AC Immune
NasdaqGM:ACIU
$
2,56
$
$-0,14 (-5,19%)
2,56
$
$-0,14 (-5,19%)
End-of-day quote: 03/30/2026
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AC Immune Company Info
EPS Growth 5Y
0,23%
Market Cap
$0,25 B
Long-Term Debt
$0,00 B
Quarterly earnings
05/06/2026 (E)
Dividend
$0,00
Dividend Yield
0,00%
Founded
2003
Industry
Country
Website
ISIN Number
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Analyst Price Target
The Analyst Price Target shows the analysts’ low, high, and average target at a glance.
$8,39
227.73%
Last Update: 03/31/2026
Analysts: 4
Highest Price Target $11,84
Average Price Target $8,39
Lowest Price Target $6,86
In the last five quarters, AC Immune’s Price Target has fallen from $11,44 to $9,31 - a -18,62% decrease. Four analysts predict that AC Immune’s share price will increase in the coming year, reaching $8,39. This would represent an increase of 227,73%.
Top growth stocks in the health care sector (5Y.)
What does AC Immune do?
AC Immune SA (AC Immune), a clinical stage biopharmaceutical company, focuses on pioneering precision medicine for neurodegenerative diseases.
The company’s highly differentiated approach integrates novel therapeutics and diagnostics to overcome the fundamental challenge in this therapeutic area – the high number of co-pathologies driving disease development and progression and the urgent need for more tailored therapeutic regimens.
The company is advancing 16 therapeutic and diagnostic progra...
AC Immune SA (AC Immune), a clinical stage biopharmaceutical company, focuses on pioneering precision medicine for neurodegenerative diseases.
The company’s highly differentiated approach integrates novel therapeutics and diagnostics to overcome the fundamental challenge in this therapeutic area – the high number of co-pathologies driving disease development and progression and the urgent need for more tailored therapeutic regimens.
The company is advancing 16 therapeutic and diagnostic programs, with one in a Phase 3 and five in Phase 2 clinical trials, targeting five different types of misfolded pathological proteins related to Alzheimer’s disease (AD), Parkinson’s disease (PD) and other neurodegenerative disorders. The company’s pipeline assets are further validated by the multiple partnerships it has established with leading global pharmaceutical companies.
The company is developing a suite of diagnostics designed to be first-in-class or best-in-class, which enables improved diagnosis of pathologies, patient selection, and assessment of clinical trial outcomes. The company has four diagnostic programs in its pipeline, developed using its proprietary technology platforms and targeting: Tau, a-syn and TDP-43.
The company has a strong track record of establishing value-driving collaboration agreements with leading pharmaceutical companies, such as Janssen, Lilly, and LMI. This strategy allows it to leverage the company’s partners’ scientific, development, manufacturing and commercialization expertise and other resources while partially monetizing its investments, de-risking and accelerating the development of its product candidates.
The company’s clinical stage product candidates include:
ACI-24.060 for AD and for AD in DS
Based on safety, tolerability, immunogenicity, and pharmacodynamics results with an earlier version of ACI-24, an enhanced formulation, ACI-24.060, which incorporates Abeta unrelated T-helper cell epitopes to increase the magnitude and the boostability of the antibody response, is being tested at 3 different incremental doses in the ABATE Phase 1b/2 trial (NCT05462106) and Abeta plaque reduction is being assessed using Abeta-PET imaging.
ABATE is a multicenter, adaptive, double-blind, randomized, placebo-controlled study designed to assess the safety, tolerability, immunogenicity, and pharmacodynamic effects of ACl-24.060 in subjects with prodromal AD and in adults with DS. The CTA has been approved by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and Spanish Agency for Medicines and Health Products (AEMPS) with the first AD patient dosed in June 2022. In June 2023, AC Immune received Fast Track designation from the FDA for ACI-24.060, for the treatment of AD. This followed FDA clearance of the Investigational New Drug (IND) application in May 2023 enabling the initiation of the ABATE study to include clinical trial sites to enroll participants with DS in the U.S. Based on the safety profiling and induction of an antibody response post dosing of ACI-24.060 in patients with AD, dosing of the first individual with DS occurred in June 2023.
ACI-7104.056
The optimized formulation of the clinically validated PD active immunotherapy PD01A, is being tested in a placebo-controlled, double-blind, adaptive, biomarker-based Phase 2 study (VacSYn; NCT06015841) in the EU and in the UK. This trial is evaluating the safety and immunogenicity of ACI-7104.056 against a-syn and pathological a-syn species in early PD. Additionally, disease-specific imaging and fluid biomarkers and progression of motor and non-motor symptoms of PD will be monitored. The VacSYn trial commenced in July 2023 with the dosing of the first patient, and enrollment of cohort 1 has been completed in December 2023, with 16 patients randomized.
ACI-35.030
AC Immune and Janssen Pharmaceuticals, Inc. (Janssen), part of the Janssen Pharmaceutical Companies of Johnson & Johnson, has evaluated the anti-phosphorylated-Tau (anti-pTau) active immunotherapy ACI-35.030 in a Phase 1b/2a study in subjects with early AD (NCT04445831). Results showed that ACI-35.030 immunization generated a rapid antibody response (anti-pTau, anti-ePHF, and anti-Tau IgG) after the first injection (at week 2) at the 3 tested doses. An apparent dose-effect was observed between low and mid doses but not between the mid and high doses. A boosting effect was observed after each injection especially against pathological Tau species (pTau and ePHF). The antibody response was strongly directed against pathological Tau species. Long-term maintenance of the anti-ePHF IgG titers against endogenous pathological Tau was observed at the mid- and high-dose.
