Back

Notification report


Full notification file


General information

Notification Number
B/ES/18/25

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
11/09/2018

Title of the Project
Phase 1/2a First-in-Human Study of BMS-986277 Administered Alone and in Combination with Nivolumab in Advanced Epithelial Tumors

Proposed period of release:
01/12/2018 to 30/09/2022

Name of the Institute(s) or Company(ies)
Bristol-Myers Squibb, ;


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:
Genus: Mastadenovirus; Species: Human Chimeric Adenovirus
BMS-986277 is a replication-competent oncolytic adenovirus selective for human epithelial tumor cells. The genome has been modified to express 2 transgenes: a full-length human T-cell co-activating antigen, CD80, and a single chain variable fragment of the mouse anti-human CD3ε monoclonal antibody, OKT3 (anti-CD3-ScFv-TM), controlled under the virus endogenous major late promoter


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
enadenotucirevMastadenovirushuman adenovirusGroup B adenovirusHuman-specific chimeric Ad11p/Ad3 chimeric-

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
09/01/2019 00:00:00
Remarks: