This project is an example of success story where there is no foreign capital, there was no acquisition of the project by huge pharma corporation or fusion with other companies, but successful collaboration with academia. How did you start the dialogue? How is it coordinated?
When the 3-CLA project began, we took a trip around Poland to establish cooperation with as high as possible number of academic institution. To the project realisation we started as a research team rich in the experience of former works carried out in Poland and abroad in the public and academic units. It seems to me that thanks to our experience we were able to establish the great way of settling the relation with academia. We believe that successful cooperation comes from the good agreement between scientists focused on particular research tasks. If there is a mutual understanding and will for co-operation , it can always be regulated also at the formal level.
How does the funding for the project work? The whole is estimated at 88 million PLN (€ 21 million).
More than half of the project is financed by Adamed and the remaining part by the funds of Polish National Centre for Research and Development. For this 88 million PLN (€ 21 million) consists ofinvestments of the both sides and VAT constituting for the costs not qualified for reimbursement from EU funds. Approximately half of the grant of 31 million PLN (€ 7.5 million) is devoted for the preclinical development in the strict sense meaning production of the molecule of suitable standards, realisation of toxicological studies and preparation of documentation enabling the start of clinical trials and execution of clinical phase I/II. This means that for the entire research, which consists of design, production of proteins and their characterisation in vitro and in vivo, we had approximately 15 million PLN (€ 3.6 million) grant.
At what stage is the project now?
We can talk about two stages of molecule development, namely the non GLP pre-clinical stage, which has been finished for chosen particles. The project, however, still continues, because we were able to develop a number of very effective molecules, which despite extensive cooperation, were not fully tested to the desired extent. Thanks to the prolongation of the laboratory work by a year given by Polish National Centre for Research and Development, we have a chance to finish the research. We are sure that the work will result in submission of further patent applications to protect new, perhaps even more effective molecules.
What is included into the pre-clinical development in the GLP standard?
First of all, the production of those molecules in appropriate standard. Unfortunately, in Poland there is no institution able to produce this type of molecule of appropriate scale and standards. So we had to search abroad. Currently, we finish the talks about transfer of KNOW-HOW technologies to our partners. We pass the knowledge to the company, which will produce the molecules. At the same time, with several companies we develop the set of analytical procedures according to EMA and EMEA guidelines enabling so called release of these molecules. The difficulty lies in the fact that our fusion protein is new in its class – it is not an antibody or growth hormone. This molecule is completely unknown, therefore the development of suitable methodology, so as to meet the requirement of registration, is very hard. The moment we finish the production process and development of analytical methods, we will get the first trials for toxicological studies. It should take place in the first half of the 2013. As soon as we receive it, we will start the toxicological studies and, depending on whether we will be able to successfully pass the test panel, we will begin preparation of registration papers. Then, depending on the speed of the analysis of the documentation by the registration authority, we will be able to start the first phase of clinical trials.
Who will fund the clinical trials?
The grant we received will cover the costs of the first phase of clinical trials. However, it does not include the second and third phase of clinical trials and the costs here increase exponentially. Therefore, we see the opportunity for further development in cooperation with major pharma corporations who have the resources essential to complete the clinical development and introduction of the drug on the market.
Is it known who will be the licensee?
List of potentially interested partners has already been defined. Our conversations have entered the confidential phase and therefore I cannot revealed details about their progress and who is involved in.
Genentech also tried their hand at development of molecule of similar mode of action.
The molecule we are talking about is TRAIL protein (TNF-related apoptosis-inducing ligand). Genentech has been developing a recombinant variant of this molecule since 2000. It belongs to the components group of apoptotic cascade. The starting point for 3-CLA project was the assumption that TRAIL protein as individual apoptosis-inducing factor is not sufficient. Even then, there was a large number of publication claiming that cancers are resistant to TRAIL protein. In 2010, after many trials of the second clinical phase and lack of expected effectiveness Genentech company abandoned further development of TRAIL protein.
If, however, there were no research outcomes from Genentech company and numerous scientists from which we also benefit, perhaps our project would not be at this stage of development as it is now.
You mentioned about the cooperation between Adamed, universities and foreign institution. How do you see the idea of BioForum fairs consolidating the biotech and biopharma sector in Central & Eastern Europe?
I believe that BioForum is a very valuable initiative. Adamed from the very beginning has participated in this event. For Polish companies alone, it s difficult to catch attention of large corporations and get them interested in researches carried out in our region. BioForum consolidates these activities and creates the critical mass essential for the existence on the international market of biopharmaceutical innovation.
Thank you for your time
Interview taken by Tomasz Sznerch
Translated by Jacek Plewka
2016-04-03 06:23:28 +0200
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