Icosagen, an Estonian drug development company that has received €18M from the European Investment Bank, will open its new innovative manufacturing facility this year. It already made a big splash with its BioBlock, an anti-covid nasal spray, that has reached many countries. What’s next? Mart Ustav, CEO of Icosagen, told Life in Estonia their story and future plans.
Going back in history, what is the story behind Icosagen?
It all started in 1999 when four people – Marika Mikelsaar, Helme Raukas, Ain Laving, and myself – founded Quattromed. Our aim was to develop molecular genetic methods for the detection of infectious diseases such as papillomavirus, herpes, hepatitis, etc. In 2008, Quattromed was the largest diagnostics company in Estonia with 80 employees, and then investors appeared who wanted to buy the diagnostics arm. The deal went through and Synlab Eesti OÜ was born, leaving the BioTech side in our hands. We took the name Icosagen and our core business became contract work for the development of biopharmaceuticals.
In 2022, our turnover rose to 20 million euros. This year, we received an 18 from the European Investment Bank to build a current Good Manufacturing Practice (cGMP) manufacturing facility to produce innovative medicines for clinical trials. The new building is due to be completed at the end of June this year and service will be available in 2024. This will allow us to offer a full drug development and production service to our customers as a comprehensive contract research, development and manufacturing organisation (CRDMO).
Our target therapeutic molecules will be produced in animal cells grown in a bioreactor, followed by purification, quality control, analysis and biocapability tests. We expect to have completed the qualification process for the GMP production by the end of this year, and the Estonian Agency of Medicine can then grant us a license to produce biological medicines.
With the new production facility, we will create a full drug development capability, a complete workflow and the capacity to deliver ready-to-use molecules. We don’t have the kind of money to do phase three clinical trials, so we have to develop molecules to phase two, proof of concept, and then we can sell these projects with data to the big pharmaceutical industry. The cost of each of these projects starts at between 100 and 200 million euros and goes up to one billion euros, depending on what the drugs are targeting.
Our development labs work along three main lines. One is the development of anti-cancer drugs, the second is pain, which is also a very serious problem, and the third is infectious diseases. In all of these, we have intensive research and development activities, and we collaborate with many companies and universities.
This spring Icosagen acquired the Carterra LSA Instrument which significantly enhances its antibody screening capabilities in the discovery and development of new therapeutic and diagnostic antibodies. The cutting-edge LSA technology will enable Icosagen to speed up and significantly enhance its end-to-end service capabilities for global biotechnology and pharmaceutical customers.
So, the new building will open up new opportunities for you, but how does biopharmaceutical development work?
First of all, you need to have an understanding of what you are treating, i.e. what is the disease, what are the main causes of the disease, and whether it is clear what is causing the disease condition. Then you can activate or inactivate the corresponding target against it. We are working on more than 20 target sites, against which we are developing neutralising antibodies or agonists that activate these target sites.
During the coronavirus pandemic, you made waves with the launch of your BioBlock nasal spray. How has it been?
I think very well. On the one hand, it was an interesting process, and on the other hand, it was very innovative. Even so that the Estonian regulatory authorities could not give it a proper name, because it is not a medicine in the strict sense of the word as that would require a long period of development and research.
We have a very large database, and we know how the immunisation of large animals is done and how the immune response works. We immunise pregnant cows and when a calf is born, the first milk, colostrum, contains a high concentration of antibodies, including those produced as a result of immunisation.
We take the colostrum with 100 milligrams of antibodies per millilitre. These antibodies have a very broad spectrum, and you can drink this colostrum if you want to protect yourself against certain pathogens. In this case, we put these antibodies in a bottle and, as far as I know, over 400,000 bottles of BioBlock nasal spray have been sold in Estonia. People are still coming to me and saying it is a very good product and it works.
I don’t want to say that it solves all the problems, but it is very much aimed at preventing coronavirus infection, not curing it. You put antibodies on the mucous membranes of your nose and when you are exposed to the virus, those antibodies inactivate the viruses. We have this data unequivocally proven in animal studies, in vitro experiments and in tissue culture experiments, and this is a good result.
I think BioBlock is a perfect example of how an innovative approach to a problem can produce a good result relatively quickly. At the moment, all the BioBlock documentation has been submitted for evaluation to the medicines regulatory authorities in several countries, so that we can enter those markets as well. But our aim for the future is not so much to create products of this kind but to develop specific monoclonal antibodies against specific targets.
How do you see the landscape of medical technology and drug development in Estonia? What are the advantages or strengths here?
I believe that Estonia’s strengths are definitely the quality and high level of research. On the application side, however, the situation is very bleak, including in the field of applied medicine, as there is no proper case of modern drug development in Estonia so far. However, this means that we are now trying to create one.
We want to create a drug development industry that operates on a commercial basis, defines the targets, develops the molecules and demonstrates through preclinical and clinical development that the molecules can have a medical curative effect. We have some very good people at work and I am very optimistic about the results of this work.
We have a number of drugs in the preclinical phase, and we have seen in animal studies that they are effective in blocking tumour growth. Now that we can get our new manufacturing facility up and running, the next step is to initiate a clinical programme and I imagine that in about two years we should be able to see the results of this work.
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