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

Phase lengths*

*The graph represents early-stage clinical development phase lengths. For molecules approved or under evaluation for marketing authorization in the US is provided a complete overview of all clinical development phase lengths. Phase lengths are calculated from the start of the first in human (FIH) study (Start of clinical phase). “Start of Phase 2” bar represents Phase 1 length (Start of clinical phase to start of Phase 2); “Start of Phase 3” bar represents Phase 1+2 length (Start of clinical phase to start of Phase 3); “Date BLA/NDA submitted” bar represents Phase 1+2+3 length (Start of clinical phase to Date BLA/NDA submitted); and “Date of first US approval” bar represents Phase 1 to first US approval length (Start of clinical phase to Date of first US approval).

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Comments about company or candidate	Phase 1/2 study updated in January 2022 was Withdrawn (The study was withdraw due to the fast spread of Omicron variant worldwide) NCT05156645 is An Adaptive Phase I/II/III Trial to Evaluate the Efficacy and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