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 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?

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

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:
09/01/2019 00:00:00