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Daily Archives: January 7, 2022
Progressivism And Bitcoin Are Not Opposed – Bitcoin Magazine
Posted: January 7, 2022 at 4:59 am
Its time to set the record straight. Too many who write or pontificate about Bitcoin do not know what progressivism means in the political realm of American politics looking at you Daniel Kuhn. In reality, many ideas among progressives and the left, are wholly aligned with Bitcoins mission.
Progressive is really an umbrella term that lumps together many left-leaning political ideologies under a set of demands that we deem to be inalienable rights of any human. These are education, healthcare, a living wage and housing. It is true that progressives do put demands on the government to protect and nurture these allegedly inalienable rights. However, you shouldnt believe that progressives and the left are defenders of the state simply because they demand better of it.
In practice, progressives do their best work when they are not focused on electoral politics. At the local level, progressives focus on mutual aid, trade unions and grassroots organizing. These stem from the revolutionary anarchist tradition which came about due to horrific working conditions during the early centuries of capitalism.
The 19th century revolutionary anarchists goal was the absolute dissolution of the state by any means necessary. Anarchists despised the state with a passion that went beyond anything Murray Rothbard could have expressed. Anarchists of the time engaged in guerrilla warfare and many died trying to destroy the state (Rothbard lived out his life comfortably under the state, I might add). Progressives may not be trying to blow up the state these days, but they put major emphasis on providing for communities without help from the government.
Many assume that since Bitcoin inherently protects the right to property and individual ownership that it must be ideologically opposed to the beliefs of progressives. Actually, progressives arent opposed to owning things, in general. What it boils down to is rent, interest and democratic enterprises. What progressives really want are rent-free economies.
In fact, if you go back to the 19th century classical economic discussions of a free market, thats what people like Adam Smith, John Stuart Mill, Karl Marx, Pierre-Joseph Proudhon, David Ricardo and others were trying to figure out. So, owning bitcoin is not in opposition to progressivism. Progressives are not inherently opposed to money, just opposed to how it is used as a means of control and power. Progressives and Bitcoiners are in opposition to neoliberalism because, among other problems that it created, neoliberalism is upheld through state violence.
As for exclusive individual ownership in Bitcoin, that is just a misunderstanding of Bitcoin. Bitcoiners are very proud of El Zonte, El Salvadors Bitcoin Beach experiment. Its hailed as a model for a successful circular economy based on Bitcoin. Here, the developers of the Bitcoin Beach wallet realized that locals would benefit from a community-based custodial option. In this case, the wallet makes it possible to designate a trusted member of the community to be the holder of the private keys for other peoples wallets. Here, responsibility is now coupled with community-based trust, not individual responsibility.
The idea of individual responsibility is one that is unique to the West and more so to the United States. Community identity is much more important in other parts of the world. Since Bitcoin has done so well in many developing nations where community is more valuable than individuality, it is hard to believe that Bitcoin is truly only for those concerned with strict individualism.
Another interesting community-owned idea in Bitcoin is the federated mint (FediMint). Here, a community with a certain amount of trust among its members, can effectively co-own the mint. This leads to a whole set of new ideas about community-based currencies that are backed by Bitcoin, that remind me a bit of Paul Grignons ideas about self-issued credit but also of Prodhouns concept of a Peoples Bank, both coupled with John Nashs work on ideal money. There is so much here that appeals to the progressive!
The only real part about Bitcoin that seems ideologically opposed to progressives at the moment is the 21 million bitcoin cap. The main reason is that there are economic leaders in the movement who are followers of John Maynard Keynes. This stems likely from the Keynesian critique of neoclassical economics and the argument that markets do not tend toward full employment, among other things.
Some of the desire for post-Keynesian approaches may be nostalgia for that long-dead constrained era of capitalism during the post-WWII period. Some of it is a seemingly pragmatic approach to softening boom-bust cycles, in which Keynes argued that deficit spending should occur during economic crises and be constrained during surpluses. Hyman Minsky, another pillar of economics for progressives, attempted to unite Joseph Schumpeter (Austrian school) and Keynes to understand how to stabilize an unstable economy. By the way, this unification (written in the early 1980s) provided a prophetic prediction of the Great Recession.
Even though there seems to be contradiction here between Keynesian ideas and Bitcoins monetary policy, some of the most progressively-aligned economists, like Michael Hudson and Steve Keen, regularly appear on Max Keisers Keiser Report for their sharp critiques of the banking system, dollar hegemony, quantitative easing, and neoclassical economics. Are you surprised? Progressive economists get it, they just arent convinced that the existing system can operate under a capped monetary policy. This is the problem in understanding, really. What Bitcoiners are really advocating for is a new system altogether.
Today, modern monetary theory (MMT) has taken hold of the progressive movement because it also centers the idea of a full employment guarantee where the government backstops the private sector employment with non-competitive jobs. MMT advocates also believe that they can control the money supply and inflation through fiscal and monetary policy. They argue that by bringing full productive forces online (no more, no less) that inflation can be properly managed. However, it has never been tried; the Federal Reserve Board does not practice real MMT at this time. To be clear, even MMT advocates are critical of quantitative easing.
This is not to say that the left gives a full-throated endorsement of MMT, either. There are plenty of critiques of MMT from the left, all one has to do is look for them. Even so, Bitcoin is still appealing to a progressive even if they are MMT supporters simply because of the concerns over the goodness of their money over time. All one really needs to do is explain to the progressive how inflation decoupled from adjustments in living wage is a silent killer of their paycheck. Whats the alternative? Save some of that purchasing power over the long term by hodling bitcoin, of course.
Progressives are well aware of the damage the Federal Reserve and the government did during the Great Recession. Progressives supported Occupy Wall Street because many of them lost their homes to illegal foreclosures. Progressives need to be reminded, though, that the ivory towers of central banks are not any more our friends than the mega-corporation banks are. We can do better to educate our fellow progressives on money as a technology and on the idea that we can have a different economic system where a 21 million cap works.
To stimulate this idea of a different economic system, lets pull from the degrowth movement. Degrowth encompasses a lot of ideas, but the main one is that our economic system should be tied to our planets ability to sustain life. Given the ease at which the banking system generates money (has anyone else compared the S&P 500 chart to the CO2 hockey puck chart?), and the obvious trends that as our Gross Domestic Product has gone up, so have our carbon emissions, it seems entirely logical that we should have a cap somewhere.
In the degrowth literature, there have been discussions about tying a currency to the amount of energy produced. Bitcoins network is backed by access to energy resources. Its mining protocol scales based on the price of electricity. It also has the ability to bring online wasted and stranded energy. This means that the network grows with a speed limit. We can plan whole economies around this prospect.
Furthermore, Bitcoin disintermediates the banking system and puts banking not only in the hands of the individual but of communities (something that Occupy Wall Street advocated for). Communities and/or cooperatives (like in the autonomous peoples economy in Rojava) can issue their own community-backed loans using bitcoin as the backing. Theres much to be explored here and progressives (and leftists more broadly) can really lead the way.
The reality is not that Bitcoin needs to be rebranded to fit a progressive narrative. It is that Bitcoiners and non-Bitcoiners alike need to realize that while the networks genesis block was a political attack on the central banking system, that this sentiment is not exclusive to American libertarianism. This is why progressives are in the Bitcoin space, because we know that Bitcoin is for everyone, and were going to make sure that everyone, not just Libertarians, know that there is a way to exit the system and that Bitcoin can help us find the way out.
This is a guest post by Margot Paez. Opinions expressed are entirely their own and do not necessarily reflect those of BTC, Inc. or Bitcoin Magazine.
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Progressivism And Bitcoin Are Not Opposed - Bitcoin Magazine
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USDA Genetic Engineered Food Label Misleads Consumers, Took Effect January 1 – Beyond Pesticides
Posted: at 4:58 am
(Beyond Pesticides. January 7, 2021)Unbeknownst to most Americans when they woke up on New Years Day 2022, a new labeling system for genetically modified-engineered foods promulgated in 2019 which does not mention genetically engineered or GMO ingredients, went into effect. Consumer, food, and environmental advocates say that the new label is misleading, insufficiently transparent, discriminatory, rife with loopholes, and confusing for consumers. The new labeling requirement mandates that genetically engineered foods bear labels that indicate that they have been bioengineered or that provide a text-messaging phone number or a QR code as avenues for further information. (Additional options such as a phone number or web address are available to small food manufacturers or for small and very small packages.) The new labeling rule from the U.S. Department of Agriculture (USDA) aims, according to the agency, to eliminate the crazy quilt of labels affixed to foods and ingredients that have been scientifically altered. According to an agency spokesperson, the rule is designed to balance the need to provide information to consumers with the interest in minimizing costs to companies.
Genetically altered food items and ingredients have heretofore been called, and labeled as, genetically engineered (GE) or genetically modified (GM), or as containing genetically modified organisms (GMO). The Washington Post reports that, The new rule requires food manufacturers, importers and retailers to disclose information whether foods are bioengineered or use bioengineered ingredients, doing away with well-established terms like genetically engineered and GMO on labels. However, other kinds of official certifications like USDA Organic and NON-GMO Project Verified will be allowed.
