Biomay: Allergy Vaccine Internationally Presented

Positive Phase IIB Data On BM32, Biomay’s Innovative Grass Pollen Allergy Vaccine Will Be Reported Next Week In Hot Topic Session At Major International Scientific Conference

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 global 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.

The study *), which was completed in 2014, convincingly provided clinical proof of concept for this first of kind B-cell epitope derived allergy vaccine. It was observed that the Rhinoconjunctivitis Symptom Score (RSS) year was reduced by 25% compared to the placebo (p=0.042, statistically significant) in this 181-patient trial during the peak pollen season in the second treatment. 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 induced by pollen exposure was significantly dampened.

The treatment was safe and very 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 honor 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 in recognition 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.

*) identifier NCT01538979

About BM32 and peptide carrier fusion vaccines
BM32 is an innovative grass pollen allergy vaccine based on recombinant peptide carrier technology invented in the lab of Prof. Rudolf Valenta at the Medical University of Vienna. This is a revolutionary concept, which offers potential for a paradigm shift in the treatment of allergies. The peptide carrier fusion proteins are constructed from the immunogenic viral coat protein PreS of the hepatitis B virus (HBV) and peptides from the IgE binding epitopes of the allergens in question; the latter have been engineered to lose their IgE binding capacity. BM32 has been designed to protect patients from the debilitating effects of grass pollen exposure and possibly provide long term cure. The product is very convenient to use for patients and doctors, as only a very small number of subcutaneous applications is needed to achieve efficient desensitization.

Based on the same technology platform, additional vaccines targeting different allergies (house dust mite, ragweed, birch and cat dander) are in preclinical development and will be advanced to clinical trials in the near future.

About Biomay:
Biomay AG is a privately held biopharmaceutical company based in Vienna, Austria. The company is committed to be a leader in the discovery and development of innovative allergy therapeutics. Besides BM32, the company has a pipeline of products for the treatment of other major allergies caused by airborne allergens.

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