Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1224 |
| INN | Afimkibart |
| Status | Clinical |
| Drug code(s) | RVT-3101, PF-06480605, RG6631, RO7790121 |
| Brand name | None |
| mAb sequence source | mAb human |
| 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) | TL1a |
| Indications of clinical studies | Crohn Disease, Ulcerative colitis |
| 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) | December 15, 2013 |
| Start of Phase 2 | October 15, 2016 |
| Start of Phase 3 | September 15, 2024 |
| 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 | Pfizer |
| Licensee/Partner | Hoffmann-La Roche, Roivant Sciences |
| Comments about company or candidate | NCT06588855 and NCT06589986 Phase 3 studies in UC started in Sep 2024; sponsored by Roche. Oct. 23, 2023 -- Roivant announced today the entry into a definitive agreement with Roche to acquire Telavant Holdings, Inc. (Telavant), a Roivant company, owned by Roivant Sciences Ltd. and Pfizer Inc. The agreement includes the development, manufacturing and commercialization rights in the US and Japan for RVT-3101, a novel TL1A directed antibody. NCT05910528 Phase 2 in Crohn disease started in June 2023. Jan. 04, 2023: Roivant Sciences announced positive results from the induction period of the TUSCANY-2 Phase 2b study of RVT-3101 (previously PF-06480605), a once monthly subcutaneously administered anti-TL1A antibody which demonstrated statistically significant and clinically meaningful efficacy results at each dose tested. RVT-3101 was well tolerated and showed a favorable safety profile. Pfizer pipeline dated May 2023 - PF-06480605 for UC removed from pipeline. NCT04090411 Phase 2 study in UC started in Dec 2019. Listed as Phase 2 in Pfizer pipeline dated July 29, 2019. NCT02840721 in UC still recruiting as of Aug 2018. EudraCT 2016-001158-16, NCT02840721 Phase 2 of PF-06480605 in ulcerative colitis started in Oct 2016; P1 started in Dec 2013. Target is tumor necrosis factor (ligand) superfamily, member 15. |
| Full address of company | 66 Hudson Boulevard East, New York, NY 10001-2192 USA North America United States of America https://www.pfizer.com/contact |
Br J Clin Pharmacol. 2019 Nov 23. doi: 10.1111/bcp.14187. First-in-human, randomized dose-escalation study of the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of PF-06480605 in healthy subjects. Target is vascular endothelial growth inhibitor (VEGI), also known as TNF-like ligand 1A (TL1A) and TNF superfamily member 15 (TNFSF15) immunoglobulin G1-kappa, anti-[Homo sapiens TNFSF15 (tumor necrosis factor (TNF) superfamily member 15, vascular endothelial cell growth inhibitor, VEGI, VEGI192A, TNF superfamily ligand TL1A)], Homo sapiens monoclonal antibody;
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |