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AC Immune, SA a switzerland-based biotech NASDAQ: ACIU

https://www.acimmune.com/
 
 


We are a clinical stage biopharmaceutical company leveraging our two proprietary technology platforms to discover, design and develop novel, proprietary medicines for prevention, diagnosis and treatment of neurodegenerative diseases associated with protein misfolding. We execute a clear strategy around the three pillars of Alzheimer's disease, other significant and neuro-orphan indications and diagnosis.

Our two proprietary technology platforms allow us to discover, design and develop antibodies, small molecules and vaccines. These platforms are the engines for our diverse pipeline of product candidates, which currently consists of nine therapeutic product candidates with four in clinical trials and three diagnostic candidates. 

Alzheimer's disease

Alzheimer’s disease (AD) is a devastating neurodegenerative disease of the central nervous system which is responsible for 60-80% of all cases of dementia and progressively destroys the cognitive abilities of its victims. 
Alzheimer’s is one of the biggest burdens of society with a dramatic and growing worldwide incidence rate of one new case every three seconds, or 9.9 million new cases of dementia each year. Since the incidence and prevalence of AD increase with age, the number of patients will grow significantly as society gets older. Worldwide in 2015 there are 46.8 million people living with dementia and by 2050 it is expected that global patient numbers will triple to 131.5 million. It is estimated that the annual societal and economic cost of dementia has risen from US$ 604 billion in 2010 to US$ 818 billion in 2015.  In the US, AD is now the 6th leading cause of death across all ages and is the fifth leading cause of death for those aged 65 and older.

It is becoming increasingly clear that AD develops because of a complex series of events that take place in the brain over a long period of time. Two proteins - Tau and beta-amyloid (Abeta) - are recognized as major hallmarks of neurodegeneration: tangles and other abnormal forms of Tau protein accumulate inside the brain cells and spread between cells, while plaques and oligomers formed by Abeta occur outside the brain cells of people with Alzheimer’s.
Today though, AD is typically diagnosed by neurologists and psychiatrists through a series of cognitive and functioning tests once symptoms are already clinically present. This results in a diagnosis at later stages of the disease where irreversible loss of neurons has already occurred. An early diagnosis with imaging methods and biomarkers is therefore crucial and is expected to translate into earlier treatment with better outcome for the patients and offer the possibility to look into disease prevention.
Currently approved treatments only include medications that help relieve the symptoms of the disease but do not treat the underlying causes of the disease. The clinical benefit derived is typically incomplete and only improves the patient’s symptoms for a short period of time underlining the urgent medical need of disease modifying treatments. Such disease modifying treatments are expected to have a major impact for the patients as they will considerably slow the cognitive decline. The benefit for the patients will increase if the treatment can start earlier in the disease course, ideally even before symptoms start to appear.
AC Immune’s therapeutic and diagnostic agents are at the forefront of fighting against one of the world’s greatest healthcare challenges – the need to develop reliable and accurate diagnostics and disease modifying treatments to improve the lives of patients suffering from Alzheimer’s and other neurodegenerative diseases. 

 

R&D strategy

Misfolded proteins are leading causes of neurodegenerative diseases

The progression of neurodegenerative diseases, such as Azheimer’s and Parkinson’s disease are all associated with pathologies that involve misfolded proteins. Research has shown that misfolded proteins, such as Abeta, Tau and α-synuclein are unable to carry out their normal functions and aggregate to form certain types of deposits that damage brain tissue.
In today’s understanding, these misfolded proteins play a key role in the pathology of neurodegenerative diseases (see diagram below). Typically, protein misfolding occurs during cellular stress, which can be triggered by many different causes, including oxidation and a lack of growth factors. A cascade of molecular events begins with the misfolding of single proteins within a cell that then continue to aggregate to ultimately form e.g. plaques (Abeta), tangles (Tau) and Lewy bodies (α-synuclein). These misfolded proteins are then exported and spread to healthy cells nearby, causing normal proteins to misfold in a process known as seeding. This process leads to cell death in various areas of the brain and is linked to a decline in cognitive function in patients with Alzheimer’s.

Image result for Brain

 

 Challenges in targeting misfolded proteins

The central challenge in targeting misfolded proteins for the development of effective therapeutics and diagnostics is a product’s ability to differentiate, or conformationally select, between a misfolded protein and a normally-folded protein. The ability to create medicines that are highly specific for only the misfolded forms of the proteins reduce the risk of side effects and are central to the development of effective therapeutics for neurodegenerative diseases.

