Project: Alzheimer's Disease - Active Immunity and Models

Alzinova AB ('Alzinova') and JSW Lifesciences GmbH ('JSW') have formed a consortium that develops novel Alzheimer’s disease therapeutics and disease models based on non-fibrillogenic amyloid-beta (Abeta) mimetics. The invention, owned by Alzinova, has been commercialized since 2008._x000D__x000D_Alzheimer’s disease is a progressive neurodegenerative disorder caused by Abeta misfolding into toxic aggregates (oligomers) that kill nerve cells, presently afflicting more than 21 million people. The AD-AIM project will evaluate oligomer mimetics as a potential vaccine that generates life-long immunity towards the oligomers, and as constituents of improved disease models. Following confirmed biologic activity in an existing Alzheimer’s disease model and in an in vitro lesion model, the pre-clinical development of the vaccine will proceed with a toxicology study for preparation of Phase I trials. The consortium will also proceed with the development of improved in vivo models._x000D__x000D_Several published proof-of-concept studies in transgenic mice, as well as clinical investigations on human subjects, support using immunotherapy for the treatment of Alzheimer’s disease. Clinical efficacy is nevertheless lacking due to low specificity for the toxic aggregates which are present in very low amounts compared to monomeric (functional) and insoluble fibrillar Abeta. There are no antibodies or vaccines now in development that selectively target only oligomers. The AD-AIM project aims to remedy this situation and strives to bring true anti-oligomer therapy to the clinic._x000D__x000D_Research and development of Alzheimer’s disease therapeutics that target Abeta oligomers is an area fraught with technical difficulty. These toxic aggregates are inherently unstable and heterogeneous. This precludes their use in vaccines, and severly aggravates the development of good reproducible oligomer lesion models. Alzinova owns the IPR of a technology platform, AbetaCC (patent pending), which effectively solves this problem of metastability and heterogeneity by conformational restriction. The technical solution that Alzinova brings to the AD-AIM project possesses the potential to dramatically improve the productivity in the field of Alzheimer’s disease therapeutics._x000D__x000D_The Abeta mimetics stem from academic research carried out at the University of Gothenburg, Sweden. The invention was supported early on by GU Holding AB, a company fully owned by the Swedish government with the mission to develop new companies based on research results from the University of Gothenburg. To date, GU Holding has financed and initiated over 70 companies, and provides support to promote business, market and technological development, in addition to providing COtenance of IPR, managerial and organizational structures, and financing. Today, Alzinova is owned by the founders, GU Holding, business angels and key personnel, investing time and money into the development of the invention in several application areas._x000D__x000D_JSW is a GLP certified and AAALAC accredited contract research organization for CNS drug development. The availability of the most predictive disease models and unparalleled experience with studies performed for biopharmaceutical companies of all sizes makes JSW an ideal P for Alzinova. JSW provides the AD-AIM project with world-leading expertise relating to all aspects of preclinical drug development. JSW's validated transgenic and non-transgenic in vitro and in vivo models cover most targets of Alzheimer’s disease and other neurodegenerative diseases. Nevertheless, oligomers of Abeta reCO an elusive target that is not easily addressed. Validation of biological activity of Alzinova's oligomer mimetics will be the first step towards the production of improved Alzheimer's disease models at JSW. The consortium expects these improved models to better reflect the true clinical pathology of this disease._x000D__x000D_The AD-AIM project will entail pre-clinical development to prepare for clinical trials and improved transgenic animal models, in addition to commercialization and Ping activities. The expected outcome of the market-oriented activity is the establishment of a dedicated commercialization P or licensee to shoulder the costs associated with proceeding into Phase I clinical trials of the vaccine set to commence within two years of completion of the project. Activity in this therapeutic area is very high, and there are many examples of Ping or licensing deals on promising candidates made already at the pre-clinical stage. Further, the consortium expects that improved and validated oligomer lesion models will be an attractive product for CRO services. Being the sole provider of oligomer specific models will significantly enhance JSW's competitive advantage, and help defend its position as one of the leading providers for contract research in Alzheimer’s and related diseases.

Acronym AD-AIM (Reference Number: 7927)
Duration 01/02/2013 - 31/10/2015
Project Topic Amyloid-beta mimetics are evaluated as therapeutic vaccines for the treatment of Alzheimer's disease. These mimetics of endogenous toxic substances enables the development of highly targeted therapeutics for increased efficacy and safety, as well as improved in vitro and in vivo models.
Network Eurostars
Call Eurostars Cut-Off 9

Project partner

Number Name Role Country
2 Alzinova AB Coordinator Sweden
2 QPS Austria GmbH Partner Austria