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Notification report


Full notification file


General information

Notification Number
B/SE/19/2019-003300-12

Member State to which the notification was sent
Sweden

Date of acknowledgement from the Member State Competent Authority
05/08/2019

Title of the Project
A phase I/II trial investigating LOAd703 in combination with atezolizumab in malignant melanoma

Proposed period of release:
01/01/2020 to 31/12/2022

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?
Yes

If yes, notification number(s):
B/SE/17/2017-002565-22;

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 genome region L5. It has deletions in E1 and E3 genome 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 (TMZCD40L) (Eriksson et al, Clin Cancer Res, 2017, 23:5846-5857).

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