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recombinant birch pollen allergen
Recombinant birch pollen allergen is used in allergen immunotherapy to desensitize the immune system to birch pollen by inducing tolerance through repeated controlled exposure to the allergen.
Recombinant birch pollen allergen is used in allergen immunotherapy to desensitize the immune system to birch pollen by inducing tolerance through repeated controlled exposure to the allergen. Used for Birch pollen-induced allergic rhinitis and/or allergic asthma.
At a glance
| Generic name | recombinant birch pollen allergen |
|---|---|
| Sponsor | Allergopharma GmbH & Co. KG |
| Drug class | Allergen immunotherapy |
| Target | Birch pollen allergens (Bet v 1 and related epitopes) |
| Modality | Biologic |
| Therapeutic area | Immunology / Allergy |
| Phase | Phase 3 |
Mechanism of action
This recombinant allergen extract contains the major birch pollen proteins that trigger allergic reactions. When administered in gradually increasing doses, it promotes immune tolerance by shifting the immune response from IgE-mediated (allergic) to IgG-mediated (protective) antibodies and inducing regulatory T cells. This reduces allergic symptoms upon natural exposure to birch pollen.
Approved indications
- Birch pollen-induced allergic rhinitis and/or allergic asthma
Common side effects
- Local injection site reactions (itching, swelling, erythema)
- Oral allergy syndrome or local oral/throat symptoms
- Systemic allergic reactions
- Rhinitis or asthma exacerbation
Key clinical trials
- A Clinical Trial for Evaluation of Efficacy, Safety and Immunogenicity of GNR-127 (Recombinant ABP Antigen Protein Which Carries a Birch Pollen Allergen [BET V 1] and an Apple Allergen [MAL D 1]) in Patients With Birch Pollen Allergic Rhinitis. (PHASE1, PHASE2)
- Sublingual Immunotherapy of Birch Pollen Associated Apple Allergy (PHASE2)
- Immunological and Histological Evaluation of Specific Immunotherapy With Recombinant Hypoallergenic Derivative (PHASE2)
- Efficacy and Safety From a Recombinant Folding Variant of Bet v 1 (PHASE3)
- Safety and Efficacy of Recombinant Birch Pollen Allergen in the Treatment of Allergic Rhinoconjunctivitis (PHASE3)
- Specific Immunotherapy With Recombinant Birch Pollen Allergen rBet v1-FV (PHASE2)
- Efficacy and Safety of Subcutaneous Immunotherapy in Birch Pollen Allergic Patients (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- recombinant birch pollen allergen CI brief — competitive landscape report
- recombinant birch pollen allergen updates RSS · CI watch RSS
- Allergopharma GmbH & Co. KG portfolio CI