genetic engineering process is inherently risky. The paper states, "It is well documented that the processes of plant transformation give rise to many mutations throughout the plant genome as well as at the insertion site of the transgene. Any robust risk assessment study needs to take several generations into account, for example to assess the stability and heritability of the transgene, unintended side effects and changes due to transformation impact."

The D58 American chestnut is the culmination of decades of effort to open the doors to GE trees in the U.S. by biotechnology and timber companies. In 1999, Monsanto joined with timber companies from the U.S. and New Zealand to form a "forestry biotechnology joint venture," which later became ArborGen, one of the world's leaders in GE tree research and development. GE tree research was originally focused on trees and traits valued by the forest products industry; trees like poplar, pine and eucalyptus, and traits like insect resistance, herbicide tolerance, faster growth or altered wood composition.

American chestnut seedling. Anne Petermann

Other early associationsincluding the Tree Genetic Engineering Research Cooperative at Oregon State University, launched in 1994brought together university researchers with timber and biotechnology giants as well as the U.S. Forest Service to develop genetically engineered trees for industrial timber plantations.

These efforts were met with widespread opposition and sabotage, leading the industry to conclude that they needed a charismatic "test tree" to try to win over the public opinion relating to GE trees.

A 2007 published paper explains, "There is opposition to commercial application of trees, engineered specifically for fast growth and increased yields, by those whose stance is that the value accrues only to 'big companies.' It will remain for traits that have broad societal benefits, such as conservation for acceptance to be gained."

The D58 is seen as a positive example for the beleaguered biotechnology industry of the benefits of 'biotechnology for conservation.' Duke Energy also sees the American chestnut for its value as a greenwashing tool. Duke Energy invested millions into the GE American chestnut through the Forest Health Initiative. Its hope was to use the American chestnut to help "green" its devastated mountaintop removal mining lands.

Naturalist and author Bernd Heinrich has one such grove growing on his land in Maine. In a New York Times op-ed in 2013, he wrote, "I have been enjoying American chestnuts for several years now, harvested from some trees that are now part of my forest of 600 acres in western Maine. I planted four seedlings in the spring of 1982. Beyond all my expectations, the trees thrived, and some are now 35 feet tall. In my small corner of western Maine, the American chestnut is now promising to again become a significant component of the ecosystem."

Once dominant in Eastern U.S. forests, the American chestnut was highly valued for its beautiful and rot-resistant wood, and abundant nuts. While few actually remember the tree, which largely disappeared from the landscape by the 1920s, a public relations effort was launched in the early 2010s with articles appearing in numerous major publications heralding the return of this "mighty giant" through the wonders of genetic engineering. Millions of American chestnut stumps, meanwhile, continue to send up shoots that occasionally grow into trees large enough to produce nuts, and in some locations, wild American chestnuts are spreading on their own, showing at least some evolving blight tolerance.

Another decades-long program by the American Chestnut Cooperators' Foundation is successfully breeding pure wild American chestnuts that are naturally blight-resistant.

In spite of examples like this, GE chestnut proponents have declared the American chestnut functionally extinct, and insist that its survival hinges on the release of unproven and risky genetic engineered American chestnut trees into forests. But Lois Breault-Melican, a former board member of the American Chestnut Foundation who publicly resigned from the TACF over the organization's support for the GE American chestnut, points out that this argument ignores the risks posed to organic and other chestnut growers: "These growers are concerned about the potential GMO contamination of their orchards caused by the unregulated and unmonitored planting of genetically engineered American chestnut trees. If the USDA approves these GE American chestnuts, the integrity of chestnut orchards would be forever compromised."

Indigenous peoples in the regions of proposed D58 releases have expressed concern that unregulated distribution of a GE tree would violate their sovereign right to keep their territories free from GMOs. They insist that Indigenous peoples be consulted in the process of reviewing the D58 American chestnut.

"Today, there remain large areas of traditional and treaty lands on which much is forested and managed as sovereign territory of many different Native American Peoples," explains BJ McManama of the Indigenous Environmental Network. "These forests are not only a source of economic self-determination but hold great cultural significance to include sacred sites where trees are an element of sustenance, knowledge and familial identity. Every living being within the forests [is] related in some form and nothing within these lands lives in isolation; therefore, changing or altering the original instructions of any one or any part of these elements threatens the natural order established over millennia."

The Eastern Band of Cherokee, members of the Lumbee Tribe of central North Carolina and Seminole Peoples from unceded Florida territory joined the Campaign to STOP GE Trees for an October 2014 gathering in the mountains of North Carolina to protest GE trees as a form of colonization. Their concerns were focused on the GE American chestnut trees.

Lisa Montelongo, a member of the Eastern Band of the Cherokee, explained, "I'm very concerned that GE trees would impact our future generations and their traditional uses of trees. Our basket makers, people that use wood for the natural colors of our clay workthere would be no natural life, no cycle of life in GE tree plantations."

Following the camp, the Band's Tribal Council passed a unanimous resolution prohibiting GE trees from their lands: Eastern Band of the Cherokee Indians (EBCI) Tribal Council Resolution No. 31 (2015): "We commit to rejecting biomass, genetically engineering the natural world, carbon trading, carbon offsets and carbon sequestration schemes as they are false solutions to the climate change." Concerns were focused on the inability of the tribe to keep the GE American chestnut tree off of their lands if it were released into surrounding forests, which they describe as a violation of the Free, Prior and Informed Consent mandate under the UN's Declaration on the Rights of Indigenous Peoples.

In the end, the potential deregulation of the D58 is not about restoring a "mighty giant" to Eastern U.S. forests. Its approval is about paving the way for the deregulation of all GE trees, toward the creation of an oxymoronic future "bioeconomy" where biodiverse forests are replaced with specially engineered trees for the manufacture of fuels, chemicals, textiles, plastics and other goods in a "green" version of "business as usual." Implicit in this scheme is a massive increase in the consumption of wood. This in turn will drive accelerated conversion of carbon-rich native forests, critical for climate regulation, and other ecosystems for conversion to fast-growing plantations that include GE trees with traits to expedite their use as feedstocks. Existing non-native plantations of eucalyptus, the most common plantation tree, are already notorious for their devastating social, ecological and climate change impacts. But new research out of Oregon State University is attempting to "green" these plantations with claims that eucalyptus trees can be genetically engineered to be infertile, through a process to "knock out LEAFY," the gene believed to control flower formation. The research claims this would prevent eucalyptus trees from invading native ecosystems, though it does nothing to address the ability of eucalyptus to spread asexually through vegetative propagation.

American chestnut tree, Halifax, Nova Scotia, Canada. Canadian Biotechnology Action Network

This new technology also does nothing to address the serious problems caused by industrial plantations of eucalyptus. These impacts, outlined in detail by the World Rainforest Movement, include depletion of fresh water; forced displacement of Indigenous groups, rural communities and subsistence farmers; and catastrophic wildfires. In fact, the addition of GE trees to these plantations could exacerbate known impacts and/or lead to new, unknown and potentially irreversible problems.

