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Bet v 1 allergen extract (specifically investigated as the recombinant folding variant rBet v 1-FV) is an investigational hypoallergenic recombinant derivative of the major birch pollen allergen, Bet v 1 (a PR-10 family protein). Developed for use in specific subcutaneous allergen immunotherapy (SCIT), it is designed to retain T-cell reactivity and immunogenicity while exhibiting significantly reduced IgE-binding capacity, thereby minimizing the risk of IgE-mediated therapy-induced side effects. The drug has been evaluated in clinical trials, including the Phase II/III BASALIT (Birch-Associated Soy ALlergy ImmunoTherapy) trial conducted by the University of Leipzig, which investigated its efficacy in desensitizing adults with birch pollinosis and cross-reactive, Bet v 1-related soy allergy (mediated by the soy homolog Gly m 4). It has also been studied in Phase III trials for birch pollen-induced allergic rhinoconjunctivitis.
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