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Notification report


Full notification file


General information

Notification Number
B/SE/17/2017-002565-22

Member State to which the notification was sent
Sweden

Date of acknowledgement from the Member State Competent Authority
03/07/2017

Title of the Project
Phase I/II trial investigating an immunostimulatory oncolytic adenovirus for cancer

Proposed period of release:
01/10/2017 to 30/11/2020

Name of the Institute(s) or Company(ies)
Lokon Pharma AB, ;


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

Has the same GMO been notified elsewhere by the same notifier?
No

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
LOAd703 is an adenovirus group C serotype 5 with changed fiber to serotype 35 in L5. It has
deletions in E1 and E3 regions: E1Adelta24, E3deltagp19K and E3delta6.7K. Ahead of E1A it has 8
E2F sites (4 palindromes) and one Sp-1 site. A transgene cassette is inserted after L5 including a CMV promoter, human full length 4-1BBL and an extracellular and intracellular domain of human CD40L fused to an isoleucine zipper domain (TMZ-CD40L) (Eriksson et al, Clin Cancer Res, 2017, Epub ahead of print).


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
Ad5Mastadenovirushuman adenovirussubgroup Cserotype 5-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known