The new labeling arises out of several developments in recent years. The first was the so-called Safe and Accurate Food Labeling Act of 2015, dubbed the DARK Act the Denying Americans the Right to Know Act by its many opponents. This legislation reacted to efforts in Vermont, Connecticut, and Maine to enact state laws that would mandate labeling of foods and ingredients that were genetically engineered, or contained such ingredients. The food industry was not happy with such developments, and spent huge sums to thwart state efforts. Some food companies even stopped selling to Vermont grocers in order to avoid the extra costs of labeling and segregating such products. The passage of the DARK Act pre-empted Vermonts successful GE labeling law, which required such items to be labeled as produced with genetic engineering.
Other contributing developments were: (1) the 2016 Congressional passage of the National Bioengineered Food Disclosure Act, which directed USDA to establish a national mandatory standard for disclosing foods that are or may be bioengineered, and (2) the Trump USDAs subsequent 2018 announcement of the National Bioengineered Food Disclosure Standard (NBFDS), which resulted in the 2019 announcement of the new labeling rule that became mandatory on January 1, 2022. That standard defined 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.
The Harvard Political Review sums up the status of GE/GMO foods in the U.S. marketplace, and the history of the battles over labeling of such food. Genetically modified crops, whichprimarilyinclude corn, soybeans, canola, and sugar beets, have been grown in the United States for 20years, and they have FDA [U.S. Food and Drug Administration]approval. Today, as much as75 percentof the food Americans buy at their local grocery store, from cereals to soups, include genetically modified ingredients. However, mostconsumersare not aware that the foods they are eating include these ingredients.
GE/GMO proponents argue that such foodstuffs are safe for human consumption. Opponents have a variety of objections (health and safety, pesticide contamination, ecosystem impacts, etc.) that are largely shared by Beyond Pesticides, but the central issue has been consumers basic right to know what they are purchasing and ingesting. Out of concern for all of those issues arose the Just Label It campaign, on which Beyond Pesticides partnered, and about which it wrote, nearly a decade ago, Beyond Pesticides goal is to push for labeling as a means of identifying products containing GE ingredients and allow for consumer choice that will drive the market toward sustainable practices.
This shift to the term bioengineered for labeling has been roundly criticized by advocates. Director of the project on biotechnology for the Center for Science in the Public Interest, Gregory Jaffe, has commented, The worst part of this law is the use of the term bioengineered because thats not a term most consumers are familiar with, adding that the move to the new jargon was made primarily because GMO had come to be perceived as pejorative.
In the summer of 2020, the Center for Food Safety (CFS) filed suit against the Trump administrations National Bioengineered Food Disclosure Standard and proposed labeling rule. CFS seeks to have the court declare the regulations unlawful and nullify them, and then return the issue to USDA with orders to fix the unlawful portions of the rules. The organization claimed that the new regulation includes provisions that will leave the majority of GMO-derived foods unlabeled; discriminate against tens of millions of Americans; prohibit the use of the widely known terms GMO and GE; and prohibit retailers from providing more information to consumers.
Among the objections CFS cites in its case are: unprecedented allowance of electronic or digital disclosure on packaging, also known as QR code or smartphone labeling without requiring additional on-package labeling
In its litigation, CFS argues that the new rule violates the National Bioengineered Food Disclosure Act, the Administrative Procedure Act (APA), and the U.S. Constitution. The first of those aimed to protect the publics right to know what is in their food and how it is produced; USDA was tasked by that law with creating and implementing rules to achieve those aims. Plaintiffs case documents state: USDAs final rule ignores virtually all the Disclosure Acts statutory provisions designed to ensure disclosure of all GE foods for all Americans. Instead, USDAs Disclosure Standard strips away the hard-fought labeling requirements of States requirements Congress sought to encompass replacing them with inaccessible digital disclosures, unfamiliar terminology, and an extra-statutory definition of bioengineered food. USDAs flawed rationales for doing so violate the plain language of the Disclosure Act and are arbitrary and capricious under the APA.
The suit also claims that the Disclosure Standard violates regulated entities First Amendment rights to provide disclosure to consumers, violates states Tenth Amendment rights by overbroadly prohibiting state laws related to GE seed labeling, and violates the Fifth Amendment by using vague and contradictory language, allowing for arbitrary enforcement.CFS adds, in its case documents: Left standing, the Disclosure Standard will result not only in de facto concealment of GE disclosures, but also a dangerous precedent for truthful and non-misleading commercial speech and for Congresss power to commandeer state governments. Accordingly, this Court should set aside the arbitrary and unconstitutional Disclosure Standard and sever and declare invalid constitutionally infirm provisions of the Disclosure Act. CFS filed a motion for summary judgment in the case in early December, 2021. (Such a motion asks a court for a judgment on the merits of a case prior to the actual trial; this is typically done when the dispute is about a question of law, rather than the facts of a case.)
The net impact of the new labeling schema, according to advocates, is that it puts a far greater burden on consumers to figure out what the labels mean, to do their homework so they are adequately informed (especially because there is, to date, no broad public campaign to apprise them of the change), and if industry takes the least transparent path of using QR codes and text messaging rather than labels to have to resort to in-the-moment research in the grocery store via smart phones they may or may not have and in settings that may or may not have cell or wifi service.
An issue for many advocates is the huge number of food items that would not be covered by the new labeling requirements. The NBFDS exempts (1) foods served in a restaurant, (2) very small food manufacturers with annual receipts of less than $2.5 million, (3) food certified under the USDA National Organic Program, and (4) food in which no ingredient intentionally contains a bioengineered substance, with an allowance for inadvertent or technically unavoidable presence of up to 5% for each ingredient.
CFS elaborates on this loophole issue and notes an additional concern: The vast majority of GE foods (by some estimates over 70%) are not whole foods, but highly processed foods with GE ingredients, like sodas and oils. Yet in the final rule USDA excluded these highly refined products, unless the GE material is detectable. Lastly, the statute invalidates state GE seed labeling laws and prohibits future GE seed labeling laws in violation of states rights to regulate in the absence of federal regulation. Even Forbes magazine has weighed in, writing that, One failing of the bill is that eventhe Food and Drug Administration (FDA) saysthat the definition of bioengineering in the bill is too narrow and would not apply to many foods that come from genetically engineered sources.
CFS Executive Director Andrew Kimbrell wrote, in a late December 2021 update on the organizations litigation, These regulations are not about informing the public but rather designed to allow corporations to hide their use of genetically engineered ingredients from their customers. It is a regulatory scam which we are seeking to rescind in federal court. In addition, we are urging our million CFS members and others to become citizen investigators and find and expose the companies that are using QR codes instead of on-package text or symbol labeling, thereby trying to keep us in the dark about what they have put in our food.
Beyond Pesticides Executive Director Jay Feldman had this to say: This label is recognition by USDA and Big Food that full and honest disclosure of GMO/GE ingredients will hurt the market. In the end, lying to consumers will not work, but it may hurt the value and credibility of other USDA labels, such as the USDA Certified Organic label that we have worked so hard to create in order to convey meaningfully important information about organic criteria, standards, and enforcement.
Few stakeholders appear thrilled by this rule at this moment in time. Some food companies, according to their trade groups, are asserting that instituting this new rule mid-pandemic, and during a supply-chain crisis, puts a significant burden on a sector already struggling. The Consumer Brands Association has urged USDA to pause implementation temporarily; a spokesperson commented: We believe the government must take a do no harm position right now that allows companies to focus on delivering essential products to consumers.
Long a proponent of transparency about the food supply, a few years ago Beyond Pesticides published advocacy points on the flaws of the then-anticipated labeling schema, asking USDA to ensure that labels are honest, transparent, and informative by adopting the following policies: reject package labeling with unreliable QR codes and other discriminatory communication methods; such options discriminate against more than 100 million Americans especially many in rural communities, as well as low-income, people of color, and elderly populations that tend disproportionately to lack access to these technologies
In light of the new labeling, consumers would do well to do their homework ahead of time, or in the grocery store, in order to parse the meaning of the new labeling. (The Washington Posts coverage of the new rule includes a useful What to Know section to help consumers understand implications of the rule for foods they buy and consume.) Perhaps an easier approach, for those who want to avoid GE/GMO food items, is to buy organic as much as possible because USDA National Organic Standards disallow the use of GEs/GMOs.
All unattributed positions and opinions in this piece are those of Beyond Pesticides.
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Nutritionally charged lettuce developed with CRISPR/Cas gene editing tech – FoodNavigator.com
Posted: at 4:58 am
The concept of genetic modification is polarising. While some believe both traditional and new plant breeding techniques are unnatural and unsafe, others see potential in the latter enabling greater yields to feed growing populations.
