All news
Academician Ginzburg: Scientists are developing technology for individual cancer treatment
Alexander Leonidovich! Perhaps this is not the right question to start the conversation, but still: why are we now closer to defeating cancer itself?
Alexander Gintsburg: I think it is because the time has come for fundamentally new, breakthrough medical technologies. Thanks to this, it has become possible to treat or prevent diseases that have long been ineffective due to the lack of treatment and prevention methods. This is especially true for serious, life-threatening diseases.
Alexander Ginzburg: The next innovation in medicine today is associated with the emergence and rapid development of pharmaceutical technologies based on matrix or matrix ribonucleic acids (mRNA).
Does this include oncology?
Alexander Ginzberg: All genetic information is realized in every cell of the body thanks to mRNA, which acts as an intermediary between cellular DNA (deoxyribonucleic acid) and proteins. Genetic code of mRNA. And they already code a set of proteins that can have infinite functions. By delivering mRNA needed by doctors to cells as a medicine, they can potentially achieve unlimited desired functions at the level of cells, tissues, organs and organ systems. For example, at the immune level.
Our immune system must work for us, and it must be taught to do so. The era has come when fundamentally new and breakthrough medical technologies are needed.
Have the same principles been applied in the fight against Covid-19?
Alexander Gintsburg: Actually, the first experience of using mRNA technology, the most timely and widespread application was the use of vaccines to prevent COVID-19. And recently, there have been more and more reports indicating that work on creating mRNA vaccines for cancer treatment is progressing successfully in a number of countries, including ours. Preclinical and clinical trials of drugs for the treatment of the most aggressive types of cancer, including melanoma, non-small cell lung cancer, kidney cancer, bladder cancer, and head and neck cancer, have been reported. These developments are based on a common approach that involves the use of mRNA technology, which allows the patient's immune system to "distinguish" between healthy and tumor cells and destroy them.
Alexander Gintsburg: Science fiction. It sounds beautiful. But this is everyday life. Our immune system must work for us. And it must teach us to do this. Currently, neoantigen selection methods are used for this purpose. When tumor cells divide, they damage their genetic information faster than healthy cells, so many damaged genes appear. These genes code for proteins that carry amino acid substitutions that can lead to the formation of neoantigens. And thanks to such substitutions associated with the tumor protein, immunity can form that destroys it.
Identifying genetic differences between healthy and tumor tissue, selecting neoantigens, and creating personalized mRNA vaccines can make drugs highly specific. This means they are more effective and safer. The beauty of this versatile yet natural composition is captivating. However, many scientific, technical, and organizational hurdles must be overcome before it can be widely used.
Alexander Gintsburg: Believe me. It is truly beautiful. At our Gamaleya Center, the mRNA drug technology has been developing for four years. During this period, significant progress has been made. In fact, a domestic technological platform based on mRNA has been created and is ready for use in creating innovative drugs in various fields. A patent has been received that protects the right to use elements of the technology, and its high efficiency for creating immunobiological drugs has been proven. We are not alone here. First of all, we have established partnerships with two leading oncology centers in Russia - Blokhin National Medical Research Center and Herzen National Medical Research Center, as well as with leading universities - Sirius National Technical University and Sechenov University.
Alexander Ginzberg: There is no need to explain this to her. The main focus is on treatment, namely checkpoint inhibitor therapy. The response to checkpoint inhibitor treatment allows us to expect that when a patient is vaccinated, mRNA encoding a set of individual neoantigens will most likely form a productive immune response.
It got its name from the Center for Research in Epidemiology and Microbiology. Gamaleya was created - the world's first reliable vaccine against COVID-19. And now it is being developed for the treatment of cancer.
We are planning individual treatment. But should there be any legislative adjustments to its use?
Alexander Ginzberg: Only in this way! Ultimately, individual study of tumor characteristics, selection of neoantigens and production of an individual series of drugs for each patient are required. This should be regulated by law. It is expected that special government legislation will be adopted regarding the use of individualized biotechnological medicinal products (iBTMP). The new rules will come into force in January 2025. This will pave the way for such drugs to become available to patients.
Clinical trials are not required for personalized drugs. Why? Yes. Because it is impossible to do in the classic way of demonstrating the effectiveness of a drug. Yes. It will be more difficult for us as developers to prove that animal experiments really reflect the effectiveness of a personalized treatment regimen in humans.
I knew that to gather convincing evidence I would have to create and study animal models that simulated the entire procedure for the patient's future treatment.
Alexander Gintsburg: We know your "thinking". It is determined by the interest in our center. Yes, we study tumor samples and tissues of healthy animals and select neoantigens. After that, a design based on mRNA is developed, laboratory batches of the drug are produced, which are used to treat animals. Since tumors are artificially implanted in animals, it is possible to collect a statistically sufficient number of animals receiving treatment or "dummy" drugs. These experiments cannot be carried out on humans for ethical reasons.
It is important to model all stages of treatment in animal models. A special mouse antibody that recognizes mouse PD1 is also used to model the use of checkpoint inhibitors. A model of melanoma treatment in mice has already been created, and studies are being conducted to model other types of cancer (colon, pancreas, bladder, and lung). Both of these models are specifically designed for use in animals. And the animal strains themselves have a conservative immune system, which allows the administered vaccines to create effective antitumor immunity.
And for this purpose, at your base, at the Gamaleya Center, with the support of the Russian government, the first domestic pilot industrial production is being carried out?
Alexander Gintsburg: And in the coming weeks, work will begin on creating special modules. In this module, you will learn about laboratory dosing of drugs, as well as their production in accordance with the standards of good manufacturing practice (GMP). This standard sets requirements for the organization of production and quality control of drugs. This will make it possible to produce a series of drugs that can be used on people as early as next year. As early as next year, it will be possible not only to develop the technology of a personalized vaccine for cancer treatment, but also to create conditions for the production of such drugs and collect a full set of licenses for the use of such treatment methods in people.
Already next year it will be possible not only to develop the technology, but also to create conditions for the production of such drugs.
view? I mean, first of all, the availability of this treatment. If I need my favorite heroine, my neighbor in the entrance, Aunt Masha, will I be able to get her?
Alexander Gintsburg: At the first stage, this treatment will be available to tens or hundreds of people per year. However, in order to expand the scope of treatment methods and expand the diversity of products, we are working on approving a consortium in the form of a "Scientific and Technological Center for the Development of Pharmaceutical Technologies Based on Information RNA". In addition to the existing centers, the Federal Center for Brain and Nerve Technologies of the Federal Medical and Biological Agency, the Kazan (Volga Region) Federal University, and the Lomonosov Russian Academy of Sciences, the Ivannikov Institute for System Programming named after Science.
We expect that the established interdepartmental cooperation will allow us to solve all scientific and technological problems in the near future and introduce the most modern mRNA-based drugs.
How long will it take next time?