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Positive phase IIb data on BM32, Biomay's innovative grass pollen allergy vaccine will be reported in hot topic session at major international scientific conference ( 3 Jun. 2015)

Biomay, a global leader in allergy immunotherapy, announced today that the results of a landmark phase IIb study with its 3rd generation grass pollen allergy vaccine BM32 will be reported at the EAACI Congress 2015 in Barcelona, Spain. This event is a major scientific conference in the field of allergy and clinical immunology organized by the European Academy of Allergy and Clinical Immunology. The presentation entitled "Clinical Efficacy of a recombinant B-cell epitope based grass pollen allergy vaccine - a phase IIb proof of concept study" will be given by Prof. Rudolf Valenta, a globally recognized leader in allergy research on June 7, 2015, in the Hot Topic Session of the congress.

This study (clinicaltrials.gov identifier NCT01538979) which was completed in 2014, convincingly provided clinical proof of concept for this first in kind B-cell epitope derived allergy vaccine. It was observed that the Rhinoconjunctivitis Symptom Score (RSS) was reduced by 25% compared to placebo (p=0.042, statistically significant) in this 181-patient trial during the peak pollen season of the second treatment year. The treatment also significantly improved patients' well-being measured by two independent methods (Visual Analogue Scale (VAS, p=0.014) and the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ, p <0.005)). A 22% difference of a Combined Symptom and Medication Score (SMS) to placebo was also found (p=0.085). The observed clinical effects were supported by a potent and sustained induction of allergen specific IgG antibodies, which are responsible for blocking the interaction of allergens with IgE on effector cells. Unlike the established allergy vaccines derived from grass pollen extracts, BM32 did not lead to any boost of disease causing IgE production. On the contrary, the seasonal boost of IgE release by pollen exposure was significantly blunted.

The treatment was safe and well tolerated. Most side effects were mild to moderate and resolved within a short period after drug application.

Rainer Henning, CEO of Biomay commented: "It is a great honour for Biomay that our study has been selected by the organizers for presentation in one of the most looked-for sessions of this prestigious conference. It is inrecognition of the cutting edge clinical science, which has been the result of excellent cooperation between the study investigators and the company. We look forward to discussing the data with opinion leaders in the field of allergy immunotherapy from around the globe at this event."

A manuscript for submission to a leading peer reviewed journal in the field of allergy and immunology is also currently in preparation and will be submitted in due course.

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