Yarin Livneh, a PhD student at the Hebrew University in Israel under the supervision of Professor Alexander Vainstein, falls into the second camp: she backs new plant breeding techniques otherwise known as gene editing to help overcome global challenges.
I am a great enthusiast when it comes to the applications of plant genome modifications, she explained. I believe a lot of the challenges our world is facing today such as climate change, malnutrition, pollution, and disease risk could be tackled with the aid of genetically improved research.
Livnehs most recent research is leveraging gene editing technology CRISPR/Cas to do exactly this, we were told: to improve the nutritional quality of an agricultural crop.
Not only could the fruits of my labour be commercialised as a healthier vegetable think more nutritious hamburgers, for example but the knowledge and experience Ive accumulated in the process could serve me in the future to tackle even more important goals.
The vegetable in question is the humble lettuce. Lettuce plants naturally produce a range of nutrients, such as vitamin C, beta-carotene, and thiamine (vitamin B). However, the plant only produces a limited amount of each only the amount required for the lettuce itself.
In Livnehs research, she leveraged CRISPR/Cas technology to target areas in the native lettuce genes that regulate the production and accumulation of these specific nutrients.
By slightly altering the regulatory components, I can trick the lettuce plants into producing or accumulating more of them, for the benefit of the consumer, she told FoodNavigator.
The genetic changes are very subtle', the researcher continued, and are considered gene editing rather than genetic engineering whereby whole genes are usually cloned from other species into the target plant.
I am editing existing genes in a way that could spontaneously occur in nature or when using traditional breeding methods.
The European Food Safety Authority (EFSA) recommends adults consume around 80mg of vitamin C per day. To meet these demands, adults would have to consume about 16 cups of regular lettuce, explained Livneh.
The recommended daily allowance of vitamin C, however, can be achieved with just two cups of the researchers shredded nutritionally-enhanced lettuce.
The research project was not without its challenges. A common issue in gene editing plants lies in delivering CRISPR/Cas machinery into the plant efficiently.
In order to do that, I utilised a delivery method based on a viral vector that usually infects plants and delivers its genetic material into them, Livneh explained. This method is relatively unique and was originally developed in our lab where it is used for other plant species as well.
Another challenge faced by the researchers was how to quantify the nutrients of the improved lettuce.
Our lab is mostly a molecular biology lab and our expertise is the use of molecular biology tools; therefore I am collaborating with several other labs that focus on specific metabolite analysis, we were told.
In Europe, the cultivation of gene edited crops is largely prohibited. Regulation is similarly tight in Israel, due to the markets trade ties in Europe, yet consumers themselves are less concerned by the technology itself, the researcher explained.
In terms of research, we are at the forefront of genetic research and application. The GMO debate is largely disregarded by the public, but still regulation here is tight because a lot of the produce grown here is exported to Europe.
Further, as a majority of Israeli start-ups seek commercialisation in larger, global markets such as Member States in Europe they must keep international GMO regulations in mind. Therefore, sadly, there is little interest in changing the current status quo.
Livneh does, however, see commercial potential for her nutritionally-enhanced lettuce, as well as other nutritionally-enhanced vegetables.
I have already received several enquiries from local lettuce growers and sellers eager to grow and sell the product, she told this publication. They are not deterred by the fact that the lettuce is genetically modified, but are unfortunately mostly unfamiliar with regulation and dont know the process required for approval.
The researcher remains very optimistic for commercialisation potential in global markets. The UK, which withdrew from the European Union in early 2020, has recently approved field studies for genetically edited crops, for example. And recently, a CRISPR-edited, nutrient-enhanced tomato entered the Japanese food market.
This suggests it is not the US alone that is embracing gene-edited crops, stressed Livneh: I think this trend will continue.
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What’s the key, mostly missing, innovation that can help us adapt to severe climate change? Agricultural biotechnology – Genetic Literacy Project
Posted: at 4:58 am
The major food staples are essential to human survival. Chocolate and coffee are not essential, but try to imagine a world without them. One of the numerous concerns with climate change is that many species will lose their habitats. Scientists are projecting that, in the coming decades, this could lead to the extinction of many crops, including cacao and coffee plants.
The cacao tree is native to the Amazon Basin in South America. Over 1,500 years ago, the Mayas and other cultures in South and Central America cultivated the plant, and todayover 90 percent of the worlds cocoa is grown on small family farms. The cacao plants range is a narrow strip of rainforest roughly 20 degrees north and south of the equator, where the temperature, rain, and humidity are relatively constant throughout the year.
Like tropical fruits native to Hawaii, the cocoa industry has been ravaged by fungal infections. In Costa Rica, it never recovered from a fungal outbreak in the 1980s. The most recent outbreak occurred in Jamaica in 2016. Attempts by scientists to breed and create new hybrid varieties have failed. Today, most varieties of the cocoa plant are derived from genetically engineered plants or clones selected in the 1940s, which means they are susceptible to the same fungal diseases from the past.
Today,two West AfricancountriesCte dIvoire and Ghanaproduce over half of the worlds chocolate. By 2050, rising temperatures could push the current growing regions more than 1,000 feet uphill into mountainous terrain, an area nowmostly preserved for wildlife, according to the National Oceanic and Atmospheric Administration. Europe and the United States currently have large markets for cacao, while the demand in India and China is steadily growing. The reduced humidity caused by rising temperatures will make cacao trees extremely vulnerable and threaten the chocolate industry.
In contrast, the coffee plant has a variety of species. Temperature and rainfall conditions are the main drivers of crop yield. Scientists are projecting longer and more extreme periods of rain and drought, and along with rising temperatures, this could reduce the area suitable for growing coffee byup to 50 percentby 2050. Anextensive study foundthat of the worlds 124 wild coffee species, 75 (roughly 60 percent) are at risk of extinction due to climate change.
If scientists can identify which genes of the cacao and coffee plants to modify to adapt to new environmental conditions, they can help them survive. Researchers at the University of California, Berkeley, and Mars, a manufacturer of food products, are collaborating to conserve the cacao plant. In 2008, Marslaunched the Cacao Genome Projectto identify traits for climate change adaptability and developing higher yield. The researchers are using the genome editing tool CRISPR to edit the DNA of the cacao plant so that it can survive in warmer temperatures and drier conditions, and grow in different climates.
Genome editing allows breeders to introduce new traits more precisely and rapidly, potentially saving years or even decades in bringing needed new varieties to farmers. The US Department of Agriculture (USDA)does not plan to regulategene-edited plants or crops if they have traits similar to plants developed through traditional breeding techniques. However, the Food and Drug Administration (FDA)has the final sayover the safety of food for human consumption.
Other alternatives to coffee-as-we-know-it includeartificial coffeeproduced in a lab, which would require government approval, and moving millions of coffee farmers to new habitats. These options might make genome editing more appealing to activists.
The conventional wisdom is that farming is an organic practice and that tinkering with genes is risky and unethical. Advances in biological sciences have allowed scientists to provide a more balanced perspective on how farming practices and genetically modified organisms (GMOs) have impacted humans and our planet.
During the Agricultural Revolution, our ancestors transitioned from hunter-gathers to domesticating plants and animals. We now know that clearing the land increased global warming and standing water created breeding grounds for mosquitos which contributed to the spread of diseases such as malaria. Forests absorb greenhousegases and cattle emit methane during the food digestion process. Today, gases emitted by farm animalsaccount for 1418 percentof global greenhouse gas emissions. Domesticating farm animals has also led to numerous viral infections and poxes in humans which have produced epidemics.
In 1970, President Richard Nixon launched the War on Cancer to better understand the factors related to the development of tumors. Some scientists researched mutations caused by chemicals, the sun, and bombs, while others focused on viruses and bacteria that invade human cells. They discovered the molecular mechanisms used by viruses and bacteria which enabled the field of genetic engineering. They can use the same mechanisms to insert DNA with desired traits.
Genetic engineering has enabled scientists to develop life-saving drugs, produce food sources that can resist fungal and viral infections and live in harsh conditions, and prevent plant species from becoming extinct. In addition, it has stimulated the economy through job creation and hundreds of billions of dollars.
Traditional economics assumes that when humans make decisions they rationally weigh the costs and benefits and calculate the best choices for themselves. Behavioral economics, on the other hand,provides valuable insightsinto why some individuals do not behave in their own best interests. Some people make irrational choices based on errors and biases, while others utilize slow thinking, acquire new information, and are rational updaters.
Biotechnology companies have offered genetically engineered products in American markets since the 1980s. Given that both genetic engineering and recombinant DNA products have not caused any health and environmental problems during that time period, it is unclear why they are not more universally accepted.
In the absence of state and federal laws, scientists took it upon themselves to develop a plan on how to proceed safely with genetic engineering or recombinant DNA technology inside the lab. This led to the 1975 Asilomar Conference organized by the National Academy of Sciences held for four days in Pacific Grove, California. One hundred and forty biologists and physicians, four lawyers, and 12 journalists assembled to discuss the potential risks involved with recombinant DNA technology and to discuss and establish the conditions under which research should proceed.
