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AC Immune SA (NASDAQ: ACIU) is a clinical-stage biopharmaceutical company headquartered in Lausanne, Switzerland, committed to pioneering precision medicine for neurodegenerative diseases. The company specializes in designing, discovering, and developing innovative therapeutic and diagnostic products aimed at preventing and modifying diseases caused by misfolded proteins. Utilizing its two proprietary technology platforms, SupraAntigen® and Morphomer®, AC Immune develops a broad spectrum of antibodies, small molecules, and vaccines targeting conditions such as Alzheimer’s disease (AD), Parkinson’s disease, and NeuroOrphan indications.
With a robust pipeline consisting of sixteen therapeutic and diagnostic programs, AC Immune currently has six product candidates in clinical trials, including five in Phase 2 and one in Phase 3. The most advanced candidate, Crenezumab, is a humanized anti-amyloid-β monoclonal antibody in Phase 3 trials aimed at treating Alzheimer’s disease. Other notable candidates include ACI-24.060, a promising anti-Abeta active immunotherapy for AD and Down syndrome, which has received FDA Fast Track Designation, and ACI-35.030, an anti-pTau active immunotherapy in Phase 2b trials for preclinical AD conducted by Janssen Pharmaceuticals.
Beyond its rich pipeline, AC Immune is known for its strategic partnerships with leading global pharmaceutical companies such as Genentech (a Roche Group member), Eli Lilly and Company, and Takeda. These collaborations have resulted in significant non-dilutive funding and milestone payments totaling over $4.5 billion.
AC Immune recently secured an exclusive option and license agreement with Takeda for its ACI-24.060 product, potentially worth $2.1 billion, and completed a $50 million equity financing to support its operations into 2026. The company's focused efforts on precision prevention are reinforced by its ongoing Phase 2 trials and collaborations aimed at leveraging advanced diagnostic techniques like PET imaging and novel therapeutic approaches for early and effective intervention in neurodegenerative diseases.
AC Immune announced positive interim findings from the Phase 1b/2 ABATE trial of its anti-amyloid-beta vaccine ACI-24.060 for Alzheimer’s disease. The vaccine showed an anti-Abeta antibody response in the first low-dose cohort and was generally well tolerated, with no safety concerns. Dosing in the second higher dose cohort has commenced, and screening for a cohort with Down syndrome is also approved. Preliminary safety and immunogenicity data are expected in H2 2023, with initial PET imaging results on plaque reduction anticipated in 2024. These results may position ACI-24.060 as a promising therapeutic option for AD.
AC Immune has announced the initiation of the Phase 3 ADvance study involving PI-2620, a Tau PET diagnostic agent for Alzheimer’s disease. This trial, conducted in collaboration with Life Molecular Imaging, aims to assess the safety and diagnostic accuracy of PI-2620 in detecting Tau pathology, a critical factor in Alzheimer’s progression. The first patient has already been imaged, marking a significant milestone. PI-2620 is recognized for its high binding affinity and potential as a best-in-class Tau tracer. Successful results may lead to market approval, furthering advancements in Alzheimer’s diagnostics.
AC Immune announced that its Alzheimer’s vaccine candidate ACI-35.030 has been selected for further development following positive interim data from a Phase 1b/2a trial. The vaccine demonstrated excellent clinical performance, inducing specific antibodies against pathological Tau, a key player in Alzheimer’s disease. This selection marks significant progress in AC Immune’s collaboration with Janssen Pharmaceuticals. The company now advances three vaccine candidates in Phase 2 trials, reinforcing its position in neurodegenerative disease treatment.
AC Immune SA (NASDAQ: ACIU) has announced the presentation of its innovative SupraAntigen® liposomal vaccine platform at the upcoming CTAD conference in San Francisco from November 29 to December 2, 2022. The company will present data on its anti-phospho-Tau vaccines, ACI-35 and JACI-35, showcasing their safety and immunogenicity. Key presentations include interim data from a Phase 1b/2a study and insights into biomarkers related to Alzheimer’s disease. This highlights AC Immune's commitment to developing targeted active vaccines for neurodegenerative diseases.
AC Immune SA (NASDAQ: ACIU), a biopharmaceutical company focused on neurodegenerative diseases, will participate in the 2022 Jefferies London Healthcare Conference from November 15-17, 2022. CEO Dr. Andrea Pfeifer will discuss the company's precision medicine approach and its pipeline, aiming for earlier diagnosis and prevention of diseases like Alzheimer’s. Notably, an interim analysis of the Phase 1b/2 ABATE study on the anti-amyloid-beta vaccine ACI-24.060 is among three key clinical readouts expected by year-end. The fireside chat is set for November 15, 2022, at 3:00 AM ET.
AC Immune SA (NASDAQ: ACIU) announced significant advancements in its clinical programs, including the initiation of dosing for the anti-Abeta vaccine ACI-24.060 in the Phase 1b/2 ABATE study targeting prodromal Alzheimer’s disease and Down syndrome patients. The company also received clearance for a Phase 2 study of the anti-alpha-synuclein vaccine ACI-7104 in early Parkinson’s disease patients. With a strong cash position of CHF 140.5 million, AC Immune expects to fund operations into Q3 2024. However, recent Phase 2 study results showed no statistically significant benefits from crenezumab.
AC Immune SA (NASDAQ: ACIU) provided an update on its Phase 1b/2 ABATE study for ACI-24.060, an anti-amyloid-beta vaccine targeting Alzheimer's disease and Down syndrome patients. The trial has received regulatory approval in the UK and Spain, with recruitment underway. A U.S. Investigational New Drug application is planned for Q1 2023. Interim analysis is expected by year-end 2022, which will inform the transition to Phase 2. ACI-24.060 demonstrates high immunogenicity and potential as a best-in-class therapy against Alzheimer's-related amyloid plaques.
AC Immune (NASDAQ: ACIU) announced that its Tau PET tracer, PI-2620, is advancing to late-stage clinical development for Alzheimer's Disease (AD) as confirmed by its partner, Life Molecular Imaging (LMI). AC Immune will receive a milestone payment from LMI. This promising Tau PET tracer shows high binding affinity for aggregated Tau, a key indicator of neurological decline. Phase 2 trial results presented at the Alzheimer's Association International Conference indicated that PI-2620 could accurately detect Tau deposits, aiding in early diagnosis and monitoring of cognitive impairment.
AC Immune (NASDAQ: ACIU) has received a new grant from The Michael J. Fox Foundation (MJFF) to advance its alpha-synuclein PET tracer, ACI-12589, bringing total funding to USD 3.7 million. This support enables enhanced clinical studies, following proof-of-concept data showcasing the tracer's ability to generate live images of alpha-synuclein in the human brain. If successful, ACI-12589 may become a pioneering diagnostic tool for Parkinson’s disease, facilitating the development of new therapies.
AC Immune SA (Nasdaq: ACIU) hosted a webinar featuring Dr. Cynthia A. Lemere discussing the potential of vaccines in treating Alzheimer's and Parkinson's diseases. The session highlighted their precision medicine approach, focusing on three clinical-stage vaccines targeting Tau, Abeta, and α-synuclein. Vaccines are positioned to provide long-lasting immunity and cost-effective treatment options. The company’s pipeline includes ACI-35.030, ACI-24.060, and ACI-7104, with expected clinical data disclosures in 2022, showcasing their commitment to combating neurodegenerative diseases.
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