OLIGOMERIX INC — Department of Health and Human Services SBIR Phase I: NIA

Description

PROJECT SUMMARY Phase I SBIR PA Title Development of an Alzheimer s disease specific antibody biomarker for a tau oligomer fragment The prevalence of Alzheimer s disease AD is increasing worldwide due to demographic shifts and an aging population and currently there are no disease modifying drugs It is the most costly disease in the US with a financial burden of over $ billion annually in direct costs that is estimated to increase to $ trillion by There is an urgent unmet need for the development of blood biomarkers for the early detection and staging of AD The lack of accurate sensitive and well validated biomarkers for AD is a rate limiting factor for identifying effective treatments Tau protein and in particular tau oligomers have become a high priority target for AD due to their high correlation with diseased regions within the brain of AD patients their newly discovered extracellular activity that is believed to result in the impairment of synaptic function and loss of memory and their role in the spread of pathology Oligomerix has developed novel methods to highly purify tau oligomers and has discovered that they undergo autoproteolytic fragmentation at specific sites creating neo epitopes at the cut ends Polyclonal antibodies pAbs to the neo epitopes were generated and one pAb showed a striking specificity for AD specimens In Aims and monoclonal Abs mAbs will be generated that have specificity for this fragment end and specificity for the uncut site Aim will be to characterize the mAbs and perform a proof of concept biomarker study The overall goal of this project is to produce a blood based non invasive diagnostic test as a biomarker for tau fragment levels from biological specimens for AD These mAbs can also be used to understand the role of tau autoproteolytic fragmentation in AD and the ratio of cut to uncut tau at this site may provide greater sensitivity in determining AD stage Additionally the tau fragment specific mAb that will be developed under the proposed program could have tremendous commercial utility for any therapeutic program immuno or small molecule therapeutics seeking to reduce tau accumulation enhance clearance or prevent the formation of tau oligomers The global CNS biomarker market is projected to reach $ billion by from $ billion in The proposed study will be enabling for Oligomerix s internal drug discovery programs and the Company will make these assays available by commercializing them via collaboration with a diagnostic or life sciences company Thus the proposed program if successful will have significant commercial potential and impact The strong management and scientific team will ensure competencies in mAb production and characterization as well as assay development and commercialization Furthermore the presence of Dr Peter Davies and Dr Steven Jacobsen on the Scientific Advisory Board provide top notch scientific and business experience to the Company PROJECT NARRATIVE There is an unmet need for the development of blood biomarkers for early detection of Alzheimer s disease AD A blood based biomarker would enable more rapid patient recruitment and better retention for clinical therapeutic and diagnostic studies because it is minimally invasive low cost and easier to perform The overall goal of this project is to produce a blood based non invasive diagnostic test as a biomarker for tau fragment levels from biological specimens for Alzheimer s disease AD