In addition to ACI-35.030, an exploratory alternative pTau active immunotherapy candidate, JACI-35.054, was also evaluated in the Phase 1b/2a trial. It generated a more varied antibody response (anti-pTau, anti-ePHF, and anti-Tau IgG) after the second injection (at week 10) at the 2 tested doses. While there was no apparent dose-effect between the 2 tested doses, a higher variability of titers was observed at the low dose. A boosting effect was seen against pathological Tau and non-phosphorylated Tau species from the 2nd injection. For JACI-35.054, there was a lower extent of specific antibody response against pathological Tau species compared to non-phosphorylated Tau as observed with ACI-35.030. Both ACI-35.030 and JACI-35.054 showed good safety and tolerability profiles. The majority of adverse events (AEs) were of mild intensity. The injection site reactions were one of the most frequently reported AEs in actively treated subjects. Serious adverse events (SAEs) mainly observed in subjects treated with ACI-35.030.
Consequently, ACI-35.030 (JNJ-64042056) that is selective for pathological phosphorylated Tau (pTau) is being advanced and will be assessed in subjects with preclinical (ie., pre-symptomatic) AD in a Phase 2b study in which the first patient will be dosed in H1 2024. The trial will randomize approximately 500 participants with confirmed early-stage Tau pathology, who will be treated over a four-year period. The trial will include interim analyses potentially allowing for acceleration towards a regulatory filing.
PI-2620
PI-2620 is the Tau-PET imaging agent discovered during the collaboration of AC Immune and LMI. The company is working with its partner, LMI, to advance PI-2620 as a highly differentiated, best-in-class Tau diagnostic for AD, as well as non-AD Tauopathies, such as progressive supranuclear palsy (PSP) and corticobasal degeneration (CBD). Results have demonstrated PI-2620’s differentiated characteristics as a diagnostic tool for studying Tau-related diseases. Results on the use of PI-2620 in AD patients from an investigator sponsored Phase 2 trial at the Asan Medical Center (NCT03903211) were presented at the 2022 AAIC. Following these results, LMI moved PI-2620 into late-stage clinical development in AD and made a milestone payment. The first Alzheimer’s patient in ADvance, the pivotal Phase 3 histopathology study in AD (NCT05641688), was imaged in January 2023.
ACI-12589
The company’s Morphomer platform has delivered the first clinically validated a-syn-PET tracer which can support the differential diagnosis of multiple system atrophy (MSA) from other neurodegenerative disease and allow precision medicine approaches and biomarker-based clinical development in this indication. ACI-12589 preclinical and clinical data has been published in October 2023 in Nature Communications. In addition, medicinal chemistry optimization strategies have allowed the identification of its next-generation clinical candidate, ACI-15916. Compared to ACI-12589, ACI-15916 shows significantly higher target occupancy in brain slices from idiopathic forms of Parkinson’s disease (PD) and has therefore the potential to enable imaging of a-syn pathology in patients with PD. IND/CTA-enabling studies for ACI-15196 will be initiated in Q1 2024 with the regulatory submission planned in Q4 2024.
Morphomer Tau aggregation inhibitors
In collaboration with its partner, Lilly, the company is researching and developing small molecule Tau aggregation inhibitors with plans to evaluate candidates in AD and NeuroOrphan Tauopathies. Continued candidate characterization across the research program has also identified new and highly differentiated candidates with excellent cerebrospinal fluid exposure and selectivity for pathological aggregated Tau.
Semorinemab
Semorinemab is an investigational monoclonal anti-Tau antibody that targets the N-terminal portion of the Tau protein and is designed to bind to Tau and slow its spread between neurons for the treatment of AD. As announced on January 22, 2024, AC Immune will regain the global rights to semorinemab following termination of the collaboration agreement with Genentech, a member of the Roche Group, which termination will be effective in April 2024. Semorinemab has been studied in two Phase 2 studies: Tauriel in early (prodromal-to-mild) AD, where the primary efficacy endpoint was not met; and Lauriet in mild-to-moderate AD. In Lauriet, a strongly positive and highly statistically significant effect was seen on ADAS-Cog11 (one of two co-primary endpoints) plus statistically significant effects on several key biomarkers, including total Tau and pTau217 in CSF and plasma. The second co-primary endpoint, ADCS-ADL and the secondary efficacy endpoints did not reach significance. Final open label extension results from the Lauriet trial will be reviewed when they become available and are received in full by AC Immune. The company will then carefully review and evaluate available data sets, before decisions are made on potential further development and other opportunities.
