GHENT, Belgium and INGELHEIM, Germany, April 21, 2016 (GLOBE NEWSWIRE) -- Ablynx [Euronext Brussels: ABLX; OTC: ABYLY] and Boehringer Ingelheim today announced the initiation of a Phase I study to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of an anti-CX3CR1 Nanobody®, administered intravenously. The start of the study triggers a €8 million milestone payment to Ablynx and brings the total number of Nanobodies that are currently in clinical development, both within Ablynx and in collaboration with pharmaceutical partners, to seven. The anti-CX3CR1 Nanobody was discovered and developed as part of a long-standing Strategic Alliance between both parties and Ablynx is entitled to receive further milestones and royalties if the product proceeds through development and then to commercialisation.
This novel Nanobody blocks the function of the G-protein coupled receptor (GPCR), CX3CR1, a protein that has proven to be difficult to address with conventional antibodies. By blocking the function of CX3CR1, the activity of inflammatory immune cells, which play a major role in chronic kidney disease, may be inhibited.
Dr Edwin Moses, CEO of Ablynx, commented: "We are very pleased that Boehringer Ingelheim has started clinical development of a second Nanobody as part of our Strategic Alliance. As far as we are aware, this Nanobody is the first biological drug candidate that has been developed against CX3CR1, which demonstrates the uniqueness and competitive strengths of our Nanobody platform. Earlier this year, Boehringer Ingelheim initiated a Phase I study in cancer patients with the bi-specific anti-VEGF/Ang2 Nanobody, BI 836880, and we look forward to seeing more Nanobody-based product candidates enter the clinic in the future."
Boehringer Ingelheim is a leader in the cardiovascular and metabolic therapy areas and is committed to researching and developing novel treatment options for patient needs of the future in these areas. Georg van Husen, Head of Therapeutic Area Cardiovascular, Boehringer Ingelheim, said: "We have ambitious strategic goals in cardiovascular and metabolism and are excited to start the clinical evaluation of this promising pipeline compound. This project is just one example of our internal and external innovation efforts aimed at bringing new therapy options to patients with high medical need."
Chronic kidney disease (CKD) is a significant public-health problem affecting an estimated 8-16% of people worldwide 1 with only limited treatment options available. Ultimately it may lead to end stage renal disease and the necessity of renal replacement, making it a major cost driver for health-care systems. Diabetes and high blood pressure are major causes of CKD and inversely, among other complications, the disease can cause high blood pressure and is a major risk factor for cardiovascular disease.
About Strategic Alliance between Boehringer Ingelheim and Ablynx
In September 2007, Ablynx and Boehringer Ingelheim entered into a Strategic Alliance on the discovery, development and commercialisation of Nanobody therapeutics across a range of diseases, including oncology, immunology, respiratory and vascular diseases. The agreement allows for potential milestone payments of up to €125 million plus royalties to Ablynx for each Nanobody which reaches the market. Boehringer Ingelheim is exclusively responsible for the development, manufacturing and commercialisation of any products resulting from the collaboration.
To date, Ablynx has earned >€83 million in cash from this Strategic Alliance and in addition to the anti-VEGF/Ang2 and anti-CX3CR1 Nanobodies, there are a number of other programmes advancing through pre-clinical development, all fully funded by Boehringer Ingelheim.
Ablynx is a biopharmaceutical company engaged in the development of Nanobodies®, proprietary therapeutic proteins based on single-domain antibody fragments, which combine the advantages of conventional antibody drugs with some of the features of small-molecule drugs. Ablynx is dedicated to creating new medicines which will make a real difference to society. Today, the Company has more than 40 proprietary and partnered programmes in development in various therapeutic areas including inflammation, haematology, immuno-oncology, oncology and respiratory disease. The Company has collaborations with multiple pharmaceutical companies including AbbVie, Boehringer Ingelheim, Eddingpharm, Genzyme, Merck & Co., Inc., Merck KGaA, Novartis, Novo Nordisk and Taisho Pharmaceuticals. The Company is headquartered in Ghent, Belgium. More information can be found on www.ablynx.com.
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 146 affiliates and a total of more than 47,700 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine. Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative "Making more Health" and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability. In 2014, Boehringer Ingelheim achieved net sales of about €13.3 billion. R&D expenditure corresponds to 19.9% of its net sales. For more information, please visit www.boehringer-ingelheim.com.
For more information, please contact
Dr Edwin Moses
t: +32 (0)9 262 00 07
m: +32 (0)473 39 50 68
Associate Director Investor Relations
t: +32 (0)9 262 00 82
m: +32 (0)479 49 06 03
Follow us on Twitter @AblynxABLX
Ablynx media relations: FTI Consulting:
Julia Phillips, Brett Pollard, Mo Noonan, Matthew Moss
t: +44 20 3727 1000
1 Chronic kidney disease: global dimension and perspectives, V Jha et al. The Lancet 382 (9888), 260-272
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