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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) 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.
The clinical-stage biopharmaceutical company AC Immune (NASDAQ: ACIU) announced its participation in the Jefferies 2024 Global Healthcare Conference in New York, scheduled for June 5-6, 2024.
Company management will engage in a fireside chat on June 5 at 3:30 PM (ET), which can be accessed via webcast. Additionally, AC Immune will hold one-on-one meetings with investors. This involvement aims to highlight their precision medicine advancements for neurodegenerative diseases.
The webcast and an archived replay will be available on AC Immune’s website.
AC Immune reported its first quarter 2024 financial results and corporate update, highlighting a landmark deal with Takeda for ACI-24.060 with $100 million upfront and potential payments of up to $2.1 billion. The ACI-24.060 ABATE Phase 2 trial is on track to report results in Q2 2024, and the ACI-7104.056 VacSYn Phase 2 trial in Parkinson's disease is progressing. The company has a three-year cash runway with CHF 104.8 million. Financially, the company had a cash balance of CHF 104.8 million, R&D expenses of CHF 15.2 million, and reported a net loss of CHF 17.9 million for the quarter.
AC Immune and Takeda have signed an exclusive option and license agreement for ACI-24.060, an active immunotherapy targeting Amyloid Beta for Alzheimer's disease. Takeda will pay AC Immune $100 million upfront, with additional potential milestones totaling around $2.1 billion. AC Immune will host a conference call and webcast to discuss the agreement.
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