Another attempt to "green" GE trees for the bioeconomy involves the development of trees specially engineered to store extra carbon as a supposed climate change mitigation tool. But a new article in Yale Environment 360 challenges schemes like this that focus on tree planting for climate mitigation. Echoing the findings of the World Rainforest Movement and others, the article reports "a growing number of scientists and environmentalists are challenging this narrative on tree-planting. They say that planting programs, especially those based on large numerical targets, can wreck natural ecosystems, dry up water supplies, damage agriculture, push people off their landand even make global warming worse." In addition, they say, "Tree planting can distract from the greater priorities of protecting existing forests and reducing fossil fuel use."

The attempts to greenwash genetically engineered trees with their unpredictable and irreversible impacts are being opposed globally by a broad coalition of scientists, Indigenous peoples, agronomists, peasant farmers, foresters, teachers and others, as well as organizations focused on protecting forests, human rights and climate justice. GE trees have no place in an ecologically and socially just future.

Author's note: Following the initial publication of this article, Reuters reported that a Memorandum of Understanding (MOU) was signed on April 21 between the Eastern Band of the Cherokee Indians (EBCI) and the American Chestnut Foundation. The MOU, described by EBCI members as highly controversial, would allow the planting of GE American chestnuts on Cherokee land.

Anne Petermann is the executive director of Global Justice Ecology Project. She has been working on issues related to protecting forests and defending the rights of Indigenous peoples since 1990 and co-founded the first global campaign against genetically engineered trees in 2000. In the years since, she has presented the social and ecological dangers of genetically engineered trees at conferences, with community groups, and at the United Nations and other international fora on five continents. She currently coordinates the Campaign to STOP GE Trees, which she co-founded in 2014. Follow her on Twitter: @AnneGJEP.

This article first appeared on Truthout and was produced in partnership with Earth | Food | Life, a project of the Independent Media Institute.

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USDA May Allow Genetically Modified Trees to Be Released Into the Wild - EcoWatch

The Development, Concepts and Doctrine Centre (DCDC) has worked in partnership with the German Bundeswehr Office for Defence Planning to understand the future implications of human augmentation (HA), setting the foundation for more detailed Defence research and development.

The project incorporates research from German, Swedish, Finnish and UK Defence specialists to understand how emerging technologies such as genetic engineering, bioinformatics and the possibility of brain-computer interfaces could affect the future of society, security and Defence. The ethical, moral and legal challenges are complex and must be thoroughly considered, but HA could signal the coming of a new era of strategic advantage with possible implications across the force development spectrum.

HA technologies provides a broad sense of opportunities for today and in the future. There are mature technologies that could be integrated today with manageable policy considerations, such as personalised nutrition, wearables and exoskeletons. There are other technologies in the future with promises of bigger potential such as genetic engineering and brain-computer interfaces. The ethical, moral and legal implications of HA are hard to foresee but early and regular engagement with these issues lie at the heart of success.

HA will become increasingly relevant in the future because it is the binding agent between the unique skills of humans and machines. The winners of future wars will not be those with the most advanced technology, but those who can most effectively integrate the unique skills of both human and machine.

The growing significance of human-machine teaming is already widely acknowledged but this has so far been discussed from a technology-centric perspective. This HA project represents the missing part of the puzzle.

The content of this publication does not represent the official policy or strategy of the UK government or that of the UKs Ministry of Defence (MOD).

Furthermore, the analysis and findings do not represent the official policy or strategy of the countries contributing to the project.

It does, however, represent the view of the Development, Concepts and Doctrine Centre (DCDC), a department within the UK MOD, and Bundeswehr Office for Defence Planning (BODP), a department within the German Federal Ministry of Defence. It is based on combining current knowledge and wisdom from subject matter experts with assessments of potential progress in technologies 30 years out supporting deliberations and deductions for future humans and society.

Read the original here:
Human Augmentation The Dawn of a New Paradigm - GOV.UK

Image: Milad B Fakurian / Unsplash

Twitter founder Jack Dorsey does it (he only eats once a day and never on a weekend); so does Elon Musk (hes developing a microchip that can be inserted straight into the brain); and even the half-naked guy shivering in the frigid tide-pool at 7am biohacking.

In its most rudimentary form, the practice of biohacking can be described as doing things that optimise your body and minds function. Essentially, having a regular sleeping schedule or cutting out sugar could be considered a biohack (though most of us would just call that healthy living). American entrepreneur and founder of Bulletproof nootropics Dave Asprey who has been boisterously claiming that he is the father of biohacking, provides a second definition: biohacking is the art and science of becoming superhuman.

In fact, biohacking personalities like Asprey, Josiah Zayner, Elon Musk and Jack Dorsey are doing all that they can to transcend what we have come to think of as regular humanness. Often claiming to be at the forefront of life-hacking technology and theory, they are constantly experimenting with the human body in attempts to make it stronger, faster, smarter, younger, more efficient. Some of their fellow biohackers around the world painstakingly track every bodily consumption and function in order to reach optimum performance, or implant chips into their hands for maximum technological efficiency, or engage in the vampire-like practice of replacing ones blood with that of young donors in an attempt to find the fountain of youth.

There is a reason these biohacking celebs have become people of intrigue: they often take things to the extreme, further than most of us would be comfortable. And indeed, using science and technology as a sort of shortcut to enhancing your body and mind, as well as potentially increasing your lifespan, is arguably appealing to most people.

But luckily there are also ways to biohack that dont involve endless hours of tracking, calculating and inserting foreign objects into your body, methods much closer to the realm of comfortable that are purported to actually help with things like boosting the metabolism, the immune system and concentration without going all the way cyborg.

All the way to extreme wellness

Remember the guy, semi-naked, frigid in the tidepool at 7am? This practice, a combination of cold therapy (diving into very cold water), dynamic stretching and breathing techniques is part of the Wim Hof method, which is said to help you realise your full potential.

As per the many deep breathing, scantily clad bodies on the beaches and in the tide pools early in the morning, the method is seemingly popular in Cape Town (perhaps because of the accessible ice water that is the ocean) and is thought to do a wealth of awesome things, including burn fat, reduce stress and boost the immune system.

The Wim Hof method is named after its founder, a self-proclaimed crazy Dutchman from the Netherlands. Also known as the ice-man for the varied but equally death-defying feats he has accomplished in exceedingly cold climates, including (but not limited to) climbing Kilimanjaro in shorts, running a half-marathon above the arctic circle barefoot, and finishing a full marathon in the Namib desert without drinking a single drop of water, Hof has made it his mission to spread his superhuman, cold-enduring abilities to those of us lesser beings who struggle to get our noodle arms out of bed in the winter.

According to Hof, all noodle arms can get out of bed and tap into happiness, strength and health by following his simple three-tier method. The tiers breathing exercises, gradual exposure to cold and training of concentration and commitment must be done in parallel with one another to feel the full effects.

The practice, usually done in the morning before breakfast, should look like some iteration of this: The first step, the breathing exercises, are surprisingly simple. They include breathing in and out purposefully (but without forcing anything) for a couple of minutes. The idea is that there is no pause between the inhale and exhale, like a cycle Hof explains in a tutorial video, like a wave. At the end of this short but intense breathing period, Hof asks you to exhale and hold your breath the tutorial starts with holding for one minute, but the idea is to hold for as long as you feel comfortable (which will get longer and longer with practice), after which you release and start all over again.

In simplified terms, the breathing technique has been developed over time by Hof to expand the diffusion surface of your lungs, thereby increasing oxygen and decreasing carbon dioxide levels in your blood. The altered ratio of oxygen/carbon dioxide allegedly raises the PH of your blood, alkalising your body and lowering the number of acids (like lactic acids) produced by your cells that are often responsible for feelings of pain. Oxygen, while not always essential, is a pretty central aspect of energy production on a cellular level, so the heightened levels of it in your blood should said Hof energise your entire body.

Next, Hof recommends push-ups and yoga-based stretching. To get your body warmed up, of course, but also to flex just how much energy the breathing exercises give you.

The last physical step of the process is the cold exposure. This can take the form of an ice bath, a very cold shower, or floating around in a freezing tide pool for a significant amount of time. Significant here, means at least one minute when you are starting out with the method, but for as long as you can once you have been practising for a while.

It is believed that the shock that your body experiences when suddenly exposed to the cold water triggers a release of norepinephrine, which, similar to adrenaline, mobilises the brain and body into action. This represses the immune system, which decreases the number of inflammatory proteins (which cause swelling and aches and pains of all sorts) produced and catalyses the cardiovascular system to redirect blood around the body in order to warm itself up. It also supposedly causes the body to burn browned fats which are energy-rich fats that burn immediately for the sake of providing the body with heat and energy. If practised regularly, the physiological systems learn and become more efficient (your veins are strengthened and white blood cell count increased) and you may even become (somewhat) cold resistant. A more in-depth explanation of the biological details (how exactly the mitochondria break down the fats into energy) can be found here.

The third tier, the training of concentration and commitment, is a little less concrete. The idea is that you have to commit and concentrate while going through the steps of the Wim Hof method, but also that, through the practice of doing the method, you will strengthen your powers of concentration and commitment. A winning cycle.

Some studies, like the one published in 2018 and dubbed Brain over body A study on the wilful regulation of autonomic function during cold exposure, raves about the positive effects of the Wim Hof method, especially those pertaining to a decrease in inflammation, an increase in metabolism and a strengthened immune system.

In fact an experiment was done on Hof himself in 2010 by scientists from UMC St Radboud, in which he was injected with components of E.coli that, while harmless, would make a normal person pretty sick with flu-like symptoms. Hof believed that through his method he could regulate the autonomic nervous system (the system that regulates breathing, internal organs, digestion, heartbeat and all the other things we do subconsciously) and thereby directly influence his immune system. Hof not only did not feel any symptoms from the E.coli, but also produced fewer than half of the inflammatory proteins that usual test subjects produce.

In 2014 a follow-up study titled Voluntary activation of the sympathetic nervous system and attenuation of the innate immune response in humans, was done to determine whether Hof was an innately superior human being who could control his own immune system, or whether other people could learn how to do it, too.

Twenty-four volunteers were involved half of them trained with Hof beforehand and half were controls. Incredibly, the 12 that were trained in the Wim Hof method showed significantly fewer flu-like symptoms, lower body temperatures and fewer inflammatory proteins in the blood. They too had benefited from Hofs teachings.

What would it mean to be able to control our immune systems? Imagine being capable of out-concentrating a disease! In the context of todays Covid-riddled world, it sounds like an incredible promise.

However, the studies only proved that Hof and his trainees were able to suppress the immune system by stimulating cortisol, a stress hormone. A suppressed immune system means fewer inflammatory proteins in the blood, which means fewer symptoms. But the E.coli components injected into Hof and co were dead, they were harmless; the symptoms they should have felt because of the injection would have been the bodys reaction to a trick, a reflex. When it comes to active and harmful diseases, there is a reason our immune system flares up. These studies did not prove that Hof could by any means avoid a real illness at all.

On that note, its important to point out that some of the more complex alleged benefits, like fibromyalgia relief, autoimmune disease relief, COPD management, and the ever-expansive and ambiguous umbrella of health improvements are not well researched enough to be considered as conclusive.

In addition, as with any method or experiment on ones body, one should be cautious about practising the method without the supervision of a medical expert or advice. In 2017, it was reported that two people had died while trying a breathing technique called controlled hyperventilation; they allegedly drowned from doing these yoga relaxation exercises in the water; the method is one promoted by Hof, although his website warns not to practise it before or during diving, driving, swimming, taking a bath or any other environment/place where it might be dangerous to faint.

Yet, Hof, having once been thought of as a fringe character a freak of nature if you will, capable of unbelievable and inhuman accomplishments is beginning to make waves in more mainstream science: from appearing in 2008, on EenVandaag, a Dutch television programme, saying, I want to take it from circus act to scientist, my body is my laboratory, to being part of a 2020 episode of Gwyneth Paltrows Goop Lab series.

The episode in question features the Goop ladies on a trip to Lake Tahoe, California, to do a workshop with Hof himself. After jumping into a dangerously cold body of water, Goop executive editor Kate Wolfson, twitching in her chunky knit sweater with tears in her eyes, tells Hof: Like I dont mean to sound cheesy. But that was like a turning point in my life. Her vocal fry touches Hof in a way that the ice never could.

To do the Wim Hof method safely and effectively one needs an instructor, or to buy a subscription to Hofs video series, starting at $300 (about R4,280), for the fundamentals course.

In the realm of biohacking products, and for something a little less extreme, there are Dave Aspreys Bulletproof products, called nootropics and known to some as smart drugs.

Avowing cognitive enhancement, these little nuggets of (alleged) genius come in the form of prescription drugs, like Adderall and Ritalin, as well as less-regulated alternatives. Aspreys brand Bulletproof falls into the latter category. The brand is most famous for its coffee, a mixture of coffee beans, MCT oil and butter which the website maintains helps you feel full while increasing your focus and metabolism. Other nootropics that the site offers include supplements that aid your mood, memory, gut health, performance, immunity and sleep. With Bulletproof, the idea, as mentioned by Jenna Wortham in a New York Times article from 2015, is that you can outsource that work. That fundamental laziness, where I want everything to be easier, is part of what drives me, he (Asprey) told me that first day. I dont want to do more work than is necessary to do great things. I dont see why anyone should do more work than is necessary to do great things.

But, as Wortham also pointed out in this article, there are more than a few nutritionists who are dubious about Aspreys bold claims. Its hard not to be theres little research outside his own that backs them up [] We all want to live forever, and if changing one thing in our diets can do that, we can all hope. The success of the dietary-supplement industry is best explained by wish-fulfilment fantasies. Thats not to say that other nootropics do not work, just make sure to do your due diligence before spending any significant amount of money on them.

Apart from his own products, Asprey is also an advocate for intermittent fasting, an increasingly popular diet that calls for extended periods of not eating. There are a few different ways to do it, the most popular being the 16/8 method, in which one fasts for 16 hours and has an eight-hour feeding window. Within the feeding window (usually falling between 12pm and 8pm), an intermittent faster may eat what they want. Other approaches include the Eat-Stop-Eat (a 24-hour fast two times a week), and alternate-day fasting (fast for a day, eat normally for the next, and so on.)

Intermittent fasting is reportedly highly effective in weight-loss endeavours, though its up for debate as to whether it is superior or similar to other calorie-restrictive diets. The reason for its alleged effectiveness has to do with metabolic switching the idea is that after 10 to 12 hours the body depletes its glycogen (stored glucose) and starts burning ketones (energy made in the liver by breaking down fat.) Ostensibly, the presence of ketone bodies also has some influence over glucose regulation, blood pressure, heart rate and abdominal fat loss.

In 1988, a study called Retardation of ageing and disease by dietary restriction showed that intermittent fasting has a direct correlation to extended life span in rodents, although it is still highly debated as to whether this translates to humans. It has become clear that a number of variables, like sex, genetic composition and age, also determine whether or not intermittent fasting works for you.

Still, as mentioned before, Dorsey eats one simple meal (usually salmon or chicken) on weekdays, and on the weekend he fasts from Friday to Sunday. The man is, one could say, robotic in his discipline, but his method also raised concerns, drawing parallels with diets that can sometimes trigger more obsessive behaviours around food, such as eating disorders.

The Wim Hof method, nootropics and intermittent fasting are really just the tip of the iceberg when it comes to hacking life. Some biohackers, like Asprey, believe that the first person who will live to be 1,000 years old is already alive today. The question becomes, if you lived to 1,000 years old, what would you look like?

As Mark Grief, co-founder of literary magazine N+1, aptly puts it in his book Against Everything, the haste to live mortal life diminishes. The temptation towards perpetual preservation grows. We preserve the living corpse in an optimal state, not so we may do something with it, but for its own good feelings of eternal fitness, confidence and safety. We hoard our capital to earn interest and subsist each day on crusts of bread. But no one will inherit our good health after weve gone. DM/ML

In part two of our series Back to the Future: Smart drugs and smart eating, we take a deep dive into the world of intermittent fasting as a way to optimise bodily functions, and smart drugs as a way to enhance ones mental capabilities.

More here:
Are we humans or are we hackers? (Part One of Four) - Daily Maverick

Google Ads clarified in its speculative and experimental medical treatment policy that cell therapies and gene therapies are therapies not allowed on the Google Ad network. This includes prohibiting stem cell therapy, cellular (non-stem) therapy, gene therapy and similar forms of regenerative medicine, platelet rich plasma and others.

Google said that violations of this policy do not lead to immediate account suspension without prior warning. Google said a warning will be issued, at least 7 days, prior to any suspension of your account. So you have time to make changes before your account is suspended for use of these ads.

Google said the following are not allowed to be advertised on Google Ads:

(1) Promotion of speculative and/or experimental medical treatments. Some examples include biohacking, do-it-yourself (DIY) genetic engineering products, gene therapy kits and so on.

(2) Promotion of cell or gene therapies, regardless of regulatory approval status. Examples include stem cell therapy, cellular (non-stem) therapy, gene therapy and similar forms of regenerative medicine, platelet rich plasma and so on.

Personally, I have no clue on the science, I am just reporting the news on this Google Ads announcement.

Forum discussion at Twitter.

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Google Ads: Cell Therapies and Gene Therapies Are Not Allowed - Search Engine Roundtable

Bloomberg

(Bloomberg) -- First they struck California, then Texas. Now blackouts are threatening the entire U.S. West as nearly a dozen states head into summer with too little electricity.From New Mexico to Washington, power grids are being strained by forces years in the making some of them fueled by climate change, others by the fight against it. If a heat wave strikes the whole region at once, the rolling outages that darkened Southern California and Silicon Valley last August will have been previews, not flukes.Its really the same case in different parts of the West, said Elliot Mainzer, chief executive officer of the California Independent System Operator, which runs most of the states grid. Its revealed competition for scarce resources that we havent seen for some time.The specter of blackouts highlights a paradox of the clean-energy transition: Extreme weather fueled by climate change is exposing cracks in societys move away from fossil fuels, even as that shift is supposed to rein in the worst of global warming. States shuttering coal and gas-fired power plants simply arent replacing them fast enough to keep pace with the vagaries of an unstable climate, and the regions existing power infrastructure is woefully vulnerable to wildfires (which threaten transmission lines), drought (which saps once-abundant hydropower resources) and heat waves (which play havoc with demand).On Wednesday, California's grid managers warned that while they're better positioned than last summer, the risk of power shortages during extreme heat remains a clear possibility. Wildfires, already getting started after a dry winter, could compound the danger if they threaten transmission lines. We are headed to yet another very dangerous fire year, U.S. Agriculture Secretary Tom Vilsack said during a briefing Thursday. We're seeing a higher level of risk and an earlier level risk. For many, Californias power crisis in 2020 was the first indication of how serious the regional power shortfall had become. While the blackouts highlighted the states reliance on solar power a resource that ebbs in the evening just as demand picks up an equally significant problem was Californias dependence on imported electricity. Utilities routinely source power supplies from out of state, drawing electricity across high-voltage transmission lines to wherever its needed. But last summer, neighboring states coping with the same heat wave as California were straining to keep their own lights on, and imports were hard to come by.This year, that dynamic is playing out on a larger scale. Across the West, states have grown dependent on importing power from one another. That works fine in temperate weather, when electricity demand is relatively low. But it's a problem when a widespread heatwave blankets the entire region. The Western Electricity Coordinating Council, which oversees electricity grids throughout the western U.S. and Canada, estimates that without imports, Nevada, Utah and Colorado could be short of power during hundreds of hours this year, or the equivalent of 34 days. Arizona and New Mexico could be short for enough hours to total 17 days, according to a report by the organization that looked at worst-case scenarios to help states develop plans to head off potential outages.Its no longer necessarily a California problem or a Phoenix problem, said Jordan White, vice president of strategic engagement for the group, known as WECC. Everyone is chasing the same number of megawatts. While blackouts arent a guarantee in any region, traders are already betting on supply shortages and sending power prices soaring throughout the West. At the heavily traded Palo Verde hub in Arizona, prices have nearly quadrupled since last summers outages, while the Pacific Northwests Mid-Columbia hub has tripled.We are already seeing record-breaking prices across the West, some of which can be attributed to a fear factor being priced in, said JP McMahon, a market associate for Wood Mackenzie. Last year was a bit of a wake-up call.The reasons behind the shortfall are two-fold: Climate change is making it harder to forecast demand for electricity while the shift to clean energy is straining power supplies.Where utilities and grid managers were once able to rely on predictable consumption patterns season to season more air conditioner use in August, less in October theyre now reckoning with record-hot summers and historic winter storms that cause great, unexpected surges in demand.Its becoming challenging to take out the crystal ball to know with any level of certainty how hot it its going to be, White said.At the same time, older coal and gas plants capable of providing power 24 hours a day are being pushed out by climate change regulations and their own dwindling profitability. In the West, power generation from such plants slipped 6% from 2010 through 2018, according to WECC. While wind and solar capacity have more than tripled in the region, the output from those resources varies by the hour, making them harder to rely on during an unexpected demand crunch. Massive batteries can help make up the difference, but their installation is just beginning.Its a global phenomenon. Sweden this summer is bracing for power outages and curbing electricity exports after nuclear retirements have left the country with too little spare capacity to balance big swings in demand. In China last winter, even a surplus of coal plants couldnt keep the lights on during a severe cold blast.At this point, no subregion in WECCs coverage area generates enough electricity to meet its own needs during periods of high demand; they all rely on imports to avoid outages.In the aftermath of the California crisis, utilities have been signing up contracts for more emergency power supplies and are trying to make sure they arent relying on the same suppliers as everyone else. Some entities, including the Imperial Irrigation District of Southern California are working to curb their reliance on imports. But its not clear that all utilities in the highest-risk areas plan to do much differently. The situation is, if not dire, getting close. Temperatures in the West are expected to be above average through the summer, with the worst heat slamming the Southwest. More than 84% of land in the 11 Western states is gripped by drought.Following last summers outages, California is among the best positioned going into summer. The state is plugging roughly 1,500 megawatts of batteries into the grid, has postponed the retirement of several aging gas plants and raised the price cap on power trades to incentivize imports if outside supplies are necessary and available. Even if imports are readily available for those that need them, theres no guarantee that transmission lines will be able to carry those electrons where they need to go. Extreme weather can take out the high-voltage conduits that stitch the Western states together, and wildfires are notorious for knocking out transmission lines. Although it received little attention at the time, a major transmission line in the Pacific Northwest that suffered damage in a storm last spring limited power flows into California throughout the summer energy crisis.Energy consultant Mike Florio, who used to sit on the board of Californias grid operator, said other states can learn from the Wests dilemma. They should keep a variety of resources as they decarbonize, learning how to balance the daily rhythms of solar and wind, and not move too quickly to shutter old gas-burning plants that can provide power in a pinch.We forget that were still learning a lot about how to run a system like this, Florio said. We probably want to keep our existing gas capacity, at least in reserve. It may be used less, but something thats already built is cheap insurance.(Adds quote from U.S. agriculture secretary in sixth paragraph. )For more articles like this, please visit us at bloomberg.comSubscribe now to stay ahead with the most trusted business news source.2021 Bloomberg L.P.

