Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 438 |
| INN | Litifilimab |
| Status | Clinical |
| Drug code(s) | BIIB059 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| 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) | BDCA2 |
| Indications of clinical studies | Cutaneous Lupus Erythematosus, Systemic Lupus Erythematosus |
| 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) | September 01, 2014 |
| Start of Phase 2 | August 15, 2016 |
| Start of Phase 3 | May 25, 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 | Biogen |
| Licensee/Partner | None |
| Comments about company or candidate | Phase 3 studies NCT06044337 (for Systemic lupus erythematosus) and NCT05352919 (for cutaneous lupus Erythematosus) Phase 3 studies are enrolling by invitation as of November 2024. Phase 2/3 study for Cutaneous lupus erythematosus (NCT05531565) is recruiting as of May 2023; phase 3 studies for Systemic lupus erythematosus (NCT04961567, NCT04895241) are recruiting as of August-November 2024. July 2022 Biogen presentation: Phase 3 study discussed, but no mention of regulatory filings. NCT04895241 and NCT04961567 Phase 3 studies have primary completion dates in 2025. NCT04961567 Phase 3 TOPAZ-2 study started in Aug 2021. NCT04895241 Phase 3 study in SLE started in May 2021. June 17, 2021 I Biogen Inc. (Nasdaq: BIIB) today announced that the first patient has been dosed in the global clinical study, TOPAZ-1. The Phase 3 study will evaluate the clinical efficacy and assess the safety of BIIB059, a first in-class, humanized IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2 (BDCA2), as compared to placebo, in participants with active systemic lupus erythematosus (SLE). Nov 2020: The LILAC study (part A) met its primary endpoint and a key secondary endpoint (SRI-4). These results, and the observed safety profile, support the continued development of BIIB059 in SLE. Dec 2019: The Phase 2 LILAC study met its primary endpoints, demonstrating statistically significant reduction of disease activity in patients with CLE and SLE who received BIIB059 compared to placebo. Listed as Phase 2 in Biogen pipeline accessed Aug 12, 2019. March 2019: Results of NCT02106897 published (Furie et al. Monoclonal antibody targeting BDCA2 ameliorates skin lesions in systemic lupus erythematosus. J Clin Invest. 2019 Mar 1;129(3):1359-1371. doi: 10.1172/JCI124466). NCT02847598 Phase 2 study in SLE still recruiting as of July 2018. NCT02106897 Phase 1 study complete. Target is blood dendritic cell antigen 2 (BDCA2). Blood dendritic cell antigen 2 (BDCA2) is a C-type lectin expressed on human plasmacytoid dendritic cells (pDCs) (Dzionek et al, J. Immunol, 165:6037-6046 (2000)), a specialized population of bone marrow-derived cells that secrete type I interferons (IFNs) in response to toll-like receptor (TLR) ligands. BDCA2 consists of a single extracellular carbohydrate recognition domain (CRD), which belongs to the type II C-type lectin group, at its C-terminus, a transmembrane region, and a short cytoplasmic tail at its N- terminus that does not harbor a signaling motif. BDCA2 transmits intracellular signals through an associated transmembrane adaptor, the FcsRIy, and induces a B cell receptor (BCR)-like signaling cascade. |
| Full address of company | Cambridge, MA 02142, United States North America United States of America https://www.biogen.com/company/contact-us.html |
BIIB059 is a humanized IgG1 mAb that specifically recognizes blood DC antigen 2 (BDCA2), which is uniquely expressed on the surface of human pDCs (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6391094/)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |