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Notification report


Full notification file


General information

Notification Number
B/ES/20/25

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
19/10/2020

Title of the Project
Title of the project: A Randomized, Controlled, Open-label, Phase 2 Study of Cemiplimab as a Single Agent and in Combination with RP1 in Patients with Advanced Cutaneous Squamous Cell arcinoma.

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

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; Greece; Poland;

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

If yes, notification number(s):


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.
RP1 utilises the HSV-1 viral vector with modifications of transgenes that allow RP1 to selectively replicate in human tumour tissue with well characterised deletions (i.e. of ICP34.5) that renders the virus non-pathogenic. Assessing the RP1 characteristics and its potential to cause adverse effects to people or the environment, as well as, the biorisk management measures applied to even further reduce any potential exposure, the overall risk of RP1 for people and the environment can be concluded as Low to Negligible.
In consideration of the vastly improved safety profile of RP1 compared to the wild-type HSV-1, Replimune’s assessment of RP1 classifies the GMO into the Hazard Group 1 due to the deletion
of ICP34.5 meaning that RP1 is non-pathogenic and replication is tumour-selective. Under the EU Directive 2000/54/EC, a Risk Group 1 biological agent is defined as “group 1 biological agent means one that is unlikely to cause human disease”. Replimune believes the classification of Hazard Group 1 is appropriate for RP1 as it is unlikely to cause human disease.


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

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known