{"id":812757,"date":"2025-02-13T08:22:36","date_gmt":"2025-02-13T13:22:36","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/new-nipocalimab-data-published-in-mabs-journal-details-differentiated-molecular-design-clinical-profile-and-potential-of-nipocalimab-to-treat-igg-driven-alloantibody-and-autoantibody-diseases\/"},"modified":"2025-02-13T08:22:36","modified_gmt":"2025-02-13T13:22:36","slug":"new-nipocalimab-data-published-in-mabs-journal-details-differentiated-molecular-design-clinical-profile-and-potential-of-nipocalimab-to-treat-igg-driven-alloantibody-and-autoantibody-diseases","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/new-nipocalimab-data-published-in-mabs-journal-details-differentiated-molecular-design-clinical-profile-and-potential-of-nipocalimab-to-treat-igg-driven-alloantibody-and-autoantibody-diseases\/","title":{"rendered":"New nipocalimab data published in mAbs journal details differentiated molecular design, clinical profile and potential of nipocalimab to treat IgG-driven alloantibody and autoantibody diseases"},"content":{"rendered":"
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PR Newswire<\/p>\n<\/p><\/div>\n

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\n Published results reinforce the high-affinity binding and immunoselective properties of nipocalimab, which has been shown to reduce IgG levels by >75%, including autoantibodies, potentially without affecting other immune functions<\/i>\n <\/p>\n

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\n SPRING HOUSE, Pa.<\/span>
\n <\/span>, Feb. 13, 2025<\/span><\/span> \/PRNewswire\/ —\u00a0Johnson & Johnson (NYSE: JNJ) today announced the publication of data detailing the differentiated molecular properties of nipocalimab, an investigational neonatal Fc receptor (FcRn) blocker, in mAbs<\/i><\/a>.a <\/sup>This publication highlights the selective, targeted and high-affinity binding properties of nipocalimab which support its differentiated potential as a treatment option for immunoglobulin G (IgG)-driven alloantibody and autoantibody diseases.1<\/sup><\/p>\n

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\n \"(PRNewsfoto\/Johnson
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Nipocalimab is a fully human IgG-1 monoclonal antibody that binds to FcRn, resulting in the reduction of circulating IgG levels including pathogenic IgG autoantibodies.1<\/sup> The studies established that nipocalimab binds both specifically and with high, pH-independent affinity to FcRn.1<\/sup> These preclinical studies also established the relationship between FcRn binding and the inhibition of IgG recycling, revealing that nipocalimab achieves time and dose-dependent IgG reductions of greater than 75% without affecting IgG production and without detectable effects on other adaptive and innate immune functions.1<\/sup> The pH-independent nature of the binding, also noted in this publication, is one factor contributing to the ability to investigate nipocalimab in alloimmune diseases of pregnancy.1<\/sup> The mechanism of action of nipocalimab was assessed through in vitro and in vivo studies, and attributes noted in the publication are consistent with clinical Phase 1, 2 and 3 studies of nipocalimab.1<\/sup> The clinical significance is not yet known.\u00a0<\/p>\n

“There is a critical need for additional approved, targeted and effective treatments with proven safety profiles to help alleviate the burden of severe IgG-driven autoantibody diseases, like generalized myasthenia gravis,” said Pushpa Narayanaswami<\/span>, M.D., FAAN, Vice Chair of Clinical Operations, Department of Neurology at the Beth Israel Deaconess Medical Center, Boston M.A. and Professor of Clinical Neurology at Harvard Medical School<\/span>, and an author of the publication.b\u00a0<\/sup> “I am excited to be a part of this important research, which underscores how the differentiated characteristics of nipocalimab may help to effectively address the underlying causes of these conditions.”<\/p>\n

\n Editor’s notes:<\/b>\n <\/p>\n

a. mAbs<\/i> is a multidisciplinary, peer-reviewed, open access journal dedicated to the art and science of antibody research and development.
b. Dr.\u00a0Pushpa Narayanaswami\u00a0has provided consulting, advisory and speaking services to\u00a0Johnson & Johnson. She has not been paid for any media work.\u00a0<\/p>\n

\n ABOUT NIPOCALIMAB<\/b>\n <\/p>\n

Nipocalimab is an investigational monoclonal antibody, designed to bind with high affinity to block FcRn and reduce levels of circulating immunoglobulin G (IgG) antibodies potentially without impact on other immune functions. This includes autoantibodies and alloantibodies that underlie multiple conditions across three key segments in the autoantibody space including Rare Autoantibody diseases, Maternal Fetal diseases mediated by maternal alloantibodies and Rheumatic diseases.2<\/sup>,3,4,5,6,7,8,9,10\u00a0\u00a0<\/sup>Blockade of IgG binding to FcRn in the placenta is also believed to limit transplacental transfer of maternal alloantibodies to the fetus.11<\/sup>,12<\/sup><\/p>\n

The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have granted several key designations to nipocalimab including:\u00a0\u00a0<\/p>\n