Crenezumab
Crenezumab is a humanized monoclonal antibody, an investigational treatment designed to slow AD progression by neutralizing neurotoxic Abeta oligomers. It was designed by AC Immune to be a conformation-specific monoclonal antibody targeting multiple forms of misfolded Abeta. As announced on January 22, 2024, AC Immune will regain the global rights to crenezumab following termination of the collaboration agreement with Genentech, a member of the Roche Group, which termination will be effective in April 2024. Crenezumab has an antibody backbone (IgG4) designed to minimize the inflammatory response in the brain, which may result in a lower incidence of side effects known as ARIA (Amyloid-Related Imaging Abnormalities). The investigational medicine has demonstrated excellent safety (e.g. less than 1% of ARIA-E cases in the Phase 3 studies; Ostrowitzki et al., JAMA Neurology, 2022) and encouraging efficacy signals while undergoing extensive Phase 2 clinical testing. While the Colombian autosomal-dominant AD prevention trial was not sufficiently powered to show significant cognitive benefits, crenezumab was proven to be safe with numeric trends on the primary and vast majority of secondary and exploratory endpoints in its favor. The lessons from this study provided useful insights regarding the desired anti-amyloid immunotherapy profile and designs for prevention trials. AC Immune will carefully review and evaluate available data sets, before decisions are made on potential further development and other opportunities.
Clinical programs
ACI-24.060
ACI-24.060 derives from AC Immune’s anti-Abeta active immunotherapy, ACI-24, that was assessed in patients with AD and in subjects with DS. As ACI-24 was shown to be safe and well tolerated with preliminary evidence of immunogenicity and pharmacodynamic effects in these two study populations, the enhanced version ACI-24.060 was created. ACI-24.060 contains additional Abeta unrelated T-helper cell epitopes and has demonstrated similar safety and tolerability in NHPs with superior immunogenicity in mouse and NHP studies as compared to the original ACI-24.
The aim of the active immunotherapy is to stimulate the patient’s immune system to produce and maintain antibodies that bind and remove pathological Abeta with the goal to prevent plaque accumulation and enhance clearance of toxic Abeta species. The company is pursuing clinical development of ACI-24.060 in early AD, as well as in people living with DS exhibiting the presence of brain amyloid pathology. ACI-24.060 is proprietarily owned.
Clinical development
ABATE Phase 1b/2: The ABATE clinical study (NCT05462106) is a multicenter, adaptive, placebo-controlled, dose-escalation, double-blind, randomized study containing two parts.
Study part 1 is conducted in subjects with prodromal AD to assess the effect of study treatment (ACI-24.060 at three different incremental doses or placebo) administered over 48 weeks. The study drug is being administered via intramuscular injections. Study part 1 is being conducted in several centers located in the UK and Spain. Dosing in prodromal AD subjects was initiated in June 2022.
Study part 2 is planned to be conducted in up to 88 non-demented adults living with DS and with confirmed presence of amyloid pathology by PET scan. The goal is to assess the effect of study treatment (ACI-24.060 or placebo) administered over 74 weeks. Dosing of DS subjects from study part 2 has been initiated in Spain and in the UK. Study part 2 is being actively expanded in the USA where the IND approval has been granted in May 2023.
ACI-24 development in AD in DS
The AD pathology that commonly develops in people with DS bears remarkable similarities to familial and sporadic forms of AD and is characterized by a progressive accumulation in the brain of Abeta into amyloid plaques leading to the appearance of AD-related cognitive decline and a modification of other relevant biomarkers. The company is pioneering the development of its anti-Abeta active immunotherapy in AD patients and subjects with DS.
ACI-7104.056 – anti-a-syn active immunotherapy
ACI-7104.056 is an optimized peptide-conjugate active immunotherapy formulation designed to induce a-syn-specific antibodies recognizing aggregated a-syn species that has been demonstrated to be toxic to neurons. In contrast, ACI-7104.056-induced antibodies do not bind to the monomeric, physiological form of a-syn and do not cross-react with other members of the synuclein family, such as beta- and gamma-synuclein.
A substantial package of preclinical and clinical data has been generated with PD01 (predecessor of ACI-7104.056). This candidate was tested in two different transgenic mouse models of PD and Dementia with Lewy bodies (DLB), the mThy1- and the PDGF-human a-syn transgenic mice. Active immunization with PD01 resulted in decreased a-syn pathology in brain areas most affected by transgene overexpression, including the substantia nigra and the striatum. This decrease was accompanied by a reduced neurodegeneration in both in vivo models and by improvements in motor and memory deficits in the mThy1 and the PDGF-human a-syn transgenic mice, respectively. Furthermore, ACI-7104.056 has been shown to be highly immunogenic in non-human primates, with induced antibodies binding selectively to pathological forms of a-syn.
PD01 was the first active immunotherapy candidate against pathological a-syn to be tested in a clinical study involving patients with early PD. A series of Phase 1 studies were completed in June 2018. The first dosing in the Phase 2 VacSYn trial in early PD patients to evaluate ACI-7104.056 was performed in July 2023.
Clinical development
Phase 1 study design
The safety, tolerability, and immunogenicity of the ACI-7104.056 anti-a-syn active immunotherapy predecessor were studied over a three-and-a-half-year period in 24 early PD subjects and has been previously published (Volc et al., The Lancet Neurology, 2020). There were four consecutive studies in this group of patients, with patients randomized to receive a lower or higher dose of the alpha synuclein active immunotherapy. After four priming doses, subjects were re-randomized to receive a booster injection at one of the two doses, followed by a second booster injection at the high dose.