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Oxitec Released a Cloud of Gene-edited Mosquitoes to Study how to Control Reproduction and Stop the Spread of Diseases - Yahoo Finance

Catch up on the investment news quickly with BioSpace'sbrief overview of the biotech companies hitting the Nasdaq and raking in fresh cash the past week.

GingkoBioworks

Going public is all the rage in the biotech space, and GingkoBioworksis taking the fast train via special acquisition company (SPAC) Soaring Eagle Acquisition Corp.Theorganism company has its hand in a variety of markets, starting in fragrance, then food and agriculture and since expanding into antibiotics, vaccines, therapeutics and enzymes. The company landed a$1.1 billion loan for COVID-19 testing and to manufacture raw materials forpotentialtherapies last year. This SPAC deal isone of the biggest,expectingto raise$2.5 billioninproceedsandvaluing the combined company at $17.5 billion.

Science 37

Also jumping aboard the SPAC train isclinical trial companyScience 37. Merging withLifeSciAcquisitions II Corp to hit the Nasdaq, the deal will raise$280 million in gross proceedsand leave the company with a valuation of over $1 billion.Science 37 conducts decentralized clinical studies for clients and has 95 trials under its belt since itsinception in 2014. Funds from the merger will be usedto finance its decentralized trial technology platform, extend into new adjacencies, and power the next generation in clinical research.Science 37 intends to establish a Diversity in Clinical Research Foundation to make clinical trial research more accessible to underserved patient populations.

NuvalentInc.

Less than four months afteremerging from stealth modewith $50 million in the pocket, cancer startupNuvalentcompleted another financing round, this time in a$135 million Series B.The sole investor in the companys launch, Deerfield Management, participated with round leader Bain Capital Life Sciences and some new investors.Funds are funneling into the companys lead programs: NVL-520 and NVL-655. Each a potentially best-in-class kinase inhibitor, the first targets ROS1-driven tumors and the other ALK-driven. Both drugs are in IND enabling studies and are designed to address the identified clinical needs of kinase selectivity, brain penetrance, and activity against drug resistance.

Aetion

Using technology to understand the safety, efficacy, and value of drugs in the real world, RWE leaderAetionscooped up a$110 million Series Cto advance its Evidence Platform.Having raised $212 million to date,Aetionclose to doubled revenue last year while retaining 100% of current customers and adding new. The New York-based health care company landed the first collaboration agreement with the FDA to study COVID-19 research. In addition to growing the capabilities of theAetionEvidence Platform, the company will also expand its European and Asian-Pacific footprint and increase its commercial team to meet growing demand from the majority of top global biopharma firms and leading regulatory agencies.

Jasper Therapeutics

Taking the SPAC route to the Nasdaq, Jasper iscombining with Amplitude Health Acquisition Corp.The deal keeps up to $100million in a trust at Amplitude along with a public investment in private equity financing of another $100million. Leadprogram, JSP191is currently in an early-stage safety trial for patients withacute myeloid leukemia and myelodysplastic syndromes and severe combined immunodeficiency.Cash from the deal will advance JSP191 through clinical developmentand also advance the companys preclinical Engineered Hematopoietic Stem Cell (eHSCs) platform. Using mRNA or DNA editing, the platform is designed to overcome the biggest limitations ofallogeneic and autologous gene-edited stem cell grafts.

Dyno Therapeutics

Sinceemerging from stealth modein 2020 with multiple collaborations in place with big pharma companies, Dyno Therapeutics now bolstered its research with$100 millionraised in a Series A financing round.The Cambridge companyis advancing itsCapsidMapplatform, which leverages the power of artificial intelligence to improve the design of gene therapies and make them safer, more effectiveand applicable to more diseases.Funds from the Series A will be used to expand theCapsidMapplatform to broaden the functionality and improve the therapeutic impact of the gene therapies developed by its partners, Novartis, Roche and Sarepta Therapeutics.

Day One Biopharmaceuticals

San Francisco-basedDay One Biopharmaceuticalsis taking the more traditional route tothe market with a$100 million IPO.Founded in 2018, the biotech hasraised $190 million in the last 12 monthsalone.Its first drug, aimed at pediatric cancer in the brain, isa brain-penetrating,highly selective type II pan-rapidly accelerated fibrosarcoma kinase inhibitor designed to fight brain and spine cancers. A Phase II trial is anticipated soon forchildrenwithrelapsed or progressivelow-gradeglioma, the most common brain tumor for kids.The hope is for an NDAfilingin 2023.

Valneva

French vaccine developer Valneva went public this week, completing a$93.5 million IPO.Valnevahas a COVID-19 vaccine in the pipeline. Its stock prices were bolstered recently as big-name Moderna andBioNTechfell amidstPresident Bidens announcement insupport of waivingthe intellectual propertyprotections for COVID-19 vaccines in an effort to stop the pandemic.Valnevaplans to use the proceeds to developits COVID-19 vaccine candidate, VLA2001, andtwo additional vaccines one to prevent Lyme disease and another to fight chikungunya virus, usually spread by mosquitos.

CellaresCorporation

Automating cell therapy manufacturing,Cellaresraked in an$82 million Series Alast week, bringingfunding to $100 million to date.The fresh dollars will support the development of the companys factory-in-a-box.Cellaris Cell Shuttle enables complete automation ofhighly individualized cell therapies, including the increasingly popular CAR-T therapies which use the patients own immune system to attack blood cancer cells.This automated solution would cut costs forautologous celltherapies by up to 75%and can produce 10 patient doses simultaneously, significantly reducing the time from initial cell extraction to treatment.

