 First-in-class TDP-43 antibody developed using SurpraAntigenTM platform The only TDP-43 antibody with reported in vivo activity LAUSANNE, Switzerland, Aug. 03, 2020 GLOBE NEWSWIRE -- AC Immune SA NASDAQ: ACIU, a Swiss-based, clinical-stage biopharmaceutical company, with a broad pipeline focused on neurodegenerative diseases, today announced the initiation of investigational new drug IND-enabling studies for the Companys first-in-class therapeutic antibody targeting TDP-43 TAR DNA-binding protein 43. The anti-TDP-43 antibody is the first therapeutic candidate shown to mitigate TDP-43 neuropathology in vivo and the Company plans to develop the antibody for the treatment of NeuroOrphan indications.Advancing the anti-TDP-43 antibody towards clinical development is the latest in a series of important milestones already achieved this year in the Companys cutting-edge therapeutic and diagnostic programs targeting TDP-43 which are amongst the most comprehensive in the field. TDP-43 pathology is strongly associated with cognitive decline and episodic memory loss in neurodegenerative diseases. Effectively slowing or stopping the spread of TDP-43 pathology throughout the brain could provide the first TDP-43 targeted therapeutic approach for treating conditions such as amyotrophic lateral sclerosis ALS and frontotemporal lobar degeneration with TDP-43 pathology FTLD-TDP, where almost half of all FTLD cases exhibit TDP-43 pathology with significant market potential for AC Immunes TDP-43 antibody. Other indications include limbic-predominant age-related TDP-43 encephalopathy LATE, and sub-populations of argyrophilic grain disease and Lewy Body Dementia. Additionally, pathological aggregation of TDP-43 has emerged as an important co-pathology in Alzheimers disease linked to disease severity and occurring in 50 of patients. Recognition that neurodegenerative diseases are driven by a complex interplay of pathologies highlights that successful treatments and cures will likely require combination therapy powered by precision medicine. This diversified approach is pioneered by AC Immune through parallel development of highly selective therapeutics and diagnostics for established targets like Tau and Abeta alongside newer targets such as TDP-43.Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: This milestone reinforces AC Immunes position as a leader in developing novel therapies against neurodegenerative diseases, with our anti-TDP-43 antibody on track to become the first in the world to reach clinical development. Aggregation of pathological forms of TDP-43 is an increasingly validated therapeutic target and a well-established hallmark of neurodegeneration. Initiation of IND-enabling studies for our first-in-class lead anti-TDP-43 antibody is a major step toward addressing pressing unmet need in NeuroOrphan indications.The Companys success is driven in part by our proprietary SupraAntigenTM platform, which has already produced therapeutic monoclonal antibody candidates targeting Abeta and Tau that were successfully out-licensed to leading pharmaceutical companies and are currently advancing in multiple Phase 2 clinical studies. Advancement of the anti-TDP-43 antibody further validates the continuing productivity of this platform, which, together with our MorphomerTM platform for small molecule development, are responsible for discovery and development of our maturing pipeline of first-in-class or best-in-class therapeutic and diagnostic candidates.TDP-43 is an RNADNA-binding protein that functions primarily in the nucleus as a regulator of gene transcription and RNA metabolism. TDP-43 pathology has been shown to start from a focal point in the brain and spread to other brain regions with disease progression. Antibody-mediated clearance of pathological TDP-43 therefore represents an attractive strategy for therapeutic intervention potentially slowing the spread by blocking the ability of pathological TDP-43 to seed aggregation in neighboring healthy cells. The anti-TDP-43 antibody binds all forms of TDP-43 with high affinity and is the only antibody with reported in vivo activity. Proof-of-concept data presented at the 2020 AAT-ADPDTM Conference demonstrated anti-TDP-43 antibodys ability to mitigate TDP-43 neuropathology in a mouse model of TDP-43 proteinopathies.About AC Immune SA AC Immune SA is a Nasdaq-listed clinical-stage biopharmaceutical company, which aims to become a global leader in precision medicine for neurodegenerative diseases. The Company utilizes two proprietary platforms, SupraAntigenTM and MorphomerTM, to design, discover and develop small molecule and biological therapeutics as well as diagnostic products intended to diagnose, prevent and modify neurodegenerative diseases caused by misfolding proteins. The Companys pipeline features nine therapeutic and three diagnostic product candidates, with six currently in clinical trials. It has collaborations with major pharmaceutical companies including Genentech, a member of the Roche group, Eli Lilly and Company, and Janssen Pharmaceuticals.For further information, please contact:Head of Investor Relations Joshua Drumm, Ph.D. AC Immune Phone: 1 917 809 0814 Email: US Media Katie Gallagher LaVoieHealthScience Phone: 1 617 792 3937 Email: Global Head of Communications Judith Moore AC Immune Phone: 41 79 826 63 82 Email: European Investors Media Chris Maggos LifeSci Advisors Phone: 41 79 367 6254 Email: Forward looking statementsThis press release contains statements that constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or AC Immunes strategies or expectations. 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