ACI-35.030 – anti-pTau active immunotherapy
ACI-35.030, AC Immune’s active immunotherapy developed in collaboration with Janssen, is selective for pathological phosphorylated Tau (pTau) and is being advanced into a Phase 2b study that is planned to be initiated in H1 2024. ACI-35.030 (JNJ-64042056) will be assessed in subjects with preclinical (ie., pre-symptomatic) AD. The trial will randomize approximately 500 participants with confirmed early-stage Tau pathology who will be treated over a four-year period. The trial will include analysis of Tau PET as a potential surrogate biomarker, which might be used for an accelerated regulatory filing. Developed using the company’s SupraAntigen technology, ACI-35.030 (JNJ-64042056) is designed to stimulate a patient’s immune system to produce antibodies against pathological phosphorylated Tau, which aggregates to create the neurofibrillary tangles that characterize AD.
ACI-35.030
ACI-35.030 is an optimized liposomal anti-pTau active immunotherapy formulation designed to elicit antibodies against extracellular pTau protein in order to prevent and reduce the spread and development of Tau pathology within the brain. In non-clinical studies, ACI-35.030 demonstrated an excellent non-clinical safety profile and highly specific antibody response against pTau that was improved compared to the initial formulation, ACI-35. ACI-35.030 (JNJ-64042056) is entering a Phase 2b clinical study with potential pathways for acceleration with Janssen, in accordance with the company’s collaboration agreement.
ACI-35.030 comprises a pTau peptide and a T-cell epitope capable of binding to human leukocyte antigen-major histocompatibility complex, class II (HLA-DR) molecules.
JACI-35.054
JACI-35.054 is an alternative pTau active immunotherapy, which was developed with Janssen in accordance with its collaboration agreement. In non-clinical studies, JACI-35.054 showed good safety and induced a strong antibody response against pTau.
JACI-35.054 is an alternative anti-pTau active immunotherapy comprising a pTau peptide antigen conjugated to an immunogenic carrier protein CRM197, combined with adjuvants.
CRM197 is a well-defined recombinant protein that is a commercially available version of a non-toxic mutant of diphtheria toxin-A (DTA) chain and has been shown to be a safe carrier protein in commercial prophylactic active immunotherapies and clinical trials for a plethora of different active immunotherapy candidates.
ACI-35.030 was selected over JACI-35.054 to progress into the next clinical phase based on an earlier trigger of the antibody response (shortly after the first immunization) and a more specific antibody response profile against pathological Tau species (notably against the endogenous ePHF).
Clinical development
Phase 1b/2a study
The Phase 1b/2a study (NCT04445831) was a randomized, multicenter, double-blind, placebo-controlled clinical study with a primary objective to assess the safety, tolerability, and immunogenicity of different dosages of ACI-35.030 and JACI-35.054 in participants with early AD. Secondary objectives assessed additional immunogenicity parameters, while exploratory endpoints included notable biomarkers of progression of AD, as well as clinical assessments. This Phase 1b/2a study conducted in Europe aimed at evaluating ACI-35.030 and JACI-35.054. The clinical trial was completed in September 2023. The clinical study report will be finalized in H1 2024.
Tau diagnostics
The company’s Tau-PET tracers are designed to bind specifically to the pathological forms of human Tau in AD and other Tauopathies. They have demonstrated an excellent PET tracer profile with their ability to cross the blood brain barrier and a high selectivity to pathological Tau even in the early-stage disease. The Phase 1 clinical study of the company’s clinical candidate PI-2620 in AD was completed in Q1 2018. The Phase 2 longitudinal study in AD in South Korea (Asan Medical Center, NCT03903211) was completed in Q4 2021 and results presented at AAIC 2022. The pivotal ADvance Phase 3 histopathology study in AD (NCT05641688) was initiated in December 2022 and the first Alzheimer’s patient imaged with PI-2620 in January 2023.
PI-2620 is selective for Tau over Abeta and other off-target binding compared with published Tau-PET agents in development, as no binding to Abeta in vivo and no ‘off-target’ retention in basal ganglia or choroid plexus was observed. In addition, PI-2620 was shown to be suitable for measuring longitudinal Tau accumulation. A major differentiator for PI-2620 is its ability to bind 4-repeat (4R) Tau isoforms, which are in varying amounts in different neurodegenerative diseases. Most Tau-PET tracers in development are not able to bind 4R Tau and are of limited use for certain diseases driven by these Tau species.
A-syn diagnostics
The company is also developing PET imaging agents to detect a-syn aggregates, which progressively accumulate in the brains of PD patients and are believed to be central to the neurodegenerative process of PD, as well as several other disorders, including Lewy body dementia and MSA, making it a priority target for the development of therapeutics and diagnostics. The company has identified molecules leveraging its Morphomer technology that selectively bind to a-syn pathological structures from human PD brain with high affinity and selectivity versus common co-pathologies.
The company is advancing clinical development of ACI-12589, the first molecule capable to detect pathological a-syn in the brain of patients with MSA and to differentiate them from controls, other synucleinopathies and more generally other neurodegenerative diseases. The preclinical and clinical data were published in October 2023 in Nature Communications. ACI-12589 has completed the biodistribution study in healthy volunteers and all the manufacturing activities required to advance into later stage of clinical development, including PET studies to monitor the longitudinal progression of the a-syn pathology in MSA.
Moreover, in 2023 the company has identified its next-generation clinical candidate, ACI-15916. ACI-15916 shows significantly higher binding and target occupancy in human brain tissues from cases with different synucleinopathies, including idiopathic PD, which is the most common form. ACI-15916 also retains the excellent selectivity and pharmacokinetic profile of ACI-12589 and has no major off-target binding. This compound will advance into IND/CTA-enabling studies in Q1 2024 with an anticipated initiation of the FiH in Q1 2025.
Morphomer Tau
Approximately 2,550 compounds have been screened thus far for the Morphomer Tau program. This has allowed for the identification of several chemical series of orally bioavailable small molecules with suitable CNS properties. The lead compounds displayed selectivity for binding to pathological Tau aggregates in preference to other protein aggregates. In addition, the lead compounds were able to prevent Tau aggregation and promote its disaggregation.
ACI-3024
ACI-3024 is a potent Tau aggregation inhibitor active against the 3R and 4R human Tau isoforms, as well as the mutant forms associated with human Tauopathies, such as FTLD-Tau (e.g. PSP, Pick’s disease, corticobasal degeneration). ACI-3024 selectively binds to aggregated Tau and does not bind to the monomeric forms of Tau. Moreover, the binding to Tau aggregates is selective, with no cross-reactivity to aggregates of Abeta and a-syn.
Preclinical safety assessments demonstrated that ACI-3024 has a good in vitro and in vivo ADME profile, including low clearance, long half-life and good CNS disposition as assessed by brain and CSF concentrations. ACI-3024 was negative in in vitro and in vivo genotoxicity assays and cleared extensive toxicology and safety pharmacology assessments. ACI-3024 was also shown to potently reduce pathological Tau-induced neuroinflammation in both in vitro and in vivo models.
Clinical development
Phase 1 study
This Phase 1 study was a first-in-human (FiH), randomized, placebo-controlled, double-blind, sequential single and multiple ascending dose study. The study assessed the safety, tolerability, pharmacokinetics, and pharmacodynamics of ACI-3024. Part I included five single ascending doses in healthy volunteers, with a food effect assessment in the fourth dose cohort. In Part II, three escalating multiple dose regimens were evaluated; regimen two was assessed in different populations of healthy volunteers.
ACI-3024 will not be further developed under the collaboration and the companies have decided to pursue other promising Tau Morphomer candidates from AC Immune’s research platform for potential clinical development in AD.
Semorinemab
Semorinemab is a humanized high-affinity IgG4 isotype antibody candidate that binds all forms of Tau. Semorinemab is designed to intercept extracellular Tau, stopping, or slowing cell-to-cell spread and propagation of pathological Tau in the brain. Semorinemab completed two Phase 2 clinical trials in AD. As announced on January 22nd, 2024, AC Immune will regain the global rights to semorinemab following termination of the collaboration agreement with Genentech, a member of the Roche Group, which termination will be effective in April 2024.
Following on from successful Phase 1 clinical testing, a Phase 2 clinical trial (Tauriel) commenced in Q4 2017 with the dosing of the first patient. This multicenter trial, which enrolled 457 participants, assessed the safety, tolerability, and efficacy of semorinemab in people with prodromal-to-mild AD. Participants received one of three active doses or a placebo for 72 weeks, followed by a 96-week optional open-label extension (OLE). Primary endpoints included safety assessment and the composite functional and cognitive endpoint CDR-SB score.
A second Phase 2 trial (Lauriet) was initiated in Q1 2019. This was a multicenter study enrolling 272 participants, and was designed to evaluate the clinical efficacy, safety, pharmacokinetics, and pharmacodynamics of semorinemab in patients with moderate AD.
In August 2021 the company reported that the Lauriet study had met one of its co-primary endpoints, ADAS-Cog 11. In November 2021, the company reported that Genentech had presented the full top-line data from the Lauriet study during a late-breaking session at the 14th Clinical Trials on Alzheimer’s Disease conference.
Crenezumab
Crenezumab is a humanized, conformation-specific monoclonal antibody that targets misfolded Abeta and has a broad binding profile, with high affinity binding to oligomeric Abeta. Its IgG4 backbone reduces microglial activation compared to IgG1 based antibodies, which together with its specificity for oligomeric Abeta leads to an excellent safety profile with ARIA-E comparable to placebo in clinical studies (Cummings et al. 2014:2018; Ostrowitzki et al., JAMA Neurology, 2022). Crenezumab was developed using the company’s proprietary SupraAntigen platform. In 2006, crenezumab was licensed to Genentech. As announced on January 22nd, 2024, AC Immune will regain the global rights to crenezumab following termination of the collaboration agreement with Genentech, a member of the Roche Group, which termination will be effective in April 2024.
Phase 2 studies (ABBY and BLAZE)
In the proof-of-concept Phase 2 studies of crenezumab, a positive trend in cognition was observed, with a greater effect on cognition in patients with a milder stage of AD (MMSE 22–26).
In the Phase 2 ABBY cognition study, there was a statistically significant 35% reduction in the rate of cognitive decline in the non-pre-specified milder AD patient population (MMSE 22–26) for the high-dose arm.
In the Phase 2 BLAZE biomarker study, the high-dose arm showed a consistent trend of reduced Abeta accumulation in the brain over time, as shown in two independent exploratory analyses of florbetapir-PET data. In addition, results have shown that crenezumab can enhance the removal of these proteins from the brain as evidenced by a significant increase in CSF Abeta, confirming target engagement by crenezumab.
