At the end of last year, US Food and Drug Administration (FDA) granted the Breakthrough Therapy designation to the Russian biotechnology company Hepatera, a Skolkovo resident, for Myrcludex, a potential hepatitis B drug. The Skolkovo biomedical cluster today includes 460 resident startups, half of them engaged in the development of innovative medicines. Kirill Kayem, Senior Vice President for Innovation at the Skolkovo Foundation (who previously headed its biomedical technology cluster), spoke about pharmaceuticals of the future, the importance of digital development in healthcare and medical innovations being born at Skolkovo in an interview with Invest Foresight.
Digital technology in medicine
— What technologies are changing medicine as an industry today?
— There is a whole range of technologies usually referred to as “digital.” Medicine is a broad field including several areas. First, there is diagnosis; then there is pharmaceuticals, and MedTech, which definitely accounts for a lot of innovations, but digital technology permeates and unites them all together. And it is digital technology that brings two fundamentally important innovations to medicine – it expands the capabilities for the development of new drugs by cutting costs and reducing risks, and opens up enormous possibilities for predictive medicine.
Digital systems can integrate the patient’s clinical data, diagnostics, lab tests and behavioral features, draw up an individual forecast and make suggestions – what should be done to live a long, happy and productive life. This is the biggest hype now, because it will really change our paradigm of what being healthy is. Development of digital platforms will have a very serious impact on diagnosis, pharmaceuticals, and MedTech. So digital technology is what is definitely changing the global medicine today. Other extremely important trends are cellular and regenerative medicine and the development of drugs that change the patient’s genetic profile.
— You are saying the concept of being healthy will change. So what will being healthy mean in the future?
— Someone will be diagnosed as healthy if the system generates a good health forecast for them. Health will be viewed as a system of balanced risks of particular pathologies, which prompts a set of preventive measures. In predictive medicine, if someone has a high risk of a stroke or heart attack, genetically confirmed, this will mean a certain lifestyle and diet, a set of regular checkups and preventive therapy, such as lowering cholesterol levels.
— Will people be able to take less responsibility for their health thanks to technology?
— My opinion is that personal responsibility for your own health must become even bigger. It means that if a person follows healthy lifestyle recommendations, his health insurance must be cheaper than for a person with the same predisposition but who drinks too much alcohol, doesn’t do sports or watch his cholesterol level. Right now people who take care of their health by reducing risks pay the same insurance premium as those who lead an unhealthy lifestyle.
— Do you think there will be fewer errors in healthcare services as technology develops? For example, resistance to antibiotics is often linked to misuse of medication.
— Will there be errors in preventive medicine? Perhaps, just as there are now errors in treatment. Even the drugs that reach the market sometimes get withdrawn. It is an inevitable price for progress. Humankind makes mistakes both in tactical decisions and at the level of global trends. Errors with antibiotics are also inevitable. But resistance to antibiotics is not only caused by their medical use. There are other factors such as dynamic industrialization of agriculture of the past 40 years, including the use of antibiotics in animal farming. One of the reasons is the amount of antibiotic residues in meat. However, it doesn’t mean that we must step back and return to the pre-antibiotics era. The same is true for predictive medicine. Of course, there will be some errors but it is still better than not doing it altogether.
Medication of the future
— Will drugs change in the future?
— Speaking about medication, we are gradually moving towards genetic medication. From treating manifestation of a disease or symptoms medicine advanced to treating the actual cause of a disease. Then drugs became more symptom-specific. Then there was targeted therapy when doctors know which specific receptor is involved, to switch off the cause of a disease. So far, this has been tried at the cellular level. The next generation of drugs will work at the subcellular level. We will be inducing body not with the substances that affect the disease but with the agents that affect the cause of a cell’s malfunction. How does genetic medication work? It affects the expression of a protein that triggers a disease or certain symptoms or, on the contrary, is not produced when it is necessary. By influencing these mechanisms we can influence deep-rooted causes of a health problem.
— Will it be possible to, simply speaking, switch off the wrong gene if necessary?
— Yes, even locally. There are some first drugs undergoing clinical trials. One of them received investment from RBV, a Russian venture foundation. This drug is supposed to treat retinopathy that causes blindness. This medication “switches off” a specific gene, stops the disease from progressing and even helps to restore vision.
— What is the role of Skolkovo resident companies in the development of innovative drugs?
— The Skolkovo Biomedical Cluster is implementing 460 projects with half of them being related to the early stage drug development. Unfortunately, there are not many institutions in Russia that support the early stages of the drug discovery process. Yes, development is conducted as part of research under the Ministry of Healthcare and Ministry of Education and Science. Yes, there are good programs conducted by the Ministry of Industry and Trade. But in the past few years, the ministry has been focused on the late stage of drug development where risks are lower. It also came up with the initiative to create a special venture fund as part of the Russian Venture Company (RVC) to support early drug development. We appreciate this very much, but the venture fund has not been launched yet. The Skolkovo Foundation was one of the few institutes that were engaged in such development. The situation around medicine is quite cynical, unfortunately. As a rule, private investors are not interested in early stage drug development and it is usually the state that is supposed to support it.
— Are Skolkovo companies working on genetic drugs?
— Yes, of course. For instance, there is the AGCT biotechnology company, a St Petersburg-based startup. They are developing genetic therapy for patients with HIV. They are trying to “turn off” a certain gene in order to prevent the development of AIDS-related complications, the most common cause of death among such patients. The startup can begin early trials involving people (animals are not suitable for this purpose), and will soon be able to help patients. I am proud that this is happening at Skolkovo; however, not only high-tech startups are beginning such research. Russian pharmaceutical companies are also getting engaged and conducting their own innovative developments. At last, the Russian companies make their own discoveries rather than copy foreign ones.
— Are there any breakthroughs?
— There are several breakthrough drugs that have already received permission for the final clinical trials. For instance, a new drug developed by Hepatera. Myrcludex B is the world’s first drug that treats previously incurable hepatitis D, a subviral satellite of the hepatitis B virus. Our colleagues made it curable. This is an orphan drug. In Russia, there are some 100K people suffering from hepatitis D, and all they could do is to use supportive therapy. Myrcludex B is the first drug that locks the virus up in the cell where it cannot reproduce, and also reduces the patient’s viral load. Patients are looking forward to receiving this drug.
Another medication is Alofanib, developed by the company Russian Pharmaceutical Technologies (Ruspharmtech), which successfully completed its preclinical studies. The primary indication for this drug is target therapy for stomach cancer, but it can also be used for treating triple-negative breast cancer in case none of three main treatment options is effective. Work is now beginning to conduct clinical trials.
— Will it be produced in Russia as well?
— Yes, these medications can be manufactured in Russia. This is one of the rare innovative cancer drugs to be clinically tested by the company that has developed it, with the permission issued by the Ministry of Healthcare. And such medications are going to help people even now, during the clinical trials period. Free use of the medication can be expected in several years.
— New medications are very expensive to develop. Isn’t it easier to simply use available foreign drugs?
— Foreign companies lack what our startups are developing. At Skolovo, criteria for choosing a startup include uniqueness, innovativeness and a potential to enter the global market. There are possibly some competitive developments available, but Myrcludex B and Alofanib have no competition. These drugs will most definitely be highly demanded both in Russia and globally.
Pill for cancer
— Fighting cancer is one of the hottest topics in healthcare today. Are there really more cancer cases registered worldwide?
— With longer life expectancy and a greater number of mutagenic agents, the number of people diagnosed with cancer is growing, mostly due to these two factors.
— What can Skolkovo do in this regard?
— I have mentionedan example of a cancer drug. We even have a special manager for oncology who works with both oncology diagnostics and cancer medications. We are working with the Russian Society of Clinical Oncology (RUSSCO), and also hold separate sessions at the oncology congress to speak about our efforts to support cancer research projects.
— Is there a chance of Russia inventing a long-awaited cancer treatment pill?
— There’s not, because there cannot be a single cancer cure as cancer refers to a family of different diseases characterized by similarity of traits. It is not even correct to say ‘breast cancer’ or ‘stomach cancer’ as their genesis is very different; it is often a combination of several important factors, although named conventionally in a similar manner. Medications that are developed today target the cause of a disease. This means that different causes call for different drugs or their combination to treat the disease. But there will not be a single cure anytime soon.
I hope that work will begin in Russia to develop and produce many efficient medications for specific types of cancer, and we actually see the number of such projects growing. But cancer is increasingly a global health issue; all countries will advance in this area and participate in the process, with each of them inventing something efficient enough to be used worldwide. Today, innovativepharmaceutics is a global market.
By Olga Blinova