B/BE/22/BVW4 - Information sheet for the public (prepared by the notifier)Public information according to the provisions of Directive 2001/18/EC
Long title
A Phase I/II, Multicenter, Open-Label Study of Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors
Date receipt dossier
EU record number
B/BE/22/BVW4
EudraCT number
2021-002823-40
Company / Sponsor
Nouscom Srl
Phase
I/II
Treated organism
Humans
Indication category
Cancer therapy
Disease
Microsatellite Unstable Solid Tumors
Therapeutic approach
Immunotherapy
Genetic modification
The study involves two GMOs: (i) A replication-incompetent adenovirus (GAd20 with deletions of the viral E1, E3 and E4 coding regions) isolated from a gorilla and encoding the FSP neoantigens; (ii) an attenuated, replication-defective orthopoxvirus (Modified Vaccinia virus Ankara), encoding for the same neoantigens.
Method of transfer of nucleic acid of interest
Non-replicating recombinant viruses
Administered biological material
Genetically modified viruses
Route of administration
Intramuscular
Locations in Belgium
Cliniques Universitaires Saint-Luc - Bruxelles
Nr of subjects
Up to 115 patients overall and 15 patients in Belgium
Foreseen duration
Start: October 2022 – End: December 2024
Type of procedure
Contained use and Deliberate release
Current status
Authorized