WIN 2011, 6-8 July, 2011, Paris
New anti-cancer drugs at Nerviano Medical Sciences
Dr Antonella Isacchi – Nerviano Medical Sciences, Milan, Italy
Nerviano Medical Sciences is a company that is focussed on the discovery and development of new anti-cancer drugs. Actually, our roots date back forty years because we started as a major Italian pharmaceutical company called Farmitaila Carlo Erba at the time. We started in the early ‘70s to discover relevant anti-cancer drugs such as anthracycline and exemestane that are still today the standard of care, important drugs in oncology. Later on, from 1993 until 2004, we were acquired by Pharmacia initially and then we went through a series of mergers and acquisitions, working for ten years as an R&D site of a major pharmaceutical company. That was a very important experience for us, of course, and is part of what we are today. In 2004 we spinned off as Nerviano Medical Science and the peculiarity, and what we think is also our strength, is that we have the experience and the competencies of a large pharmaceutical company but nowadays we also have the organisation and the mind-set of more a biotech company with more flexibility. This is actually the basis for our new interaction with the regional oncology network.
This interaction is a new initiative that was recently started in order to leverage on our industrial and scientific expertise in order to bridge between the academy and the clinic, so to form a full circle that allows us to identify and discover new targets on one side, develop new drugs and then test them in the clinical setting. The new initiative has two components: one is clinical in nature and is managed by our business unit, that is Milan International Oncology, that also works to support external partners in managing and running clinical trials. As part of this initiative there are fifteen projects that have been now selected and are being run within this initiative. These are original clinical trials that are conceived in the Italian clinical network and thanks to this initiative can actually take place with the support of Nerviano Medical Sciences. Some of them also include biomarker genomic analyses that are done at our site.
Another initiative which is even more ambitious, if possible, is the interaction with the discovery part in the implementation of a number of new discovery projects. Here the idea is really to address a model that is probably too limited for the needs of the modern drug discovery which sees, on one side, the academy focus on the basic science, the industry which cannot afford, of course, to do the deep target validation that is needed and to start the new projects, and on the other side the clinicians. Since now the targeted therapy requires really, from the beginning, a very specific hypothesis of the clinical population that has to be treated with the future drugs to have access, for instance, from the beginning to clinical specimens, to study them with new approaches such as next generation sequencing and gene sequencing in order to study their genetic background and to identify the patient population for which the new drug will be important is mandatory. So this is one of the added values of this interaction.
As I was mentioning, the initiative aims at selecting the best projects that will help either to identify and validate new targets or to develop new drugs. So academia can propose ideas for models that we can use to validate these new targets. Again, they can be pre-clinical but also clinical specimens or they can propose new targets that they have identified in the course of their research that they have functionally validated and we can, in that case, start from the target and develop a new drug. This is a very interesting model, we are at the beginning of this experience so I can only mention some early considerations and it has been very interesting that even in relatively small, local environments such as the Lombardy region where everybody knows each other, this structured approach has given us the possibility to be more proactive in these type of collaborations and to really find a more structural frame within which we can define and then run these projects.
Where will the pre-clinical trials take place?
The activities will be, in principle, carried out in Nerviano. There will be, however, specific contributions by academic or clinical groups that will be run in those institutions and so those will be the collaborative component of the initiative.
Where will the clinical trials take place?
The clinical studies will be performed in practice in the hospital as usual but the protocol definition, the operational aspects of patient recruitment, monitoring, report, all of those will be supported by NMS. In a way Nerviano is unique in Italy because it is the largest R&D centre in Italy and because of these special features of being an R&D site which is an industry but with a biotech mind-set but also very used and with a track record of bringing drugs into the clinic. I did not mention our pipeline, we have now five new clinical entities in clinical development; four of them are drugs that are targeted drugs, kinase inhibitors that were entirely conceived, developed up to the phase I/II trials in Nerviano. So the idea is really to use Nerviano as a unique entity that can interface with multiple academic groups with clinicians and provide a missing link, if you want, also with the hope to create a system, really. So it’s a very ambitious project because it really requires the ability to work in a team, to respect the differences in the job of every component but at the same time to put all these competencies together and to deliver something that is more than the sum of its components. I think there has been much interest in finding excellence and interesting ideas or competencies in a reciprocal, meet each other experience.