While researching the mechanisms of cancer, scientists discovered that viruses can alter human cells in culture and transform cell lines into a cancerous state. At the time, they were concerned with the potential dangers of viruses if they spread in labs, while activists were worried they might harm the environment and infect humans outside the labs if they were misused. The scientists agreed to a voluntary moratorium on certain types of recombinant DNA experiments and containment on others until the risks were better understood.
Only months after the Asilomar Conference in 1975, as Chairman of the Subcommittee on Health, Senator Edward Kennedy chaired a hearing on genetic engineering and recombinant DNA. Kennedy was initially inclined to have an extended moratorium on research and allow more time for viewpoints from the concerned public and activists. The City Council of Cambridge, Massachusetts, did declare a moratorium on research, an act that was followed by similar bans in a number of other cities.
After further research, however, scientists learned that if they applied a knockouta technique used to make a harmful gene inoperativeit would make the virus harmless. In his 2001 book, A Passion for DNA, James Watson recalls that Kennedy then did an about-face and said, Following a period without the determination of any real risks; public hysteria cannot be maintained indefinitely in the absence of a credible villain of recombinant DNA technology. The Asilomar Conference has provided a successful framework for assessing the risks of emerging technologies.
In order to provide oversight in the lab, it is necessary to understand the technical aspects of genetic engineering, and to distinguish between real and perceived risks. Without the technical understanding there is a tendency to conflate oversight of the process and the product. Genetic engineering is a lab procedure used to recombine DNA (a process). Scientists can recombine DNA from two different species in order to produce an animal or plant with a desired trait (a product). Now that scientists have made the lab procedure safe, it is the responsibility of the appropriate federal government agenciesincluding the FDA, USDA, and Environmental Protection Agency (EPA)to test and approve the products.
Regulating the risks and safety of automobiles provides an interesting analogy which makes these concepts easier to understand than learning the technical aspects of molecular biology. In the United States, when the production of a Ford vehicle makes it to the Ford factory, the Occupational Safety and Health Administration (OSHA) provides oversight for the safety of the factory workers. As the car moves from a dealership to the highways, the Department of Transportation (DOT) and other government agencies mandate safety precautions such as seat belts, speed limits, laws on texting while driving, air bags, and so on to make driving safer and ultimately lower the fatality rate on American highways.
Human procreation is also a process that recombines DNA. Randomly and through natural selection, it recombines genes from the male and female genomes. In this case, the outcome is more unpredictable. But when DNA is recombined using genetic engineering, genes are selected for their functions.
Scientists later suggested that the National Institutes of Health (NIH) should form a Recombinant DNA Advisory Committee to establish safety guidelines, standards for conducting experiments, and oversight for NIH-funded projects. In 1976, a committee composed of experts in the field set safety guidelines matching the type of containment necessary for different types of experiments. Similar to the containment facilities for research on nuclear weapons during World War II, the levels of risk were categorized as minimal, low, moderate, and high, and required that scientists followed the appropriate safety standards and procedures at each level.
Given the uncertainty of outcomes with human procreation and the guidelines of the committee, one participant at the Asilomar Conference realized that they had just made human procreation amoderate risk experiment.
Historically, scientists have not fully understood the risks of most of the important technological innovations at the time of their invention.Today, the use of GM crops in the United States, South America, and Asia is a mainstream practice. The United States uses the proactionary principle, according to which risk assessment is based on science and self-regulation utilizing experts in the field.
The proactionary approach utilizes proportionality with an equal emphasis on risks and benefits. Restrictive measures are employed only if the potential impact of an activity is both significantly probable and severe, and the restrictions areproportionate to the extent of the risk. With the Asilomar model, manufacturers are held liable for the safety of their products, and regulators must demonstrate that they are not squandering resources and delaying social benefits to address minimal gains in safety.
Some European countries have utilized the precautionary principle for GMOs. With the precautionary approach, the burden of proof is on a manufacturer to prove the health and environmental impacts related to a new product is safe before it is approved. Using the precautionary approach, farmers have suffered financial losses and the benefits of products which can alleviate food shortages and nutritional deficiencies to citizens were delayed or denied.
In 1982,Genentechdeveloped the worlds first genetically engineered drug for patients suffering from Type I diabetessynthetic insulin. Prior to synthetic insulin, diabetes patients used insulin derived from human cadavers and animal insulin derived from pigs, sheep, and cows. Using the precautionary approach would have significantly delayed the medical benefits to many diabetics.
Societies do not accept the risks of technologies equally. Americas social contract with automobiles is very different than GMOs. According to the National Highway Traffic Safety Administration, over the last 20 years, Americans have accepted roughly40,000 annual traffic fatalitiesin return for a convenience that is engrained as part of our lifestyle. This figure fluctuates with regulations including speed limits and safety features in the automobiles, and technologies such as smart phones with texting which cause distractions.
To ensure citizens safely receive the social benefits of biotechnology, oversight would ideally take place through a rigorous clinical trials process similar to the pharmaceutical industry. However, the drug trials are time-consuming and cost-prohibitive for the development of most industrial products, and most biotechnology companies would likely not pursue development. Even with the time and costs dedicated to pharmaceutical clinical trials, a1998 study revealedthat roughly 106,000 people die each year in American hospitals as the result of the adverse health effects or side effects from prescribed medication.
In the past, failed regulatory oversight of the chemical industry left legacy issues and is a legitimate concern. With irrational fears, perhaps due to the inability to differentiate between science fiction and reality, activists are holding the biotechnology industry to a higher standard than other technologies.
Thousands of years ago, humans relied on wind and water wheels for power which were neither reliable nor scalable. Prior to the Second Industrial Revolution (18701914) human labor and farm animals were the major sources of power. Then electricity and internal combustion engines powered by fossil fuels lifted billions of people out of poverty and contributed to the growth of the middle class, reducing the number of hours they had to work and the amount of disposable income spent on subsistence.
In the 1950s, automobiles led to the rise of the suburban lifestyle in the US with gas-guzzling station wagons, modern kitchens, and numerous household appliances. Unfortunately, the Second Industrial Revolution is also remembered for contributing to climate change, and the start of the Anthropocene epoch is characterized by the influence of human activities on land-use changes, deforestation, and burning fossil fuels which accelerated species extinction and global warming.
Scholars have pointed out that, based on these human activities, the Anthropocene would have begun before the Second Industrial Revolution. Paul Crutzen argues that if it began with the production of carbon dioxide and methane at rates sufficient to alter the composition of the atmosphere this would coincide with James Watts design of the steam engine in 1784. William Ruddiman suggests that it began even earlier, and that the Agricultural Revolution that began around 8,000 years ago is a more accurate starting point.
Professional futurists look into the past to better understand probable scenarios for the future. Looking towards the future, societies should focus on making climate change manageable using this knowledge and learning how to best adapt to its inevitable effects. Much of the climate change debate is focused on causality. Deforestation, farming, cow flatulence, and using appliances and internal combustion engines are all contributors. Regardless of the politics of climate change, the effects are the same. Hopefully, planners, business executives, and public policy officials will have a game plan for adapting to the Anthropocene.
Given that climate change is occurring, regardless of the causenatural, man-made, or bothand that genome recombination and editing have enabled scientists to deliver a variety of foods and drugs safely, there is at least one option to prevent numerous species from becoming extinct. Thanks to advances in science and rational thinking, we gourmet chocolate and coffee lovers can continue to feed our addictions. This will confront GM opponents with a trilemmalabeled GM coffee, the artificial variety, or do without.
Randall Mayes is a technology analyst, author, futurist, and instructor of emerging technologies in Duke Universitys OLLI program.
A version of this article was originally posted at Quillette and is reposted here with permission. Quillette can be found on Twitter @Quillette
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What's the key, mostly missing, innovation that can help us adapt to severe climate change? Agricultural biotechnology - Genetic Literacy Project
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Synlogic Announces Progress Toward 2022 Clinical Milestones and Participation at Upcoming … – KULR-TV
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- On track to initiate Phase 3 for treatment of phenylketonuria (PKU) in H2 2022 -
- Additional milestones include multiple clinical read-outs across programs including enteric hyperoxaluria and homocystinuria (HCU) during 2022 -
CAMBRIDGE, Mass., Jan. 06, 2022 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company developing medicines for metabolic and immunological diseases through its proprietary approach to synthetic biology, today provided an update on progress towards multiple 2022 clinical milestones.
The past year was transformational for Synlogic as we achieved clinical proof of concept in phenylketonuria (PKU), a disease that causes tremendous burden to all of those affected. Current treatments leave a need for a safe, effective, and convenient oral treatment option and we are thrilled to be on track to begin the pivotal Phase 3 program in the second half of 2022, said Aoife Brennan, M.B. Ch.B., Synlogic President and Chief Executive Officer. Last year brought additional progress, including clinical proof of mechanism in enteric hyperoxaluria, a research collaboration with Roche and a new clinical candidate for homocystinuria (HCU) developed in partnership with Gingko Bioworks. Our plans for 2022 will build on this progress with multiple clinical data readouts expected across our programs.
