Suptavumab Terminated Naked monospecific

Antibody Information

Entry ID	2416
INN	Suptavumab
Status	Terminated
Drug code(s)	REGN2222, SAR438584
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	kappa
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	Transgenic mouse (Velocimmune)

Therapeutic information

Target(s)	RSV (F glycoprotein)
Indications of clinical studies	Phase 1 in healthy volunteers, Prevention of Medically Attended RSV Infection in Preterm Infants
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 3
Status	Inactive
Start of clinical phase (IND filing or first Phase 1)	December 15, 2013
Start of Phase 2
Start of Phase 3	June 01, 2015
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	Regeneron Pharmaceuticals
Licensee/Partner	None
Comments about company or candidate	Aug. 14, 2017: Regeneron Pharmaceuticals, Inc. today announced that a Phase 3 study evaluating suptavumab (REGN2222), an antibody to respiratory syncytial virus, did not meet its primary endpoint of preventing medically-attended RSV infections in infants. Suptavumab did show signs of efficacy in a subgroup of patients. Adverse events were generally balanced between suptavumab and placebo. Regeneron plans to discontinue further clinical development of this antibody. NCT02325791 Phase 3 study recruiting as of June 2015. Phase 1 study NCT02121080 completed in March 2015; the antibody was listed as inn Phase 1 in Regeneron 2013 annual report
Full address of company	Tarrytown, New York, United States North America United States of America https://www.regeneron.com/

Description/comment

Targets the prefusion F protein according to https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8653633/

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None