ND Biosciences announced today that it was awarded a grant by The Michael J. Fox Foundation for Parkinson’s Research (MJFF) to accelerate its diagnostics research and development programs to develop more accurate assays for measuring total alpha-synuclein (αSYN) levels.
Several therapeutic approaches are currently being pursued in academia and industry for Parkinson’s disease (PD) and other synucleinopathies, including strategies aimed at: lowering αSYN levels; inhibiting αSYN aggregation, seeding or propagation; and enhancing the clearance and degradation of αSYN, all of which require sensitive assays for accurate assessment of αSYN levels to assess target engagement and therapeutic efficacy. Nevertheless, accurate detection and quantification of total αSYN and pathologically relevant αSYN variants continues to represent a major challenge, as demonstrated by the marked discrepancies in total αSYN levels reported by different studies and laboratories.
This award is the result of ND Biosciences successful completion of two MJFF funded programs that demonstrated the limitations of existing immunoassays used in preclinical and clinical research, and the unique capabilities of ND Biosciences’ antibody screening and validation platforms for the development of next-generation quantitative assays of total αSYN.
Scientists at ND Biosciences showed that several of the most common immunoassays used in biomarker discovery and clinical studies do not capture the diversity of disease-relevant αSYN species, and thus may not provide an accurate assessment of total αSYN protein levels in biological fluids. To address these limitations, ND Biosciences deployed its unique protein libraries and antibody screening and validation platforms to successfully identify antibodies that detect more than 24 forms of the protein, including all disease relevant species.
“This project aims to capitalize on ND Biosciences’ unique tools and technologies to develop a novel total αSYN immunoassay that allows accurate quantification of total αSYN by capturing the diversity of both modified and aggregated forms of αSYN. MJFF’s grant will allow this unique assay to be validated in human biofluids, including human plasma and CSF. Separately, our end goal from this project is to follow up with clinical validation in cohorts of PD patients and age-matched healthy controls”, says Lara Petricca, head of immunoassay development at ND Biosciences.
“The successful development of this assay will provide a critically needed tool for the elucidation of whether total αSYN levels could serve as a useful diagnostic biomarker or measure of disease progression for PD and other synucleinopathies. Moreover, this assay would allow more accurate assessment of target engagement and efficacy of αSYN targeting therapies, and the discovery of novel biomarkers based on measuring the ratio of specific forms of αSYN to total αSYN”, says Bilal Fares, co-founder and director of R&D at ND Biosciences.
ND Biosciences is a spinoff from the EPFL that was founded to develop next-generation therapeutics and diagnostics for neurodegenerative diseases (NDs), such as Parkinson’s and Alzheimer’s Disease.
ND Biosciences has developed unique technologies that allow for the first time reproducing the biochemical, structural, and functional properties of pathological protein aggregates observed in NDs. These unique capabilities are used by ND Biosciences to develop therapies that can prevent the initiation of protein aggregation, and that can clear and neutralize the activities of existing protein aggregates, including their ability to spread and propagate pathology in the brain.
This is accomplished using ND Biosciences’ integrated and proprietary platforms that allow: