Benzinga | Dec 15, 2020 08:03AM EST

AC Immune Reports Competitive Target ALS Foundation Grant To Accelerate Development of Proprietary Phosphorylated TDP-43 Immuno-Assay

AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced the receipt of a highly competitive grant awarded by Target ALS. The grant, which was awarded in response to the organization's call for new industry-led biomarker consortia projects, will support a world-class collaboration between AC Immune and Investigators at the Healey Center for ALS at Massachusetts General Hospital to accelerate the development of the Company's proprietary immuno-assays to detect disease-associated forms of TAR DNA-binding protein 43 (TDP-43) in cerebrospinal fluid and blood samples.

The pathological aggregation of TDP-43 is strongly associated with motor and cognitive decline and episodic memory loss in several neurodegenerative diseases including amyotrophic lateral sclerosis (ALS), frontotemporal lobar degeneration with TDP-43 pathology (FTLD-TDP) and limbic-predominant age-related TDP-43 encephalopathy (LATE). AC Immune's SupraAntigenTM-based detection assays for aggregation-prone forms of TDP-43 in biofluids have the potential to serve as an early-stage diagnostic that may enable the development of precision medicine approaches for these diseases as well as Alzheimer's disease (AD), where pathological aggregation of TDP-43 has emerged as an important co-pathology linked to disease severity.

Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "This award provides further validation for our comprehensive diagnostic and therapeutic programs targeting pathological TDP-43, which represents a key component of our broad and industry-leading pipeline. Our proprietary TDP-43 immuno-assays have shown great promise, with data highlighting their high sensitivity and large dynamic range for total and phosphorylated TDP-43. The recognition of this program has mirrored that offered to our first-in-class TDP-43 positron emission tomography (PET)-tracer, which recently received a (euro)1.45M grant from the European Union."

"These activities, together with the development of our anti-TDP-43 therapeutic antibody, which we expect to be the first therapeutic in its class to enter clinical trials, reinforce AC Immune's position as a leader in developing precision medicine-based approaches towards the treatment of neurodegenerative diseases. Additional programs advancing both therapeutics and diagnostics against targets such as Tau and alpha-synuclein highlight the comprehensive nature of this approach, which is crucial given the increasing recognition that neurodegenerative diseases are driven by a complex interplay of pathologies. The effective treatment of these diseases is thus likely to require combination therapies that are informed and enabled by novel diagnostics and therapeutics able to target specific proteinopathies."

AC Immune's proprietary immuno-assays utilize anti-TDP-43 antibodies derived from the Company's innovative SupraAntigenTM platform, which accelerates the discovery and development of conformation-specific antibodies to successful diagnostic and therapeutic approaches. The SupraAntigenTM platform has produced multiple antibodies that bind selectively to pathological forms of human proteins involved in neurodegenerative disease such as Tau, Abeta, TDP-43, alpha-synuclein and NLRP3-ASC. This grant will accelerate the development AC Immune's anti-pTDP-43 immuno-assay to enable ex vivo diagnostic tests capable of identifying early stages of TDP-43 related diseases such as ALS. Such diagnostic tests may facilitate the effective treatment of these diseases.