Genetically modified probiotic
Coming soon: GM bacteria in pills
Anatoly Alizar, Geektimes
Synlogic, an American startup founded jointly with professors from the Massachusetts Institute of Technology, is ready to bring a new class of medicines to the market. It is called "synthetic bacteria" and "live therapy". Capsules for oral use contain a colony of live bacteria. Getting into the intestines, they begin useful activities. The task is to eliminate certain metabolic anomalies that are the result of diseases and rare genetic disorders.
Trillions of various bacteria constantly live in the human body, which are in symbiosis with us. The number of microbes exceeds the number of cells of the human body by more than an order of magnitude. The total mass of intestinal microflora is from 1 to 3 kg. Without these symbionts, we simply will not survive.
All of them are collectively called the human microflora or microbiota. The human intestinal microflora consists of more than 500 species, most of which are bacteria, for example, E. coli. Other representatives of the microflora are microscopic fungi, in particular, yeast, as well as protozoa. One cubic centimeter of human saliva alone contains from ten million to a billion bacteria.
The study of intestinal microflora is one of the promising areas of modern science. In recent years, scientific research has shown that the microbiota is a complex ecosystem that has a key impact on human health, including his physical and mental state. A person can be considered as a "superorganism". A community of microbes controls the human body by programming the body's metabolism with the help of enzymes that are encoded by the bacterial genome.
Scientists are forced to admit that they are unable to give a complete qualitative and quantitative characterization of the microbiocenoses of the human body by traditional methods, and even more so to analyze the population interactions of microorganisms, microbial "signaling systems" and determine other characteristics of the microflora. This is due to the practical impossibility of cultivating more than 50% of the representatives of the human microflora.
Fundamentally new directions and methods of microbiology have been developed for microbiota analysis, primarily molecular genetic methods using genetic platforms for metagenomic research.
Synlogic startup is working in this innovative direction, studying the microflora and trying to influence it somehow in order to indirectly correct human metabolism. For example, synthetic bacteria can eliminate excess ammonia in the body. The first clinical trials of the experimental drug Synlogic are scheduled for early 2017 (see the press release Synlogic Expands Leadership Team to Support Rapid Advancement of the First Synthetic Biotic Towards the Clinic).
A synthetic bacterium to eliminate excess ammonia is only the first trial balloon in a new class of programmable bacteria that are designed to treat various diseases. Scientific research in this area has been going on for more than 15 years, and Synlogic bacteria in capsules is one of the first specific medications that can be approved for medical use. At the moment, the US Food and Drug Administration is considering from 8 to 10 genetically modified microorganisms.
The main idea is to genetically correct the bacterium E. coli, a common E. coli, which is present in large quantities in the body. A genetically modified bacterium has a special appetite for harmful ammonia, which is constantly formed in all tissues and organs of the body, and especially actively in the liver, intestines, muscles and nerve tissues. This is an extremely toxic compound that needs to be bound (neutralized) and removed from the body.
Usually ammonia is excreted through the urine, but the body of some people is not able to bind and remove it quickly enough. Because of this, a fairly high and toxic level of ammonia is heating up in the body. Up to the point that a person becomes irritable, falls into delirium, and in newborns such a metabolic disorder can even cause death. Synthetic intestinal bacteria helps to convert ammonia into harmless arginine.
According to the Synlogic recipe, it will be enough for a person to normalize the exchange of ammonia in the body to take one capsule of the drug daily, which contains 100 billion bacteria of genetically modified E. coli.
The biotech startup has already received about $70 million in venture funding. Independent experts believe that this is a very promising area of pharmacology. For example, another startup, Ernest Pharmaceuticals, is experimenting with the treatment of malignant tumors using genetically modified salmonella. This is a specific bacterium that tends to accumulate in cancerous tumors. Scientists are trying to use this property of salmonella. The body constructed by them should secrete an anti-cancer drug when it gets into the cells of a malignant tumor.
Clinical trials should verify that the GM bacteria of E. coli are harmless to the body and do not exchange genes with normal bacteria of the human microflora. Engineers have made it so that the division of a synthetic organism requires the presence of a specific substance – thymidine, which is very small in the human intestine. This ensures that the GM bacterium will not leave offspring.
Perhaps a few years later, we will see many different bacteria with gene modifications on the shelves of pharmacies. In general, such GMOs are used not only in medicine. For example, recently it was reported about the development of a microorganism that synthesizes morphine from glucose, so the future promises to be interesting.
In fact, the synthesis of morphine from glucose was only brought to the middle, but in a few years, most likely, those who wish will be able to drink a brew with opiates – VM.
According to experts, the American pharmaceutical market for synthetic bacteria – medicinal pills and yoghurts with live bacteria – is $3.5 billion.
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09.11.2016