Core Insights - AC Immune SA announced the peer-reviewed publication of results from the Phase 1b/2a trial of ACI-35.030, an active immunotherapy targeting Tau, in eBioMedicine [2][3] - The trial demonstrated that ACI-35.030 generated a rapid and durable polyclonal response against pathological Tau without clinically relevant safety issues [2][4] Company Overview - AC Immune SA is a clinical-stage biopharmaceutical company focused on precision therapeutics for neurodegenerative diseases, including Alzheimer's disease [12] - The company utilizes its proprietary SupraAntigen® technology to develop its immunotherapies, which are designed to elicit strong immune responses against misfolded proteins [12][8] Trial Results - ACI-35.030 showed a rapid and potent polyclonal antibody response against pathological forms of Tau after the first dose, with 94% to 100% response rates maintained until week 74 in high-dose cohorts [4][5] - The trial included two formulations, ACI-35.030 and JACI-35.054, with ACI-35.030 requiring only one injection to induce anti-pTau IgG antibody titers in all participants [5][6] - ACI-35.030 is currently advancing in the Phase 2b ReTain trial, which aims to assess its potential to modify the disease in preclinical Alzheimer's disease [6][9] Future Developments - The ongoing Phase 2b ReTain trial will include approximately 500 participants and aims to evaluate the cognitive effects of ACI-35.030 over a maximum of four years [10][11] - The primary endpoint of the trial is to measure cognitive decline using the Preclinical AD Cognitive Composite 5 (PACC-5) score, while secondary endpoints will assess the impact on Tau pathology [11]

Company Overview - AC Immune has a broad and diverse pipeline of 16 programs, including 1 in Phase 3 and 5 in Phase 2, focused on neurodegenerative diseases [4] - The company has potential milestones exceeding CHF 4.3 billion through multiple global partnerships [4] - As of March 31, 2024, AC Immune has cash reserves of CHF 104.8 million, plus $100 million upfront from Takeda, funding operations into 2027 [4, 7] - The company anticipates a 2024 annual cash burn of CHF 65 million – 75 million [17] Pipeline and Milestones - AC Immune's pipeline includes clinical stage programs targeting Alzheimer's disease (AD), Parkinson's disease (PD), and other a-synucleinopathies [12] - Key milestones in H2 2024 include initial 6-month amyloid plaque data from the ABATE Phase 1b/2 trial of ACI-24.060 in AD, interim safety and immunogenicity data from the Phase 2 VacSYn clinical trial of ACI-7104.056 in PD, and first patient in Phase 2b clinical trial (ReTain) of ACI-35.030 [21] - The company is developing TDP-43-PET tracer with Phase 1 initiation planned [21] Technology and Partnerships - AC Immune's SupraAntigen platform is designed to stimulate the patient's immune system to produce their own antibodies, offering potential advantages over passive immunotherapy [22] - The company entered into a deal with Takeda for ACI-24.060, including a $100 million upfront payment and potential payments up to approximately $2.1 billion [29] - ACI-35.030 induced anti-ePHF Ab responses in 100% of patients after the first injection [46] Financials - The company's total potential deal value exceeds CHF 4.75 billion, including upfront payments of CHF 255.2 million and milestones received of CHF 147.4 million [83]