Biomay announces Initiation of First Phase II Trial with its Grass Pollen Allergy Vaccine BM32
Biomay announces today that the company has initiated a first-in-patient phase II trial with its innovative recombinant grass pollen allergy vaccine BM32. Previously, the expected superior safety profile has been demonstrated in a phase I skin test study led by Prof. Verena Niederberger at the Vienna General Hospital.
The study is conducted as a single centre trial at the Allergie-Zentrum Wien West. Professor Friedrich Horak, head of the centre, is the Principle Investigator of the study. The study will include 60 patients which enrolment has begun recently. Primary endpoint of the study is a reduction of allergy symptoms compared to baseline, using controlled environmental exposure in the Vienna Challenge Chamber. A number of additional physiological and immunological parameters will also be measured. The goal of the study is to demonstrate product efficacy by symptom reduction after just three subcutaneous injections. The study will also establish a safe and effective dosing scheme for further development of the product in larger clinical trials with pollen exposure in the patients’ natural environment.
It is expected that top line data from the study will be available as early as April 2012.“We are extremely excited to work with Prof. Horak in this important trial, which we hope will establish our concept that eliciting blocking IgG antibodies against allergens will lead to effective immunotherapy”, commented Angela Neubauer, Head of Product Development at Biomay. “Positive results will boost our confidence that this new treatment mode will revolutionize allergy therapy.”
Biomay´s BM32 against grass pollen allergy is the first clinical product of a series of candidates from the companies proprietary Peptide-Carrier platform. After clinical proof of concept with BM32, Biomay plans to start development programs against other allergies by utilizing its generic Peptide-Carrier approach.
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Biomay Initiates Development of its Novel Ragweed and Japanese Cedar Allergy Vaccines – Project Granted and Awarded by ZIT
(Vienna, Nov. 3, 2011) Biomay announces today that the company received 500.000 Euro funding supporting the development of its novel vaccine candidates against ragweed and Japanese cedar pollen allergy. The grant was awarded by a jury convened by the Technology Agency of the City of Vienna (ZIT).
Ragweed and Japanese cedar pollen are major causes of seasonal allergy worldwide. Almost one out of two of all allergy patients in North America is suffering from ragweed allergy, and this weed is rapidly gaining importance in South and East Central Europe, including Austria. A large proportion of the Japanese population is suffering from cedar (“sugi”) sensitization. The allergenic components in the pollen of both species belong to the same molecular class of pectate lyases. In cooperation with the group of Prof. Fatima Ferreira at the Christian Doppler (CD) Laboratory for Allergy Diagnostics and Therapy at the University of Salzburg, a technology for the recombinant expression of these proteins has been developed, also including hypoallergenic variants with a side effect profile significantly improved over conventional pollen extracts. The grant money will be used to perform preclinical studies of the novel vaccines and demonstrate their safety in a phase I clinical trial. This important milestone will be reached in approximately 3 years.
In addition to the grant, Biomay was awarded the third price among the 30 projects submitted by 29 companies in the call for grant proposals. “We are very proud to have been awarded this grant and the prize from ZIT. It provides further validation of the technological leadership of Biomay and the CD labs assembled in the Austrian Allergy Research Network in the field of recombinant allergens and their use in revolutionary approaches to allergy immunotherapy”, commented Rainer Henning, CEO of Biomay. “It gives us the possibility to broaden our development product pipeline addressing the needs of many patients in Austria and worldwide.”
The complete final report on the grant call published by ZIT (in German) can be viewed under
NewsarchivBiomay Appoints Clinical Advisory Board
Biomay announces the appointment of world leading allergy specialists to its Clinical Advisory Board (CAB). These distinguished and internationally acclaimed scientists agreed to accept the appointment to the CAB:
- Marianne van Hage (Prof. at Karolinska Institute, Stockholm, Sweden)
- Peter S. Creticos (Prof. at Johns Hopkins University, Baltimore, Maryland, USA)
- Stephen R. Durham (Prof. at Imperial College, London, UK)
- Marek Jutel (Prof. at Wroclaw Medical University, Wroclaw, Poland)
- Hans Ulrich Wahn (Prof. at Charité, Berlin, Germany)
The CAB’s charter is to support the clinical development process of the company’s lead product BM32 through expert advice. The members have committed themselves to support Biomay conducting its clinical development program according to the highest medical standards using cutting edge scientific concepts.
“We are extremely pleased and honoured that these renowed experts in the field of allergy immunotherapy have accepted the invitation to join our CAB. It provides testimony to the cutting edge science behind our lead product BM32, the innovative grass pollen allergy vaccine”, commented Rainer Henning, CEO of Biomay. “We will work very closely with this group to optimally characterize BM32 in the ongoing clinical studies.”
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