Phase 3 studies (CREAD and CREAD 2)
The randomized, double-blind, placebo-controlled, parallel-group Phase 3 CREAD study enrolled about 750 participants with prodromal or mild AD at the age of 50-85 years. A high dose of crenezumab (60 mg/kg) was administered intravenously once every 4 weeks for 100 weeks. The primary outcome measure was the change from baseline to week 105 in CDR-SB score.
In January 2019, Roche, the parent company of the company’s collaboration partner, announced the discontinuation of the CREAD and CREAD 2 (BN29552 and BN29553) Phase 3 studies of crenezumab in people with prodromal-to-mild sporadic AD. The decision came after an interim analysis of the first CREAD study conducted by the IDMC, which indicated that crenezumab was unlikely to meet its primary endpoint of change from baseline in CDR-SB score.
preclinical programs
Using the company’s SupraAntigen and Morphomer platforms, it has generated additional discovery and preclinical stage molecules targeting key pathologies that drive a range of neurodegenerative diseases, including TDP-43, a-syn, and NLRP3-ASC. The company is accelerating the development of several therapeutic product candidates in preclinical development, including several programs focused on indications outside of AD as a critical part of its expansion strategy.
A-syn antibody
The a-syn antibodies generated using the company’s SupraAntigen platform has unique binding properties allowing them to bind preferentially to the pathological forms of a-syn. Leveraging the wide collection of anti-a-syn antibodies generated with diverse binding epitopes and sub-nM binding affinities to aggregated a-syn, new immunoassays are being developed for the detection of pathological a-syn in biofluids. A-syn aggregation and spreading are established targets for PD, MSA and other synucleinopathies. Antibodies that interfere with the aggregation and spreading mechanisms of a-syn provide a therapeutic option for the treatment of PD. The a-syn antibodies were able to significantly delay the seeded aggregation of pathological a-syn in an in vitro aggregation assay and were able to significantly decrease pathological a-syn spreading in an in vivo animal model of PD. Characterization using multiple orthogonal in vitro and in vivo tests addressing binding, specificity, functionality, and pharmacological properties has led to the identification of the lead candidate ACI-5755.
ACI-5755 selectively binds to pathological forms of a-syn with low-nanomolar affinity and shows a significant preference over monomeric a-syn. Additionally, ACI-5755 shows strong recognition for pathological a-syn in patient-derived tissues in both PD and MSA. ACI-5755 showed a potent and dose-dependent reduction in the seeding capacity of pathological a-syn in a proprietary in vitro aggregation assay. Moreover, ACI-5755 substantially reduced the propagation of a-syn aggregates in a cell-based model.
Morphomer a-syn
Leveraging the company’s Morphomer platform, it discovered and characterized the first biologically active small molecule inhibitors targeting intracellular a-syn aggregates. Identified compounds, from several distinct chemical series, which significantly decrease a-syn aggregate accumulation in neurons by interfering with the seeding and fibrillation processes. Iterative medicinal chemistry optimization led to the identification of orally available compounds with favorable CNS-penetrant pharmacokinetic properties, which progressed into in vivo proof-of-concept study in an animal model of alpha-synucleinopathies. Treatment with hit compound resulted in significant, dose-dependent decrease of pathological a-syn aggregates in vivo. Successful medicinal chemistry optimization yielded a new candidate with improved potency in vitro and affinity for pathologic a-syn than earlier compounds, as well as an in vitro safety and pharmacokinetic profiles.
TDP-43 antibody
TDP-43 is an identified target of growing interest for NeuroOrphan indications, such as frontotemporal dementia (FTD) and ALS. Interestingly, TDP-43 also plays an important role in other significant neurodegenerative indications, such as AD or LATE.
Anti-TDP-43 antibodies binding to various regions of TDP-43 were generated by the company’s SupraAntigen platform. A subset displayed conformational selectivity to misfolded TDP-43, while others recognized all TDP-43 isoforms. Multiple antibodies were generated and characterized in vitro, from which two pan-TDP-43 antibodies (ACI-5891 and ACI-5886) were selected for the evaluation of their efficacy in mitigating TDP-43 aggregation in vitro and in vivo. ACI-5891 showed a high binding affinity for TDP-43 and ability to reduce TDP-43 aggregation in vitro and in vivo. ACI-5891 was successfully humanized and clinical lead selected (ACI-5891.9). The lead molecule shows excellent pharmacokinetics in non-human primates and good developability profile.
Strategy
The key elements of the company’s strategy include accelerate development of novel therapeutics in AD with the company’s partners; expand its strategic focus in Parkinson’ disease (PD) and non-AD neurodegenerative diseases, including NeuroOrphan indications and limbic-predominant age-related TDP-43 encephalopathy (LATE); and a continued focus on diagnostics enabling Precision Medicine to be an ultimate differentiator for the company.
The company’s strategy to date has been to focus on identifying partnerships for its early-stage product candidates as both a way to secure non-dilutive capital to fund its other research and development programs and as a way to accelerate the development of these partnered products by leveraging its partners’ extensive knowledge in clinical studies, drug development, manufacturing and commercialization.
