Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2413 |
| INN | Freneslerbart, mevonlerbart |
| Status | Clinical |
| Drug code(s) | REGN1908-1909 |
| Brand name | None |
| mAb sequence source | mAb human |
| General Molecular Category | Mixture of 2 |
| 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) |
| Target(s) | Fel d 1 |
| Indications of clinical studies | Cat allergy, Allergy |
| 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) | August 15, 2013 |
| Start of Phase 2 | April 01, 2015 |
| Start of Phase 3 | July 30, 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 | Regeneron Pharmaceuticals |
| Licensee/Partner | Sanofi |
| Comments about company or candidate | NCT06602726 Phase 3 in Allergic Conjunctivitis in Participants With Cat Allergy due to start in Oct 2024 Q3 2022 update: Regeneron discontinued (i) further clinical development of fasinumab, an antibody to NGF, which was previously being studied in osteoarthritis pain of the knee or hip in collaboration with Teva and Mitsubishi Tanabe Pharma; and (ii) the Phase 3 study of REGN1908-1909, a multi-antibody therapy to Fel d 1, in cat allergy, due to futility. Aug 2022 Regeneron presentation: listed as Phase 3 asset. NCT04981717 Phase 3 in cat-allergic asthmatics started in July 2021 has primary completion date in Jan 2024; Regeneron update in Aug: the Company initiated a Phase 3 study in cat allergic asthmatics. Phase 2 study results: https://www.jacionline.org/action/showPdf?pii=S0091-6749%2820%2932330-7 Listed in Regeneron pipeline update May 2021 as Phase 2. NCT03838731 Phase 2 study in cat allergy started in Feb 2019. July 2018: still listed in Regeneron pipeline. Phase 1 studies NCT01922661 completed; NCT02127801 Phase 1/2 started recruiting in early April 2015 |
| Full address of company | Tarrytown, New York, United States North America United States of America https://www.regeneron.com/ |
REGN1908-1909, a 1:1 cocktail of two fully human IgG4 monoclonal antibodies (mAbs): https://ascpt.onlinelibrary.wiley.com/doi/full/10.1111/cts.13112
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |