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
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?
Austria; Belgium; Germany; Denmark; Spain; France; United Kingdom; Italy; Sweden;

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

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

- 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