Objectif
The applicant aims at delivering economically sustainable and innovative cell therapy dedicated to the treatment of DM1 with the use of TREGs vaccine. The TREG therapy, covers almost all aspects listed in the call, i.e. cell identification, sorting, culture, multiplication (all 4 steps covered in patent), banking, transport, delivery (running clinical trial) and strict quality control. The project’s objective is to increase the commercial success of the therapy while making it economically effective to the payer (state, local government, national health funds/insurance). The project’s outcome will be an innovative model for treatment of highly devastating disease even with the possibility of preventing highly undesirable side effects for a patient and on a macro-scale for the economy, society and pension scheme. However, in scaling-up, the Company has to identify regulatory pathways to abide even when the technology is out of scope of current regulatory landscape. New therapy means also identification of new business models. Reaching market authorization will be determined on the basis of acceptance of currently carried out academic clinical trials and any further clinical trials ordered by the EMA. Elaboration of feasibility study will allow PolTREG to prepare the necessary strategy for this regulatory requirements.
Champ scientifique
- medical and health sciencesclinical medicineendocrinologydiabetes
- medical and health sciencesbasic medicineimmunologyautoimmune diseases
- medical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsvaccines
- medical and health sciencesmedical biotechnologycells technologies
- medical and health sciencesclinical medicinenephrologykidney diseases
Programme(s)
Régime de financement
SME-1 - SME instrument phase 1Coordinateur
80-298 GDANSK
Pologne
L’entreprise s’est définie comme une PME (petite et moyenne entreprise) au moment de la signature de la convention de subvention.