Entry ID | 2505 |
INN | Upanovimab |
Status | Terminated |
Drug code(s) | SCTA01 |
Brand name | None |
mAb sequence source | mAb humanized |
General Molecular Category | Naked monospecific |
Format, general category | Full length Ab |
Format details | None |
Isotype (Fc) | IgG1 |
Light chain isotype | kappa |
Linker | None |
Ave. DAR | None |
Conjugated/fused moiety | None |
Discovery method/technology | None |
Target(s) | SARS-CoV-2 (spike protein) |
Indications of clinical studies | COVID-19 |
Primary therapeutic area | Infectious diseases |
Most advanced stage of development (global) | Terminated at Phase 2/3 |
Status | Inactive |
Start of clinical phase (IND filing or first Phase 1) | July 25, 2020 |
Start of Phase 2 | |
Start of Phase 3 | March 27, 2021 |
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 | Sinocelltech Ltd. |
Licensee/Partner | None |
Comments about company or candidate | Phase 1/2 study updated in January 2022 was Withdrawn (The study was withdraw due to the fast spread of Omicron variant worldwide) NCT05156645 is An Adaptive Phase I/II/III Trial to Evaluate the Efficacy and Safety of Anti-SARS-CoV-2 Monoclonal Antibody Combination (SCTA01C and SCTA01) for Treatment of Outpatients With COVID-19 due to start in Jan 2022 NCT04644185 Phase 2/3 in COVID-19 started in March 2021; NCT04683328 and NCT04709328 Phase 2/3 studies not yet recruiting as of last updates in Jan and March 2021, respectively. NCT04483375 is a Randomized, Double-blinded, Placebo-controlled, Single Ascending Dose, Phase I Study to Evaluate the Tolerability, Safety, Pharmacokinetics of SCTA01 in Healthy Subjects; First-in-Human Study of SCTA01(Anti-COVID-19 monoclonal antibody) in Healthy Chinese Subjects. Not yet recruiting when first posted on July 23, 2020. |
Full address of company | No. 31, Kechuang 7th Street, Beijing Economic and Technological Development Zone Asia China http://www.sinocelltech.com/ |
Recombinant humanized anti-SARS-CoV-2 monoclonal antibody. SCTA01 and SCTA01C bind to different epitopes of the spike RBD. Produced in a Chinese hamster ovary (CHO)-DG44 cell line. SCTA01, monotherapy and in combination with SCTA01C
Anticipated events | None |
Factor(s) contributing to discontinuation | None |