Russian Medical Development: News

She suggests that a course of treatment will cost approximately one and a half to two million rubles for one patient, while in the US its cost could range from 200 to 400 thousand dollars.

To put that into perspective using a currency converter (cash.rbc.ru)...

https://cash.rbc.ru/converter.html?from=RUR&to=USD&sum=2000000&date=&rate=cbrf

2 million rubles is just under 22 thousand US dollars.... !!!!

That would barely cover the ambulance ride in the US...

A vaccine against Marburg fever is being developed in Russia, 10.08.2024.

MOSCOW (Sputnik) — Russia's Vector Virology and Biotechnology Center has created a vaccine against Marburg fever that has already successfully passed preclinical studies, the press service of the Russian consumer protection agency Rospotrebnadzor reported.

"The employees of the Vector Center of Rospotrebnadzor have developed a vaccine for the prevention of Marburg fever. The project has already passed the preclinical tests, which shows its safety and effectiveness," the message released by the entity states.

The vaccine is ready to a high degree for clinical trials, and a package of documents is being prepared to obtain the corresponding permission, Rospotrebnadzor explained.

The Marburg virus is transmitted to humans from fruit tree bats and spreads between people through direct contact with biological fluids of those infected, as well as with surfaces and materials.

There are no vaccines against this fever or specific drugs to treat it. To increase the survival of the infected, maintenance therapy (oral or introvenous rehydration) and symptomatic treatment are used.

Yandex Translate from Spanish.

https://noticiaslatam.lat/20241008/crean-en-rusia-una-vacuna-contra-la-fiebre-de-marburgo-1158087179.html

Ginzburg spoke about the successes in developing a vaccine against cancer, 10.12.2024.

Ginzburg reported success in preclinical studies of cancer vaccine.

The Russian mRNA cancer vaccine is being developed by several institutes at once, its preclinical trials were completed last month. According to Ginzburg, in animal tests the drug showed the ability to suppress tumors.

Preclinical studies of the Russian cancer vaccine demonstrate that the drug suppresses tumor development and can also probably suppress the possibility of metastases, Alexander Ginzburg, director of the Gamaleya National Research Center for Epidemiology and Microbiology, told TASS .

"It has been proven on animal models that this vaccine drug suppresses tumor development very well. Apparently, it also suppresses the possibility of metastasis of this tumor," he noted.

According to Ginzburg, scientists are currently working to find out whether it is possible to transform a mutation that has arisen in a tumor into an antigen that would stimulate the patient's immune system to work against his own tumor. "Next year, the Herzen and Blokhin Centers should begin using the vaccine in patients," he promised.

The Russian cancer vaccine is being developed jointly by several scientific teams - the Gamaleya Center, the Herzen Moscow Cancer Research Institute, and the Blokhin National Medical Research Center of Oncology. The work on developing the vaccine is financed by the state. Preclinical trials of the drug were completed last month.

https://www.rbc.ru/society/12/10/2024/670a41409a7947aa3ddcddcc

Vaccine against tumor. Academician Ginzburg on whether it is possible to create an individual drug against cancer, by Irina Krasnopolskaya for Rossiyskaia Gazeta. 10.15.2024.

Academician Ginzburg: We must teach our immune system to work for us.

Cancer vaccine. It is difficult to overestimate the reaction to such information. How else! Let's get rid of this ominous scourge? A centuries-old scourge that does not take into account anything: age, place of residence, nutrition, habits, following or not following a healthy lifestyle. Yesterday you were healthy, today... Mortality from cancer is second only to heart and vascular diseases. And sometimes it even pushes them into the background. And then there's the vaccine. So, you get vaccinated and are healthy for the rest of your life? Not everything is so simple and straightforward. We are talking about this with the director of the N.F. Gamaleya National Research Center of Epidemiology and Microbiology, Academician Alexander Ginzburg. It was in this center that the world's first reliable vaccine against COVID-19 was created. And now against cancer itself...

Alexander Leonidovich! Perhaps this is not a very appropriate question to start a conversation with, but still: why is it that now we are closer to defeating cancer itself?

Alexander Ginzburg: I ​​think it is because the time has come for fundamentally new, breakthrough medical technologies. Thanks to them, it becomes possible to treat or prevent those diseases for which there have long been no treatment or prevention methods. Especially when it comes to really serious, life-threatening diseases.

