Database for
Therapeutic Antibodies
Therapeutic Antibodies
| 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 |
| Target(s) | CD40L |
| Indications of clinical studies | Diabetes, Systemic Lupus Erythematosus, Sjögren's Syndrome, Multiple sclerosis |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| 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 | 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/ |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |