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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 interim safety data from the Phase 1b/2 ABATE trial of ACI-24.060 in individuals with Down syndrome (DS). The trial evaluates an active immunotherapy targeting toxic forms of amyloid beta. Key findings from the first two cohorts receiving low and mid-dose treatments showed:
- No serious adverse events related to the study drug
- No cases of amyloid-related imaging abnormalities (ARIA)
- Subjects treated for up to one year
Based on these encouraging results, AC Immune plans to proceed with the high-dose cohort. The ABATE study is ongoing at sites in the U.S., U.K., and Spain. ACI-24.060 has received Fast Track designation from the FDA for Alzheimer's disease treatment.
AC Immune (NASDAQ: ACIU) announced positive interim results from its Phase 2 VacSYn trial of ACI-7104.056, an active immunotherapy for early Parkinson's disease. The treatment showed significant efficacy, inducing anti-a-synuclein antibody levels 16-fold higher than placebo after 3 immunizations, with a 100% patient response rate. The trial reported positive safety data with only minor side effects including injection site reactions (49%) and headaches (18%). The study may expand to Part 2 with up to 150 patients in H1 2025, focusing on motor symptoms and biomarkers for potential pivotal study transition.
AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company focused on neurodegenerative diseases, has announced its participation in the Jefferies 2024 London Healthcare Conference. The company will engage in a fireside chat on November 20, 2024, at 6:00 AM (ET) / 11:00 AM (GMT), along with one-on-one investor meetings during the conference scheduled for November 19-21, 2024. The event will be held in-person in London, with a webcast available on AC Immune's website Events Page, including a replay option for later viewing.
AC Immune (NASDAQ: ACIU) reported Q3 2024 financial results with a net income of CHF 5.5 million, compared to a net loss of CHF 15.1 million in Q3 2023. Contract revenues reached CHF 25.5 million, primarily from a CHF 24.6 million milestone payment from Janssen. The company ended Q3 with CHF 157.9 million in cash, providing runway into 2027.
Key developments include Fast Track designation from FDA for JNJ-2056 in Alzheimer's disease and progress in the Phase 2 VacSYn trial for Parkinson's disease. R&D expenses increased to CHF 14.5 million from CHF 12.4 million year-over-year, while G&A expenses rose slightly to CHF 3.8 million.
AC Immune SA (NASDAQ: ACIU) has received a second milestone payment of CHF 24.6 million from Janssen Pharmaceuticals for the rapid prescreening rate in the Phase 2b ReTain trial of ACI-35.030 (JNJ-2056) for preclinical Alzheimer's disease. This brings the total milestone payments for this trial to CHF 40 million. The potentially registrational trial aims to enroll about 500 participants with pre-symptomatic AD.
Key points:
- JNJ-2056 received FDA Fast Track designation in July 2024
- AC Immune has received approximately CHF 425 million in milestone and upfront payments from collaborations
- The company has a three-year cash runway
- ACI-35.030 targets pathological phosphorylated-Tau protein (pTau)
- The trial is the first to test an active immunotherapy in preclinical AD population
AC Immune's partner, Life Molecular Imaging (LMI), has received Fast Track Designation from the FDA for the Tau-PET diagnostic [18F]PI-2620 in three neurodegenerative conditions: Alzheimer's disease (AD), progressive supranuclear palsy (PSP), and corticobasal degeneration (CBD). PI-2620, currently in Phase 3 clinical development for detecting Tau pathology in AD, is a next-generation PET imaging agent. This designation aims to accelerate development and review, highlighting the importance of early and accurate diagnoses in neurodegenerative diseases.
The Fast Track status for PI-2620 follows similar designations for AC Immune's active immunotherapies ACI-35.030 and ACI-24.060, both in Phase 2. This recognition underscores AC Immune's leadership in developing precision therapeutics for neurodegenerative diseases and its commitment to improving patient care through early diagnosis and treatment.
AC Immune reported Q2 2024 financial results and provided a corporate update. Key highlights include:
- Exclusive option and license agreement with Takeda for ACI-24.060, with $100 million upfront and potential milestones up to $2.1 billion
- ACI-24.060 ABATE Phase 2 trial in Alzheimer's disease progressing as planned
- ACI-7104.056 VacSYn Phase 2 trial in Parkinson's disease on track for interim data in H2 2024
- Promising preclinical results for ACI-19764, an NLRP3 inhibitor
- Cash balance of CHF 175.2 million, providing a three-year runway
Financial results: Contract revenues of CHF 0.7 million, R&D expenses of CHF 17.1 million, G&A expenses of CHF 4.6 million, and a net loss of CHF 22.8 million for Q2 2024.
AC Immune SA (NASDAQ: ACIU) unveiled a novel class of neurodegenerative disease-fighting drug-candidates called morADC (Morphomer® Antibody Drug Conjugate) at AAIC 2024. This technology combines brain-penetrant Morphomer® small molecules with SupraAntigen® monoclonal antibodies to target toxic proteins in the central nervous system. Key findings include:
1. Significant synergies in blood-brain barrier penetration and protein aggregation inhibition
2. Capability for single or dual-targeting strategies
3. Enhanced anti-aggregation effects compared to parent molecules
4. Multiplied antibody brain exposure
The morADC platform aims to overcome challenges faced by existing modalities and improve clinical outcomes for patients with neurodegenerative diseases.
AC Immune SA (NASDAQ: ACIU) announced that its active-immunotherapy candidate, ACI-35.030 (now called JNJ-2056), has received Fast Track designation from the FDA for Alzheimer's disease treatment. The therapy targets the pathologic form of the Tau protein, phosphorylated Tau (pTau). A Phase 2b clinical trial called ReTain is currently recruiting participants with preclinical Alzheimer's disease.
Key points:
- First active immunotherapy tested in a preclinical AD population
- Potential therapeutic advantages and benefits in convenience and access
- Shown to specifically target toxic form of Tau in Phase 1b/2a clinical testing
- Developed in partnership with Janssen Pharmaceuticals
- ReTain trial is fully funded and conducted by Janssen
AC Immune SA (NASDAQ: ACIU) will present three oral presentations at the Alzheimer's Association International Conference (AAIC 2024) in Philadelphia, showcasing its precision medicine pipeline for neurodegenerative diseases. The presentations will focus on:
1. [18F]ACI-19626, a first-in-class TDP-43-PET tracer
2. ACI-24.060, an active immunotherapy inducing anti-Abeta antibodies
3. morADC (Morphomer®-Antibody Drug Conjugates), a new class of neurodegenerative disease-fighting drugs
Additionally, a poster presentation will compare clinical endpoint progression rates in sporadic Alzheimer's disease and Down Syndrome-related Alzheimer's disease.
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