And today?

Alexander Ginzburg: Today, the next breakthrough in the field of medicine is associated with the emergence and rapid development of pharmaceutical technologies based on matrix or informational ribo-nucleic acids (mRNA).

Including oncology?

Alexander Ginzburg: Thanks to mRNA, which acts as an intermediary between cellular DNA (deoxyribonucleic acid) and proteins, all genetic information is realized in each cell of the body. Genes encode mRNA. And they encode a sequence of proteins, which can have an unlimited number of functions. Delivery of the mRNA needed by the doctor to the cell as a medicine potentially allows for the realization of an unlimited number of necessary functions at the level of cells, tissues, organs and organ systems. For example, at the level of immunity.

The immune system must work for us, and it must be taught to do so. The time has come for fundamentally new, breakthrough medical technologies.

Was the same principle at work in the fight against Covid?

Alexander Ginzburg: Indeed, the first experience and the most timely widespread use of mRNA technology was carried out using vaccines to prevent COVID-19. And recently, more and more reports have appeared indicating that in different countries, including our country, work is successfully underway to create mRNA vaccines for the treatment of cancer. There are reports of preclinical and clinical trials of drugs for the treatment of the most aggressive types of cancer: melanoma, non-small cell lung cancer, kidney cancer, bladder cancer, head and neck cancer. These developments are based on a general approach related to how, using mRNA technology, to force the patient's immune system to "distinguish" healthy cells from tumor cells and destroy the latter.

Force immunity. Science fiction?

Alexander Ginzburg: Science fiction sounds beautiful. But this is the current everyday life. The immune system must work for us. And it must be taught to do this. Now, the technology of selection of neo-antigens is used for this. Since tumor cells damage genetic information faster than healthy cells during division, many damaged genes appear in them. These genes code for proteins that carry amino acid substitutions that can lead to the formation of neoantigens. And it is thanks to such substitutions in relation to tumor proteins that immunity can be formed that will destroy it.

Identifying genetic differences between healthy and tumor tissue, selecting neoantigens, and creating a personalized mRNA-based vaccine allows us to make the drug very specific. And therefore more effective and safe. The beauty of this universal and at the same time nature-like scheme is attractive. But for its widespread use, it is necessary to overcome many scientific, technological, and organizational obstacles.

"The beauty of the scheme." An unexpected phrase for you.

Alexander Ginzburg: Believe me, it really is beauty. At our Gamaleya Center, the mRNA drug technology has been developing for four years already. During this time, we have managed to make significant progress. In fact, a domestic technological platform based on mRNA has been created, which is ready for its use in a variety of areas for the creation of innovative drugs. Patents have been received that protect the rights to use elements of the technology, and its high efficiency for the creation of immunobiological agents has been demonstrated. We are not alone here. First of all, we have an alliance with two leading oncology centres in Russia: Blokhin National Medical Research Centre and Herzen National Medical Research Centre of Radiology, with leading universities NTU Sirius and Sechenov University.

Clear emphasis on oncology.

Alexander Ginzburg: There is no need to explain why it is specifically targeted. The main focus is on treatment - therapy with checkpoint inhibitors. The response to therapy with checkpoint inhibitors allows us to expect that when vaccinating a patient with mRNA encoding a personal set of neoantigens, there is a high probability that a productive immune response will be formed.

The world's first reliable vaccine against COVID-19 was created at the Gamaleya National Research Center of Epidemiology and Microbiology. Now it is being developed for cancer.

The treatment is planned to be personalized. But there should be some legislative adjustments for its use?

Alexander Ginzburg: Only this way! After all, individual studies of the tumor characteristics, selection of neo-antigens and release of an individual series of the drug for each patient are required. This should be regulated by law. There will be a special government decree on the use of individualized biotechnological drugs (iBTLP). It is expected that the new "regulatory framework" will come into force in January 2025. This will open the way to the use of such drugs in patients.

Clinical trials of personalized drugs will not be required. Why? Because they cannot be conducted in the classical scheme of proving the effectiveness of drugs. Yes, it will be even more difficult for us, the developers, to prove that experiments conducted on animals will truly reflect the effectiveness of a personalized treatment scheme in humans.