Clinical Programs and Anticipated 2022 Milestones
In rare metabolic diseases, Synlogic reported positive interim data from the Phase 2 SynPheny-1 study in patients with PKU with its lead drug candidate, SYNB1618, in September 2021. PKU is an inherited inborn error of metabolism that results in significant disease burden, with current options leaving the majority of PKU patients either untreated or in need of better treatment options. In November, Synlogic announced SYNB1353, a drug candidate designed to consume methionine in the gastrointestinal tract developed through the Companys research collaboration with Gingko Bioworks, for the treatment of HCU, an inherited inborn error of metabolism that, like PKU, results in significant disease burden with limitations in todays treatment options.
In April 2021, Synlogic reported proof-of-mechanism with robust dose-dependent urinary oxalate lowering for SYNB8802, which is being developed for the treatment of enteric hyperoxaluria, a progressive, chronic disease characterized by recurrent kidney stones and risk of progressive kidney damage.
Synlogics research collaboration with Roche to develop a Synthetic Biotic drug candidate for the treatment of inflammatory bowel disease is continuing with the potential for additional research milestones during 2022. Synlogic and Ginkgo are also advancing their research collaboration to include additional, undisclosed preclinical assets.
Expected clinical milestones across these programs include:
Upcoming Industry and Banking Conferences
Synlogic will participate in the banking and industry conferences listed below in early 2022. Recorded presentations will be available at https://investor.synlogictx.com.
H.C. Wainwright BIOCONNECT Virtual Conference. Synlogic will present a corporate update at the H.C. Wainwright BIOCONNECT Virtual Conference taking place from January 10-13, 2022. The recorded presentation will be available beginning Monday, January 10, 2022, at 7:00 a.m. Eastern Time. BIO CEO & Investor Conference. Synlogic will attend and present at the 2022 BIO CEO & Investor Conference taking place virtually and in-person from February 14-17, 2022, in New York City. 11th Annual SVB Leerink Global Healthcare Conference. Synlogic will attend and present at the 11th Annual SVB Leerink Global Healthcare Conference taking place virtually from February 14-18, 2022.
About Synlogic
Synlogic is a clinical-stage biotechnology company developing medicines through its proprietary approach to synthetic biology. Synlogics pipeline includes its lead program in phenylketonuria (PKU), which has demonstrated proof of concept with plans to start a pivotal, Phase 3 study in the second half of 2022, and additional novel drug candidates designed to treat homocystinuria (HCU) and enteric hyperoxaluria. The rapid advancement of these potential biotherapeutics, called Synthetic Biotics, has been enabled by Synlogics proprietary, reproducible, target-specific drug design. Synlogic uses precision genetic engineering of well-characterized probiotics to exert localized activity for therapeutic benefit, with a focus on metabolic and immunologic diseases. Synlogic is also working with Roche in a research collaboration focused on the discovery of a novel Synthetic Biotic for the treatment of inflammatory bowel disease and with Ginkgo Bioworks to include additional undisclosed preclinical assets, combining Synlogics approach to Synthetic Biotics with Ginkgos Codebase and Foundry services. For additional information visit http://www.synlogictx.com.
About SYNB1618 and SYNB1934
SYNB1618 and SYNB1934 are orally administered, non-systemically absorbed drug candidates being studied as potential treatments for phenylketonuria (PKU), a genetic disease caused by potentially neurotoxic levels of the amino acid phenylalanine (Phe). Treatment options for PKU are currently limited due to efficacy and safety, with an estimated 80% of US patients remaining in need of treatment, and many of those who are treated in need of additional Phe-lowering. Synlogic designed drug candidates to reduce levels of Phe in people with PKU using precision genetic engineering of the well-characterized probiotic E. coli Nissle. Findings to date support the potential for an efficacious, safe, convenient, and flexible treatment option for PKU, and SYNB1618 has received both Orphan Drug and Fast Track designations by the US Food and Drug Administration (FDA). Both drug candidates are being studied in the Phase 2 Synpheny-1 study, with data expected in H1 2022, and initiation of the Phase 3 program to begin in H2 2022.
About SYNB1353
SYNB1353 is a novel orally administered, non-systemically absorbed drug candidate designed to consume methionine in the gastrointestinal tract thereby lowering homocysteine levels in patients with homocystinuria (HCU). HCU is an inherited disorder characterized by high levels of homocysteine and risks including thromboembolism, lens dislocation, skeletal abnormalities, developmental delay, and intellectual disability. Treatment options for HCU are currently limited due to efficacy and tolerability. SYNB1353 is currently in IND-enabling studies and was developed as part of a research collaboration with Synlogic and Gingko Bioworks. Synlogic holds worldwide development and commercialization rights to SYNB1353, which is expected to begin clinical development and report Phase 1 data in healthy volunteers in H2 2022.
About SYNB8802
SYNB8802 is a novel, orally administered, non-systemically absorbed drug candidate being developed for the treatment of enteric hyperoxaluria, a chronic, progressive disease characterized by high levels of urinary oxalate, the leading cause of recurrent kidney stones. Oxalate crystals can damage kidneys, leading to chronic kidney disease and end-stage renal disease (ESRD). SYNB8802 was designed using precision genetic engineering of the well-characterized probiotic E. coli Nissle to lower urinary oxalate levels by consuming oxalate throughout the GI tract. In 2021, Synlogic reported positive proof-of-mechanism for SYNB8802 from a Phase 1b study that demonstrated lowering of urinary and fecal oxalate levels in healthy volunteers with diet-induced hyperoxaluria. Data from a proof-of-concept study assessing the lowering of urinary oxalate in patients who have undergone Roux-en-Y gastric bypass surgery is expected in 2022.
Forward-Looking Statements
This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, clinical development plans, future financial position, future revenue, projected expenses, prospects, plans and objectives of management are forward-looking statements. In addition, when or if used in this press release, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to Synlogic may identify forward-looking statements. Examples of forward-looking statements, include, but are not limited to, statements regarding the potential of Synlogic's approach to Synthetic Biotics to develop therapeutics to address a wide range of diseases including: inborn errors of metabolism,and inflammatory and immune disorders; our expectations about sufficiency of our existing cash balance; the future clinical development of Synthetic Biotics; the approach Synlogic is taking to discover and develop novel therapeutics using synthetic biology; and the expected timing of Synlogic's clinical trials of SYNB1618, SYNB1934, SYNB1353 and SYNB8802 and availability of clinical trial data. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including: the uncertainties inherent in the clinical and preclinical development process; the ability ofSynlogicto protect its intellectual property rights; and legislative, regulatory, political and economic developments, as well as those risks identified under the heading "Risk Factors" inSynlogic'sfilings with theSEC. The forward-looking statements contained in this press release reflectSynlogic'scurrent views with respect to future events.Synlogicanticipates that subsequent events and developments will cause its views to change. However, whileSynlogicmay elect to update these forward-looking statements in the future,Synlogicspecifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Synlogic's view as of any date subsequent to the date hereof.
SOURCE Synlogic, Inc.
Media Contact: Bill Berry, Berry & Company Public Relations, Phone: 212-253-8881, Email: bberry@berrypr.com
Investor Contact: Andrew Funderburk, Kendall Investor Relations, Phone:617-914-0008, Email: afunderburk@kendallir.com
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Intense meditation may boost immunity: Study – Hindustan Times
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According to a study conducted by the University of Florida, eight days of intense meditation causes robust activation of the immune system.
The study has been published in the 'Proceedings of the National Academy of Sciences Journal'.
The findings are believed to be the first comprehensive genomic study of how meditation affects the biological processes directly involved in disease development. At the heart of the research is Inner Engineering practices, which are meditation and yoga programs that emphasize inner well-being.
ALSO READ: Here's how meditation can help in relieving stress
While the positive effects of meditation are well documented, far less is known about its molecular and genetic effects, said Vijayendran Chandran, PhD, an assistant professor of paediatrics and neuroscience in the UF College of Medicine.
Chandran's interest in the molecular roots of Inner Engineering actually started with some prodding by his wife -- and a dose of healthy scepticism. Just try it for 48 days, she said. He did so for about 21 minutes a day.
"I tried it and it worked really well. I just felt great," Chandran said.
That also awoke his scientific curiosity: How exactly did Inner Engineering practices benefit the body? To establish their findings, Chandran and his collaborators studied the genetic profiles of 388 samples obtained from 106 people before and after an April 2018 advanced Inner Engineering retreat at the Isha Institute of Inner-Sciences in McMinville, Tennessee. The retreat was tightly controlled: Participants remained silent for eight days, meditated for more than 10 hours a day, ate vegan meals, and followed a regular sleep schedule.
Blood samples from retreat participants were collected five to eight weeks in advance, then just before and after the retreat as well as three months later. The genomic analysis ultimately found several immune-related and other cellular pathways were altered after the meditation retreat.
Strikingly, they found increased post-retreat activity in 220 genes directly related to the immune response. That included heightened activity in 68 genes associated with interferon signalling, a key part of the body's anti-virus and anti-cancer responses. They also established that the enhanced immune system after the retreat is primarily due to meditation and not diet, sleep patterns, or gender differences.
Chandran, whose research specialties include bioinformatics and "big data" analysis, had more than 70 million data points from the blood samples. Like a police detective following a trail of evidence, Chandran let the data be his guide.
"What we found was that multiple genes related to the immune system were activated -- dramatically -- when you do Inner Engineering practices," Chandran said.
The increased gene activity among interferon-signalling genes is particularly significant, according to Chandran. Interferon proteins rally other parts of the immune system to defend against viruses and several recent studies have shown that interferon signalling is imbalanced in patients with severe COVID-19. Essentially, meditation used a coordinated network of core genes and regulators to unleash a positive effect on the immune system, the researchers found.
"This is the first time anyone has shown that meditation can boost your interferon signalling. It demonstrates a way to voluntarily influence the immune system without pharmaceuticals," he said.
The researchers reported that the findings also have potential implications for many immune-related conditions such as COVID-19 and multiple sclerosis. While meditation boosted activity in the 68 interferon-related genes, patients with severe COVID-19 have the opposite problem: a dearth of interferon activity that inhibits virus-fighting.
When researchers compared interferon gene activity in the retreat participants and severely ill COVID-19 patients, the differences were stark. Meditation activated 97 per cent of interferon-response genes, compared with 76 per cent gene activation in mild COVID-19 patients and 31 per cent in severe COVID-19 cases.
They also observed the opposite trend for inflammation-signalling genes, where they saw significantly high levels of inflammatory genes in severe COVID-19 patients, compared with mildly ill patients, and no change in inflammatory genes after meditation. Likewise, meditation produced beneficial gene activity comparable to conventional interferon treatments given to multiple sclerosis patients. Taken together, the findings supported the idea that meditation contributed to potentially improving multiple health conditions, the researchers concluded.
While the findings are intriguing, Chandran also said that the beneficial gene-activity effects need further study, including replication in a randomized clinical trial. It could also be helpful to determine if a less intense meditation regimen in the long term might produce similar beneficial immune-system effects, he said.
Research funding was provided by the UF Department of Pediatrics. Collaborators from the Indiana University School of Medicine, the University of Louisville, and the Beth Israel Deaconess Medical Center contributed to the research.
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IN8bio Announces Clinical Updates from the Phase 1 Clinical Trial of its Genetically Modified Gamma-Delta T Cell Therapy in Newly Diagnosed…
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NEW YORK, Jan. 06, 2022 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company focused on the discovery and development of innovative gamma-delta T cell therapies utilizing its DeltEx platform, provided an update today from the ongoing Phase 1 clinical trial of INB-200, an autologous DeltEx drug resistant immunotherapy (DRI). DeltEx DRI consists of gamma-delta T cells that have been genetically engineered to be chemotherapy resistant, allowing them to be administered concurrently with alkylating chemotherapeutic agents, including temozolomide (TMZ). This clinical trial, conducted in patients newly diagnosed with glioblastoma multiforme (GBM), is the first and most clinically advanced trial to use genetically modified gamma-delta T cells and includes a multi-dose escalation regimen.
Cohort 1 accrual and treatment is complete with three patients having received a single dose of DeltEx DRI via intracranial infusion concurrent with maintenance TMZ administration. Cohort 2 is currently recruiting and treating patients, with one patient having completed all three doses administered intracranially at 28-day intervals concurrent with maintenance TMZ. The Phase 1 clinical trial of INB-200 (NCT04165941) and the progress reported here constitute the first single- and multiple-dosed patients with genetically modified gamma-delta T cells in any indication.
INB-200 has had a manageable safety profile in all four patients treated to date, with no DLTs, CRS, immune effector cell-associated neurotoxicity syndrome (ICANS) or treatment-related serious adverse events (SAEs). The data to-date indicate promising PFS and OS, which will continue to be assessed on an on-going basis, with additional data anticipated at medical meetings later this year along with comprehensive biological correlative data.
Patients with GBM have poor prognoses with a median survival of 14.6 to 16.6 months and PFS of approximately 4 to 6.9 months. The data reported today suggest that INB-200 may have the potential to extend both progression-free and overall survival compared with standard-of-care in the front-line setting, said Trishna Goswami, MD, Chief Medical Officer at IN8bio. We believe that the combination of our DRI technology and the potential to administer multiple doses of INB-200 could lead to improved efficacy results by making our gamma-delta T cells resistant to chemotherapy induced cell death, potentially permitting prolonged and more efficient tumor killing. This approach may overcome the limited efficacy observed in clinical trials of other cellular therapies in patients with solid tumors.
We are pleased to see that INB-200 has continued to be well-tolerated in both the single and multiple-dose treated patients to-date, said principal investigator, L. Burt Nabors, MD at the ONeal Comprehensive Cancer Center at the University of Alabama at Birmingham (UAB). GBM is one of the most difficult cancers to treat, with an urgent need for new therapies. One of the significant hurdles to the use of cellular therapies in solid tumors is the impact of chemotherapies on immune cells, which has been uniquely addressed in the engineering of the DeltEx DRI cells.
Four patients have been treated to-date. In cohort 1, all have exceeded their expected PFS interval, with an encouraging trend in OS based on standard-of-care for their respective age and methylguanine-DNA methyltransferase (MGMT) status1-3. One of these patients remains alive at 17 months post-treatment, having exceeded their expected PFS and OS. As previously reported, a second patient survived for 15.6 months, with a PFS of 8.3 months, and died from an unrelated medical event without further progression. The third patient in cohort 1 exceeded predicted PFS and died at 9.6 months due to progression. In cohort 2, the first patient to complete all three doses has stable disease at 6.9 months and remains in follow-up. An earlier patient enrolled in cohort 2 completed two doses of INB-200 but died due to an acute cardio-pulmonary event without further disease progression. This was reviewed by the data safety monitoring board (DSMB) and the FDA who deemed the event unlikely to be related to therapy, and the study was allowed to continue uninterrupted. Neither patient dosed in cohort 2 experienced any infusion reactions, CRS, DLTs, or ICANS. Patient recruitment and treatment are ongoing with anticipated completion of enrollment in 2022.
INB-200 is an investigator initiated, open-label Phase 1 clinical trial evaluating IN8bios DeltEx DRI therapy in newly diagnosed GBM patients. Patients in cohort 1 received a single dose of INB-200, while patients in cohort 2 receive three doses at 28-day intervals and patients in cohort 3 are planned to receive six doses at 28-day intervals. All doses are given concurrently with maintenance TMZ and are intended to eliminate residual cancer during the vulnerable period of chemotherapy-induced tumor injury, when immune stress ligand expression is upregulated. The primary endpoints of this Phase 1 trial are safety and tolerability, with secondary endpoints based on biologic response, progression free and overall survival.
References1 NEJM 2005;352:987-996. DOI: 10.1056/NEJMoa0433302 NEJM 2005;352997-1003. DOI: 10.1056/NEJMoa0433313 NEJM 2017;376:1027-1037 DOI: 10.1056/NEJMoa1611977
About IN8bioIN8bio is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of gamma-delta T cell product candidates for solid and liquid tumors. Gamma-delta T cells are a specialized population of T cells that possess unique properties, including the ability to differentiate between healthy and diseased tissue.
The proprietary IN8bio DeltEx platform is designed to overcome many of the challenges associated with the expansion, genetic engineering, and scalable manufacturing of gamma-delta T cells. The DeltEx platform employs allogeneic, autologous, and genetically modified approaches to develop cell therapies, designed to effectively identify and eradicate tumor cells. This approach allows us to expand the cells ex vivo to administer a potentially therapeutic dose to patients, harnessing the unique properties of gamma-delta T cells, including their ability to broadly recognize cellular stress signals on tumor cells. We have used the DeltEx platform to create our deep pipeline of innovative allogeneic, autologous and/or genetically modified product candidates designed to effectively target and potentially eradicate disease and improve patient outcomes.
IN8bio is currently conducting two investigator-initiated Phase 1 clinical trials for its lead gamma-delta T cell product candidates: INB-200 for the treatment of newly diagnosed glioblastoma and INB-100 for the treatment of patients with leukemia undergoing hematopoietic stem cell transplantation. IN8bio also has a broad portfolio of preclinical programs focused on addressing other solid tumor types.
For more information about IN8bio and its programs, please visitwww.IN8bio.com.
Forward Looking StatementsCertain statements herein concerning the Companys future expectations, plans and prospects, including without limitation, the Companys current expectations regarding the advancement of its product candidates through preclinical studies and clinical trials and the prospects for such candidates and underlying technology, including the ability of INB-200 to treat GBM, constitute forward-looking statements under the Private Securities Litigation Reform Act of 1995. The use of words such as may, might, will, should, expect, plan, anticipate, believe, estimate, project, intend, future, potential, or continue, the negative of these and other similar expressions are intended to identify such forward looking statements. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown, many of which are beyond the Companys control. Consequently, actual future results may differ materially from the anticipated results expressed in such statements. Specific risks which could cause actual results to differ materially from the Companys current expectations include: scientific, regulatory, technical and clinical developments; failure to demonstrate safety, tolerability and efficacy; final and quality controlled verification of data and the related analyses; expense and uncertainty of obtaining regulatory approval, including from the U.S. Food and Drug Administration; the impact of the ongoing COVID-19 pandemic on the Companys clinical trials; and the Companys reliance on third parties, including licensors and clinical research organizations. Do not place undue reliance on any forward-looking statements included herein, which speak only as of the date hereof and which the Company is under no obligation to update or revise as a result of any event, circumstances or otherwise, unless required by applicable law.
ContactsIN8bio, Inc.Charles Butler+1 646.600.6GDT (6438)cbutler@IN8bio.com
Investors:Solebury TroutDavid Buck+ 1 646.378.2927dbuck@soleburytrout.com
Media:Burns McClellan, Inc.Robert Flamm, Ph.D. / Katie Larchrflamm@burnsmc.com/klarch@burnsmc.com
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What books should our leaders be reading … and why – Sydney Morning Herald
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An agile attorney-general should be anticipating online challenges. Van Badhams QAnon and On dives down the rabbit hole of conspiracy theories and finds more than a few mad hatters. An Ugly Truth: Inside Facebooks Battle for Domination, by US journalists Sheera Frenkel and Cecilia Kang, investigates the misbehaviour of the worlds largest social network eerily anticipating the recent revelations of whistle-blower Frances Haugen.
For an outlook on the Australian economy, John Edwards Reconstruction and Ross Garnauts Reset paint starkly different pictures. Edwards is sanguine about the strength of the economy in the 2010s, and optimistic about the future, provided we can repair relations with China. Garnaut is pessimistic, noting that from 2013 to 2019, Australias output per person grew more slowly than Japan. Edwards would have the Treasurer make some tweaks; Garnaut believes a transformation is required.
Far be it from me to tell the Minister for Women what to read, but in a year when thousands marched to protest against sexual harassment, I found a plethora of insights in new books by women who have served in the House of Representatives.
Julia Banks detailed the culture of the Liberal Party in her book.Credit:Simon Schluter
In Power Play, Julia Banks details the culture of the modern Liberal Party, drawing insights from her experiences in corporate Australia. In Enough Is Enough, Jenny Macklin and Kate Thwaites reflect on the Labor Party and how it has evolved. In Sex, Lies and Question Time, Kate Ellis interviews women from across the political spectrum and offers a suite of reforms that would improve the culture of Parliament.
As Curtin knew, a great education isnt just about imparting facts but building understanding and a deep love of learning. My English teacher, Judith Anderson, might not have approved but John McWhorters Nine Nasty Words brings the talent of a great linguist to the topic of profanity. Did you know that our taboo swear words have evolved from religion to bodily functions to identity groups? Its f---ing fascinating.
And what maths student couldnt be captivated by Jordan Ellenbergs Shape: The Hidden Geometry of Absolutely Everything? In our family, it led to a lively dinner table debate over one of Ellenbergs quirky questions: how many holes are there in a pair of pants one, two or three?
Finally, if the Education Minister wants a sophisticated analysis of academic freedom in universities, Carolyn Evans and Adrienne Stones Open Minds is it.
This year, the author who has most shaped how I think about the world is Cal Newport. Over the past two decades, Newport has evolved from writing advice books for students (How to Be a High School Superstar, How to Win at College) to writing advice books for professionals seeking to make an impact on the world (So Good They Cant Ignore You, Deep Work) to critiquing the way that social media and email are undermining our ability to truly connect with our friends and produce high-quality work.
His latest books, Digital Minimalism and A World Without Email, go beyond advice to critique the systems themselves. The next productivity revolution, Newport says, will come from companies that free their employees from multitasking madness and create space for people to do great uninterrupted work.
Im yet to fully implement Newports philosophy, but Im excited by its implications. Social media has its place, but a full life also involves bushwalks and picnics, craft projects and ocean swims. Living well also means books glorious books that enrich our souls, challenge our beliefs, and help us empathise with people in different times and places. What Curtin missed in formal education, he made up by immersing himself in books for the rest of his life. Leaders should be readers, and a life of books is a life well lived.
Andrew Leigh is a member of the Australian Parliament. His most recent book, Whats the Worst That Could Happen? Existential Risk and Extreme Politics, is published by MIT Press.
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What books should our leaders be reading ... and why - Sydney Morning Herald
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Silk lauded as future solution in food waste and preservation – FoodNavigator.com
Posted: at 4:58 am
Writing in Applied Physics Reviews the researchers outlined how silk's unique and versatile properties present many possibilities for future technologies in the food supply chain both as a crop booster and a food protective coating.
Silk has recently come to the forefront of sustainability research. It is made in nature and can be reprocessed from recycled or discarded clothing and other textiles.
Silk fibroin is an ideal candidate as a method to preserve crop freshness, minimize food loss and ensure food safety, said author Giulia Guidetti. Once applied as a coating, it is edible, tasteless, odourless, transparent, biodegradable, and possesses outstanding mechanical properties as well as low permeability to oxygen and water vapours.
"We are continuing to improve the integration between different disciplines," she continued. "For example, we can use silk as a biomedical device for drug delivery but also include an optical response in that same device. This same process could be used someday in the food supply chain. Imagine having a coating which preserves the food but also tells you when the food is spoiled."
In a 2016 Tuftsstudy, silk fibroin was applied as an edible coating on strawberries and bananas by dipping the fruits in a silk fibroin suspension. The coatings were able to extend the shelf life of both kinds of fruit, decreasing the respiration rate, weight loss, water vapor and oxygen diffusion, preserving firmness and colour, and delaying ripening of bananas compared to uncoated control during 14 and 9days of storage for strawberries and bananas, respectively.
Silk's use has also been investigated as a crop booster. In this context, silk fibroin was used in combination with sugar additive trehalose to develop a seed coating that boosted seed germination and mitigated abiotic stressors by encapsulating, preserving, and releasing biofertilizers in the soil.
However, a few challenges remain unsolved and partially hinder silk's use as a ubiquitous material both at the laboratory scale and at the industrial level, cautioned the researchers.
Silk is versatile and often superior to more traditional materials, because it can be easily chemically modified and tuned for certain properties or assembled into a specific form depending on its final use. However, controlling and optimizing these aspects depends on understanding the material's origin.
The bottom-up assembly of silk by silkworms has been studied for a long time, but a full picture of its construction is still lacking. The team emphasized the importance of understanding these processes, because it could allow them to fabricate the material more effectively and with more control over the final function.
"One big challenge is that nature is very good at doing things, like making silk, but it covers an enormous dimensional parameter space," said author Fiorenzo Omenetto. "For technology, we want to make something with repeatability, which requires being able to control a process that has inherent variability and has been perfected over thousands of years."
As with all natural materials, the silk fibroins is dependent on environmental factors. This will require the development of dedicated, monitored, and automated large-scale production approaches to mitigate batch to batch variability, external contaminants, and environmental influence, explained Guidetti.
Genetic engineering techniques could help to achieve higher protein yields, she added, ultimately leading to silk proteins with new capabilities and, in the future, more economically competitive products. Genome editing, indeed, could enable the advancement of silk-based devices with finely tuned physicochemical properties along with advanced functionalities, wrote Guidetti, while broadening the manufacturing capacity as a result of a robust control on genomic sequence, protein size, and homogeneity, as well as degradation rate, thereby generating responsive materials.
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How we view the world Ivo Vegter – BizNews
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Who rules and how they rule, manage people and economies, is cause for deep global concern but those who create, innovate and invent are the opposite theyre cause for great delight and optimism. That about sums up Ivo Vegters outlook for 2022 in the Daily Friend which initially invokes depression and a sinking heart but dont stop reading; its ultimately uplifting and hopeful. From America and the UKs bumbling leaders to China and Russias expansionist ambitions, the world is full of dangerous, cunning, greedy and/or clumsy presidents and prime ministers. Yet it has an equal share of amazingly creative people (a disproportionate number South African-born) transforming earth and space travel, energy and communication and solving problems and creating stuff in nano seconds, using artificial intelligence. Were all living longer, (until some despot leader goes too far), healthier and more virus-resistant lives thanks to ground-breaking bio-medical developments, and we have more economic freedom the list goes on. Pick your view the glass is either half empty or half full; your happiness quotient probably depends on it. Chris Bateman
By Ivo Vegter*
Every new year, I try to write a piece to remind us (and perhaps reassure myself) of reasons for being satisfied with the present and remaining optimistic for the future. It isnt always easy.
