Database for
Therapeutic Antibodies
Therapeutic Antibodies
| 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) |
| Target(s) | LAG-3 |
| Indications of clinical studies | Non-small cell lung cancer, Melanoma, Advanced cancers |
| Primary therapeutic area | Cancer |
| 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 | 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/ |
Immune checkpoint target. Hinge-stabilized Fc
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |