Pharma Focus Asia

Competitive EU Grant Supports Collaboration to Accelerate Development of AC Immune's First-in-Class TDP-43 Diagnostic Agent

Saturday, October 10, 2020

AC Immune SA, a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, announced that a highly competitive European Union grant has been awarded to support the partnership between AC Immune and the JPND ImageTDP-43 consortium to accelerate development of the Company’s first-in-class TDP-43 positron emission tomography (PET) tracer.

The grant, which is awarded in response to the European Union JPND’s call for novel imaging and brain stimulation methods and technologies related to neurodegenerative diseases, will be spearheaded through a world-class collaboration with the University of Zurich, Fondazione Santa Lucia-IRCCS, Skåne University Hospital, the International Centre for Genetic Engineering and Biotechnology, and the Erasmus University Medical Center through the JPND’s ImageTDP-43 Consortium.

Advancement of AC Immune’s TDP-43 PET tracer could deliver the world’s first imaging agent capable of accurately detecting and monitoring the progression of a wide range of TDP-43-related neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS), frontotemporal lobar degeneration with TDP-43 pathology (FTLD-TDP) and limbic-predominant age-related TDP-43 encephalopathy (LATE). Such a TDP-43 imaging agent may also enable the development of precision medicine approaches for 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: “We are very proud to receive this validation from the EU’s JPND, which reinforces our position as the leader in developing novel therapies and diagnostics against neurodegenerative diseases. Our first-in-class TDP-43 PET tracer has exhibited great promise to date, as it has been shown to bind to brain-derived pathological TDP-43 aggregates with high affinity and direct target engagement on patient brain tissue. The rapid progress made in this program complements the ongoing development of our anti-TDP-43 antibody, which is on track to become the first such therapeutic to enter clinical development.”

“The combined progress of our TDP-43-targeted therapeutic and diagnostic programs is yet another example of how AC Immune is leveraging its proprietary drug discovery platforms to develop an industry-leading pipeline against a wide-range of targets. Through the continued advancement of this pipeline, AC Immune is taking a comprehensive approach towards the treatment of neurodegenerative diseases through precision medicine. This strategy is crucial, as it is becoming increasingly clear that neurodegenerative diseases are driven by a complex interplay of pathologies and will likely require combination therapies that are informed and enabled by novel diagnostics and therapeutics able to target specific proteinopathies.”

TDP-43 is an RNA/DNA-binding protein that functions primarily in the nucleus as a regulator of gene transcription and RNA metabolism. Pathological aggregation of TDP-43 is strongly associated with cognitive decline and episodic memory loss in neurodegenerative diseases. AC Immune’s TDP-43 PET tracer candidates are derived from the Company’s innovative Morphomer™ discovery platform, which accelerates the design, development and synthesis of conformation-specific small molecules to power successful diagnostic and therapeutic approaches. The Morphomer™ platform has produced multiple small molecules with clinical proof-of-concept that bind selectively to pathological forms of human proteins such as TDP-43, alpha-synuclein and Tau. The Company’s orally available small molecule Morphomer™ TDP-43 therapeutic candidate is currently in pre-IND development. This grant offers an opportunity to better understand how AC Immune’s proprietary Morphomer™ compounds interact with various forms of TDP-43 aggregates, such as the intranuclear aggregates present in frontotemporal lobar dementias (FTLDs).

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