Dupilumab is a fully human investigational monoclonal antibody delivered by subcutaneous injection that targets the alpha subunit of the interleukin 4 receptor (IL-4R alpha). By blocking IL-4R alpha, dupilumab modulates signaling of both IL-4 and IL-13, drivers of Th2 (Type 2 helper T cell) immune response. Dupilumab was created using Regeneron’s VelocImmune® gene modification technologies and is being co-developed with Sanofi. Dupilumab is currently in Phase 2b studies in atopic dermatitis, asthma and nasal polyposis.
Yung-Jue Bang, MD, PhD, Professor of Medical Oncology, Seoul National University College of Medicine; President, Biomedical Research Institute, Seoul National University Hospital discusses pembrolizumab for the treatment of advanced gastric cancer.
|Target||IL4 receptor alpha|
|Chemical and physical data|
|Molar mass||146.9 kg/mol|
Dupilumab, sold under the trade name Dupixent, is a monoclonal antibody designed for the treatment of allergic diseases such as eczema. Side effects include allergic reactions, cold sores, and inflammation of the cornea. It was developed by Regeneron Pharmaceuticals and Sanofi Genzyme. It received FDA approval in 2017. As of 2017 it costs about 37,000 USD per year.
Mechanism of action
It binds to the alpha subunit of the interleukin-4 receptor (IL-4Rα), making it a receptor antagonist. Through blockade of IL-4Rα, dupilumab modulates signaling of both the interleukin 4 and interleukin 13 pathway. In clinical trials, patients saw decreased levels of Th2 bio-markers.
As per the FDA, dupilumab was manufactured in accordance with current GMP. In October 2016, Regeneron posted a phase III CHRONOS trial, contrasting dupilumab with topical corticosteroids. The study showed that in conjunction with topical corticosteroids, people had a larger decrease in symptoms than steroids alone.
Phase III SOLO 1 and SOLO 2 trials were also performed, which evaluated the efficacy of dupilumab in combination with topical corticosteroids. In these trials 38% and 36% of patients respectively, met the primary efficacy goal of the trial, compared to 8% and 10% under placebo.
Phase II trials for asthma treatment showed increased lung function for patients, showing increased levels of forced expiratory volume.
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