Johnson & Johnson Submits IND Application in China for Nipocalimab, a Best-in-Class Anti-FcRn Antibody Acquired Through $6.5B Momenta Deal

Article Source: Pharma Insights

Recently, the Center for Drug Evaluation (CDE) under China's National Medical Products Administration (NMPA) announced that Johnson & Johnson has submitted a clinical trial application in China for nipocalimab injection, a Class 1 innovative biological drug, and the application has been accepted by the CDE. Publicly available information indicates that nipocalimab (M281) is a clinically validated, potential "best-in-class" anti-FcRn antibody with the potential to treat various autoimmune diseases.

Screenshot source: CDE official website

The presence of pathogenic antibodies that promote tissue damage and organ dysfunction is a hallmark of immune-mediated diseases. Nipocalimab is an IgG1 antibody developed by Momenta Pharmaceuticals that binds to the neonatal Fc receptor (FcRn), thereby preventing FcRn from interacting with pathogenic autoantibodies. FcRn normally facilitates antibody recycling, which sustains elevated levels of autoantibodies in the circulation. By inhibiting FcRn function, Nipocalimab effectively reduces circulating levels of pathogenic autoantibodies. Previously, it was granted orphan drug designation by the US FDA for the prevention of hemolytic disease of the fetus and newborn, and has yielded positive results in a Phase 2 clinical trial for the treatment of myasthenia gravis.

In August 2020, Johnson & Johnson announced that it had entered into a definitive agreement to acquire Momenta for approximately $6.5 billion, thereby gaining access to Momenta's development pipeline, including its lead investigational product, nipocalimab.

Previously, Momenta announced data from a Phase 2 study of nipocalimab for generalized myasthenia gravis (GMG), showing that all four nipocalimab treatment groups demonstrated improvement in Myasthenia Gravis-Activities of Daily Living (MG-ADL) scale scores.

In Phase 1 clinical trials of single ascending dose (SAD) and multiple ascending dose (MAD) conducted in healthy volunteers, nipocalimab demonstrated safety and tolerability, validating its mechanism of action. In the 98-day MAD study, the candidate drug was not associated with any serious adverse events, was well tolerated, and reduced circulating IgG levels by up to 89%, with a mean reduction of 84%.

Note: The original text has been abridged.

References:

[1] Center for Drug Evaluation, National Medical Products Administration. from http://www.cde.org.cn/news.do?method=changePage&pageName=service&frameStr=25#

[2] Johnson & Johnson to Acquire Momenta Pharmaceuticals, Inc., Expanding Janssen's Leadership in Novel Treatments for Autoimmune Diseases https://www.prnewswire.com/news-releases/johnson--johnson-to-acquire-momenta-pharmaceuticals-inc-expanding-janssens-leadership-in-novel-treatments-for-autoimmune-diseases-301114715.html

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