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Genentech to Present New Data Demonstrating the Breadth and Depth of Its Alzheimer's Program at the Upcoming Alzheimer's Association International Conference (AAIC)

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  • Late-breaking Phase II exploratory analysis of investigational
    crenezumab to show impact on beta amyloid oligomer levels in cerebral
    spinal fluid (CSF)
  • Two-year open-label extension updates for investigational gantenerumab
    will include data on effects of higher doses in reducing amyloid PET
    load and long-term safety

Genentech, a member of the Roche Group ((SIX: RO, ROG, OTCQX:RHHBY),
announced today that it will present 16 new data presentations across
its Alzheimer's disease (AD) pipeline at this year's Alzheimer's
Association International Conference (AAIC) from July 22-26 in Chicago,
Illinois. Roche and Genentech's AD pipeline includes two late-stage
investigational molecules, crenezumab and gantenerumab, which are both
in Phase III clinical trials, and an anti-tau molecule in Phase II.

"The range of data that Roche and Genentech are presenting at AAIC is a
testament to our commitment to bring new treatments to help the many
millions of people living with Alzheimer's disease," said Sandra
Horning, M.D., chief medical officer and head of Global Product
Development.

In a late-breaking session, an exploratory analysis is being presented
on crenezumab from the completed Phase II BLAZE and ABBY clinical trials
that will show the impact of crenezumab treatment over the whole trial
duration on beta amyloid oligomer levels in cerebrospinal fluid (CSF) in
people with mild to moderate AD. Baseline data from the CREAD 1 study in
prodromal to mild AD will also be presented. Crenezumab is an
investigational, monoclonal antibody designed to preferentially bind to
and promote removal of oligomers, a form of beta amyloid.

Additionally, updates from open-label extension studies of gantenerumab,
including data on the effects of higher doses of gantenerumab in
reducing amyloid PET load at 24 months, as well as long-term safety
data, will be presented. Data on the effects of low doses of
gantenerumab on amyloid and tau biomarkers in CSF will also be
presented. Gantenerumab is an investigational, monoclonal antibody
designed to bind to aggregated beta amyloid and remove beta amyloid
plaques. Two recently initiated Phase III GRADUATE clinical studies are
evaluating the safety and efficacy of gantenerumab for the treatment of
early AD.

The full range of data from Roche and Genentech's Alzheimer's clinical
development program, including investigational medicines and
diagnostics, being presented at AAIC include:

Investigational
Medicine

  Abstract Title  

Abstract Number (type),
Presentation Date, Time

Crenezumab  

LATE BREAKER: Target Engagement in an AD Trial: Crenezumab Lowers
Aβ Oligomer Levels in CSF

 

DT-02-03 (platform),
Wednesday,
July 25, 2018,
4:45-5:00
PM CDT

  Baseline Characteristics from a Phase 3 Trial of Crenezumab in
Prodromal to Mild Alzheimer's Disease (CREAD)
 

O1-02-04 (platform),
Sunday,
July 22, 2018,
8:45
AM-9:00 AM CDT

Gantenerumab   The Effect of Low Doses of Gantenerumab on Amyloid and Tau
Biomarkers in Cerebrospinal Fluid (CSF) in the Marguerite Road Study
 

O1-09-02 (platform),
Sunday,
July 22, 2018,
2:15-2:30
PM CDT

  24-Month Amyloid PET Results of the Gantenerumab High-Dose Open
Label Extension Studies
 

O1-09-03 (platform),
Sunday,
July 22, 2018,
2:30-2:45
PM CDT

  Update on the Safety and Tolerability of Gantenerumab in the Ongoing
Open-Label Extension (OLE) of the Marguerite Road Study in Patients
with Mild Alzheimer's Disease (AD) after Approximately Two Years of
Study Duration
 

O1-09-04 (platform),
Sunday,
July 22, 2018,
2:45-3:00
PM CDT

  Update on the Safety and Tolerability of Gantenerumab in the Ongoing
Open-Label Extension of the Scarlet Road Study in Patients with
Prodromal Alzheimer's Disease after Approximately 2 Years of Study
Duration
 

O1-09-05 (platform),
Sunday,
July 22, 2018,
3:00-3:15
PM CDT

CSF Biomarkers   LATE BREAKER: Detecting Brain Amyloid Status Using Fully Automated
Plasma Aβ Biomarker Assays
 

DT-02-04 (platform),
Wednesday,
July 25, 2018,
5:00-5:15
PM CDT

  Analysis of Cerebrospinal Fluid (CSF) Biomarkers to Predict Risk of
Clinical Decline and Progression to Dementia in Patients with Mild
Cognitive Impairment and Mild Cognitive Symptoms
 

P3-267 (poster),
Tuesday,
July 24, 2018,
9:30
AM-4:15 PM CDT

  Multicenter Evaluation of the Analytical Characteristics of the
Elecsys® Total-Tau Cerebrospinal Fluid (CSF) and Elecsys®
Phospho-Tau (181P) CSF Immunoassays
 

P1-285 (poster),
Sunday,
July 22, 2018,
9:30
AM-4:15 PM CDT

  Technical Validation and Multicenter Evaluation of the Elecsys®
β-Amyloid 1–40 Prototype Immunoassay for Quantitation in
Cerebrospinal Fluid (CSF)
 

