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 |
Target(s) | CD73 |
Indications of clinical studies | Metastatic Non-Small Cell Lung Cancer, ovarian cancer, Solid tumors |
Primary therapeutic area | Cancer |
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 | 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 |
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.
Anticipated events | None |
Factor(s) contributing to discontinuation | None |