Esker Therapeutics

Focused on precision therapies for autoimmune diseases, thisForesite-labs incubated company launched last week with a$70 million Series A.The companys precision analyticsplatform is made up of high-quality curated genetic, clinical and medical record data, a systems immunology approach for prospective data collections and tools for building patient registries. Its lead product ESK-001, a highly selective TYK2 inhibitor with greater selectivity for TYK2 over JAK1, is currently in a Phase I trial for psoriasis.

AlebundPharmaceuticals

Renal disease-focusedAlebundscooped up$60 million in a Series Bround this week. The fresh funds will be harnessed to further drive the companys focus on renal disease, a health condition with a fairly high prevalence in China. The raised funding represents a record for financing raised during a single round by any other Chinese nephrology-related biopharmaceutical company.Current pipeline candidates target renal chronic kidney disease (CKD)/dialysis complications, IgA nephropathy, diabetic kidney disease, and autosomal dominant polycystic kidney disease.

AppioBio

Jumping into the cell therapy fray this week is newcomer Appia Bio. Backed by a$52 million Series A, thecompanyhopes to bringcelltherapy to more peoplewith moreoff-the-shelf treatments, which are typically far more affordable.Appia is developing engineered allogeneic cell therapies from hematopoietic stem cells (HSCs) for cancer patients. Its ACUA platform utilizes the biology of lymphocyte development with CAR and TCR gene engineering to produce CAR-engineered invariant natural killer T (CAR-iNKT) cells from HSCs.

Adaptive Phage Therapeutics

Every year 35,000 Americans die from antibiotic-resistant superbugs.Adaptive Phage Therapeuticsis fighting back with bacteriophage therapies, and landed a$40.75 million Series Bto fund the war. Deerfield Management took the lead on this round, joined by existing investor Mayo Clinic.Funds from this round will be used to advance clinical-stage programs in prosthetic joint infection and diabetic foot osteomyelitis. Further development of thePhageBankSusceptibility Test, a tool to rapidly identify which phage therapy is needed for a specific condition, is also moving ahead.

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Money on the Move: May 5 - 11 - BioSpace

New Zealand scientists interviewed on Newshub [1] calling for loosening regulatory controls on Genetic Engineering must heed warnings from overseas, and international standards of regulation need to be strengthened against the risks of genetically engineered (GE) viruses and microbes.

A new report by the Institute for Responsible Technology [2] is an alert for government regulators and scientists that GE technologies like CRISPR- of viruses and microbes urgently requires stronger controls in the US and globally.

This contradicts the views of The Malaghan Institute scientists calling for changes to New Zealands Hazardous Substances and New Organisms (HSNO) Act that would exempt regulation of GE techniques like CRISPR for medical trials.

"The need for regulation is increasing with the ease and power of emerging gene technologies. In an emergency like Covid-19 the rules have helped provide safety of vaccines approved for emergency use and trials are continuing. This must not be used to justify deregulation of Gene Editing in food and the wider environment," said Jon Carapiet, spokesman for GE-Free NZ in Food and Environment

"Regulation is vital for public confidence. The IRT report reveals the need for regulation of GE viruses and microbes in non-medical as well as medical uses."

In New Zealand The Environmental Protection Agency (EPA) evaluates all applications for live GE products using the stipulations set out by the HSNO Act. The HSNO Act is an environmental law that is in place to protect the environment from the introduction of unknown risks of pesticides and new organisms.

"This requires applicants to show safety of their products by conducting contained trials, indoors or outdoors, in the New Zealand environment," said Claire Bleakley, president of GE Free NZ in food and environment.

"If the HSNO Act is changed and GE organisms are exempted, the level of pesticide use will increase in both the environment and food crops".

GE regulatory exemptions are dangerous as they remove the need for proof of safety. Already, in the six years CRISPR technology has existed, research has shown that mutations, unintended effects, and off target effects are common.

New Zealand has had a range of GM field trials on a variety of onion species, brassica, and canola in the last 22 years, all engineered to tolerate either herbicides or produce insecticides. All these have failed due to poor performance, disease susceptibility, and negligence. However, persistence of the GE canola weeds meant that the field trials had to be monitored for 10 years. [3]

AgResearch has trialled GM ryegrass in the US at a cost of $25 million over the last 5 years, but has been left behind. In the meantime, conventionally bred high performance rye grass is being sold in New Zealand with excellent performance outcomes. NZ is leading the research in animal methane reduction in cattle feed trials [4] and cross-bred sheep that produce less methane emissions. [5]

Animal welfare issues also require that outcomes of Gene Editing be regulated. GM Animals have suffered horrifying problems, including sterility and deformities, while viable production of pharmaceutical proteins in the milk has failed. [6]

The International trial in which NZ participated; on the GE drug Pexa Vec, was withdrawn early due to a high level of risks to patient health. [7]

"Clinical trials are important to understand the risks that GE poses," said Claire Bleakley "It appears that frustration at slow commercialisation and failure of GE organisms to perform in trials is clouding the judgment of GE proponents."

The Government must ensure that regulation and public consultation on issues that affect the New Zealand publics wellbeing are enshrined in law.

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NZ scientists warned about danger of GE viruses and microbes - Voxy

SAN DIEGO, May 11, 2021 /PRNewswire/ -- Poseida Therapeutics, Inc.(Nasdaq: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, today will give multiple oral and poster presentations at the American Society of Gene and Cell Therapy 2021 Virtual Annual Meetingbeing held May 11-14, 2021.

The Company's oral presentation will highlight new data demonstrating the potential of its proprietary piggyBac DNA Delivery System for the treatment of genetic liver disorders in children and infants. Two additional presentations will highlight preclinical data supporting Poseida's first allogeneic CAR-T product candidate, P-BCMA-ALLO1 for R/R multiple myeloma, as well as preclinical data supporting the Company's anti-c-kit CAR-T program as a potentially safer preconditioning regimen for hematopoietic stem cell transplantation in patients with AML.

"At Poseida, we are applying our proprietary technology platforms to develop the next wave of cell and gene therapies to not only treat severe cancers but to also unlock the potential of single treatment cures," said Eric Ostertag, M.D., Ph.D., Chief Executive Officer. "The preclinical data being presented today further validate our CAR-T approach in multiple myeloma and in preconditioning for patients with AML, as well as demonstrate the exciting potential of our liver directed gene therapies, particularly in juvenile patients."

Presentation Highlights:

Oral Presentation: "Preclinical Evaluation of Combined Adeno-Associated Virus and Nanoparticle Delivery of piggyBac Transposon System for Durable Transgene Expression in the Growing Neonatal Murine Liver" Session Date/Time: Tuesday, May 11, 2021, 5:45pm - 6:00pm ETAbstract Number: 30

In a preclinical study, Poseida evaluated concomitant delivery of recombinant adeno-associated virus (rAAV) vectors and novel nanoparticle (NP) vectors using its piggyBac and "Super" piggyBac (SPB) technologies in order to deliver transposon and transposase in a growing neonatal mouse model. Data demonstrated that the piggyBac DNA Delivery System was effective in using both rAAV and NP vectors to introduce edited genes into targeted hepatocyte genomes. Poseida also found that SPB, a hyperactive form of the transposase, produced stable vector integration into the hepatocyte genome for more than three months, compared to transpose alone. Similarly, delivery of a novel NP formulation using SPB produced efficient delivery of mRNA to the liver hepatocytes, with similarly high levels of durability in the transgene expression. Taken together, these preclinical findings suggest the potential of piggyBac and SPB technology for gene therapies that treat congenital liver disease in infants and young children.

Poster Presentation: "P-BCMA-ALL01: A Fully Allogeneic Stem Cell Memory T Cell (TSCM) CAR-T Therapy Targeting BCMA for the Treatment of Multiple Myeloma Shows Potent Anti-Tumor Activity"Session Date/Time: Tuesday, May 11, 2021, 8:00am 10:00am ETAbstract Number: 789

P-BCMA-ALLO1 is Poseida's first fully allogenic product candidate targeting B-cell maturation antigen (BCMA) for the treatment of relapsed/refractory multiple myeloma. In in vitro and in vivo preclinicalstudies, P-BCMA-ALL01 showed effective, targeted cancer cell killing and cytokine secretion, with similar or superior performance in anti-tumor efficacy compared to an autologous CAR-T therapy. Inclusion of a proprietary "booster molecule" in the allogeneic manufacturing process further improved expansion of gene-edited cells and enabled production of hundreds of patient doses from a single manufacturing run, thereby reducing the manufacturing cost per dose into the same range as that of a monoclonal antibody.

Poster Presentation: "Anti-c-kit CAR-T Cells Afford Effective Eradication of Human AML and Normal Hematopoietic Cells in a Preclinical Model of Safer Non-Genotoxic Stem Cell Transplant Conditioning"Session Date/Time:Tuesday, May 11, 2021, 8:00am 10:00am ETAbstract Number:715

Poseida is investigating its anti-c-kit CAR-T program, which leverages its proprietary piggyBac DNA Delivery System in preclinical studies as a potentially safer precursor conditioning therapy to the transplantation of hematopoietic stem cells (HSC) for patients suffering from AML. The piggyBac delivery vectors under investigation include a transposon that generates pure CAR+ product as well as a safety switch that allows rapid clearance of the reactive CAR-T cells prior to donor transplant of hematopoietic stem cells. Preclinical data to be presented in the poster showed that the lead CAR-T cells that express the anti-c-kit binder (CAR 1) deplete up to 92% of human CD34+ stem and progenitor cells in bone marrow within 48 hours. Additionally, an enhanced anti-c-kit CAR-T product, CAR 2, killed an estimated >99% of leukemia cells, exceeding the killing ability of a single dose of 30 mg/kg dose of busulfan. These encouraging data suggest that stem cell-directed CAR-T cells may be a safer preconditioning regimen compared to the current standard of care and may expand access to treatment for acute myeloid leukemia patients needing HSC transplant.

AboutPoseida Therapeutics, Inc.Poseida Therapeuticsis a clinical-stage biopharmaceutical company dedicated to utilizing our proprietary geneticengineering platform technologies to create next generation cell and gene therapeutics with the capacity to cure. We have discovered and are developing a broad portfolio of product candidates in a variety of indications based on our core proprietary platforms, including our non-viral piggyBacDNA DeliverySystem, Cas-CLOVER Site-specific Gene Editing System and nanoparticle- and AAV-based gene delivery technologies. Our core platform technologies have utility, either alone or in combination, across many cell and gene therapeutic modalities and enable us to engineer our wholly-owned portfolio of product candidates that are designed to overcome the primary limitations of current generation cell and gene therapeutics.To learn more, visitwww.poseida.comand connect with us onTwitterandLinkedIn.

Forward-Looking StatementsStatements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regardingthe clinical data presented, the potential benefits ofPoseida'stechnology platforms and product candidatesandPoseida'splans and strategy with respect to developing its technologies and product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based uponPoseida'scurrent expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with development and regulatory approval of novel product candidates in the biopharmaceutical industry, the fact that future clinical results could be inconsistent with results observed to dateand the other risks described inPoseida'sfilings with theSecurities and Exchange Commission. All forward-looking statementscontained in this press release speak only as of the date on which they were made.Poseidaundertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

SOURCE Poseida Therapeutics, Inc.

http://www.poseida.com

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Poseida Therapeutics Presents Encouraging Preclinical Data Across its CAR-T and Gene Therapy Programs at the American Society of Gene and Cell Therapy...

DUBLIN, May 10, 2021 /PRNewswire/ -- Irish based cell engineering company, Avectas today announces the publication of 'A novel non-viral delivery method that enables efficient engineering of primary human T cells forex vivocell therapy applications' in leading international cell and gene therapy publication, Cytotherapy.1

Cytotherapy is the official journal of the International Cell & Gene Therapy Society (ISCT).

Dr Shirley O'Dea et al. examined the suitability of Avectas' SOLUPORE non-viral delivery system for engineering primary human T cells for cell therapy applications.This publication describes how the next generation of immune cell therapy products will require complex modifications using engineering technologies that can maintain high levels of cell functionality and how non-viral engineering methods such as SOLUPORE have the potential to address limitations associated with viral vectors.

Data demonstrates efficient transfection of human primary T Cells with mRNA and CRISPR CAS9 RNP cargos while consistently maintaining high levels of cell viability. Gene expression profiling revealed minimal up or down regulation of genes, demonstrating the low level of perturbation experienced by the cells during this transfection process in contrast to electroporation which resulted in substantial changes in immune gene expression. CAR T cells engineered using the SOLUPOREsystem exhibited high cytotoxicity against target cancer cellsin vitro and in vivo.

Avectas has previously published on the SOLUPORE Technology in PLOS ONE2 with citations in both Nature Biomedical Engineering3 and Chemical Reviews4.

Commenting on the publication, Dr Michael Maguire, CEO of Avectas, said: "It is impressive to see further published evidence showing the advantages of the SOLUPOREplatform in preserving cellular functionality essential for cell therapies. Congratulations to Avectas CSO, Dr Shirley O'Dea and the Avectas R&D team on this additional publication of important work to support the efficacy and potential ofSOLUPORE technology to the cell and gene therapy industry."

Using its patented SOLUPORE technology, Avectas partners with leading cell and gene therapy companies and research institutions to enable the next-generation of gene-modified cell therapies.

1. https://www.sciencedirect.com/science/article/pii/S1465324921001845

2. https://journals.plos.org/plosone/article/authors?id=10.1371/journal.pone.0174779

3. https://www.nature.com/articles/s41551-018-0246-6

4. https://pubs.acs.org/doi/abs/10.1021/acs.chemrev.7b00678

About Avectas

Avectas is a cell engineering company that has pioneered - SOLUPORE- a proprietary, simple, highly effective automated non-viral cell engineering system to enable efficient and safe genetic modification, accelerating the manufacture of cells for the next generation of immuno-oncology therapies.

The company is partnering its cGMP aligned SOLUPOREclinical-grade system with cell therapy companies to address emerging cell delivery challenges associated with multiple cell modifications and engineering of limited or fragile cells. Additionally, it will provide regulatory support to partners. Avectas is a private, international company with research facilities inDublin, IrelandandToronto, Canada, and an office inCambridge, MA, USA. It has over 30 employees and is led by a team of highly experienced pharmaceutical executives supported by a world-class Scientific Advisory Board of cancer cell therapy experts.

For further information, seewww.avectas.com.Follow us onLinkedInandTwitter.

SOURCE Avectas

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Avectas announces publication in leading cell therapy journal Cytotherapy of 'A novel non-viral delivery method that enables efficient engineering of...

Climate change, growing populations and less arable land means advanced farming practices are more important than ever before.

While many in agriculture showed collective outrage over the so-called Impossible Burger, science supporters missed a critical benefit hiding in the controversy. The Impossible Burger is one of the few consumer-facing companies that proudly boasts GMO ingredients and customers still flock to it.

The team at Impossible Burger showcases the climate-saving benefits biotechnology can provide by showcasing the value of soy leghemoglobin the key protein element that gives the Impossible Burger its flavor and texture is a genetically engineer protein. Soy leghemoglobin is made by splicing soybean DNA into yeast, which is then produced in large-scale fermentation.

Seeing this market success, why arent GMOs widely accepted?

Frankly, because agriculturalists from the farm gate, to the lab, to the desks of CEOs have done a bad job telling the story.

I think its everybodys responsibility who is involved in agriculture to be involved in communicating, says Robb Fraley, who commercialized the first genetically modified soybean and now acts as a communicator for the industry. When I was growing up on a small farm in Illinois, more than half of the people who lived in the state were involved in agriculture. Today its less than 1%.

Its the responsibility of everyone involved in food and agriculture to reach out to the other 99% regarding the importance of new scientific advances to increase food production and improve the sustainability of farming, he continues.

The Challenge

Think back to the early 1990s when the FLAVR SAVR tomato was commercialized albeit short lived. It carried promise to reduce waste and improve flavor, a promise that never came to fruition.

When the first GMO product, the FLAVR SAVR tomato, came out people had no idea what GMO even meant, says Kurtis Baute, climate change activist who produces frequent videos promoting science. It was something that really came out of the dark for them, and it was surprising and scary for many. Because of that, we ended up shelving the idea.

The long and short of it, if you need a reminder, is public backlash led to pulling FLAVR SAVR tomatoes from the shelf despite the scientific reality there was no risk in consuming them. People didnt know what they were, and ignorance bred fear, which manifested itself into nixing the product.

Fear lives on. Activist groups around the world are still fighting against GMOs, despite what has now been more than 20 years of research indicating no adverse human or environmental effects.

And the stakes are high. GMO products could be the key to reducing the impact of climate change and tackling hunger and food insecurity around the world. If science isnt trusted, GMOs and other modern practices are at risk.

Start the Conversation

For many scientists and experts in their fields, its easy to overload people with facts. But the fact is, most people who dont have scientific backgrounds dont care about the nitty-gritty details of scientific testing as an expert would. It takes a different approach.

Anytime you are promoting scientific ideas, youre going to have people who are not excited about them, says Kevin Folta, professor at the University of Florida. It applies to all science, whether youre talking about genetic engineering or climate change.

Before starting the conversation, think about how to be a better communicator. It starts by figuring out what neighbors, friends, relatives and, really, anyone cares about. Here are a few tips to get the conversation started the right way:

Its tough to convert someone to 100% stand behind science, but its possible to sway them on several aspects. Understand their backgrounds and why they think the way they do. Employing these three tactics helps get the conversation off on the right foot.

Where to Reach People

The world of communications has changed dramatically since the early 90s when the first GMOs were commercialized. This presents immense opportunity to reach a wide array of people, but that opportunity is not without challenge.

When I first joined Monsanto, you published papers, did newsprint and that kind of thing, Fraley says. Today most of the information people get is on social media its digital. If youre not on social media, basically, your voice doesnt count.

Social media takes the audience from one or two people, to potentially millions. However, its not just any post that will capture the attention of the masses communication looks different online.

Ive basically made a career by building over-the-top projects, explains Baute. For example, I set up 13,799 dominoes so I could show a timeline of the history of the universe. It was a spectacle that engaged people in personal storytelling so I could talk about real science.

There are amazing stories to be told we shouldnt miss that opportunity, he continues. For example, if theres a new product engage people in personal storytelling about how these products came to be. For some technology, it could be 100 years in the making.

Not everyone will want to set up nearly 14,000 dominos or live in a bubble like Baute did to talk about climate change, but theres opportunities to find a fun way to talk about science all the same. Perhaps it makes more sense to tell someone about a personal connection to agriculture and science. Find the story and tell it.

I once baked a cake in 418 steps to explain genetics, Baute says. Sometimes it helps to have a little fun when explaining complex topics.

Protect Science for Tomorrow

Its never been more critical than today to advocate for science literacy. While social media, television and other platforms represent opportunity to talk about science, it also dispels a tremendous amount of misinformation.

We need to be champions and advocates across the biological, the digital and the agronomic space to amplify the accurate messages, Fraley says. Because its just 1% of the population in agriculture reaching out to the 99%.

Europes Science Desert

Scientists looking for new opportunities to apply the latest and greatest technologies in agriculture: steer clear of the European Union. Policies in the region are virtually devoid of scientific reason and instead are political decisions based on pressure from activist groups, along with misunderstanding and emotions.

For example, the 27-member countries are facing a new proposal called the Farm to Fork Strategy that threatens producer access to technologies and could force them to abandon common farming techniques.

Im not sure there was much science involved [in creating the Farm to Fork Strategy], says David Zaruk, EU risk and science communications specialist. The proposed strategy, in a nutshell, would reduce pesticide use by 50%, fertilizers by 20% and convert 25% of all agricultural land to organic production under the assumption these moves would reduce the impact of climate change.

This isnt the first-time agricultural practices have come under fire in the EU either. The countries previously passed regulations that require all products made with gene editing technology to be labeled as GMO regardless of whether or not new genes were introduced in the process.

Researchers in the EU who oppose such rules are between a rock and a hard place, Zaruk explains. Many scientists who support GMOs, gene editing, pesticide use and other common agricultural technologies find themselves without jobs or under attack personally from activist groups.

Most of the scientist that do speak out are retired, he continues. Regardless of the risk, Zaruk still speaks out about the benefits of changing policies to enable farmers to use the latest agricultural technologies available and encourages other scientists to do the same.

The EU can, and should, serve as a warning to other countries about what happens when science is ignored in the policy arena and what happens when agriculturalists arent consulted when planning policy.

Canadas Gene Editing Conundrum

The clock is ticking in Canada. At the end of May, the comment period regarding Canadas Novel Food Regulations will be over and a decision that could make or break the future of plant breeding will be rendered.

This decision will directly impact how gene editing, through technologies such as CRISPR/Cas9, is used and identified to consumers. The question? Should there be additional regulations for crops created by gene editing like the regulations applied to GMO crops?

Cas9 [based gene editing] is a great example of something thats happened naturally for billions of years and now were applying a process to our benefit, says Kurtis Baute, a Canadian native who advocates for science literacy and improving the climate on various channels. Its important to communicate the benefit. This technique will be more precise, and well know exactly what were breeding for, compared to older breeding techniques.

CRISPR/Cas9 and other gene editing technologies could revolutionize the breeding industry if given the latitude to be used. The precision associated with the technique results in better products, faster production and the ability to cater breeding to the needs of todays farmer and consumer.

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Want GMOs, Gene Editing and Access to New Science? Communication is Key - Seed World