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."
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."