License agreements and collaborations
The company’s SupraAntigen and Morphomer platforms has generated large numbers of clinical assets that address multiple diseases related to protein misfolding. Selected key assets in the product pipeline has been licensed for upfront payments, milestones, and royalties to help offset the cost of the company’s research and internal product development. The company has signed a number of licensing agreements with leading pharmaceutical companies to assist and accelerate the development of its product pipeline, including:
A worldwide licensing agreement with Janssen signed in December 2014 (and amended in April 2016, July 2017, January 2019, November 2019, December 2022, and November 2023) for therapeutic anti-Tau active immunotherapies for AD, and potentially other Tauopathies, under which the company may become eligible to receive payments totaling up to CHF 500 million, excluding royalties;
a worldwide licensing and collaboration agreement (LCA) with LMI (formerly Piramal Imaging SA) signed in May 2014 (and amended in June 2022) for small-molecule Tau ligands for use as PET tracers under which the company may become eligible to receive payments totaling up to EUR 160 (CHF 151) million, excluding royalties; and
a worldwide license agreement with Lilly to research and develop Morphomer Tau small molecules for the treatment of AD and other neurodegenerative diseases, which was entered into in December 2018 (and amended in September 2019 and March 2020). The agreement was deemed effective on January 23, 2019. Under this agreement, the company may become eligible to receive payments up to approximately CHF 1.9 billion, excluding royalties.
Intellectual property
As of December 31, 2023, the company owned or co-owned with its collaboration and licensing partners, approximately 53 issued U.S. patents and 421 issued patents in other jurisdictions, as well as 37 pending U.S. patent applications and 515 pending foreign patent applications. The company licensed approximately 34 issued U.S. patents and 312 issued patents in other jurisdictions, as well as 10 pending U.S. patent applications and 213 pending foreign patent applications.
The patent portfolios for the company’s most advanced product candidates as of December 31, 2023, are summarized below:
Anti-Tau active immunotherapies
The company’s patent portfolio for anti-Tau active immunotherapies includes a patent family with composition-of-matter claims (including claims directed to the ACI-35 antigenic peptide and a pharmaceutical composition comprising, such an antigenic peptide), claims directed to treating certain indications using ACI-35, including AD, and claims directed to using ACI-35 to induce an immune response. This patent family contains approximately 29 issued patents and two pending patent applications in 27 countries. The issued patents in this patent family, if the appropriate maintenance, renewal, annuity, or other governmental fees are paid, are expected to expire in 2030, excluding any additional term for patent term adjustments or patent term extensions.
The company’s patent portfolio for anti-Tau active immunotherapies also includes a patent family relating to therapeutic Tau active immunotherapies, including claims directed to a pharmaceutical composition comprising an antigenic Tau peptide, claims directed to using such active immunotherapies to induce an immune response in a subject, and claims directed to methods for preventing or treating a neurodegenerative disease or disorder, including AD, among others. This patent family contains 4 issued patents and approximately 51 pending patent applications in 41 countries. The issued patents and any patents issuing in this patent family, if the appropriate maintenance, renewal, annuity, or other governmental fees are paid, are expected to expire in 2038, excluding any additional term for patent term adjustments or patent term extensions.
ACI-24
The company’s patent portfolio for ACI-24 includes a patent family with composition-of-matter claims (including claims directed to the ACI-24 antigenic construct), claims directed to treating certain indications using ACI-24, including AD, and claims directed to using ACI-24 to induce an immune response. As of December 31, 2023, in this patent family, the company owned approximately 29 issued patents and 4 pending patent applications in 30 countries. With respect to the U.S., it owned two issued U.S. patents. The issued patents in this patent family, if the appropriate maintenance, renewal, annuity, or other governmental fees are paid, are expected to expire in 2026, excluding any additional term for patent term adjustments or patent term extensions.
The company’s patent portfolio for ACI-24 also includes a patent family directed to the use of the ACI-24 active immunotherapy in the treatment and/or prevention of memory and/or cognitive impairments or abnormalities in the DS population, among others. As of December 31, 2023, in this patent family, the company owned approximately 14 issued patents and 5 pending patent applications in 18 countries. Issued patents in this patent family, if the appropriate maintenance, renewal, annuity, or other governmental fees are paid, are expected to expire in 2032, excluding any additional term for patent term adjustments or patent term extensions.
The company’s patent portfolio for ACI-24 also includes a patent family relating to therapeutic anti-Abeta treatment claims (including claims directed to a pharmaceutical composition comprising an antigenic peptide), and claims directed to using such active immunotherapies in treating, preventing, inducing a protective immune response against, or alleviating the symptoms associated with an Abeta-associated disease in a subject, among others. As of December 31, 2023, in this patent family, the company owned one issued U.S. patent and approximately 34 pending patent applications in 32 countries. Any issued patents in this patent family, if the appropriate maintenance, renewal, annuity, or other governmental fees are paid, are expected to expire in 2039, excluding any additional term for patent term adjustments or patent term extensions.
ACI-7104
The company’s patent portfolio relating to ACI-7104 includes patents and patent applications with composition-of-matter claims (including claims directed to the peptide, as well as pharmaceutical formulations comprising the peptide), and claims directed to the use of compounds comprising the peptide in treating or preventing synucleinopathies, including PD and MSA.
The company’s patent portfolio relating to ACI-7104 includes patents and patent applications that it owns in two different patent families. As of December 31, 2023, in these patent families, the company owned approximately 16 issued patents and 16 pending patent applications, in 11 countries. With respect to the U.S., it owned three issued U.S. patents. Issued patents in the basic patent family, if the appropriate maintenance, renewal, annuity, or other governmental fees are paid, are expected to expire in 2029, excluding any additional term for patent term adjustments or patent term extensions.
