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
Phase 3 study of ADXS11-001 administered following chemoradiation as adjuvant treatment for high risk locally advanced cervical cancer AIM2CERV (Advaxis IMmunotherapy 2 prevent CERVical recurrence)

Proposed period of release:
01/08/2017 to 01/08/2022

Name of the Institute(s) or Company(ies)
Advaxis Inc., 305 College Road Est
Princeton, NJ 08540, USA;

3. Is the same GMO release planned elsewhere in the Community?
Spain; Netherlands; Poland; Romania;

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

GMO characterization

GMO is a:

Identity of the GMO:
The GMO is an attenuated Listeria monocytogenes strain which has been engineered to express the tLLO-E7 fusion protein.The E7 protein sequence was derived from Human Papilloma Virus 16. The Listeria monocytogenes strain is named axalimogene filolisbac, and is also known as ADXS11-001. Axalimogene filolisbac is a clinical drug product administered to patients for cancer treatment.

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
XFL7Listeriamonocytogenes--serovar 1/2a

European Commission administrative information

Consent given by the Member State Competent Authority:
17/05/2017 00:00:00