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Notification report


Full notification file


General information

Notification Number
B/ES/18/17

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
29/08/2018

Title of the Project
Clinical Study IMDZ-04-1702: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Determine the Efficacy and Safety of CMB305 in Unresectable Locally-advanced or Metastatic NY-ESO-1+ Synovial Sarcoma Patients Following First-line Systemic Anti-cancer Therapy

Proposed period of release:
01/01/2019 to 11/06/2023

Name of the Institute(s) or Company(ies)
Immune Design Corp., ;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
Austria; Belgium; Germany; Denmark; Spain; France; United Kingdom; Italy; Sweden;

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

If yes, notification number(s):


GMO characterization

GMO is a:
RNA Virus

Identity of the GMO:
Genus: Lentivirus
Species: Human immunodeficiency virus 1

LV305 is a purified DC-tropic, replication-incompetent, integration-deficient, third-generation
lentivirus vector. LV305 will be used with G305 together in a prime-boost regimen known as
CMB305:

- LV305: A lentiviral vector derived from Immune Design’s ZVEX platform that encodes the
unaltered human form of the NY-ESO-1 cancer testes antigen and is designed to prime the immune
system by targeting RNA antigen delivery to dendritic cells in vivo.
- G305: an immune system “boost” component, which is a recombinant NY-ESO-1 protein admixed
with the adjuvant Glucopyranosyl lipid A stable emulsion (GLA-SE), an agonist of toll-like
receptor 4. Please note that as G305 is not a GMO, it is not discussed in this document.


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
ZVex2.0LentivirusHuman Immunodeficiency Virus 1N/AN/AN/A

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known