Reasons to be pessimistic I can recite at length.
Russia will likely invade the Ukraine this year, as Vladimir Putin continues to flex his tsarist ambitions. The North Atlantic Treaty Organisation (NATO) will wag fingers and scold Vlad the Great, but beyond sanctions it will do nothing. And Vlad the Impalers territorial hunger will not end with the Ukraine.
China will probably invade Taiwan, taking advantage of the geopolitical instability created by its northern neighbour. Once again, the West will feign outrage, but be unwilling to get into a shooting war over what is essentially a large microchip factory. After all, they might as well buy those chips from Red China. Chinas territorial ambitions will not end there, either.
So, on a geopolitical level, the world appears to be getting more dangerous.
In South Africa, someone just waltzed into Parliament and set the joint on fire. Nobody cared enough to make sure the place was guarded, or that the sprinkler system worked.
All economic indicators continue to point in the wrong direction. Unemployment is unsustainably high, and still rising. The number of working municipalities is dwindling. The number of functional SOEs is at or near zero. Government debt to GDP has turned exponential.
President Cyril Ramaphosas new dawn has been a damp squib;as I wrote days after his installation as president: Cyril Ramaphosa will not be South Africas saviour. He will lead it further into the mire of socialism. It is easy to oppose evil that blatantly appears to be evil. Even a child can do that. The far more dangerous evil is that committed by a person who is intelligent and well-educated, who appears well-meaning, and who expresses his intentions with charm and charisma. That, in essence, is the difference between Jacob Zuma and Cyril Ramaphosa.
As expected, he had neither the political strength, nor the appetite, for sweeping action against corruption. A few scapegoats will be hanged in the town square, perhaps, but the majority of the ANC will march on hopefully to defeat at the hands of the electorate.
In the third quarter of last year, GDP was the same as it was in the first quarter of 2016, meaning that in the last five and a half years, South Africa has achieved zero GDP growth.
Yet inflation is higher than it was before the pandemic, at 5.5%. Food inflation runs even higher. The fuel price is astronomical, having broken the R20/litre barrier. Electricity tariffs are going through the roof, while 2021 was the worst year for blackouts yet.
South Africa has one of the highest tax burdens in Africa and in the world, which is why nobody wants to invest here, and people with the ability to do so are fleeing the country in droves.
Those of us who arent leaving are getting poorer.
Business confidence has been dismal since 2008, and although it has recovered from the lockdown lows, it remains at about half of what it was at the height of the Mbeki era.
Consumer confidence likewise has recovered from its pandemic dip, but remains negative. After a brief spike of excitement when Saint Cyril became our daddy, consumer confidence has returned to levels last seen in the darkest days of the Zuma administration.
Violent protest and lawlessness is on the rise; the police powerless against it. Trust in the government is at an all-time low.
Worldwide, central banks are printing more money than ever before, and government officials are shocked (shocked!) that inflation is no longer confined to pushing up the value of the properties and stocks that they own, but is starting to run out of control in consumer prices, too. (Buy Bitcoin, if youre not shocked.)
The rampant crony-capitalism of the green technology sector is making vast new fortunes for investors, but at the cost of spiralling energy prices for consumers.
Meanwhile, popular movements are pushing to redirect trillions into futile efforts to modify the climate, instead of allowing poor countries to get prosperous so they can pay for weatherproofing just like rich countries do.
Politically, both the left and the right are getting more radical.
A new generation with no memory of the deadly legacy of socialism is openly calling for a new era of socialism, and clamouring for governments to save us from everything from bad language to bad weather.
A new generation with no memory of the catastrophic consequences of xenophobia and protectionism is calling for a new era of right-wing nationalism, and clamouring for governments to save us from everything from hard-working immigrants to hard-working foreigners.
The choice the younger generation offers us is not one of freedom versus tyranny, its which tyranny you prefer.
Nowhere is this political divide more clear than in the idiocracy that elected first a clown and then a dotard to its highest office. Whos next? Oprah Winfrey? Alex Jones? Alexandria Ocasio-Cortez? Marjorie Taylor Greene? Dr. Oz? Milo Yiannopoulos? Ken Ham? The ghost of Bernie Sanders?
This is the country that invented jazz and where people fly to space for fun, but they cannot find a remotely competent and respectable person to place in high office.
And I havent even scratched the surface of reasons to be pessimistic. At leastbeing pessimistic can be good for you.
Yet, while the future looks bleak, it probably isnt. There are many reasons to remain optimistic, even in the face of inevitable setbacks.
Out of the pandemic comes the first reason: mRNA vaccines. These things are awesome.
Vaccines were already among the wonders of 20thcentury medicine. Along with antibiotics, sanitation and clean drinking water, they have been instrumental in the dramatic decline in death and suffering from infectious disease, and save millions of lives every year.
Now, the idea that you can simply script a vaccine to produce whatever proteins you want, is ground-breaking. Instead of taking months or years to develop, this technology reduces the speed of vaccine development to days or hours. Already, the platform is being turned towards previously intractable diseases such as rabies, influenza, malaria, Zika, HIV and cancer.
This will revolutionise preventative healthcare in the 21stcentury, albeit only for the smart people who are in favour of preventing disease. I expect theres a Nobel Prize in it, probably forKatalin Karik and Drew Weissman(andnot for Robert Malone).
More broadly, genetic engineering is earning a place in the sun. Gene therapy is already proving to be successful in treating a range of diseases, and the ability to edit geneswill change everything, forever.
Even more broadly than biotechnology, the march of technology has not slowed down, as many had fearedas Moores Lawbeginsto reach its physical limits. Just the other day, we witnessed the launch of a long-delayed, heavily over-budget new space telescope. It is a glorious piece of engineering that promises amazing insights and will dethrone Hubble as the desktop wallpaper-maker of choice.
Elon Musk, for all his obnoxious personality, is doing amazing things at SpaceX, finally revitalising a sector that has been unproductive and mismanaged by governments since the end of the Apollo programme.
The promise of a commercial space industry, ranging from tourism to scientific research to exploration to mining extraterrestrial resources, is huge.
Musk is also in the vanguard although followed by many competitors in the electric vehicle market, which will, eventually, revolutionise transport for all of us, and have spin-off benefits for an all-electric future.
The internet really came to the party during the pandemic, dragging reluctant technophobes into the brave new world of video conferencing and instant messaging.
Dont be put off by Zuckerbergs creepy metaverse vision. Dont be put off by the Chinese Communist Partys global surveillance network, TikTok, which becamethe most-visited website in the worldin 2021, beating the Five Eyes global surveillance network, Google.
The early internet was also a shitshow of walled gardens, animated gifs, unencrypted network connections, viruses and trojans. Somehow, smart people tamed it and made it work for everyone.
Ubiquitous computing power, ubiquitous high-speed connectivity, ever-evolving artificial intelligence, and robotics, while scary at times, will continue to change our lives, as the internet and smartphones have done in only a few short decades.
Up until the pandemic broke out,economic freedomwas, on average, rising in the world:
There will undoubtedly be a dip as a result of the draconian lockdowns, but the long-term trend should revert to the mean in due course.
The reason this is important is that economic freedom correlates strongly and I believe causally with a host of indicators of wellbeing, including higher income per capita, a higher income share for the poor, a higher nominal income level for the poor, lower poverty rates, improved life expectancy, reduced infant mortality rates, higher school enrolment, a higher score on the UN World Happiness Index, better gender equality, and improved environmental performance.
Although the UNs Intergovernmental Panel on Climate Change persists with its apocalyptic warnings, itsmost scary predictions are also the most unlikely. Contrary to the alarming images in the news, natural disasters used to be far more deadly than they are today:
That economic freedom is on the rise is alsogood news for the climate. In contrast with government-led top-down control (such as the measures imposed to deal with Covid-19),free markets are the best and fastest wayto address the challenges posed by a changing climate.
And although the nuclear fission industry has been hamstrung by irrational public fears and dishonest but successful lobbying by its competitors both in fossil fuels and renewable energy, there is growingexcitement about, and investment in, nuclear fusion, which if successful will be transformational for both civilisation and the environment.
Thanks to the pandemic, global death rates have increased, and thanks to the lockdowns imposed in a vain attempt to slow the pandemic down,half a billion people have been thrust into extreme poverty. This is a great tragedy. However, the pandemic response did not kill the poverty-eradication project. It merelysetitback bya decade or so. It need not be a long-term catastrophe, unless we accede to a new normal of socialist redistribution,or a Great Reset.
Although things might look grim, todays circumstances are not uniquely dreadful. In fact, they remain better than living conditions have been for the vast majority of human history.
If we steadfastly continue to advocate for private and secure technology, public accountability, classically liberal political principles and free markets, the long arc of human development will continue tomake the world a better place.
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How we view the world Ivo Vegter - BizNews
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