“New diagnostic and therapeutic tools for the targeted and personalized treatment of oncological patients”
The general objective of this research project is the development of an integrated approach to the personalized therapy of high-medical-need haematological cancer, with particular reference to acute leukaemias, with the purpose of providing patients and operators with therapeutic instruments more and more targeted to the patients’ features.
Furthermore, a new diagnostic/prognostic approach will be developed, in order to identify the expression of selective melanoma markers, that can be used for patient stratification.
The project involves companies working in the fields of molecular diagnostics and pharmacogenetics and biotherapeutics.
With the collaboration of the haematology clinic of the Marche Polytechnic University, of regional healthcare facilities and national centres of reference, that will make the biological samples from patients available to the companies and the newly-instituted biobank, Diatech Pharmacogenetics will develop and validate new diagnostic assays for the identification of chromosomal mutations in adult and paediatric patients with leukaemia, while Diatheva will work on the industrial development of new, specific therapeutic antibodies for the targeted treatment of acute leukaemias.
In particular, the therapeutic antibodies will be tested on biological samples from genetically characterized patients, together with the new assays developed by Diatech Pharmacogenetics, linking the response to the treatment with the genetic profile and therefore developing an example of precision medicine. Thanks to the collaboration of the dermatology clinic of the Marche Polytechnic University, Diatheva will also develop a new diagnostic/prognostic approach, based on the use of a monoclonal antibody, to identify the expression of selective melanoma markers.
Diatech Pharmacogenetics Srl
Marche Polytechnic University
“Platform for the development of new therapeutic instruments, for the personalized treatment of patients with specific needs and rare conditions”
The project aims at the creation of a support platform for the development of new therapeutic approaches for patients with specific needs and rare disease, and it will involve the companies Angelini Pharma, Pharmaprogress, Prosopika and Diatheva and the research institutions Marche Polytechnic University and Urbino University.
Specifically, Angelini Pharma will develop innovative formulations of selected active principles, which will make the therapies for patients with specific needs safer and more targeted, thanks to their body mass-based scalability, their suitability for dysphagic patients and their ease of management for caregivers.
Innovative formulations will also be developed using emerging technologies, including 3D printing, significantly increasing the related know-how available at the local level.
Next to the formulation activities, stress tests will be carried out on prototypes by Pharmaprogress.
Furthermore, formulation studies on skin conditions will be carried out by Prosopika, in collaboration with Angelini Pharma. The Urbino University, in collaboration with Diatheva, will carry out a preclinical study on enzyme replacement therapy in a phenylketonuria (the most common among rare metabolic diseases) animal model, with the aim of developing a new biotherapeutic drug to prevent neurological damage and improve the patients’ quality of life.
After identifying new molecular targets for treating scleroderma, a rare condition that mainly affects young-to-middle-aged women, causing extended damage, disabilities and high mortality, the Marche Polytechnic University will develop, together with Diatheva, new biotherapeutic drugs to be associated to a new companion diagnostic, which will be useful to identify molecular markers for patient stratification and therapy monitoring.
The samples from patients and the cell lines used in the studies will be deposited in the new biobank.
Angelini Pharma Spa
Marche Polytechnic University
“Development of new pharmaceutical and nutraceutical approaches for the treatment/management of chronic pathologies”
The project has two objectives: developing targeted nutraceutical approaches for the prevention and management of two chronic diseases, that are affecting a growing number of individuals, i.e. type II diabetes mellitus and osteopenia, by integrating preventive therapies with the development of predictive diagnostic tools, that can identify subjects who are at risk for the same pathologies and/or who are drug-resistant; and tackling crippling chronic diseases that are difficult to prevent, such as nervous system chronic diseases for specific populations, age groups or sub-groups and the auto-immune pathology called atopic dermatitis.
In particular, Mivell will develop two new nutraceutical products which, thanks to the collaboration of the Marche Polytechnic University, will be tested in vitro and then in vivo in two clinical studies on subjects at risk of developing type II diabetes mellitus and osteoporosis.
In parallel, Diatech Pharmacogenetics will develop and test assays for the identification of polymorphisms that predispose for both the above-mentioned pathologies or are involved in the response to pharmacological treatments, identifying the at-risk subjects who may benefit more from preventive treatments. In those same clinical studies, the patients treated with the new nutraceutical products will be genotyped with specifically developed kits. The patients’ samples used for the studies will be then deposited in the new biobank.
While developing the two new nutraceutical products, Pharmaprogress will collaborate in the development of new analytical methods for the determination/characterization of active principles, it will carry out stability studies on formulated products and it will develop tests to precisely define the dissolution profile and release of active principles in the two formulated products, while Angelini Pharma will participate in the study of formulations that may improve the bioavailability of active principles, exploring the use of the spray-drying technology.
Gluos will develop a new medical device to be tested at the dermatology clinic of the Marche Polytechnic University for the treatment of atopic dermatitis, for which Italy has the highest incidence among adults in the world (8.1%). During the study, biological samples will be collected and deposited in the new biobank.
Angelini Pharma will develop new liquid and solid paediatric formulations of active principles or active principle combinations, which are used in clinical practice for the treatment of nervous system pathologies or for pain management. During the study, relevant analytical methods will be developed and preclinical studies will be carried out to verify that they are suitable for the objective. The subsequent stability tests will be carried out in collaboration with Pharmaprogress.