J&J's Next Immunology Act Centers On Nipocalimab For Autoantibody-Driven Diseases
Executive Summary
The company has ramped up a broad R&D program for the FcRn inhibitor in 11 autoantibody-driven disease areas.
Johnson & Johnson is looking to continue its commercial success in immunology by building in new therapeutic areas as categories like psoriasis and rheumatoid arthritis have matured and the competitive dynamics have intensified. The company has homed in on the neonatal Fc-receptor (FcRn) inhibitor nipocalimab as the next pillar in its immunology portfolio, targeting 11 initial indications for various autoantibody-driven diseases.
"Given the unmet need and the size of the addressable patient population, we see the potential for nipocalimab to deliver billions in annual revenue." – Janssen worldwide VP-immunology Teri Lawver
J&J is taking a "pathway-centric" development strategy with nipocalimab, which the company gained with the $6.5bn acquisition of Momenta Pharmaceuticals, Inc. last year. (Also see "J&J Seeks Command Position In FcRn Space With Momenta Buyout" - Scrip, 19 Aug, 2020.) The acquisition marked J&J's move into autoantibody-driven diseases, in which an antibody attacks an individual's own tissues. The FcRN receptor naturally regulates the level of antibodies in the body, and nipocalimab targets the FcRn antibody-binding site and drives a potent and dose dependent decrease in circulating antibodies, according to J&J.
Management laid out the first wave of development plans for nipocalimab during a pharmaceutical business overview on 18 November, during which the company said it was on track to become a $60bn pharmaceutical company by 2025. (Also see "No Way To Go But Grow: J&J Outlines Plans To Become A $60bn Pharma In 2025" - Scrip, 18 Nov, 2021.) Reaching that target will require continued growth in immunology, J&J's top revenue-generating therapeutic area, made up of brands like Remicade, (infliximab), Stelara (ustekinumab) and Tremfya (guselkumab).
"With nipocalimab, a potentially best-in-class FcRn inhibitor, we've systematically assessed the spectrum of autoantibody-driven diseases, prioritizing 11 with the highest unmet medical need and actionability," Janssen worldwide VP-immunology Teri Lawver said. "We're off to a fast start with parallel clinical programs across indications, ranging from larger familiar diseases and specialties, where Janssen has a leading presence, to rare orphan indications."
Across the 11 prioritized disease areas the company forecasts an addressable patient population of 2.1 million in the G8, Lawver said, a market about the same size as the therapeutic market for inflammatory bowel disease, Crohn's disease and ulcerative colitis combined.
"That was a $19bn market in 2020," she said. "Given the unmet need and the size of the addressable patient population, we see the potential for nipocalimab to deliver billions in annual revenue."
Beyond even the initial focus on 11 diseases, there are more than 70 autoantibody-driven diseases that impact nearly 200 million patients worldwide, or 2.5% of the population, according to J&J.
Among the new areas J&J is looking to move into are rare diseases like maternal/fetal disorders, myasthenia gravis, idiopathic inflammatory myopathy, and warm autoimmune hemolytic anemia, where the company hopes to position nipocalimab as the standard of care treatment for conditions definitively driven by a specific autoantibody. (see Table)
For example, in the case of myasthenia gravis, that would mean reducing autoantibodies directed against acetylcholine receptors, restoring normal muscle contraction. In a Phase II trial in patients with myasthenia gravis, treatment with nipocalimab resulted in rapid and sustained clinical response over placebo; a Phase III trial is ongoing.
J&J is also pursuing other higher-prevalence disease areas where the current standard of care is suboptimal like lupus nephritis, systemic lupus erythematosus and Sjogrens syndrome and where the disease pathway is more complex.
"Complex autoantibody diseases are defined by the presence of multiple autoantibody specificities, which implicate other pathways in disease," immunology global therapeutic area head David Lee said. "These are often subpopulations of prevalent diseases such as rheumatoid arthritis or lupus. Here, our development strategy will be guided by stratifying patients and based on quantifying autoantibody pathway activities."
Momenta had already been running clinical trials testing nipocalimab in myasthenia gravis, hemolytic diseases of the fetus and newborn and warm autoimmune hemolytic anemia at the time of the acquisition. Now J&J said it believes that it could file for 11 indications within six years.
Nonetheless, the space could be competitive. argenx N.V.is planning to launch the FcRn antagonist efgartigimod for the treatment of myasthenia gravis shortly. A biologics license application is under review by the US Food and Drug Administration with action anticipated by 17 December. It is also under review in the EU and Japan. Efgartigimod is in development for other indications as well, including primary immune thrombocytopenia, pemphigus vulgaris and chronic inflammatory demyelinating polyneuropathy.
Others are also exploring FcRn drugs, including Immunovant, Inc.., UCB S.A.. and AstraZeneca PLC through the acquisition of Alexion Pharmaceuticals Inc..