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
Johnson & Johnson (NYSE: JNJ) has published new data in mAbs journal about nipocalimab, their investigational neonatal Fc receptor (FcRn) blocker. The research highlights the drug's selective and high-affinity binding properties in treating IgG-driven alloantibody and autoantibody diseases.
The studies demonstrate that nipocalimab, a fully human IgG-1 monoclonal antibody, can reduce circulating IgG levels by more than 75%, including pathogenic IgG autoantibodies, without affecting IgG production or other immune functions. The drug's pH-independent binding characteristic makes it particularly suitable for investigating alloimmune diseases of pregnancy.
The findings are consistent with clinical Phase 1, 2, and 3 studies of nipocalimab, though clinical significance remains to be determined.
Johnson & Johnson (NYSE: JNJ) ha pubblicato nuovi dati sulla rivista mAbs riguardanti nipocalimab, il loro bloccante investigativo del recettore neonatal Fc (FcRn). La ricerca evidenzia le proprietà di legame selettivo e ad alta affinità del farmaco nel trattamento delle malattie da alloanticorpi e autoanticorpi guidate da IgG.
Gli studi dimostrano che nipocalimab, un anticorpo monoclonale IgG-1 completamente umano, può ridurre i livelli di IgG circolanti di più del 75%, inclusi gli autoanticorpi IgG patogeni, senza influenzare la produzione di IgG o altre funzioni immunitarie. La caratteristica di legame indipendente dal pH del farmaco lo rende particolarmente adatto per l'indagine delle malattie alloimmuni in gravidanza.
I risultati sono coerenti con gli studi clinici di Fase 1, 2 e 3 di nipocalimab, sebbene la significatività clinica debba ancora essere determinata.
Johnson & Johnson (NYSE: JNJ) ha publicado nuevos datos en la revista mAbs sobre nipocalimab, su bloqueador investigacional del receptor neonatal Fc (FcRn). La investigación destaca las propiedades de unión selectiva y de alta afinidad del fármaco en el tratamiento de enfermedades por aloanticuerpos y autoanticuerpos impulsadas por IgG.
Los estudios demuestran que nipocalimab, un anticuerpo monoclonal IgG-1 completamente humano, puede reducir los niveles de IgG circulantes en más del 75%, incluidos los autoanticuerpos IgG patogénicos, sin afectar la producción de IgG ni otras funciones inmunitarias. La característica de unión independiente del pH del fármaco lo hace particularmente adecuado para investigar enfermedades aloinmunes del embarazo.
Los hallazgos son consistentes con los estudios clínicos de Fase 1, 2 y 3 de nipocalimab, aunque la significancia clínica aún debe ser determinada.
존슨앤드존슨 (NYSE: JNJ)은 mAbs 저널에 대한 새로운 데이터를 발표했습니다. 데이터는 신생아 Fc 수용체(FcRn) 차단제인 nipocalimab에 관한 것입니다. 연구는 IgG에 의해 유도된 알로항체 및 자가항체 질환 치료에서 약물의 선택적이고 높은 친화력 결합 특성을 강조합니다.
연구에 따르면 nipocalimab은 완전 인간 IgG-1 단클론 항체로, 75% 이상 혈중 IgG 수치를 감소시킬 수 있으며, 병원성 IgG 자가항체를 포함하되 IgG 생성이나 다른 면역 기능에는 영향을 미치지 않습니다. 약물의 pH 독립적 결합 특성은 임신 관련 알로면역 질환을 조사하는 데 특히 적합합니다.
이 발견은 nipocalimab의 1, 2 및 3상 임상 연구와 일치하지만, 임상적 중요성은 아직 결정되지 않았습니다.
Johnson & Johnson (NYSE: JNJ) a publié de nouvelles données dans le journal mAbs concernant le nipocalimab, leur bloqueur expérimental du récepteur Fc néonatal (FcRn). La recherche met en évidence les propriétés de liaison sélectives et à haute affinité du médicament dans le traitement des maladies à alloanticorps et autoanticorps induites par les IgG.
Les études démontrent que le nipocalimab, un anticorps monoclonal IgG-1 entièrement humain, peut réduire les niveaux d'IgG circulants de plus de 75%, y compris les autoanticorps IgG pathogènes, sans affecter la production d'IgG ou d'autres fonctions immunitaires. La caractéristique de liaison indépendante du pH du médicament le rend particulièrement adapté à l'étude des maladies alloimmunes pendant la grossesse.
Les résultats sont cohérents avec les études cliniques de phase 1, 2 et 3 du nipocalimab, bien que la signification clinique reste à déterminer.
Johnson & Johnson (NYSE: JNJ) hat neue Daten in der Zeitschrift mAbs über Nipocalimab veröffentlicht, ihren experimentellen neonatalen Fc-Rezeptor (FcRn)-Blocker. Die Forschung hebt die selektiven und hochaffinen Bindungseigenschaften des Medikaments bei der Behandlung von IgG-gesteuerten Alloantikörper- und Autoantikörpererkrankungen hervor.
Die Studien zeigen, dass Nipocalimab, ein vollständig humaner IgG-1-Monoklonalkörper, die zirkulierenden IgG-Spiegel um mehr als 75% senken kann, einschließlich pathogener IgG-Autoantikörper, ohne die IgG-Produktion oder andere Immunfunktionen zu beeinträchtigen. Die pH-unabhängige Bindungseigenschaft des Medikaments macht es besonders geeignet für die Untersuchung alloimmuner Erkrankungen während der Schwangerschaft.
Die Ergebnisse stimmen mit klinischen Studien der Phasen 1, 2 und 3 zu Nipocalimab überein, obwohl die klinische Signifikanz noch bestimmt werden muss.
- Demonstrated >75% reduction in circulating IgG levels
- Drug shows selective targeting without affecting other immune functions
- Successful completion of preclinical studies with consistent results across Phase 1, 2, and 3 trials
- Clinical significance of the findings is not yet established
Insights
The newly published data in mAbs journal represents a significant milestone in J&J's immunology pipeline, particularly highlighting nipocalimab's potential as a breakthrough therapy for IgG-driven diseases. The drug's ability to achieve
The molecular profile demonstrates three important advantages:
- High-affinity binding that remains pH-independent, enabling unique applications in pregnancy-related conditions where current treatment options are
- Selective targeting that preserves other immune functions, suggesting a potentially superior safety profile compared to broader immunosuppressive approaches
- Consistent performance across preclinical and clinical studies, indicating robust translational potential
The generalized myasthenia gravis (gMG) market, one of nipocalimab's target indications, is projected to grow significantly, with current treatments leaving substantial unmet needs. The drug's mechanism of action, particularly its precision in reducing pathogenic antibodies without compromising broader immunity, could provide J&J with a competitive edge in this expanding market segment.
The publication timing aligns strategically with ongoing Phase 3 trials, building scientific credibility and market awareness ahead of potential regulatory submissions. The data's validation through peer review in a respected journal like mAbs strengthens the drug's position for both regulatory consideration and market acceptance.
Published results reinforce the high-affinity binding and immunoselective properties of nipocalimab, which has been shown to reduce IgG levels by >
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 The studies established that nipocalimab binds both specifically and with high, pH-independent affinity to FcRn.1 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
"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, 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, and an author of the publication.b "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."
Editor's notes:
a. mAbs is a multidisciplinary, peer-reviewed, open access journal dedicated to the art and science of antibody research and development.
b. Dr. Pushpa Narayanaswami has provided consulting, advisory and speaking services to Johnson & Johnson. She has not been paid for any media work.
ABOUT NIPOCALIMAB
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.2,3,4,5,6,7,8,9,10 Blockade of IgG binding to FcRn in the placenta is also believed to limit transplacental transfer of maternal alloantibodies to the fetus.11,12
The
U.S. FDA Fast Track designation in hemolytic disease of the fetus and newborn (HDFN) and warm autoimmune hemolytic anemia (wAIHA) in July 2019, gMG in December 2021 and fetal neonatal alloimmune thrombocytopenia (FNAIT) in March 2024U.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 2023U.S. FDA Breakthrough Therapy designation for HDFN in February 2024 and for Sjögren's disease in November 2024U.S. FDA granted Priority Review in gMG in Q4 2024- EU EMA Orphan medicinal product designation for HDFN in October 2019
ABOUT JOHNSON & JOHNSON
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.
Learn more at https://www.jnj.com/ or at https://innovativemedicine.jnj.com/
Follow us at @JNJInnovMed.
Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies.
CAUTIONS CONCERNING FORWARD-LOOKING STATEMENTS
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of nipocalimab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
REFERENCES
1 Seth N, et al. Nipocalimab, an immunoselective FcRn blocker that lowers IgG and has unique molecular properties. mAbs. 2025 Feb; 17(1). https://doi.org/10.1080/19420862.2025.2461191
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11 Lobato G, Soncini CS. Relationship between obstetric history and Rh(D) alloimmunization severity. Arch Gynecol Obstet. 2008 Mar;277(3):245-8. DOI: 10.1007/s00404-007-0446-x.
12 Roy S, Nanovskaya T, Patrikeeva S, et al. M281, an anti-FcRn antibody, inhibits IgG transfer in a human ex vivo placental perfusion model. Am J Obstet Gynecol. 2019;220(5):498 e491-498 e499.
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