AC Immune’s approach

We use our two unique proprietary platform technologies, SupraAntigen™and Morphomer™, to discover, design and develop disease modifying therapeutics and diagnostics to target misfolded proteins. The technology platforms are our engines for generating novel antibodies, vaccines and small molecules that are designed to bind to their targets with high affinity and conformational specificity. All of our products and our development programs have been derived from our proprietary platforms.

Technology platforms

Our two proprietary technology platforms are product focused and highly productive engines for the sustained growth of our Company.
Our biological SupraAntigenTM  and chemical MorphomerTM platforms are our scientific basis to generate a robust pipeline of antibodies, vaccines and small molecules which selectively bind to misfolded proteins representing the underlying causes of a broad range of neurodegenerative diseases. 

 

SupraAntigen™ platform

Immunotherapy against conformation specific targets

The SupraAntigen™ technology platform was initially developed by our co-scientific founders, Dr. Claude Nicolau in collaboration with Dr. Fred van Leuven to solve the problem of the lack of immunogenicity of “self” proteins. This technology generates conformation specific antibodies and is used to create products for active immunization (vaccines) and passive immunization (antibodies).



 

Active immunization

The vaccine product approach is based on the ability of peptide antigens attached to liposomes to elicit the body’s own immune system to produce antibodies against “self”-proteins. The vaccines are composed of synthetic peptides and liposomal anchors to mimic the pathological conformation of the antigen, an adjuvant to enhance the immunogenicity and liposomes as carriers for the peptides and adjuvant. The key features of the vaccines derived from this platform include the high selectivity for conformational targets and a favorable safety profile due to a T-cell independent mechanism of action that does not trigger T-cell correlated inflammation.

The anti-Abeta vaccine ACI-24, currently in Phase 1/2a clinical trials, and the anti-pTau vaccine ACI-35, currently in a Phase 1b clinical study, were derived from the active immunization approach of the SupraAntigen™ platform.

Passive immunization

Our SupraAntigen™ platform can also be used to generate antibodies that can be used as therapeutic and diagnostic products. Such antibodies are generated by injecting the SupraAntigen constructs in mice and by selecting the antibodies for their ability to break up aggregated forms of misfolded proteins and to change the equilibrium from the insoluble pathological to the soluble forms which are depleted by the antibodies.

The anti-Abeta antibody Crenezumab, in two phase 3 clinical trials , and the anti-Tau antibody in a phase 2 clinical trial were derived from the passive immunization approach of the SupraAntigen™ platform.

 

Morphomer™ platform

Generation of conformation specific small molecules
 

 The Morphomer™ technology platform was initially developed through a collaboration of our co-scientific founders Dr. Jean-Marie Lehn and Dr. Claude Nicolau. The rational chemical design enables us to generate small molecules, so called Morphomers, which bind very specifically to misfolded proteins, break up neurotoxic aggregates and inhibit their aggregation and seeding. Other key assets of the robust library of Morphomers include promising CNS drug features such as excellent brain penetration, bioavailability and metabolic stability which are important for the development of both therapeutic and diagnostic agents for multiple neurodegenerative diseases.

Three therapeutic (Morphomer Tau, Morphomer Abeta and Morphomer α-syn) and two diagnostic development candidates (Tau-PET imaging agent and α-syn-PET imaging agent) originate from the Morphomer™ technology platform.



 
 

Intellectual property

We have built a strong intellectual property portfolio to protect both our technology platforms and our therapeutic and diagnostic products.
Patent applications have been filed that cover the SupraAntigen™ and Morphomer™ technology as well as composition of matter and disease-specific and product–specific applications of those technologies. The company’s patents and applications are extensive and are grouped into more than 43 patent families.
AC Immune has about 303 pending patent applications and more than 266 granted patents to date.


 
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Crenezumab
PASSIVE ALZHEIMER'S DISEASE IMMUNOTHERAPY TARGETING ABETA
Crenezumab is a fully humanized IgG4 monoclonal antibody that binds all forms of misfolded Abeta proteins, with a higher affinity to Oligomers, to prevent and break up Abeta aggregation and promote the disaggregation of existing Abeta aggregates including plaques. The IgG4 subclass is designed to reduce the effector function of microglia and to clear Abeta from the brain while limiting inflammation, thereby suggesting a favorable safety profile. Crenezumab was discovered at AC Immune using the SupraAntigenTMplatform and out-licensed to Genentech in 2006, a company with a long standing history of developing and commercializing innovative biologics.

