Human IL-31R (IL-31RA) Antibody - Nemolizumab Biosimilar

Anti-human IL-31R (IL-31RA) - Nemolizumab biosimilar - CAS #1476039-58-3

Binding of anti-IL-31R mAb

Anti-hIL-31R-hIgG2 is a biosimilar antibody of Nemolizumab, a human interleukin 31 receptor A (IL-31RA) antibody that blocks IL-31 signaling. This monoclonal antibody (mAb), also known as anti-IL-31RA or anti-IL-31Rα, is FDA-approved for the treatment of prurigo nodularis (PN) and atopic dermatitis (AD).

 More details

Anti-hIL-31R-hIgG2 comprises the variable region of Nemolizumab and the IgG2 constant region of Nemolizumab for mild effector functions. 

This mAb can be used together with HEK-Blue™ IL-31 cells for screening and neutralization assays to block IL-31R signaling induced by recombinant human IL-31 (see figure).

Key features

• Each lot is functionally tested and validated.
• The complete sequence of the antibody construct was verified.
• The absence of endotoxins is determined by the EndotoxDetect™ assay.

All InvivoGen products are for internal research use only, and not for human or veterinary use.

Figures

Dose-dependent inhibition of HEK‑Blue™ IL-31 cellular response using Nemolizumab biosimilar. Increasing concentrations of Anti-hIL-31R-hIgG2 (1 ng/ml - 1 µg/ml) were incubated with HEK‑Blue™ IL-31 cells for 3 hours before the addition of recombinant human IL-31 (10 pg/ml). After overnight incubation, SEAP activity in the cell culture supernatant was assessed using QUANTI-Blue™. Data are shown in percentage of activity (mean ± SEM).

Specifications

Application: Neutralization assay, ELISA

Isotype:  Human IgG2, kappa

Recommended isotype control: Human IgG2

Target: Human IL-31Rα (IL-31RA)

Species reactivity: Human

Clone: Nemolizumab, CIM331

Cas number: 1476039-58-3

Sterility: 0.2 µm filtration

Source: CHO cells 

Production: Animal-free

Purification: Protein A

Molecular weight: 145 kDa

Physical form: Lyophilized

Formulation buffer: Sodium phosphate buffer with glycine, saccharose, and stabilizing agents

Preservative: Azide-free

Reconstitution buffer: Sterile water (not provided)

Purity: ≥ 95 %

Quality control: Each lot is functionally tested and validated.

Contents

Anti-hIL-31R-hIgG2 purified monoclonal antibody is provided azide-free and lyophilized. It is available in two quantities:

• hil31r-mab2: 100 µg
• hil31r-mab2​-03: 3 x 100 µg

 The product is shipped at room temperature.

 Upon receipt, store lyophilized antibody at -20 °C.

 Lyophilized product is stable for at least 1 year.

 Avoid repeated freeze-thaw cycles.

Details

Nemolizumab and IL-31 background

Nemolizumab (formally known as CIM331) is a humanized IgG2 monoclonal antibody (mAb) that blocks interleukin 31 (IL-31) signaling by targeting the IL-31 receptor A (IL-31RA or IL-31Rα) [1].

IL‐31, a member of the type I/II cytokine receptor family, is often referred to as the "itchy" cytokine [2]. Its binding to IL-31RA triggers the activation of the JAK/STAT, Akt/PI3K, and MAPK signaling pathways [2,3]. Little is known about the physiological function of IL-31. It is mainly secreted by IL-4-activated T cells, thereby contributing to Th2-weighted inflammation [2,3]. Several reports indicate that IL-31 is a pruritogenic cytokine that is highly implicated in disorders such as atopic dermatitis, asthma, and inflammatory bowel disease [2,3]. Thus, targeting the IL-31 pathway is a promising therapeutic option for dermatologic and non-dermatologic diseases with enhanced IL-31 expression [2,3].

Nemolizumab, marketed as Nemluvio®, received FDA approval in 2024 for the treatment of moderate-to-severe atopic dermatitis and prurigo nodularis, a chronic skin condition [4].

References:

1. Nemoto O, et al., 2016. The first trial of CIM331, a humanized antihuman interleukin-31 receptor A antibody, in healthy volunteers and patients with atopic dermatitis to evaluate safety, tolerability and pharmacokinetics of a single dose in a randomized, double-blind, placebo-controlled study. Br J Dermatol. 174(2):296-304.
2. Datsi A., et al., 2021. Interleukin-31: The “itchy” cytokine in inflammation and therapy. Allergy. 76:2982-97.
3. Bagci I.S. and Ruzicka, T., 2018. IL-31: A new player in dermatology and beyond. J. Allergy Clin Immunol. 141(3):858-866.
4. U.S. Food and Drug Administration (FDA) (Report). 2024. New Drug Therapy Approvals 2024.