Denne var litt interessant.
(14 dager gammel).
https://prosjektbanken.forskningsradet.no/#/project/NFR/299917
PES2020 — PROSJ.ETABL.STØTTE H2020
Bringing Nordic Nanovector’s Betalutin® to market: antibody-radionuclide-conjugate for advancing treatment of non-Hodgkin’s lymphoma
Sammendrag
The purpose of this EU project is to bring Betalutin®, to the market as the treatment of choice for relapsed refractory 3rd line Follicular Lymphoma patients. NHL is the 10th most common cancer and the most common type of blood cancer. Follicular lymphoma (FL) accounts for roughly 22% of NHL cases. FL is an incurable disease characterised by alternating periods of remission and relapses, and there is a need for new treatments less toxic than chemotherapy, particularly in patients who have already failed many prior lines of therapy.
Betalutin® is a next generation radioimmunoconjugate in clinical development as a potential new targeted therapy for patients with recurrent FL. It has been designed as an alternative and to complement existing treatments for NHL.
Not every patient responds to current regimens and many relapse after an initial response. Therefore, it is necessary to develop new strategies to enhance current treatment regimens in these patients.
We are aiming at performing final activities to bring Betalutin® to the market. The SMEi Phase 2 will be a crucial step for Nordic Nanovector to validate additional technical aspects of the product and to further validate the business opportunity and commercialization plan.
The greatest challenges in establishing and participating in the SMEi Phase 2 project relate to the ability to financially support the development of each specific activity of the proposal, namely:
a) the phase IIb clinical trial that will include the recruitment of FL patients from different institutions;
b) the involvement of CROs to assist Nordic Nanovector in patient recruitment and cleaning and analysing clinical data;
c) the involvement of CMOs to validate the manufacturing processes and document the stability of the drug
d) the development of the regulatory documents necessary for filing the biologics licence application.