I happen to know that in order to collect convincing evidence, you create and study animal models that simulate the entire procedure of future treatment in patients.

Alexander Ginzburg: We know about your "accident": it is dictated by the attention to our center. Yes, we study tumor and healthy animal tissue samples, select neo-antigens. After that, a design based on mRNA is developed, a laboratory series of the drug is produced, and it is used to treat animals. Since the tumor is implanted into the animal artificially, this allows us to collect a statistically sufficient number of animals receiving therapy or a "dummy" drug. Such experiments cannot be conducted on humans for ethical reasons.

It is important to simulate all stages of therapy on an animal model. Even to simulate the use of checkpoint inhibitors, special rat antibodies that recognize mouse PD1 are used. A model has already been created for mouse melanoma therapy, and work is underway to simulate other types of cancer (colon, pancreas, bladder, lung cancer). All these models are special for use on animals. And the animal lines themselves have an intact immune system so that the administered vaccine can form effective antitumor immunity.

And for this purpose, on your base, on the base of the Gamaleya Center, the first pilot industrial production facility in the country is being created, supported by the Russian government?

Alexander Ginzburg: And in the coming weeks, work will begin on creating a special module, within the framework of which it will be possible to obtain not just laboratory batches of the drug, but according to the Good Manufacturing Practice (GMP) standard. This standard sets requirements for the organization of production and quality control of medicines for medical use. This will make it possible to obtain batches of drugs next year that can be used in humans. Already next year, it will be possible not only to develop the technology of personalized oncotherapeutic vaccines, but also to create conditions for the production of such drugs, collect a full set of permits for the use of such therapy in humans.

Already next year it will be possible not only to develop the technology, but also to create conditions for the production of such drugs.

Prospects? I mean, first of all, the availability of this therapy. Will my favorite heroine, my neighbor Aunt Masha from the entrance, be able to get it if necessary?

Alexander Ginzburg: At the first stage, such therapy will be available to tens and hundreds of people per year. However, in order to expand the application of therapy and increase the range of products being created, we have worked out the issue of approving a consortium in the form of a "Scientific and Technological Center for the Development of Pharmaceutical Technologies Based on Matrix RNA". In addition to the already actively operating centers, we have invited several more participants, including Lomonosov Moscow State University, the Federal Center for Brain and Neuro-Technology of the Federal Medical and Biological Agency of Russia, the Federal State Autonomous Educational Institution of Higher Education "Kazan (Volga Region) Federal University" and the Ivannikov Institute for System Programming of the Russian Academy of Sciences.

We expect that the created interdepartmental cooperation will soon allow us to solve all scientific and technological problems and introduce the most advanced mRNA-based drugs.

The nearest time is how much?

Alexander Ginzburg: We are optimists.

https://rg.ru/2024/10/14/zagnat-rak-v-kletku.html

"We are developing a product to treat Parkinson's at the Moscow Technology Park", 10.18.2024.

The Drug Research and Development Centre (CIDEM) of Cuba collaborates with Russia to conduct studies of new medications for the treatment of neurodegenerative diseases such as Parkinson's.

"The Drug Research and Development Centre is one of the pioneers in negotiating innovative products with Russia. Our first successes in international collaboration were with that nation, which has similar structures to ours. The interest in us was related to our prestige, expertise, seriousness and ability to work. The first approaches were looking for technical collaborations in some events," Alejandro Saúl Padrón, general director of CIDEM, told Acentos.

"Thanks to the expertise of our professionals, we created a Russian-Cuban company in the Moscow Technology Park (Neirus) related to the research of neurodegenerative, infectious and oncological diseases," he added.

The specialist announced that they already have a signed contract for the commercialization of the molecules CIDEM 112 and CIDEM 113, which are candidates for a drug. "Our product proved that it is effective in treating Parkinson's in animals. It has not yet been tested in humans, but it is ready to start with the Phase 1 clinical trial. This is the first time that we have a completely new molecule created by us that is a candidate for a drug."

Yandex Translate from Spanish.

https://noticiaslatam.lat/20241018/estamos-desarrollando-en-el-parque-tecnologico-de-moscu-un-producto-tratar-el-parkinson-1158331005.html

Russian anti-tumor drug passes first phase of trials, 10.23.2024.

Russian drug based on oncovirus passes first phase of trials.

NOVOSIBIRSK, 23 Oct – RIA Novosti. The first Russian anti-tumour drug created on the basis of a genetically modified oncolytic virus has successfully passed the first phase of clinical trials, its safety and effectiveness have been confirmed, RIA Novosti was told on Wednesday at the Institute of Chemical Biology and Fundamental Medicine (ICBFM) of the Siberian Branch of the Russian Academy of Sciences.

The drug was developed by the Institute of Chemical Biology and Fundamental Medicine of the Siberian Branch of the Russian Academy of Sciences, the Vector Center of Rospotrebnadzor in partnership with Oncostar LLC (a Skolkovo resident ).

"Phase I clinical trials of the first Russian antitumor drug created on the basis of the genetically modified oncolytic virus VV-GMCSF-Lact have been completed. The trials not only confirmed its safety, but also demonstrated its effectiveness in suppressing the growth of breast tumors," the research institute reported.

The goal of the first phase of clinical trials was to evaluate the safety, tolerability, and pharmacokinetic parameters of the drug. At first, doctors administered it to different patients once, and then examined how the body responded to multiple administrations. At the second stage of the phase, patients received the maximum permissible dose of the drug four times with an interval of one week. The tests confirmed that the drug is non-toxic and safe for patients, and also causes a positive therapeutic effect, noted the Institute of Chemical Biology and Fundamental Medicine SB RAS.

"The study involved patients in the terminal stage of the disease. They had obvious progression of breast cancer. After the drug was administered, doctors observed a decrease in the tumor size and stabilization of the process in approximately 55% of patients. The data obtained make it possible to state that the drug is effective, which means we can move on to the second phase of testing," the institute quoted one of the authors of the development, head of the biotechnology laboratory of the ICBFM SB RAS Vladimir Richter as saying.

The anti-tumour drug is based on the recombinant VV-GMCSF-Lact strain of the vaccinia virus. Scientists cut out two regions of the virus genome responsible for its virulence and inserted genes that enhance the oncolytic activity of the virus. For the first time in the world, a gene encoding a protein that kills cancer cells has been introduced into an antitumor drug. Clinical trials of the drug, which is the first in its class, began in Russia in 2022.

https://ria.ru/20241023/preparat-1979466557.html

Is there a chance to create a universal vaccine against cancer?, by Irina Nevinnaya for Rossiyskaia Gazeta. 11.17.2024.

Professor Artamonova spoke about the prospects of developments.

Professor Artamonova told when vaccines against cancer can be used.

The news that at least two anti-cancer vaccines are being developed in Russia has interested many and raised many questions. How promising are such developments? Will we ever be able to protect ourselves from cancer with the help of such drugs? Elena Artamonova, professor of the Department of Oncology and Radiation Therapy at the Institute of Surgery at Pirogov University, answered the questions of "RG".

How new is this direction of creating cancer vaccines?

Elena Artamonova: Vaccines against cancer have been created and studied for decades. There are vaccines that are routinely used, such as BCG therapy for non-invasive bladder cancer after resection. This is a registered vaccine that reduces the likelihood of relapse.

There have been many attempts to develop a vaccine, and not all of them have been successful.

For example, after the discovery of dendritic cells (special cells of the immune system) in the 1980s and the deciphering of their role in the development and implementation of the anti-tumour immune response, work was carried out to create dendritic vaccines. But clinical studies of dendritic vaccines that were conducted at that time were not successful. In addition, other anti-tumour vaccines did not show significant advantages during verification trials.

Therefore, in the 1990s, a certain skepticism regarding cancer vaccine therapy set in around the world.

But now oncology research has advanced far, and recently there have been many reports again about the development of cancer vaccines. What has changed?

Elena Artamonova: In the new millennium, in connection with discoveries in the field of cancer immunology, a real renaissance of immunotherapy has occurred. It is associated with the discovery of immune checkpoints (they block the development of an anti-tumour immune response) and the development of immuno-oncological drugs that are able to "open" this blockade and thus release the inhibition of the anti-tumour immune response.