 

ACI-24
ACTIVE ALZHEIMER'S DISEASE IMMUNOTHERAPY TARGETING ABETA
ACI-24 is a liposomal therapeutic anti-Abeta vaccine, discovered utilizing our SupraAntigenTM technology platform and is wholly owned by AC Immune.
The vaccine is designed to stimulate a patient’s immune system to produce antibodies that specifically target the oligomeric and fibrillary Abeta proteins to prevent beta amyloid plaque accumulation and to enhance plaque clearance. Preclinical data demonstrate a significant activity in plaque reduction and memory restoration as well as a favorable safety profile characterized by a lack of local inflammation and a mode of action independent of inflammatory T-cells.


ACI-35
ACTIVE ALZHEIMER’S DISEASE IMMUNOTHERAPY TARGETING pTau

ACI-35 is a liposomal, therapeutic anti-pTau vaccine, discovered utilizing our SupraAntigenTM platform and was outlicensed to Janssen Pharmaceuticals in 2015.
The vaccine is designed to stimulate a patient’s immune system to produce antibodies against the misfolded and phosphorylated pathogenic forms of Tau protein. Those pathogenic forms of Tau aggregate to create neurofibrillary tangles which represent one of the major hallmarks of Alzheimer’s disease. In preclinical testing the vaccine induced an antibody response that was highly specific to pathogenic Tau and resulted in a reduction of both misfolded and phosphorylated Tau as well as in an improvement in cognitive clinical parameters. ACI-35 has a T-cell independent mechanism of action suggesting a favorable safety profile.


Anti-Tau antibody
The anti-Tau monoclonal antibody program was outlicensed to Genentech in 2012 and comprises monoclonal humanized antibodies which are specific for pathological Tau.
An antibody known as RO7105705 is in Phase 2 clinical study to assess its safety, tolerability and efficacy in people with prodromal-to-mild Alzheimer’s disease, the trial is conducted by Genentech.  RO7105705 is an IgG4 humanized anti-Tau monoclonal antibody with  a high specificity for pathological Tau and  designed to intercept the cell-to-cell spread of pathological Tau in the extracellular space of the brain.

Morphomer Tau
SMALL MOLECULE FOR ALZHEIMER’S DISEASE TREATMENT
The Morphomer Tau program discovers small molecules that are designed to inhibit the aggregation and seeding process of misfolded proteins and promote the disaggregation of already formed protein aggregates. Preclinical studies suggest reduction of pathological Tau aggregates leading to memory improvement.

ACI-24
ACTIVE IMMUNOTHERAPY TARGETING ABETA IN DOWN SYNDROME

The liposomal therapeutic vaccine ACI-24 is also being investigated in a phase 1b trial for the prevention of cognitive decline in people with Down syndrome. Individuals with Down syndrome have an extra copy of chromosome 21, the chromosome on which the gene for amyloid precursor protein resides, leading to Abeta accumulation. These individuals develop AD-like characteristics at a rate three to five times greater than that of the general population and at a much younger age. AD-like characteristics develop in more than 98% of people with DS over age 40 with up to 80% developing associated dementia over the age of 60. Preclinical studies demonstrated the reduction of Abeta level and compelling memory enhancement.

Morphomer Abeta
SMALL MOLECULE FOR GLAUCOMA PREVENTION
Misfolded Abeta is reportedly involved in the retinal disease glaucoma, a major cause of irreversible blindness worldwide representing an important opportunity for our Morphomer Abeta program. Preclinical studies have shown a strong ability to protect the eyes exposed to ocular pressure and chronic ocular hypertension which are clinical features of glaucoma. 

Morphomer a-syn
SMALL MOLECULE FOR PARKINSON’S DISEASE TREATMENT
Misfolded and aggregated α-synuclein is a key protein involved in the pathology of Parkinson’s disease. Preclinical studies show significant reduction of Lewy body like structures combined with promising CNS drug features.

Anti a–syn antibody
(not shown in chart)

Alpha-synuclein is an established target for Parkinson’s disease and other Lewy body diseases, while TDP-43 is a recently identified target of growing interest for neuro-orphan indications such as Frontotemporal Lobar Degeneration. Interestingly, both targets also play an important role in other significant neurodegenerative indications such as Alzheimer’s disease, beyond the established hallmarks of Abeta and Tau. These two latest antibody programs were discovered using the company’s proprietary SupraAntigen™ platform and have unique binding properties to only the pathological forms of alpha-synuclein and TDP-43 respectively. 