PI-2620
The company’s patent portfolio relating to PI-2620 includes patent applications with claims directed to composition of matter (including claims directed to the molecule, its precursor and a diagnostic composition comprising such molecule), claims directed to diagnosis of certain indications using PI-2620, including AD and PSP, and claims directed to a method of manufacturing PI-2620, among others.
The company’s patent portfolio relating to PI-2620 includes patent applications that it owns or co-owns in three different patent families. As of December 31, 2023, the company owned or co-owned 12 patents and approximately 6 patent applications in 16 countries in its main patent family directed to the PI-2620 molecule, its precursor, and methods of using the PI-2620 to diagnose certain indications, including AD and PSP. This main patent family includes one issued U.S. patent. If the appropriate maintenance, renewal, annuity, or other governmental fees are paid, national-stage applications claiming priority from this PCT patent application, if issued, are expected to expire in 2037, excluding any additional term for patent term adjustments or patent term extensions.
ACI-12589
The company’s patent portfolio relating to a-syn diagnostics includes composition of matter claims (including claims directed to the ACI-12589 molecule, its precursor, and diagnostic compositions comprising the molecule), and claims directed to use of the molecule in imaging and in diagnostics of a-synucleinopathies, including PD and MSA.
The company’s patent portfolio relating to a-syn diagnostics includes patents and patent applications that it owns in ten different patent families. As of December 31, 2023, the company owned or co-owned approximately 17 patent applications in 17 countries in its main patent family directed to the ACI-12589 molecule, its precursor, diagnostic compositions, and methods of using ACI-12589 for imaging and diagnostics of a-synucleinopathies, including PD and MSA. If the appropriate maintenance, renewal, annuity, or other governmental fees are paid, any issued patents are expected to provide protection up to 2041, excluding any additional term for patent term adjustments or patent term extensions.
Morphomer Tau
The company’s patent portfolio relating to Morphomer Tau therapeutics includes patent applications with claims directed to composition of matter (including claims directed to the molecule, a pharmaceutical composition comprising such molecule and a mixture comprising such molecule), and claims directed to prevention and treatment of certain indications using such molecules, including AD and PSP, among others.
The company’s patent portfolio relating to the Morphomer Tau therapeutic program includes patent applications that it owns or co-owns in four different patent families. As of December 31, 2023, the company owned approximately 10 pending patent applications and 6 issued patents, including one U.S. issued patent in its main patent family directed to the ACI-3024 small molecule Tau aggregation inhibitor. If the appropriate maintenance, renewal, annuity, or other governmental fees are paid, national-stage applications claiming priority from this PCT patent application, if issued, are expected to expire in 2039, excluding any additional term for patent term adjustments or patent term extensions.
Semorinemab
The company’s global patent portfolio relating to semorinemab includes patents and patent applications with claims directed to compositions of matter, methods of treatment for certain indications, including AD, and methods of use, among others.
Crenezumab
The company’s patent portfolio relating to crenezumab includes patents and patent applications with claims directed to composition of matter (including claims directed to the crenezumab antibody or a fragment thereof, a polynucleotide encoding the crenezumab antibody or a fragment thereof, a cell line used to produce the crenezumab antibody, as well as pharmaceutical compositions comprising the crenezumab antibody), claims directed to treating certain indications using the crenezumab antibody, including AD, claims directed to a method of manufacturing the crenezumab antibody and claims directed to diagnostic and prognostic uses of the crenezumab antibody.
The company’s patent portfolio relating to crenezumab includes patents and patent applications that it owns or co-owns in four different patent families. As of December 31, 2023, the company owned or co-owned approximately 51 patents (not including the patents in the individual countries where the issued European patent was validated) and 13 patent applications in 34 countries in its main patent family directed to the crenezumab antibody and methods of using the crenezumab antibody to treat certain indications, including AD. This patent portfolio includes three issued U.S. patents and one pending U.S. patent applications, which, if the appropriate maintenance or other governmental fees are paid, are expected to expire in 2027, excluding any additional term for patent term adjustments or patent term extensions. This patent portfolio also includes a PCT patent application that was filed on July 13, 2007. If the appropriate maintenance, renewal, annuity, or other governmental fees are paid, national-stage applications claiming priority from this PCT patent application, if issued, are expected to expire in 2027, excluding any additional term for patent term adjustments or patent term extensions.
Research and Development
The company’s research and development expenses were CHF 54.6 million for the year ended December 31, 2023.
Government Regulations
Besides informal conversations with the authorities, the company’s regulatory department has conducted several pre-Investigational New Drug (pre-IND), Type B and Type C meetings with the Food and Drug Administration (FDA) (ACI-24.060 for AD and DS, ACI-7104.056 and PI-2620) and Scientific Advice meetings, which are the European equivalent of pre-IND meetings (with the German Paul-Ehrlich-Institut, Swedish Medical Products Agency; UK Medicine & Healthcare Products Regulatory Agency, Finnish Medicines Agency, the Spanish Agency of Medicines and Medical Devices and the EMA). Furthermore, the company’s regulatory department successfully applied for and obtained FDA Fast Track designation for ACI-24.060 in AD.
History
AC Immune SA was founded in 2003. The company was incorporated as a Swiss limited liability company (societe à responsabilite limitee) in February 2003 and transformed into a Swiss stock corporation (societe anonyme) under the laws of Switzerland in August 2003.
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