TAbS







Oleclumab Clinical Naked monospecific

Antibody Information

Entry ID 992
INN Oleclumab
Status Clinical
Drug code(s) MEDI9447
Brand name None
mAb sequence source mAb human
General Molecular Category Naked monospecific
Format, general category Full length Ab
Format details None
Isotype (Fc) IgG1
Light chain isotype lambda
Linker None
Ave. DAR None
Conjugated/fused moiety None
Discovery method/technology Phage display-derived

Therapeutic information

Target(s) CD73
Indications of clinical studies Metastatic Non-Small Cell Lung Cancer, ovarian cancer, Solid tumors
Primary therapeutic area Cancer

Development stage information


Most advanced stage of development (global) Phase 3
Status Active
Start of clinical phase (IND filing or first Phase 1) July 15, 2015
Start of Phase 2 February 01, 2018
Start of Phase 3 February 15, 2022
Date BLA/NDA submitted to FDA
Year of first approval (global) None
Date of first US approval
INN, US product name None
US or EU approved indications None

Company information

Company AstraZeneca
Licensee/Partner None
Comments about company or candidate Nov 2024: 4 Phase 2 studies and 1 Phase 3 study recruiting NCT05221840 Phase 3 in NSCLC started in Feb 2022. NCT05061550 Phase 2 in NSCLC due to start in Dec 2021. Phase 1 development in combination with A2aR inhibitor in NSCLC terminated in Q4 2020. NCT03822351 and NCT03334617 Phase 2 studies in NSCLC recruiting as of Aug 2019. NCT03773666 Phase 1 study in bladder cancer started Feb 20, 2019. NCT03267589 Phase 2 in ovarian cancer started in Feb 2018; NCT03611556 Phase 1/2 in pancreatic cancer started in June 2018 completed in July 2022. NCT02503774 Phase 1 started in July 2015. NCT03819465 Phase 1 study in NSCLC recruiting as of Dec 2018; NCT03381274 Phase 1/2 in NSCLC not yet recruiting as of March 28 2018.
Full address of company Cambridge, United Kingdom
Europe
United Kingdom
https://www.astrazeneca.com/our-company/contact-us.html

Description/comment

Immune checkpoint target. IgG1 lambda1. MEDI-9447 inhibits both recombinant and cellular CD73 ectonucleotidase activity, provides relief from AMP-mediated lymphocyte suppression in-vitro, and inhibits syngeneic tumor growth. MEDI9447 drives changes in both myeloid and lymphoid infiltrating leukocyte populations within the tumor microenvironment.

Additional information

Anticipated events None
Factor(s) contributing to discontinuation None