It was for the discovery of these mechanisms that the Nobel Prize was awarded in 2018. Oncoimmunology is developing rapidly, new discoveries have led to the fact that the technology for obtaining vaccines has fundamentally changed. Today, the emphasis is on the development of so-called mRNA vaccines. Work is actively underway to develop and use these vaccines both in monotherapy and in combination with immunotherapeutic drugs. Such research is being conducted both abroad and in our country.

mRNA vaccines are high-tech vaccines that allow the patient's immune system to be directed against his or her tumour.

So, these vaccines are able to strengthen the immune system's defences? How do they work?

Elena Artamonova: It is a mistaken idea that the immune system of a cancer patient is capable of coping with the tumour on its own, and that it only needs to be stimulated.

After all, if a tumour has already grown in the body, it means that the immune system was unable to destroy it.

Tumour cells can arise in a healthy organism as a result of mutation. If the immune system functions well, it recognizes and destroys such cells at the earliest stage. The modern concept of the relationship between the immune system and the organism is called the "concept of immune editing." The idea is that sensitive tumour cells that can be recognized by the immune system are destroyed, but there may be cells that have escaped the influence of the immune system. When the number of these cells increases, we diagnose a tumour.

In addition, there are immune cells in the body that stop the immune response - normally they block the development of autoimmune reactions aimed at normal tissues of the body. But under certain conditions, these cells begin to "protect" the tumour itself.

Therefore, simply stimulating the immune system is completely useless; it will not be able to recognize and destroy the tumour.
This is why new principles of vaccine therapy have been developed. A sample of tumour tissue is taken from the patient, the so-called neoantigens that are associated with a specific tumour in a given patient are identified. Then an individualized or personalized mRNA vaccine is prepared, directed against a large number (up to 34) of neoantigens that are specific to this particular tumour of a specific patient. This process of personalized vaccine preparation for a patient is very high-tech.

It turns out that in each specific case the vaccine is prepared individually. It is clear that this is a very expensive treatment. What are the prospects for wider use of such drugs?

Elena Artamonova: Similar studies are conducted not only in our country, but also in many countries around the world, by large pharmaceutical companies and oncology centers. This area is widely discussed at world congresses. For example, at the recent congress of the European Scientific Society of Clinical Oncologists, a significant section was devoted to immunotherapy. Now we are seeing a surge of interest in vaccines at a completely new level. Oncologists see prospects in the use of vaccines, because immuno-oncology is a special area where discoveries are made every 10-20 years in the mechanisms of the immune system, and the opportunity arises to create new immunological approaches.

Is there a chance to create a universal vaccine that is effective against different types of cancer?

Elena Artamonova: The basis of the immuno-oncological approach is the recognition of cells that are characteristic of a specific patient. The set of antigens is quite specific for each type of tumor: there are common tumor-specific antigens, and there are personalized individual sets. The antigen profile of a specific tumor differs from the antigen profile of the same type of cancer, but in another patient.

This is why personalized types of therapy are actively developing, and there are quite a lot of them. There are monoclonal antibodies that recognize antigens, there is T-therapy aimed at tumour cells with a certain mutation (targeted therapy), and so on. The current level of development of immuno-oncology has led to the development of mRNA vaccines.

We will wait for the clinical stages of these studies, because the most important thing is the clinical use of drugs in cancer patients. Only then will we be able to draw a conclusion about the effectiveness of a particular approach.

https://rg.ru/2024/11/15/professor-artamonova-rasskazala-kogda-mogut-primeniatsia-vakciny-protiv-raka.html

The government has allowed PSK Pharma to produce an analogue of Ozempic, 11.19.2024.

The government has allowed PSK Pharma to produce an analogue of Ozempic.

MOSCOW, November 19 - RIA Novosti. The Russian government has authorized the company "PSK Pharma" to produce an analogue of the diabetes drug "Ozempic", produced by the Danish company Novo Nordisk. The corresponding government order has been posted on the website of the official publication of legal acts.

"In accordance with Article 1360 of the Civil Code of the Russian Federation, due to extreme necessity related to the protection of life and health of citizens, to allow ... "PSK Pharma" to use inventions protected by Russian patents, ... owned by the company "NOVO NORDISK A/S" (DK), until December 31, 2025 inclusive, without the consent of the company "NOVO NORDISK A/S" (DK) for the purpose of providing the population of the Russian Federation with medicinal products with the international non-proprietary name "Semaglutide", - the document says.

https://ria.ru/20241119/ozempik-1984706001.html