Johnson & Johnson FcRn antibody to be included in breakthrough therapy

TextPharmaceutical Guanlan

According to the official website of the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China, nipocalimab injection, a class 1 new drug declared by Johnson & Johnson, is planned to be included in the breakthrough therapy category, and the indication for generalized myasthenia gravis ( gMG)
.
According to public information, nipocalimab (M281) is an anti-FcRn antibody under development, which was obtained from Johnson & Johnson’s acquisition of Momenta for about $6.

Screenshot source: CDE official website

The neonatal Fc receptor (FcRn) is widely expressed throughout the body and plays a central role in preventing the degradation of immunoglobulin G (IgG) antibodies
.
Nipocalimab is an antibody therapy targeting FcRn developed by Momenta, which has the potential to treat a variety of autoimmune diseases caused by autoantibodies

According to reports, Nipocalimab can bind to FcRn, so that autoantibodies taken up by monocytes and endothelial cells are not re-released into the blood, but degraded in the cells
.
It has been shown to reduce circulating IgG levels, including disease-causing autoantibodies, by more than 75%

▲Introduction to Nipocalimab (Image source: Johnson & Johnson's official website)

Previously, nipocalimab was granted orphan drug designation by the U.
S.
FDA for the prevention of hemolytic disease of the fetus and neonate, and has achieved positive results in a Phase 2 clinical trial for the treatment of myasthenia gravis
.
In August 2021, it was approved in China to carry out clinical research on generalized myasthenia gravis.

Myasthenia gravis is a rare disease in which autoantibodies block signaling at synapses
.
In a phase 2 clinical trial for myasthenia gravis, significant responses were observed in patients treated with nipocalimab after two weeks

According to a presentation by Johnson & Johnson at an investor meeting in November 2021, the company plans to explore the therapeutic potential of nipocalimab in a variety of autoimmune diseases
.
Currently, J&J is conducting or planning to conduct 8 registrational studies and 4 proof-of-concept studies in more than 11 indications

Autoimmune diseases driven by autoantibodies include myasthenia gravis, fetal and neonatal hemolytic diseases, and other serious skin, rheumatism, neurological, hematological, and renal diseases
.
It is hoped that the follow-up clinical development of nipocalimab will progress smoothly and bring new treatment options to patients as soon as possible

References:

[1] Center for Drug Evaluation, National Medical Products Administration of China.

[3] JOHNSON & JOHNSON PHARMACEUTICAL BUSINESS REVIEW 2021.

[4] As J&J moves to split its business, execs lay out future R&D focus — and tout megablockbuster potential.
Retrieved November 19, 2021, from https://endpts.
com/as-jj-moves-to-split-its- business-execs-lay-out-future-rd-focus-and-tout-megablockbuster-potential/