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The Ascend of Colossal Biotech: cloning and de-extinction

Introduction


In the last couple of weeks there has been shocking news about the cloning of an extinct species, the dire wolf, whose last appearance on earth dates back to the Late Pleistocene and Early Holocene epochs (125,000–10,000 years ago) in the Americas. The company who accomplished this “groundbreaking” experiment is Colossal Biosciences, which is a pioneering biotechnology company based in Dallas, Texas, co-founded in September 2021 by tech entrepreneur Ben Lamm and renowned Harvard geneticist George Church. The company is at the forefront of de-extinction science, aiming to revive extinct species such as the woolly mammoth, dodo, thylacine, and, more recently, the dire wolf. Utilizing advanced gene-editing technologies like CRISPR, Colossal modifies DNA from extinct species with the help of closely related modern animals. In a notable achievement, the company successfully engineered three pups exhibiting dire wolf traits within 18 months, marking a significant milestone in de-extinction efforts. Beyond de-extinction, Colossal's work has broader implications for conservation biology, environmental restoration, and biotechnology. The company has attracted substantial investment, raising over $435 million from prominent figures including filmmaker Peter Jackson and Chelsea FC co-owner Mark Walter. Colossal's initiatives extend to developing technologies with applications in health, environmental restoration, and artificial reproduction, positioning the company at the intersection of science, ecology, and commercial innovation. So the infamous company has the primary mission to get back extinct species and to prevent the extinction of some endangered species such as the Vaquita or the Orangutan.

 

But why so ?


Throughout the millennia a lot of species face extinction due to the inability of adapting, in fact in nature the applicable law to determine whether a species is going to last is the survival of the fittest, as the famous scientist Charles Darwin stated; so why stop this natural process, moreover without extinction there will be too many players competing for a limited amount of resources, however it’s important to keep in mind that if the number of players is too scarce there will be a bottleneck scenario where the consequences will be simply disastrous for the entire ecosystem, us humans included.

 

Business model & Marketing strategy

 

The hard truth


In reality the company doesn’t really clone or de-extinguish the species, thus their claims result to be inaccurate and misleading, their actual work is more related to phenotype (the appearance of an organism) rather than the genotype (the unique combination of genes) of the extinct species, which is the core principle of cloning.

Nevertheless the outcome of the research is still impressive, but how did they do it ?

In brief they conduct their experiments by applying genetic engineering to existing species in order to modify the appearance and some other minor features of living species.

 

How genetic engineering works


Since the very beginning the human civilisation had always tried to modify the surrounding environment in order to edge against his natural competitor and establishing an hegemony in the Animal Kingdom, but we were not the only one who tried to do so, actually the vast majority of animals modify their habitat in order to fit better, like the bees build their nest or the beavers that create dams, but we managed to take a step further. The human gained his crown in the very moment in which understood that could manipulate not only the environment but also the other lifeforms at his pleasure, establishing relationships of subordination rather than symbiosis. The process started with animal farming, then evolved with selective breeding which is an ancient technique that consist in breeding animals with some desired traits in the hope to pass those genes, which sometimes are the outcome of a non-silent mutation, to the offspring an example of that in the animal world are the dogs, which as we know came from the wolf’s family, however when the same rationale is applied to plants it’s called innest, for instance lemons are not a “natural” product, because there are the result of an innest of citron and sour orange. Thanks to the technological advancements we then discover the immense world of genetic engineering, which comes down to alter an organism's genome, and the reasons for endure this process are usually 2: organism enhancement, to either try to preserve the species or to improve the nutritional values, if the targeted organism falls in the category of farming animal; Gene pharming, also known as transgenic hormone harvesting, involves genetically modifying animals to produce human hormones and therapeutic proteins. These proteins are harvested from the animal's milk, eggs, or blood, and then purified for human use.


Perspective for the future


Genetic engineering (GE) has revolutionized modern agriculture, offering numerous potential benefits that could reshape our food systems. Here are the key advantages:

  • Enhanced Nutritional Value: Genetic modification can boost the vitamin, mineral, and protein content of crops, helping address nutritional deficiencies in populations worldwide

  • Improved Taste and Quality: Scientists can enhance flavor profiles and texture while maintaining nutritional benefits

  • Environmental Resilience: Plants can be engineered to withstand harsh conditions like drought and disease, significantly reducing water usage and the need for chemical fertilizers

  • Reduced Pesticide Dependency: By developing naturally pest-resistant crops, farmers can substantially decrease pesticide use, benefiting both the environment and consumer health

  • Enhanced Food Security: Modified crops with longer shelf life and increased yield help ensure stable food supplies while reducing waste and production costs

  • Accelerated Growth Cycles: Faster-growing plants and animals can increase food production efficiency to meet growing global demand

  • Safety Improvements: Genetic modification can reduce naturally occurring toxins in certain foods, such as acrylamide in fried potatoes


However, the field of genetic engineering has faced several concerns from various stakeholders:

  • Health Safety: Potential risks of allergic reactions or toxic effects in modified foods

  • Genetic Stability: Concerns about unexpected mutations or changes in the modified organisms over time

  • Cross-Contamination: The possibility of unintended gene transfer between modified and non-modified organisms in the environment

  • Nutritional Impact: Questions about whether genetic modifications might inadvertently reduce nutritional value

  • Ecological Effects: Potential impacts on biodiversity and natural ecosystems


It's important to note that extensive scientific research and regulatory oversight have consistently demonstrated the safety of approved GMO products. The United States maintains a robust regulatory framework through three primary agencies: The Food and Drug Administration (FDA) conducts comprehensive safety assessments before any GMO products reach the market. The Environmental Protection Agency (EPA) evaluates environmental impact and safety, while the Department of Agriculture (USDA) oversees the development and cultivation of bioengineered crops. Looking toward the future, genetic engineering research continues to expand beyond agriculture. Scientists are exploring applications in medicine, including the development of new treatments and therapeutic approaches. This could potentially lead to breakthrough applications in pharmaceutical production, gene therapy, and personalized medicine.