Anti TDP-43 antibody
(not shown in chart)

Alpha-synuclein is an established target for Parkinson’s disease and other Lewy body diseases, while TDP-43 is a recently identified target of growing interest for neuro-orphan indications such as Frontotemporal Lobar Degeneration. Interestingly, both targets also play an important role in other significant neurodegenerative indications such as Alzheimer’s disease, beyond the established hallmarks of Abeta and Tau. These two latest antibody programs were discovered using the company’s proprietary SupraAntigen™ platform and have unique binding properties to only the pathological forms of alpha-synuclein and TDP-43 respectively. 

Tau-PET imaging agent
It is now well established that Tau correlates well with cognitive decline and disease progression making it a potential strong target for diagnostic approaches. Morphomers with high specificity for the pathological forms of Tau and outstanding PET tracer profiles have been identified. The Tau-PET imaging agent program was outlicensed to Piramal Imaging in 2014.

In-vitro diagnostics
Anti-Abeta and anti-Tau antibodies are used to develop in vitro diagnostics for blood and cerebrospinal fluid. 

a-syn-PET imaging agent
α-synuclein is a key protein involved in the pathology of Parkinson’s disease. Morphomers with good selectivity and high affinity for α-synuclein and promising properties as PET ligands have been identified. The research is funded by a grant of The Michael J. Fox Foundation for Parkinson’s research. An R&D collaboration to further develop such an alpha-synuclein-PET tracer was signed with Biogen in 2016.

 

 

 

 




 
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ACIU News: AC Immune Awarded Third Follow-up Grant from The Michael J. Fox Foundation for First-in-Human Study of a Positron Emission To... 11/15/2018 04:01:20 AM
ACIU News: Report of Foreign Issuer (6-k) 11/13/2018 06:09:59 AM
ACIU News: AC Immune Reports Third Quarter 2018 Financial Results and Corporate Update 11/13/2018 04:01:04 AM
ACIU News: AC Immune to Present at the Jefferies 2018 London Healthcare Conference 11/12/2018 04:01:17 AM
ACIU News: AC Immune Shares Insights from Key Opinion Leader Meeting on Abeta Oligomers in Alzheimer's Disease (AD) and Other Misfolded ... 11/09/2018 04:01:02 AM
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#24   WOW! 3 consecutive prs recently. This is getting corpus 11/04/18 12:31:58 AM
#23   AC Immune Announces Important Clinical Milestones for ACI-24 corpus 08/21/18 09:29:24 PM
#22   ACIU is getting back on track looks like,up novicetrader 08/06/18 10:56:35 AM
#21   Bought some @9.75 today.Odd that it was nicely novicetrader 08/02/18 09:06:11 PM
#20   You're right. Oversold! on Positive data even??? Truly corpus 08/01/18 10:41:02 AM
#19   Is this 2 day drop overdone?It's now much novicetrader 07/27/18 07:27:33 PM
#18   WOW! Awesome move today! Next week's sentiment should corpus 07/20/18 05:45:40 PM
#17   AC Immune (NASDAQ: ACIU) MILESTONES/HISTORY corpus 07/08/18 12:29:37 PM
#16   Awesome move last Friday. Yes, been quiet for corpus 07/08/18 12:25:25 PM
#15   Stealth mode indeed. Not even “profiled” as a jimmy667 07/07/18 10:45:51 AM
#14   This is very well kept in stealth-mode. Great corpus 07/04/18 02:50:50 PM
#13   Awesome news today! corpus 03/15/18 11:18:22 AM
#12   SEC form sc13g/a filed. Looking good! corpus 02/14/18 01:07:03 PM
#11   Good NEWS! Today...AC IMMUNE COMPLETES RECRUITMENT FOR LOW-DOSE corpus 09/12/17 09:22:28 AM
#10   We are approaching the lowest price for ACIU billmick11 07/19/17 07:00:34 PM
#9   GOOD LUCK! corpus 04/11/17 11:40:29 AM
#8   On watch, probably won't jump in until after T695 04/02/17 11:02:14 AM
#7   Added more today. Great pipeline. corpus 03/24/17 11:27:09 AM
#6   ACIU bearish 12.22 stocktrademan 11/29/16 10:49:55 AM
#5   End of quiet period....should be interesting. Just took T695 11/23/16 08:20:40 AM
#4   On watch for entry. Solid fundamentals here T695 11/07/16 12:18:47 PM
#3   Wow! This is a beast! Unstoppable! $$$ corpus 09/28/16 04:13:59 PM
#2   Looking Good here $$$ :) corpus 09/27/16 03:08:55 PM
#1   I got my Long Term position of 1000 corpus 09/26/16 01:41:35 PM
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