Hay fever vaccine shows efficacy in phase IIa trial

A novel vaccine for grass pollen allergy has shown significant improvements for patients in a Phase IIa trial. The vaccine BM32 is based on an innovative recombinant peptide carrier technology that allows for fewer injections and shows fewer side effects compared with other immunotherapy treatments for allergy sufferers. BM32 has been developed by Biomay AG, an Austrian biopharmaceutical company specialized in the discovery and development of innovative allergy therapeutics. The company has already initiated a Phase IIb trial for BM32 with 180 allergic patients.

Biomay AG announced today promising results from a First-in-Man Phase IIa trial with its innovative allergy vaccine BM32. The vaccine significantly reduced allergy-related nasal symptoms in a study group of 70 patients suffering from grass pollen allergy. The environmental challenge study also showed that BM32 significantly reduced skin reactivity to grass pollen as demonstrated by skin prick testing. The treatment was shown to be safe and was generally well tolerated, despite the fact that a full dose of the vaccine was given from the first day of treatment.

All in all, patients were given three doses of BM32 or a placebo by subcutaneous injections over a period of two months. This dosing regimen offers a dramatic improvement over conventional immunotherapy, which requires multiple injections.

Dr. Rainer Henning, CEO of Biomay AG, commented: "We are very encouraged by these exciting data. They validate our scientific hypothesis that Biomay´s proprietary recombinant peptide carrier technology can form the basis of vaccines that induce the production of protective antibodies against allergenic proteins contained in grass pollen, which are the root cause of the disease. At the same time, this technology reduces the risk of side effects and the need for multiple injections."

Recombinant peptides

Biomay´s recombinant peptide carrier technology has been developed in close cooperation with Prof. Rudolf Valenta, Head of the Christian Doppler Laboratory for Allergy Research at the Medical University Vienna. He explains the success of the technology: "Our technology enables an efficient production of IgG antibodies, which are specific for the allergy causing epitopes of allergen proteins.

In order to achieve this we fuse allergen derived B-cell peptides, which lack IgE reactivity to an immunogenic carrier protein, which provides the requisite T-cell help." In fact, a team lead by Prof. Valenta is already developing similar vaccines for the other major causes of allergies in partnership with Biomay. This project includes vaccines against allergies caused by house dust mites, other pollen, mold and pets.

Currently BM32 remains Biomay´s lead product as Dr. Henning explains: "We are aggressively pushing forward in our development of BM32, to make this new treatment available to patients as quickly as possible. In fact, Biomay has already initiated a Phase IIb trial, where BM32 will be tested in 180 allergic patients under natural pollen exposure over two pollen seasons. Eleven leading allergy centers across Europe have agreed to participate in this new trial and more than 60 patients have already been enrolled. Results are expected in the fall of 2014."

About allergies and immunotherapy

Allergies are an increasing public health concern, affecting up to 25% of the overall population in the industrialized world, with increasing tendency. More than half of these patients suffer from grass pollen allergy, commonly known as "hay fever". This disease is severely affecting the well-being of patients and their activities of daily living, and causes billions of Euros in overall healthcare costs each year.

Immunotherapy (desensitization) is the only causal treatment for allergies, not only alleviating symptoms, but changing the course of the disease. First invented more than a hundred years ago, the treatment as practiced today continues to have low acceptance due to inconvenient dosing and a poor side effect profile.

About BM32

BM32 is a novel grass pollen allergy vaccine based on recombinant peptide carrier technology invented in the lab of Prof. Rudolf Valenta at the Medical University of Vienna. It has been designed to protect patients from the debilitating effects of grass pollen exposure and possibly provide long term cure. The product requires only 3 to 4 annual injections and promises to be free from side effects. The now finished Phase IIa trial was conducted in the Vienna Challenge Chamber (VCC) under the lead of Prof. Friedrich Horak. VCC is an internationally unique facility which conducts clinical allergy studies under controlled and reproducible conditions.

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.