Why to start with de-extinction ?


A groundbreaking approach to self-promotion has captured media attention and sparked discussions across scientific communities and public forums. This innovative technology could play a crucial role in preserving vulnerable ecosystems in the near future. For example, when applied to coral polyps, it could safeguard coral reef populations through several mechanisms: increasing their reproductive capacity, engineering their genomes for enhanced pathogen resistance, and developing genetic modifications to help them withstand environmental stressors and other survival threats. This represents a carefully planned strategy to shift public perception of genetic modification from fear to acceptance. By starting with organisms that have minimal human contact, researchers and policymakers can systematically normalize these practices and introduce them responsibly into daily life. In regions facing food scarcity or dietary concerns due to poverty or traditional limitations, scientists could modify key food sources to add essential nutrients. While this intervention may raise concerns, we have already successfully implemented similar modifications in various plant species, with "golden rice" being the most well-documented example, and the same rationale applies to salt in Europe. In 1922, Switzerland became the first country in the world to introduce salt iodization to protect public health. While this is not a genetic modification of the food item, it is still an artificial transformation—specifically, a laboratory process.

 

Golden Rice Case


Golden Rice was engineered from conventional rice by Ingo Potrykus and Peter Beyer in the 1990s to improve human health. It contains an engineered multi-gene biochemical pathway in its genome that produces beta-carotene, which the human body converts into vitamin A. Potrykus worked at the Swiss Federal Institute of Technology in Zurich, while Beyer worked at the University of Freiburg in Germany. Their collaboration was supported by the US Rockefeller Foundation. The team first succeeded in expressing beta-carotene in rice in 1999 and published their results in 2000. Although scientists have continued to improve Golden Rice through laboratory and field trials, no countries grew it commercially until recently. Golden Rice represents a technology that bridges scientific innovation and ethical considerations beyond its role as a grain. In July 2021, following the release of a biosafety permit for commercial propagation, DA-PhilRice, in collaboration with IRRI and other partners, began working to make this vitamin A-enhanced rice available to farmers through seed production. The process requires 3-4 cropping seasons to produce enough seeds for commercial farming. For the Wet Season 2022, a limited quantity of seeds was distributed for pilot-scale deployment. These seeds will be made available in other regions with high vitamin A deficiency by late 2023. DA-PhilRice continues to lead seed production efforts to ensure adequate supply for on-farm cultivation.

 

Regulatory challenges (EU vs. US)

 

To this date, there are no specific laws within the EU regulatory framework which governs the cloning of animals and their use in commerce. However, over the years, the EU has built a strong regulatory network which effectively prevents cloning for commercial purposes in order to protect animal welfare and consumers' rights, in fact the cloning operation can fall under the taxonomy of the GMO products, in which the EU always expressed reticence and carefulness.


A clear example of regulatory intervention is Regulation 1829/2003, which grants EU authorities the power to control genetically modified foods and to approve or reject their use.


The European Parliament further intervened with Regulation 2283/2015 on “Novel Food”, which streamlined the authorization process for genetically modified foods by centralizing the procedure under the responsibility of the European Commission, which acts with the support of the EFSA (European Food Safety Authority). However, as of today, since the regulation entered into force on January 1, 2018, no product has been authorized.


In the past, there has been only one significant attempt, unfortunately unsuccessful, to clearly regulate the cloning of farm animals: COM(2013) 892 final – Proposal for a Regulation of the European Parliament and of the Council, titled "Proposal for a Regulation of the European Parliament and of the Council on the cloning of animals for food production purposes".


The European Commission proposed this regulation following numerous requests from the Parliament and civil society to ban cloning for food purposes, due to ethical and scientific concerns.


The proposal also emerged as a response to the growing practice of cloning in countries such as the United States, Brazil, and China, which could lead to cloned-derived food products reaching Europe through imports.


The main objectives of the regulation were to ban the cloning of farm animals (cattle, pigs, sheep, goats, and horses) for food production, for both commercial and scientific purposes. Another goal was to impose a ban on the placing on the market of cloned animals and clone embryos. The duration of the ban would have been temporary but renewable, until scientific evidence could demonstrate that cloning is compatible with the ethical principles and animal welfare standards of the EU.

 

Unlike the European Union, the United States has a more permissive approach toward cloning, both for scientific and commercial purposes. Food regulation in the U.S. is overseen by the Food and Drug Administration (FDA), a federal agency responsible for protecting consumer rights. The FDA's comprehensive report titled "Animal Cloning: A Risk Assessment" provides a detailed analysis of the safety of food products derived from cloned animals. The report concludes that meat and milk from clones of cattle, swine, and goats, as well as their offspring, are as safe to consume as those from conventionally bred animals.

 

In conclusion, in the U.S. it is legal to sell meat and food products derived from cloned animals without any mandatory labeling to make them identifiable to consumers. However, in practice, such products are not widely sold, due to the high costs involved in cloning an animal, which restricts the use of this method to the cloning of rare or high-value animals.


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