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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 SA (NASDAQ: ACIU) announced that the Phase 2 Lauriet trial of semorinemab in mild-to-moderate Alzheimer's disease met one co-primary endpoint, ADAS-Cog11, showing a 43.6% reduction in cognitive decline compared to placebo (p<0.0025). However, the second endpoint, ADCS-ADL, was not met, and no significant effects were seen on other cognitive measures. The safety profile of semorinemab was consistent with prior studies. Genentech will continue the open label portion of the trial, with top-line results scheduled for presentation at the CTAD conference in November 2021.
AC Immune SA (NASDAQ: ACIU) announced a strategic acquisition of the PD01 vaccine candidate for Parkinson's disease and secured investments from prominent backers of BioNTech SE. With a robust cash position of CHF 199.1 million, the company is financed through at least Q1 2024. Recent clinical results for ACI-24 demonstrated immunogenicity in Down syndrome-related Alzheimer’s, while the Phase 1b/2a anti-pTau trial has been expanded with promising interim results. However, the company reported a net loss of CHF 19.1 million for Q2 2021.
AC Immune announced promising Phase 1b results for the anti-Abeta vaccine ACI-24 in adults with Down syndrome, correlating immune response with target engagement. The study found ACI-24 to be safe, with no serious adverse events reported. Additionally, the administration of ACI-24 resulted in increased plasma Abeta levels. The company plans further development of ACI-24 and aims to shift towards earlier treatment of Alzheimer’s disease (AD). ACI-12589, a diagnostic for Parkinson’s disease, is also being presented, with further advancements expected in the pipeline.
AC Immune (NASDAQ: ACIU) announces the acquisition of Affiris' portfolio, including the clinically-validated active vaccine candidate for Parkinson's disease, PD01, in an all-stock transaction valued at USD 58.7 million. This acquisition, supplemented by a USD 25 million private placement led by Athos Service GmbH, enhances AC Immune's cash position and accelerates therapeutic development. AC Immune plans to launch a Phase 2 study of the vaccine targeting alpha-synuclein in Parkinson’s patients, combining their expertise in vaccine development with Affiris' innovative technology.
AC Immune SA (NASDAQ: ACIU) held its Annual General Meeting, where shareholders re-elected the Board of Directors, including Douglas Williams as Chairman. The company remains focused on advancing its Alzheimer’s disease vaccine programs despite the challenges posed by COVID-19. These vaccines target key proteins related to the disease, positioning AC Immune as a potential leader in the field. All AGM resolutions were approved, and the meeting complied with COVID-19 regulations.
AC Immune SA (NASDAQ: ACIU) recently reported significant developments regarding its vaccine candidate, ACI-24, for Alzheimer's disease. The Phase 2 interim analysis confirmed a strong safety profile without any CNS inflammation or adverse events. Notably, non-human primate studies showed that the optimized ACI-24 formulation generates a robust antibody response against neurotoxic pyroglutamate Abeta, surpassing earlier formulations. The company plans to file an Investigational New Drug (IND) application by the end of 2021 and aims to enter Phase 2 trials for Down syndrome-related Alzheimer's as early as 2022/23.
AC Immune SA (NASDAQ: ACIU) announced its participation in the UBS Global Healthcare Virtual Conference on May 26, 2021, and the Jefferies Virtual Healthcare Conference from June 2-4, 2021. CEO Prof. Andrea Pfeifer will present the company’s strategy and Alzheimer’s disease vaccine programs targeting phospho-Tau and Abeta. Webcasts of the events will be available on AC Immune’s website. The company focuses on precision medicine for neurodegenerative diseases, holding a diversified pipeline with six clinical trials ongoing.
AC Immune (NASDAQ: ACIU) announced the expansion of its Phase 1b/2a clinical trial of the ACI-35.030 vaccine for Alzheimer's disease, following encouraging interim results. Vaccination at the second highest dose cohort will proceed, while the highest dose group continues to be evaluated, with initial results expected in Q4 2021. The trial aims to assess safety, tolerability, and immunogenicity of the vaccine candidates ACI-35.030 and JACI-35.054, both targeting phosphorylated Tau proteins. Encouraging data reported includes a 100% antibody response in early Alzheimer’s patients.
AC Immune SA (NASDAQ: ACIU) reported potent interim results for its anti-pTau Alzheimer’s vaccine in a Phase 1b/2a study and initiated a first-in-human study for a new alpha-synuclein PET diagnostic.
The company maintains a robust cash position of CHF 216.1 million, ensuring funding through at least Q1 2024. However, it recorded a net loss of CHF 16.7 million for Q1 2021, a significant increase from CHF 7.7 million in the previous year. The decrease in contract revenues by CHF 12.3 million mainly contributed to this loss, highlighting challenges in generating income.
AC Immune SA (NASDAQ: ACIU) has appointed Dr. Alan Colowick to its Board of Directors, enhancing its leadership in precision medicine for neurodegenerative diseases. Dr. Colowick brings over 20 years of experience in biotech, having served in executive roles at notable companies such as Celgene and Amgen, and as a Partner at Sofinnova Investments. His expertise is expected to strengthen AC Immune's pipeline, which features nine therapeutic and three diagnostic candidates, with six currently undergoing clinical trials. The appointment is seen as a pivotal move for the company's growth and strategic development.
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