A Randomized, Double-Masked, Placebo-Controlled Study to Assess the Efficacy and Safety of REGN5713-5715 to Reduce Signs and Symptoms of Allergic Conjunctivitis in Participants With Birch Pollen Allergy

This study is researching 2 experimental drugs, REGN5713 and REGN5715, which are called REGN5713-5715 when mixed together (called "study drug") to reduce eye allergy signs and symptoms due to birch tree pollen allergy.
The aim of the study is to see how safe and effective the study drug is at lowering allergic eye signs and symptoms compared with placebo. A placebo looks like a treatment but does not contain any real medicine.
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drug
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects).

Start Date19 Nov 2024

Sponsor / Collaborator

Regeneron Pharmaceuticals, Inc.

NCT05430919

/ CompletedPhase 2

A Two-Part Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy of the Anti-Bet v 1 Monoclonal Antibodies to Reduce Allergic Rhinitis and Conjunctivitis Symptoms and Skin Test Reactivity Upon Exposure to Birch Allergen

Primary objective: To assess the efficacy of a single dose of the anti- Bet v 1 monoclonal antibodies (mAb(s ) in the reduction of allergic nasal symptoms during an out-of-season birch allergen environmental exposure unit (EEU) challenge in participants receiving REGN5713-5714-5715 versus placebo (Part A)

Start Date15 Aug 2022

Sponsor / Collaborator

Regeneron Pharmaceuticals, Inc.

100 Clinical Results associated with Bet v 1

100 Translational Medicine associated with Bet v 1

0 Patents (Medical) associated with Bet v 1

619

Literatures (Medical) associated with Bet v 1

01 Mar 2025·Allergy

Short‐course subcutaneous treatment with birch pollen allergoids greatly improves symptom and medication scores in birch allergy

Article

Author: Rybachuk, Anna ; Xenofontos, Elena ; Neuhof, Christian ; Sahin, Hacer ; del Pozo Collado, Sandra ; Pfaar, Oliver ; Raskopf, Esther ; Zielen, Stefan ; Cuevas, Mandy ; Klimek, Ludger ; Casanovas, Miguel ; Acikel, Cengizhan ; Subiza, José Luis ; Mösges, Ralph ; Decker, Lea ; Allekotte, Silke

AbstractBackgroundSubcutaneous immunotherapy has emerged as an effective option for treating allergic diseases. Here, we assessed the clinical impact of the mannan‐conjugated birch pollen polymerized allergoid T502 in birch pollen‐induced allergic rhinoconjunctivitis.MethodsIn this prospective, randomized, double‐blind placebo‐controlled phase III trial, 298 birch pollen–allergic adult patients were treated across 28 trial sites in Germany. Patients received either placebo or 23,000 mTU T502 subcutaneously over five pre‐seasonal visits. Efficacy was assessed by comparing the combined symptom and medication score (CSMS) between placebo and T502 during the peak birch pollen season 2022. Safety, tolerability and immunologic effects were also analyzed.ResultsDuring the peak birch pollen season, the median CSMS of the T502 group was reduced by 33% (p = 0.002) compared to placebo. The median daily symptom score and daily medication score were reduced by 30.4% (p < 0.001) and 56.3% (p = 0.045), respectively. Health related quality of life improved as reflected by reduction of RQLQ values by 31.5% (p < 0.0001). Production of Bet v 1 sIgG4 and Bet v 1 sIgG increased up to 6.2‐fold and 3‐fold respectively in the T502 group (p < 0.0001). The sIgE/sIgG4 ratio was strongly reduced in the T502 group at V7 (−62.9%, p < 0.0001).No fatalities nor serious adverse events were reported. In total, 16 systemic allergic reactions occurred (Grade I/II).ConclusionsTreatment with T502 significantly reduced symptoms and medication need in rhinoconjunctivitis patients. The treatment is well tolerated and safe.

01 Mar 2025·Allergy

Cross‐protection of allergen immunotherapy‐induced antibodies to related allergens requires a high degree of structural identity

Article

Author: Scheurer, Stephan ; Demir, Hilal ; Strobl, Maria R. ; Kinaciyan, Tamar ; Radauer, Christian ; Bohle, Barbara

AbstractBackgroundIn contrast to sublingual immunotherapy (SLIT) with recombinant Mal d 1 (rMal d 1‐SLIT), SLIT with rBet v 1 (rBet v 1‐SLIT) induced Mal d 1‐cross‐reactive antibodies without IgE‐blocking activity. To elucidate whether the development of cross‐protective IgG responses depends on the degree of molecular identity of allergens we compared the cross‐reactivity, cross‐blocking activity, and affinity of SLIT‐induced antibodies with allergens of varying amino acid sequence identities to Bet v 1 and Mal d 1, namely Cor a 1.04 (hazelnut), Pru av 1 (cherry), and Dau c 1 (carrot).MethodsAllergen‐specific antibodies were quantified by ELISA. IgE blocking was analyzed by inhibition of allergen‐induced basophil activation and IgE‐facilitated allergen‐presentation to T cells. The affinity of SLIT‐induced antibodies was studied by acidic dissociation ELISA and competition ELISA. Identical surface areas on allergens were predicted using an in‐house designed script based on structural alignments.ResultsrBet v 1‐SLIT‐induced IgG antibodies cross‐reacted with all allergens except Dau c 1. rMal d 1‐SLIT‐induced antibodies predominantly cross‐reacted with Pru av 1 and displayed significantly higher IgE blocking to Pru av 1 than rBet v 1‐SLIT‐induced antibodies. rMal d 1‐SLIT‐induced IgG1 showed higher affinity to Mal d 1 and Pru av 1. Surface analysis revealed 84% identical area on Mal d 1 and Pru av 1. Furthermore, we identified two surface areas potentially containing epitopes present on these allergens and absent on Bet v 1.ConclusionIn summary, our findings suggest that a relatively high threshold of similarity is required to establish effective cross‐blocking antibodies to related allergens. Apparently, the structural identity between Bet v 1 and Mal d 1 is below this threshold. Therefore, this study may explain why immunotherapy with birch pollen allergen often fails to reduce birch pollen‐related apple allergy.

01 Feb 2025·Food Chemistry

Proteomic identification of allergenic proteins in holm oak (Quercus ilex) seeds

Article

Author: Rey, María-Dolores ; Triviño, Marina Muñoz ; Muñoz Triviño, Marina ; Jorrín-Novo, Jesús V. ; Labella-Ortega, Mónica ; Jorrín-Novo, Jesús V ; Rodríguez-Pérez, Rosa ; Castillejo-Sánchez, María Ángeles ; Hernández-Lao, Tamara ; Pedrosa, María

Humans have used Quercus ilex acorns as a staple food since ancient times. Recently, their nutritional and nutraceutical value has revived interest for human consumption. Ensuring their safety as food requires assessing their allergenic potential. In this work, we predicted the allergenic profile of acorns by in silico analysis of the Q. ilex genome and transcriptome. In addition, immunoblot analysis of pooled sera from patients allergic to various dry fruits was performed, with immunoreactive bands subjected to mass spectrometry analysis. The most remarkable allergens identified belong to the Bet v 1, profilin, prolamin, Hsp70 and cyclophilin families. Acorns from different mother trees exhibited also different IgE sensitization patterns. Thus, acorns from trees showing damage symptoms, and located in declined areas, had higher allergen contents than those from healthy ones, which corresponded to higher abundance of stress-related proteins.

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