|·||A non-exclusive research and development agreement with Biogen signed in April 2016 to collaborate in the research and early
clinical development of our alpha-synuclein PET Tracer program for Parkinson’s disease and other synucleinopathies, and a
second program for the identification, research and development of novel PET ligands against TDP-43, a protein recently linked
to neurodegeneration in diseases such as amyotrophic lateral sclerosis. This collaboration is expiring in April 2019. AC Immune
has identified an alpha-synuclein PET lead candidate and will commence clinical development in H1 2019.|
|·||AC Immune entered into a research collaboration agreement with Essex Bio-Technology Limited signed in May 2017 to collaborate
in the research and early clinical development of a new therapeutic agent targeting basic Fibroblast Growth Factor for the treatment
of neurodegenerative and neuroinflammatory diseases.|
|·||AC Immune entered into a license agreement with Eli Lilly and Company to research and develop Tau Morphomer
small molecules for the treatment of Alzheimer’s disease and other neurodegenerative diseases in December 2018. The agreement
was deemed effective on January 23, 2019. AC Immune may become eligible to receive payments up to approximately CHF 1.8 billion,
Further information concerning details
of AC Immune’s agreements and collaborations can be found under Item 5: Operating and Financial Review and Prospects.
The biopharmaceuticals industry is highly
competitive across all therapeutic fields. In the field of neurodegenerative diseases, there are many public and private companies
or institutions that are actively engaged in the discovery and development of therapeutic and diagnostic products. Some of these
products may have a similar target to our product candidates or address similar markets. The industry is still in its infancy in
terms of defining the pathology of neurodegenerative diseases. As disease understanding progresses, the number of novel product
candidates may well increase and broaden the therapeutic and diagnostic options in our product markets.
Currently, there are no approved disease-modifying
products for AD or any other neurodegenerative disease. Current approved therapies seek to treat the symptoms of AD, such as cognitive
decline, but do not slow or stop the progression of the disease. In addition, commonly, there is off-label prescription of antidepressant
and antipsychotic agents for more advanced AD patients who may suffer from agitation, aggressive behaviors, psychosis and depression.
No new drugs have been approved for the treatment of AD since 2003.
We expect there to be several classes of
disease-modifying agents that will enter the AD market. One target for monoclonal antibodies is pathological Tau protein. Therapeutic
vaccines are a second class of disease-modifying therapies, and include our candidate products ACI-24, that targets Abeta plaque,
and ACI-35, that targets aggregated Tau protein.
The availability of novel diagnostic agents
to visualize the disease development in AD patients is critical for successful clinical development of disease-modifying products
in AD. At the forefront of this new diagnostic effort are PET agents for in-life imaging of disease, and in particular, Tau-targeting
PET agents which we believe will allow precise assessment of disease AD patients.
Crenezumab: Crenezumab is
the first monoclonal antibody candidate that targets Abeta in cognitively healthy individuals with risk of developing familial
AD. However, Biogen’s aducanumab, Lilly’s solanezumab and Roche’s gantenerumab are being evaluated in presymptomatic
ACI-24 in AD: ACI-24, if
approved, would compete with other approved anti-Abeta-targeting therapeutic vaccines. Several potential competing product candidates
have not continued through the regulatory approval process, including ACC-001 (Janssen / Pfizer) and AN-1792 (Elan / Janssen),
both of which were discontinued after completing Phase 2 studies. Other potential competing product candidates for ACI-24 include
ABvac 40 (Araclon Bioscience) which is currently evaluated in a Phase 2 study; Novartis is currently conducting a Phase 2/3 study
with CAD-106. Lundbeck is also currently evaluating Lu AF20513 in a Phase 1 clinical trial and United Therapeutics is developing
UB311, which is in a Phase 2 study.