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Targeting Cancer
May 31, 2012   
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Dr. Jerzy Pieczykolan, manager of the ONCO - 3 CLA project being carried out by Polish pharmaceutical and biotechnology company Adamed with a view to developing a new cancer drug, talks to Karolina Olszewska.

The ONCO - 3 CLA project aims to develop a new “targeted” drug to treat cancer with three stages of delivery. What is this targeted treatment all about?

There are many substances known to pharmacology and medicine that destroy cancer cells in in vitro tests, and in many cases also in clinical treatment. But the problem is that these substances not only destroy cancer cells but also damage healthy tissues and organs in the patient, often leading to serious complications. The best solution would be a therapy that would specifically target and destroy cancer cells without damaging the healthy cells. The ideal substance, while taking advantage of all the means of delivery available in the body, like blood and lymph, would only reach and destroy cancer cells.

This assumption underlies the ONCO - 3 CLA project, as in the case of many other targeted therapies developed in other countries. Our therapy consists of three stages of reaching the target. In the first stage we use the natural mechanism of perforation occurring in the cancer process, which means the loosening and destruction of connections between blood vessel cells. This is how active substances, which means drugs, can reach the tumor with the blood.

In the second stage we take advantage of the specific properties displayed by our substance. It is built in such a way that it only recognizes cancer cells and binds with them, while bypassing healthy cells.

The third stage uses the ability of cancer cells to metastasize. Most patients do not die because of the primary site of cancer, which we are usually able to remove, but due to the metastasis process as a result of which cancer cells spread throughout the body. These cells, in the process of metastasis, detach from the tumor with the help of specific proteases. We have used these proteases to activate our drug in the cancer site. This drug, which contains highly toxic substances, when administered to the patient, becomes fully active only in the tumor area, while it does not at all affect healthy organs.

What kinds of cancers can be destroyed with this kind of therapy?

Chiefly solid cancers, which means tumors. We will not use this therapy for blood cancers—leukemia. Since the 1990s, the problem of leukemia has been brought under control to a certain extent, thanks to the introduction of a breakthrough drug. However, the problem of solid tumors is still unsolved. Experiments on animals have shown that some human cancers—of the lung and the gastrointestinal tract, especially the colon and rectum, liver and cervix—seem to be responding well to our therapy. In the case of breast cancer, we are only at the beginning of the road in our research. As we develop our treatments we need to determine whether there are receptors on the surface of the breast cancer cell that our substance can detect. Only then will we be able to determine whether our substance is capable of binding with cancer cells and destroying them.

Although such projects are typically burdened with high risk, the indications are that your project will end in success. When, therefore, can patients expect this revolutionary drug to hit pharmacies?

The project started in the fall of 2008 and will run for seven years. This means that its actual appearance on the market is still a distant prospect, in comparison with other research and development projects covered by the Innovative Economy Operational Program. This is not because we are working slow, but because such are the specific features of work on developing new drugs. Such work usually lasts 12 to 15 years, starting from the laboratory, through three phases of clinical trials, to the registration process. What we do is in line with international research standards.

Is there a chance that the drug will be affordable for patients in Poland?

While developing this therapy, we took into account the situation in Poland and knew that the costs cannot be too high for the patient. Therefore we took into account the price of the final product. Our substances are based on biotechnology, which means proteins. They can be compared to monoclonal antibodies, which are proteins. If we compare the production costs of our substance to those of a standard antibody, it will turn out that they are from 20 to up to 100 times lower. In order to reduce the price, we used a technology that will significantly lower the production costs—if production does take place. It is worth noting that there is no producer in Poland who could undertake this task. The Adamed company will have to find such a producer abroad.

The relationship between the cost of production and the final price is not always that simple. It is necessary to take into account the growing requirements of pharmaceutical registration offices. It may be assumed that they are not aware that by introducing further restrictions, they increase the cost of the drug—and the patient pays for that—and thereby limit the availability of treatment. It is worth remembering that the greatest costs are incurred in the laboratory during the production process. And even though companies usually take great care to minimize costs, this is not the only factor that determines the price of the end product.

Thorough tests seem to be indispensable to ensure the safety of pharmaceuticals and exclude any side effects, don’t you agree?
Yes. However, these procedures take on tremendous proportions and increase project budgets. A large part of the costs relates to the stage of clinical evaluation. Yes, this stage of work is important, but it is the costs of registration that to a large extent determine the price at which the product reaches the patient.

How does it work that a private company, rather than a public research institution or a university, receives substantial funds from the Ministry of Science and Higher Education and subsequently from the National Center for Research and Development?

Thanks to programs carried out jointly with the European Union, this is an increasingly common situation in Poland. The popular misconception that pharmaceutical companies employ different scientists than those working in academic centers is slowly changing. The work of a scientist in a pharmaceutical company does not differ much from their work in a research institution. I think it is more difficult in the sense that the company must meet the expectations of the management board when it comes to financial issues and deadlines, especially in the case of projects co-financed from public funds. This is the reason why research work must be more dynamic.

As far as research methodology is concerned and the ways in which results are obtained, they are no different from what we have in most research institutions and universities.

Why did Adamed receive the funding? Simply put, we got a positive evaluation from experts, who highlighted the great potential of our company and its suppliers, as well as the potential of the scientists Adamed works with, who come from many major academic centers in Poland.

It is worth noting that when the project was beginning, Adamed had fully equipped research laboratories, skilled staff and research equipment that was unique at that time. This included equipment for studying the life expectancy of mice with cancer that was not available anywhere else in Poland. Across Europe, such equipment was available in only four places. Today many universities have such equipment, including the Jagiellonian University, whose scientists learned to operate it in our laboratories.

With such a large project, it is probably necessary to work with other research and development centers...

The ONCO - 3 CLA project originated at Adamed’s laboratory and is the brainchild of our scientists. However, support from specialists in many different fields is necessary in certain tasks and research problems, at each stage of the project. Collaboration with academic centers has led to the development of our idea.

We are a fully Polish-owned company, and that’s why we wanted to use the know-how of Polish universities. Each member of our team comes from an academic center, is proficient in certain research areas and knows scientists who are experts in their respective fields, also internationally. This has enabled us to build a network of cooperation. We wanted to create a core team on an in-house basis and work together in various areas of research with academic centers throughout Poland and beyond.

Intellectual property is an important issue when it comes to organizing such cooperation. In fact, although our in-house research team is 11 strong, nationwide it comprises around 100 people linked with universities, research institutions and companies. Among these institutions are the Jagiellonian University, the Wrocław-based Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences, the universities of technology in Wrocław and Gdańsk, the Adam Mickiewicz University in Poznań, the medical universities in Białystok, Gdańsk, Lublin and Warsaw, the Marie Curie-Skłodowska University in Lublin, the Institute of Biology at the Catholic University of Lublin, the University of Warsaw, and the University of Gdańsk.

It is also worth mentioning that the Adamed team works with international experts in oncology and pharmacology, who constitute a kind of advisory group. These include researchers from the National Cancer Institute in the U.S., which is the world’s oldest cancer research institution. We take advantage of their expertise and experience. The cooperation is based on an exchange of ideas, analysis and evaluation of research trends—and is purely scientific in nature.

Is confidential business information compatible with the need for academics to share their findings at conferences, in publications, and during classes with students?

In December last year, our first international patent application appeared, involving the protection of a group of substances we have developed; in Poland, we have made six patent applications. Since our international patent application was made public, we have been preparing together with our partners to disseminate the results of our research. This process, as in the case of universities, is linked, for example, with the publication of the results in scientific journals and with taking part in many conferences and symposiums. Doctoral dissertations will also be written. Scientists from the partner institutions which participated in the implementation of specific research tasks will of course be the co-authors of the scientific publications discussing individual stages of the research carried out.

Will they also have a share in profits generated from the commercial use of research results?

The commercial use of research results depends on intellectual property, and this is owned by Adamed. Under the research agreements signed with universities, scientists from our partner institutions will obtain inventor status if they make innovative changes to our ideas. The project continues to develop and we are open to broad, constructive scientific cooperation.

The project is classified as one of key importance to the economy and science. How is that possible if it is designed to benefit a private company?

Adamed has been around for 27 years. From the beginning we have contributed to the development of certain sectors of the Polish economy. As part of the ONCO - 3 CLA project and generally during this period many small and large biotechnology companies have been established in Poland, with which we worked together and continue to cooperate, often contributing to their development. These companies include Lipopharm, Selvita, Pure Biologic, and BLIRT. Their scientists and people dealing with business agree that Adamed has helped stimulate the development of these organizations, thanks to cooperation at individual research stages of the oncology project under way. Now some of these companies are going public via the New Connect market and also going global with their services.

Also, many of the agreements we have signed with universities have changed the relatively difficult financial situation of the young Ph.D. students and researchers with Ph.D. degrees working there. As part of the ONCO - 3 CLA project we sponsor several Ph.D. students. Thanks to this they are not leaving science, and some of them will be writing publications about selected aspects of the project and will contribute to other publications.

Our laboratory is also where numerous student internships take place. Every year we participate in the Grasz o staż (Win an Internship) program. We are contacted by more and more young people who are looking for opportunities to develop their talent in the future.

The ONCO - 3 CLA project and smaller R&D projects are joined together in the Oncology Platform set up by Adamed. With each new research project, we can take advantage of the experience and existing contacts with academic institutions developed in the course of the oncology project. We are convinced—and this is reflected by the newly signed research agreements with our partners—that their contribution to the development of innovative substances will be even greater than before. And joint patent applications will be a measure of this involvement.

The Trendsetters
Marcin Szczeciński, member of the ONCO - 3 CLA project management team
If the project ends in success and an innovative, fully original cancer drug based on biotechnology is developed in Poland, this will be a defining moment for the development of pharmaceutical science and the Polish pharmaceutical industry. This will mean that we are in a position to develop products meeting the highest international standards, and that we are capable of setting trends, not just following them. At the same time, we cannot be thinking only from the Polish perspective. Developing an innovative drug is a costly process that can only pay back if we go global with our product. Cancer treatments are expensive, but this is chiefly due to the specific features of this industry. The risk borne by companies covers hundreds of projects that end in failure so that one of them could succeed and so that a drug could finally be put on the market.

The ONCO - 3 CLA project comprises four research areas, which means it is like four projects in one, hence the high research budget. This multi-pronged approach to the project is designed to deal with the risk of research failure. The total cost of this project, including laboratory work, preclinical testing of the new drug and its evaluation under clinical conditions, exceeds zl.88 million.

Co-funding from EU structural funds comes to zl.31 million, and the rest of the tab is being picked up by the Adamed group.

We keep track of what the competition is doing and are comparing our results to those of the competition. This is a natural thing to do for a business and it additionally testifies to our responsibility for the public funds that we have received from the National Center for Research and Development, which is the intermediate body in the EU’s Innovative Economy Operational Program.

Cancer research is an area in which the largest number of projects are carried out around the world. The intensity of this research grows with the medical needs that have to be met in a given area. To stay abreast of what happens in the industry, we attend the world’s largest biotechnology trade fair, Bio International Convention, in the United States and its counterparts in Europe. Only by setting higher goals for yourself than the competition is success guaranteed.
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