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Notification report


Full notification file


General information

Notification Number
B/ES/21/15

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
07/04/2021

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?
Yes:
Germany; France;

Has the same GMO been notified elsewhere by the same notifier?
No

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