Notification report

Full notification file

General information

Notification Number

Member State to which the notification was sent

Date of acknowledgement from the Member State Competent Authority

Title of the Project
An Open-Label, Multicenter, Phase 1/2 Study of RP1 as a Single Agent and in Combination with PD1 Blockade in Patients with Solid Tumors [IGNYTE]

Proposed period of release:
01/07/2021 to 31/07/2023

Name of the Institute(s) or Company(ies)
Replimune Inc., 500 Unicorn Park, 3rd Floor
Woburn, MA, USA 01801;

3. Is the same GMO release planned elsewhere in the Community?
Germany; France;

Has the same GMO been notified elsewhere by the same notifier?

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Group: Double stranded DNA; Genus: Simplex virus
Species: RP1 is a recombinant of a wild-type Herpes simplex virus (HSV-1) strain RH018, with the deletion of genes ICP34.5 (both copies) and ICP47, with hGM-CSF and GALV-GP-R-inserted in place of the ICP34.5 deleted genes.

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
HSV-1SimplexvirusHerpes simplex virus-RH018-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known