We use cookies in order to analyze traffic of this website. Your further use of this website will be considered consent. For more information visit our Cookie Policy.

AD Treatment and Prevention

Crenezumab

Passive Alzheimer's disease immunotherapy targeting Abeta

Crenezumab is a fully humanized IgG4 monoclonal antibody that binds all forms of misfolded Abeta proteins 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 SupraAntigenTM platform and out-licensed to Genentech in 2006, a company with a long standing history of developing and commercializing innovative biologics.

In 2014 Genentech disclosed data from the phase 2 studies ABBY (cognition study,431 patients) and BLAZE (biomarker study, 91 patients) showing potential clinical activity paired with a favorable safety profile. The milder patient subset in ABBY (MMSE 22-26) exhibited a 35.4 percent reduction in cognitive decline (p=0.036), measured by the 12-item cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-cog12). Those data were replicated in the mild patient subset (MMSE 20-26) of BLAZE with a 52 percent reduction in cognitive decline (p=0.29). A positive trend in reduction in functional decline was observed in both studies. The analysis of the PET data with white matter reference suggest a reduction of amyloid accumulation. One case of ARIA-E was observed in a person who received IV crenezumab in the ABBY study. No cases of ARIA-E were reported in the ABBY placebo arm, nor in either arm of the BLAZE study.

In 2015 Genentech decided to move crenezumab into phase 3 clinical development in people with prodromal-to-mild Alzheimer’s disease which staretd beginning of 2016.The design of the pivotal clinical trial program  builds upon today’s significantly better understanding of Alzheimer’s disease pathology. We strongly believe that crenezumab has the potential to be one of the most promising therapies for this major global disease.

Currently multiple clinical trials are ongoing to further explore potential benefit of crenezumab for the treatment and prevention of Alzheimer’s disease including the first-ever Alzheimer’s disease prevention trial. The trial, a $100 million collaboration between the National Institutes of Health, the Banner Alzheimer’s Disease Institute and Genentech, is the cornerstone of the global Alzheimer’s Prevention Initiative. Crenezumab is being administered pre-symptomatically to 300 members of an extended Columbian family of which 200 members carry a mutation that causes early-onset Alzheimer’s disease. 

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-24 is currently in a phase 1/2a clinical study in patients with mild to moderate Alzheimer’s disease.

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.

ACI-35 is currently in a clinical phase 1b study in patients with mild to moderate Alzheimer’s disease. It is the first vaccine against phosphorylated pathological Tau to reach this stage of development by any company. 

Anti-Tau antibody

The anti-Tau monoclonal antibody program was outlicensed to Genentech in 2012 and comprises monoclonal humanized antibodies which  specific for pathological Tau.
 

A phase 1 clincial study in people with mild to moderate Alzheimer's disease and healthy volunteers to study safety, tolerability and pharmacokinetics of the anti-Tau antibody is being conducted by Genentech. 

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.

Crenezumab (anti-Abeta antibody)
AD treatment
Phase 3
Biologics
AD prevention
Phase 2
Biologics
ACI-24 (anti-Abeta vaccine)
AD treatment
Phase 2
Biologics
ACI-35 (anti-pTau vaccine)
AD treatment
Phase 1
Biologics
Anti-Tau antibody
AD treatment
Phase 1
Biologics
Morphomer Tau (Tau inhibitor)
AD treatment
Discovery
Small molecules

Crenezumab

anti-Abeta antibody

Crenezumab is a fully humanized IgG4 monoclonal antibody that binds all forms of misfolded Abeta proteins 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 SupraAntigenTM platform and out-licensed to Genentech in 2006, a company with a long standing history of developing and commercializing innovative biologics.

In 2014 Genentech disclosed data from the phase 2 studies ABBY (cognition study,431 patients) and BLAZE (biomarker study, 91 patients) showing potential clinical activity paired with a favorable safety profile. The milder patient subset in ABBY (MMSE 22-26) exhibited a 35.4 percent reduction in cognitive decline (p=0.036), measured by the 12-item cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-cog12). Those data were replicated in the mild patient subset (MMSE 20-26) of BLAZE with a 52 percent reduction in cognitive decline (p=0.29). A positive trend in reduction in functional decline was observed in both studies. The analysis of the PET data with white matter reference suggest a reduction of amyloid accumulation. One case of ARIA-E was observed in a person who received IV crenezumab in the ABBY study. No cases of ARIA-E were reported in the ABBY placebo arm, nor in either arm of the BLAZE study.

In 2015 Genentech decided to move crenezumab into phase 3 clinical development in people with prodromal-to-mild Alzheimer’s disease which staretd beginning of 2016.The design of the pivotal clinical trial program  builds upon today’s significantly better understanding of Alzheimer’s disease pathology. We strongly believe that crenezumab has the potential to be one of the most promising therapies for this major global disease.

Currently multiple clinical trials are ongoing to further explore potential benefit of crenezumab for the treatment and prevention of Alzheimer’s disease including the first-ever Alzheimer’s disease prevention trial. The trial, a $100 million collaboration between the National Institutes of Health, the Banner Alzheimer’s Disease Institute and Genentech, is the cornerstone of the global Alzheimer’s Prevention Initiative. Crenezumab is being administered pre-symptomatically to 300 members of an extended Columbian family of which 200 members carry a mutation that causes early-onset Alzheimer’s disease. 

ACI-24

anti-Abeta vaccine

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-24 is currently in a phase 1/2a clinical study in patients with mild to moderate Alzheimer’s disease.

ACI-35

anti-pTau vaccine

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.

ACI-35 is currently in a clinical phase 1b study in patients with mild to moderate Alzheimer’s disease. It is the first vaccine against phosphorylated pathological Tau to reach this stage of development by any company. 

Anti-Tau antibody

The anti-Tau monoclonal antibody program was outlicensed to Genentech in 2012 and comprises monoclonal humanized antibodies which  specific for pathological Tau.
 

A phase 1 clincial study in people with mild to moderate Alzheimer's disease and healthy volunteers to study safety, tolerability and pharmacokinetics of the anti-Tau antibody is being conducted by Genentech. 

Morphomer Tau

Tau inhibitor

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.