Safer, better and quicker therapeutic vaccines will make allergen-specific immunotherapy (AIT) more efficient and more patient-friendly
BM4SIT focuses on birch pollen allergy, the third most common respiratory allergic disease in Europe. In BM4SIT an allergen derivative designed to achieve the overall objective will be tested in AIT, to replace extract-based vaccines. The drug substance that has been developed to this end is BM4 a mutant of the major birch pollen allergen Bet v 1.
The molecule BM4 was designed as a so called "hypo-allergen", meaning that its safety profile is greatly enhanced. On top of that, the BM4 molecule was engineered to be highly efficient for the treatment of birch pollen allergy, as it has increased immunogenicity.
The novel adjuvant vitamin D3 is expected to help to increase treatment efficacy by exploiting its anti-inflammatory properties, allowing earlier onset of treatment effect. BM4SIT will be carried out by a small product-focused multidisciplinary consortium. The nucleus of the consortium is formed by the biotech company Biomay AG, bringing in the relevant background IP on BM4, essential for future protection and exploitation, and the industrial environment and expertise needed to bring academic progress from bench to bedside.
Together with partners from academia, including four expert clinical centers, the consortium is perfectly suited to produce the proposed drug substances and drug products, complying with GMP regulations and to evaluate the new concept in human clinical trials, complying with all GCP requirements.