TAbS







Upanovimab Terminated Naked monospecific

Antibody Information

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

Therapeutic information

Target(s) SARS-CoV-2 (spike protein)
Indications of clinical studies COVID-19
Primary therapeutic area Infectious diseases

Development stage information


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 information

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Comments about company or candidate Phase 1/2 study updated in January 2022 was Withdrawn (The study was withdraw due to the fast spread of Omicron variant worldwide) NCT05156645 is An Adaptive Phase I/II/III Trial to Evaluate the Efficacy and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/

Description/comment

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

Additional information

Anticipated events None
Factor(s) contributing to discontinuation None