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Notification report


Full notification file


General information

Notification Number
B/ES/17/20

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
24/11/2017

Title of the Project
Clinical study 64041757LUC2002: An Open-label Randomized Phase 1b/2 Study of the Efficacy and Safety of JNJ-64041757, a Live Attenuated Listeria monocytogenes Immunotherapy, in Combination with Nivolumab Versus Nivolumab Monotherapy in Subjects With Advanced Adenocarcinoma of the Lung.

Proposed period of release:
15/02/2018 to 15/02/2021

Name of the Institute(s) or Company(ies)
Janssen-Cilag International NV, Turnhoutseweg 30
Beerse
B-2340
Belgium;


3. Is the same GMO release planned elsewhere in the Community?
No

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:
JNJ-64041757 is a genetically modified version of Listeria monocytogenes (Lm) which is
intended for use as a human cancer immunotherapeutic in the treatment of advanced
adenocarcinoma of the lung. The genetic modifications result in the following changes:
1. Attenuation of virulence by the deletion of the coding sequences of two wild-type
virulence determinants (ActA and Internalin B)
2. Heterologous gene expression by stable integration of epidermal growth factor
variant III (EGFRvIII) human mesothelin (hMeso) expression cassette into the
tRNAArg locus of the Lm ΔactA/ΔinlB chromosome.
JNJ-64041757 is derived from the Live Attenuated Double-Deleted (LADD) Lm platform
strain ANZ-100. In the absence of comprehensive data for JNJ-64041757, data derived from
the platform strain (ANZ-100) and derived strains (CRS-207 and JNJ-64041809) are
referenced in support of this notification.


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
Listeria monocytogenesListeriamonocytogenes-10403)-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known