Fianlimab Clinical Naked monospecific

Antibody Information

Entry ID	1177
INN	Fianlimab
Status	Clinical
Drug code(s)	REGN3767
Brand name	None
mAb sequence source	mAb human
General Molecular Category	Naked monospecific
Format, general category	Full length Ab
Format details	None
Isotype (Fc)	IgG4
Light chain isotype	kappa
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	Transgenic mouse (VelocImmune)

Therapeutic information

Target(s)	LAG-3
Indications of clinical studies	Non-small cell lung cancer, Melanoma, Advanced cancers
Primary therapeutic area	Cancer

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)	Phase 3
Status	Active
Start of clinical phase (IND filing or first Phase 1)	November 15, 2016
Start of Phase 2
Start of Phase 3	June 30, 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 information

Company	Regeneron Pharmaceuticals
Licensee/Partner	Sanofi
Comments about company or candidate	Nov 2024: 6 Phase 3 studies recruiting Phase 3 studies for Melanoma (NCT05352672, NCT05608291) are recruiting as of May 2023; NCT05800015 Phase 2/3 study for Non-small Cell Lung Cancer started recruiting in June 2023; Phase 3 NCT05785767 study for NSCLC not yet recruiting as of March-April 2023. Positive results for melanoma announced in May 2023 https://investor.regeneron.com/news-releases/news-release-details/fianlimab-lag-3-inhibitor-combined-libtayor-cemiplimab-shows NCT05785767 Phase 2/3 in NSCLC started in Mar 2023. NCT05352672 Phase 3 study started in June 2022. Aug 5 2021: Positive data from the Phase 1 trial in combination with Libtayo in advanced melanoma were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting; the Company intends to initiate a Phase 3 study in 2022. Listed in Regeneron pipeline as of May 2021. NCT03005782 Phase 1 study (administered alone or in combination with REGN2810 (cemiplimab)) in advanced malignancies started in Nov 2016 still recruiting as of Aug 2019.
Full address of company	Tarrytown, New York, United States North America United States of America https://www.regeneron.com/

Description/comment

Immune checkpoint target. Hinge-stabilized Fc

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None