P1-272 (poster)
Sunday,
July 22, 2018,
9:30 AM-4:15
PM CDT

  A Unified Pre-Analytical Protocol for Handling of CSF Samples before
Analyses of AD Biomarker Levels
 

O2-09-02 (platform),
Monday,
July 23, 2018,
2:15-2:30
PM CDT

  CSF Biomarkers in the General Population: Associations with
Demographics and APOE Genotype
 

O2-04-05 (platform),
Monday,
July 23, 2018,
9:00-9:15
AM CDT

  Diagnostic Performance of Elecsys® Immunoassays for
Cerebrospinal Fluid Alzheimer's Disease Biomarkers in a Non-Academic
Multicenter Memory Clinic Cohort: the ABIDE Project
 

O2-09-03 (platform),
Monday,
July 23, 2018,
2:30-2:45
PM CDT

PET Tau Tracers   Tau Burden Measured Using [18F]GTP1 Correlates with CSF Tau
Phosphorylation at Sites T217 and T205 More Closely Than T181
 

O3-14-02 (platform),
Tuesday,
July 24, 2018,
4:30-4:45
PM CDT

 

Baseline Tau Burden Measured by [18F]GTP1 Imaging is Associated
with Subsequent Cognitive Decline in Prodromal to Mild Alzheimer's
Disease

 

P4-353 (poster),
Wednesday,
July 25, 2018,
9:30
AM-4:15 PM CDT

Non-Molecule   Estimand in Early Alzheimer's Disease: Progress Update from the
International Alzheimer's Disease Scientific Working Group (AD SWG)
Substream
 

P4-014 (poster),
Wednesday,
July 25, 2018,
9:30
AM-4:15 PM CDT

Follow Genentech on Twitter via @Genentech and keep up to date with AAIC
2018 news and updates by using the hashtag #AAIC18.

About crenezumab

Crenezumab is an investigational, monoclonal antibody designed to
preferentially bind to and promote removal of neurotoxic oligomers, a
form of beta amyloid. Crenezumab has an antibody backbone (IgG4)
designed to minimize the inflammatory response in the brain, which may
result in a lower risk of MRI abnormalities. It is currently being
studied in two Phase III, two-year, randomized, double-blind,
placebo-controlled, multicenter clinical trials (CREAD 1 and 2) in early
AD. Based on the learnings from two completed Phase II trials, the CREAD
studies are using higher doses of crenezumab and have enrolled people
with early AD who have confirmed AD pathology. These studies are now
fully enrolled. Crenezumab is also being studied in a landmark
Alzheimer's Prevention Initiative (API) trial of cognitively healthy
individuals in Colombia with an autosomal dominant mutation who are at
risk to develop early-onset AD. Crenezumab is being developed by Roche
and Genentech and was discovered by Swiss biotechnology company AC
Immune SA.

About gantenerumab

Gantenerumab is an investigational, monoclonal antibody designed to bind
to aggregated beta amyloid and remove beta amyloid plaques. It is being
investigated in two Phase III studies (GRADUATE 1 and 2) for the
treatment of early AD. In completed Phase III clinical studies,
gantenerumab removed beta amyloid plaques, which have been shown to be
toxic to the brain. Ongoing open-label extension studies have informed
the design of the GRADUATE program. The new studies, which are enrolling
people with early AD with confirmed AD brain pathology, include higher
doses of gantenerumab. The target dose is achieved through a titration
regimen to optimize safety. Gantenerumab is also being studied as part
of the DIAN-TU trial, a worldwide clinical study evaluating multiple
compounds in individuals at risk for or with a type of early-onset AD
caused by a genetic mutation. Gantenerumab is being developed by Roche
and Genentech and was identified and optimized by phage display
technology in cooperation with MorphoSys AG, a Munich-based Biotech.

About Alzheimer's disease

Alzheimer's disease is a progressive, fatal disease of the brain that
gradually destroys memory, thinking skills and problem solving and
impairs daily functioning such as the ability to manage one's own
activities. Biological changes are believed to start decades before
clinical symptoms of Alzheimer's disease become evident. In the early
stages (prodromal to mild dementia), people may have difficulty
remembering things, but daily function may or may not be impaired. In
the later stage of the disease, people increasingly become reliant on
others for even simple day-to-day tasks. Dementia affects 44 million
people worldwide with 7.7 million new cases each year, of which
Alzheimer's disease is the most common form. There is no cure for
Alzheimer's disease. Current treatments focus on alleviating symptoms
and are unable to stop Alzheimer's from progressing because they do not
affect the disease's underlying causes.

About Genentech in neuroscience

Neuroscience is a major focus of research and development at Genentech
and Roche. The company's goal is to develop treatment options based on
the biology of the nervous system to help improve the lives of people
with chronic and potentially devastating diseases. Roche has more than a
dozen investigational medicines in clinical development for diseases
that include multiple sclerosis, Alzheimer's disease, spinal muscular
atrophy, Parkinson's disease and autism.

About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology
company that discovers, develops, manufactures and commercializes
medicines to treat patients with serious and life-threatening medical
conditions. The company, a member of the Roche Group, has headquarters
in South San Francisco, California. For additional information about the
company, please visit http://www.gene.com.

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