Frexalimab Clinical Naked monospecific

Antibody Information

Entry ID	1233
INN	Frexalimab
Status	Clinical
Drug code(s)	SAR441344, INX-021
Brand name	None
mAb sequence source	mAb chimeric
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)	CD40L
Indications of clinical studies	Diabetes, Systemic Lupus Erythematosus, Sjögren's Syndrome, Multiple sclerosis
Primary therapeutic area	Immune-mediated / inflammatory disorders

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, 2018
Start of Phase 2	November 12, 2020
Start of Phase 3	December 15, 2023
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	ImmuNext
Licensee/Partner	Sanofi
Comments about company or candidate	NCT06141473 Phase 3 in MS started in Dec 2023; NCT06141486 Phase 3 in MS started in Dec 2023. NCT06111586 Phase 2 in diabetes started in Nov 2023. May 31 2023. Sanofi plans to initiate pivotal trials in multiple sclerosis in early 2024. New data, being presented in a late-breaking session at the 2023 Consortium of Multiple Sclerosis Centers (CMSC) annual meeting, demonstrate that frexalimab, Sanofi’s novel second-generation investigational anti-CD40L antibody, with a unique mechanism of action, significantly reduced disease activity in a Phase 2 trial of patients with relapsing multiple sclerosis (MS). Following 12 weeks of therapy, the number of new gadolinium-enhancing (GdE) T1-lesions was reduced by 89% and 79% in the higher- and lower-dose treatment arms, respectively, compared with placebo, meeting the study’s primary endpoint. Included in Q4 2023 pipeline update NCT04572841 Phase 2 in Sjögren's Syndrome started in Nov 2020. NCT05845996 Phase 1 started in Feb 2019 Feb 7, 2019 update on Q4 2018: Asset listed as in Phase 1 (p. 10 https://www.sanofi.com/-/media/Project/One-Sanofi-Web/Websites/Global/Sanofi-COM/Home/en/investors/docs/press-releases/Q42018results.pdf?la=en&hash=CDCE30350F0C658C000A909535AD9AF636A93560). A 2017 agreement between ImmuNext and Sanofi will grant Sanofi development and marketing rights to INX-021, a monoclonal antibody for the treatment of autoimmune diseases such as lupus and multiple sclerosis.
Full address of company	1 Medical Center Dr, Lebanon, NH 03766, United States North America United States of America https://www.immunext.com/

Description/comment

None

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None