Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 854 |
| INN | Nipocalimab |
| Status | Regulatory review |
| Drug code(s) | JNJ-80202135, M281 |
| Brand name | (Pending) |
| 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 | lambda |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | FcRn |
| Indications of clinical studies | Rheumatoid arthritis, Hemolytic Disease of the Fetus and Newborn, Myositis, Chronic Inflammatory Demyelinating Polyradiculoneuropathy, Lupus Nephritis, Lupus Erythematosus, Autoimmune Hemolytic Anemia, Generalized Myasthenia Gravis, Phase 1 in healthy volunteers |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Regulatory review EU, US |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | June 01, 2016 |
| Start of Phase 2 | December 11, 2018 |
| Start of Phase 3 | August 01, 2019 |
| 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 | Janssen Research & Development LLC |
| Licensee/Partner | None |
| Comments about company or candidate | September 12, 2024 I Janssen-Cilag International NV, a Johnson & Johnson company, today announced the submission of the Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking first approval of nipocalimab for the treatment of people living with generalised myasthenia gravis. Summary of regulatory agency designations: EU EMA Orphan medicinal product designation for HDFN in October 2019; U.S. FDA Fast Track designation in haemolytic disease of the foetus and newborn (HDFN) and warm autoimmune haemolytic anaemia (wAIHA) in July 2019, gMG in December 2021 and foetal neonatal alloimmune thrombocytopenia (FNAIT) in March 2024; U.S. FDA Orphan drug status for wAIHA in December 2019, HDFN in June 2020, gMG in February 2021, chronic inflammatory demyelinating polyneuropathy (CIDP) in October 2021 and FNAIT in December 2023; U.S. FDA Breakthrough Therapy designation for HDFN in February 2024. Aug 29, 2024: Johnson & Johnson announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking the first approval of nipocalimab globally for the treatment of people living with generalized myasthenia gravis. June 28, 2024– Johnson & Johnson announced positive results from the nipocalimab Phase 3 Vivacity-MG3 study in patients with generalized myasthenia gravis (gMG). Patients treated with nipocalimab plus standard of care (SOC) achieved superiority over placebo plus SOC as measured by the primary endpoint of improvement in the MG-ADL score from baseline over 24 weeks. These data are included in a presentation and are among eight abstracts that Johnson & Johnson will present at the European Academy of Neurology (EAN) 2024 Congress1 and will be included in submissions to regulatory authorities later this year. Mar 2024: U.S. Food and Drug Administration has granted Fast Track designation for nipocalimab to reduce the risk of FNAIT in alloimmunizeda pregnant adults during their current pregnancy. The Phase 3 FREESIA program is underway and nipocalimab is the only investigational therapy currently reported to be in clinical development for the treatment of FNAIT. https://www.prnewswire.com/news-releases/johnson--johnsons-nipocalimab-granted-us-fda-fast-track-designation-to-reduce-the-risk-of-fetal-neonatal-alloimmune-thrombocytopenia-fnait-in-alloimmunized-pregnant-adults-302099499.html NCT06028438 Phase 2 in RA started in Aug 2023 Phase 2/3 and 3 studies for Warm autoimmune hemolytic anemia (NCT04119050); Generalized myasthenia gravis (NCT05265273, NCT04951622) ; Polyradiculoneuropathy (NCT05327114) are recruiting as of May 2023. Although only NCT04951622 is listed as phase 3 on clinicaltrials.gov, on Janssen pipeline, studies of nipocalimab in the above indications are all phase 3. Feb. 6, 2023: The Janssen Pharmaceutical Companies of Johnson & Johnson today announced positive topline results from the proof-of-concept Phase 2 open-label UNITY clinical trial for the treatment of pregnant adults at high risk for severe hemolytic disease of the fetus and newborn (HDFN Planned filing in Generalized Myasthenia Gravis 2021-25, as of July 2022 NCT05327114 Phase 2/3 started in Sep 2022. April 2021: Phase 2 data featured as part of an oral presentation at the American Academy of Neurology (AAN) Virtual Meeting taking place April 17-22, 2021. Momenta acquired by Janssen in Oct 2020. July 2020: Momenta Pharmaceuticals announced that its novel drug candidate, nipocalimab, has received rare pediatric disease designation from the U.S. Food and Drug Administration (FDA) for the prevention of hemolytic disease of the fetus and newborn (HDFN). Additionally, FDA granted nipocalimab orphan drug designation in HDFN. Orphan drug designation in the EU. NCT04119050 Phase 2/3 study recruiting when posted on Oct 8, 2019. Aug. 01, 2019: Momenta Pharmaceuticals, Inc. announced the launch of an adaptive Phase 2/3 clinical study for its FcRn inhibitor nipocalimab (M281) in warm Autoimmune Hemolytic Anemia. July 2019: Momenta Pharmaceuticals' candidate nipocalimab, or M281, a treatment to prevent the blood disorder hemolytic disease of the fetus and newborn, has received Fast Track designation from the FDA. NCT03772587 Phase 2 study started in Dec 2018. Jan. 05, 2018: Momenta Pharmaceuticals, Inc. reported positive top-line data showing safety, tolerability and proof of mechanism for M281 in a phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) study of normal human volunteers. Over the 98-day MAD study, M281 exhibited no serious adverse events, was well tolerated, and decreased circulating IgG levels up to 89% with a mean reduction of 84%. Company plans to finalize their development strategy and initiate a proof of concept clinical trial in the second half of 2018, pending regulatory feedback NCT02828046 Phase 1 completed in Aug 2017. |
| Full address of company | Raritan, New Jersey, United States North America United States of America https://www.janssen.com/ |
M281 is a fully human aglycosylated, effectorless IgG1 monoclonal antibody that targets the IgG-binding site of FcRn. In preclinical models, M281 potently antagonizes FcRn binding of IgGs and rapidly diminishes circulating levels of IgG antibodies, the primary pathogenic agent in a number of autoimmune diseases.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |