| Quantity: | |
|---|---|
Clinically Relevant – Summary of human type I hypersensitivity reactions: IgE-mediated mast cell degranulation and wheal and flare reactions.
Quantifiable endpoints —clinical characteristics scores (wheal size, erythema, edema), local skin reaction measurements.
Mechanism-driven – direct assessment of the IgE/FcεRI pathway and mast cell function in vivo.
Translational Value – Ideal for testing anti-IgE biologics (omalizumab, ligelizumab), mast cell stabilizers (cromolyn, ketotifen), H1-antihistamines, and other anti-allergic drugs.
IND Ready Packet – Research can be conducted in accordance with GLP principles.
DNP-IgE and DNFB-induced NHP PCA model
• Efficacy testing of anti-IgE biologics (omalizumab, ligelizumab, other anti-IgE antibodies)
• Evaluation of mast cell stabilizers (cromolyn, ketotifen, nedocromil) and H1 antihistamines
• Target validation of the IgE/FcεRI pathway and mast cell biology
• Biomarker discovery (IgE, mast cell mediators)
• Pharmacology and toxicology studies to support IND
scope | Specification |
Species/Strain | cynomolgus monkey ( Macaca fascicularis ) |
induction method | Intradermal injection of DNP-specific IgE (day 1) followed by topical application of DNFB to the same site (day 2) |
study time | 2–3 days (sensitization + challenge) |
critical endpoint | Clinical feature score (wheal size, erythema, edema), local skin reaction measurement (diameter, thickness), optional: skin histopathology (mast cell degranulation), serum IgE level |
packet | Raw data, analysis report, clinical photos, histology slides (optional), bioinformatics (optional) Raw data, analysis report, clinical chemistry, urinalysis, histology slides, bioinformatics (optional) |
Q: How does the DNP-IgE and DNFB-induced PCA model work?
Answer: DNP-specific IgE is passively transferred through intradermal injection and binds to FcεRI receptors on mast cells. Subsequent local DNFB challenge at the same site cross-links IgE, triggering mast cell degranulation, histamine release, and local wheal and flare reactions.
Q: What are the key similarities to human Type I hypersensitivity?
A: This model exhibits IgE-mediated mast cell activation, histamine release, vasodilation, and local edema, directly reflecting human allergic reactions such as urticaria and anaphylaxis.
Q: Can this model be used for IND support studies?
Answer: Yes. Studies can be conducted according to GLP principles for regulatory submissions (FDA, EMA).
Q: Do you offer customized study protocols (eg, different IgE doses, challenge concentrations)?
Answer: Of course. Our scientific team customizes IgE concentrations, challenge protocols, and endpoint analyzes based on your specific drug candidate.
Q: What is the typical timeline for a pilot efficacy study?
A: The model is completed in 2-3 days and can quickly screen anti-allergic compounds.
