Lab Bulletin

AFFiRiS AG will explore ProBioGen's proprietary Human Artificial Lymph Node Technology (HuALN) as analytical tool for its AFFITOME®-based vaccination concept. Under the contract with ProBioGen, AFFiRiS will evaluate the HuALN technology as a human organoid model to investigate drug-related effects in the context of the human immune system in order to select vaccine candidates best suited to be applied in humans. Using the HuALN technology AFFiRiS anticipates accelerating the progression of its human vaccine candidates into clinical trials.

"We have been looking for a system like the Human Artificial Lymph Node for quite a long time and are excited by the possibilities the system offers to test our peptide vaccine candidates which are delivered by our proprietary AFFITOME® technology", commented Walter Schmidt, CEO of AFFiRiS.

"AFFiRiS with its cutting-edge technology in the vaccine field is an ideal partner to further underline the strengths of ProBioGen's HuALN technology. We are very much looking forward to this co-operation" said Michael Schlenk, CEO of ProBioGen.

About the Human Artificial Lymph Node Technology
ProBioGen's portfolio of cell-based activity assays for biopharmaceutical drug development includes its self-developed, proprietary and unique human in-vitro system, the Human Artificial Lymph Node (HuALN) model. In this sophisticated system, human T-cells, B-cells, and dendritic cells of selected donors are cultivated in the 3D-matrix of a miniaturized bioreactor, leading to the cells' self-organization into immune-competent micro-organoid structures. The constantly perfused and fully autologous co-culture system enables long-term cell cultivation and repeated exposition of the cells to the to-be-tested substances. The use of this unique tool is to predict drug-related effects (wanted or unwanted) on the human immune system in vitro, to investigate immunofunction and immunotoxicity of substances, e.g. to bridge the gap between pre-clinical animal studies and first-in-man clinical trials.

HuALN read-outs include soluble as well as cellular biomarkers, notably monitoring the induced cytokine secretion profiles to characterize T-cell-mediated immune responses (e.g. shifts in the TH1/TH2 pathways) and antibodies secretion patterns (IgM, IgG). Harvesting the cells after bioreactor operation allows their functional testing and analysis of surface markers by flow cytometry. Together with plasma cell analysis (by ELISPOT, flow cytometry, and organoid-histology) humoral and cellular immune responses can be determined. For literature see e.g. Giese et al., J Biotechnol., 2010 "Immunological substance testing on human lymphatic micro-organoids in vitro".

About ProBioGen AG - www.probiogen.de
ProBioGen is a technology and service provider that supports and adds value to its clients' biopharmaceutical drug development. A proven track record of fee-for-service-based projects, from cell line development, over process engineering, up to GMP manufacturing is strengthened by novel expression systems and unique analytical testing services.

In addition to its CHO platform, ProBioGen has developed proprietary AGE1® producer cell lines, for safe and cost-efficient production of highly active glycoproteins, monoclonal antibodies and virus-based vaccines. ProBioGen employs a broad range of qualified cell-based assays, including its proprietary Human Artificial Lymph Node technology. All services and technologies are embedded in a total quality management system, compliant with international ISO and GMP standards. ProBioGen was founded in 1994 and is located in Berlin, Germany.

About AFFiRiS AG - www.affiris.com
On the basis of the company's own patents, AFFiRiS develops tailor-made peptide vaccines against Alzheimer's disease, atherosclerosis, Parkinson's disease, hypertension and four other conditions with an urgent medical requirement and attractive market volumes. Alzheimer's is currently the most advanced project, with two potential products having just completed the phase I clinical studies. In October 2008 GlaxoSmithKline Biologicals became the license partner for the Alzheimer's vaccine. The contract envisages (milestone-dependent) payments of up to EUR 430 million. A payment of EUR 10 million was triggered in October 2009 by the positive completion of two clinical phase I studies. At present AFFiRiS has 70 highly qualified employees working at the St. Marx campus of the Viennese Biocenter in Vienna, Austria.