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Notification report


Full notification file


General information

Notification Number
B/ES/21/19

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
18/05/2021

Title of the Project
Efficacy of AloCELYVIR (Mesenchymal allogenic cells + ICOVIR-5) in children, adolescent and young adults with newly diagnosed diffuse intrinsic pointine glioma (DIPG) in combination with radiotherapy or medulloblastoma in relapse/progression in monotherapy.

Proposed period of release:
01/09/2021 to 31/12/2023

Name of the Institute(s) or Company(ies)
FUNDACION PARA LA INVESTIGACION
BIOMEDICA HOSPITAL UNIVERSITARIO INFANTIL NIÑO JESUS, ;


3. Is the same GMO release planned elsewhere in the Community?
Not known

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

If yes, notification number(s):
B/ES/11/27; B/ES/12/17; B/ES/20/09;

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
ICOVIR-5 (HAd5-DM-E2F-K^24-RGD) is an oncolytic adenovirus derived from HAd5.
It has been designed for systemic treatment of disseminated tumors. ICOVIR-5 genome contains several modifications that confer selective replication in tumoral cells with deregulated retinoblastoma/E2F pathway. ICOVIR-5 includes the following modifications:
1. Endogenous E1A promoter substitution by E2F-1 promoter, to control viral E1A protein expression.
2. DM-1 genomic insulator insertion preceding E2F-1 promoter.
3. Kozak sequence insertion at E1A start codon (K)
4. 8-amino acid deletion at the pRb-binding domain in E1A protein (Δ24 deletion)
5. RGD-tripeptide insertion in the viral fiber protein.


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
HAd5Mastadenoviruswildtype human adenovirus (HAd) - Cwildtype human adenovirus (HAd) serotype 5--

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known