ACI-24 in Down syndrome:
ACI-24 is the first disease-modifying vaccine candidate addressing AD in Down syndrome, with a potential preventive and therapeutic
application. While there are symptomatic treatments of Down syndrome in clinical development, to our knowledge there are currently
no other disease-modifying treatments in development for AD in Down syndrome.
ACI-35: ACI-35, if approved,
would compete with other approved Tau-targeting therapeutic vaccines. This includes AADvac1, being advanced by Axon Neuroscience.
It is an anti-Tau vaccine product candidate and is currently in a Phase 2 clinical trial to examine safety and efficacy in patients
with mild AD.
Anti-Tau Antibodies: The
anti-Tau antibody, designated RG6100 by Genentech, is one of several monoclonal antibodies in development targeting Tau to potentially
act as disease-modifying agents. Biogen is evaluating BIIB092 (licensed from Bristol-Myers Squibb) in a Phase 2 clinical trial
in PSP and AD. Abbvie is currently investigating ABBV-8E12 in AD and PSP in Phase 2 studies. BIIB-076 is currently developed by
Biogen/Neuroimmune in phase 1 study in healthy volunteers and AD patients.
Morphomer Tau: AC Immune
has developed the first small molecule targeting aggregated Tau with high selectivity for the target. The molecule will enter Phase
1 in 2019. To date, no other preclinical molecule with these characteristics is in development according to out information.
alpha-synuclein and TDP-43 antibodies:
Several alpha-synuclein antibodies are currently in development; Biogen entered Phase 2 with BIIB054 in May 2017; Roche/Prothena
entered Phase 2 with PRX002 in June 2017; and Astra Zeneca/Takeda is set to enter Phase 1 shortly with MEDI1341. To our knowledge,
there are no TDP-43 antibodies in the clinic.
Diagnostics: Currently, there
are no approved Tau-PET imaging products. However, should our Tau-PET imaging agent be approved, it would compete with other approved
Tau-PET agents. These include (i) Flortaucipir (previously known as 18F-AV-1451 or T807), which is being advanced by Eli Lilly
and is currently in Phase 3 clinical studies, (ii) APN-1607 (previously known as 18F-PM-PBB3), a product candidate in Phase
1 studies and being advanced by Aprinoia, (iii) Roche is evaluating 18F-RO6958948 in Phase 1 clinical studies in AD patients,
(iv) Genentech is developing 18F-GTP1 in Phase 1 studies in AD patients (v) Cerveau is evaluating 18F-MK-6240 in Phase 1 clinical
trials in AD patients and (vi) Janssen is evaluating 18F-JNJ-067 in Phase 1 clinical studies in AD patients.
Many of our competitors have significantly
greater financial, technical and human resources than we have available. Mergers and acquisitions in the pharmaceutical and biotechnology
industries may result in even more resources being concentrated among a smaller number of our competitors. Our commercial opportunity
and our success will be based in part on our ability to identify, develop and manage a portfolio of product candidates that are
safer and more effective than competing products. However, this opportunity could be eroded or even eliminated if our competitors
develop and/or market products that are novel and have superior safety and efficacy profiles, that may be brought to the market
more rapidly due to greater available resources, or that are less costly than our current or future product candidates.
Our strategy to date has been to focus
on identifying partnerships for our early stage product candidates as both a way to secure non-dilutive capital to fund our other
research and development programs but also as a way to accelerate the development of these partnered products by leveraging our
partners’ extensive knowledge in clinical studies, drug development, manufacturing and commercialization.
With greater financial resources at our
disposal but also given the significant knowledge acquired by our scientists and scientific leadership, we intend to retain selected
promising product candidates in-house for a longer period of time and fund their development from our own resources. This will
allow us to generate greater value from these product candidates, allowing us to demand more significant terms from a prospective
partner. For example, our current plan is to retain full control of our two Abeta vaccine programs focused on AD and Down syndrome,
meaning that we are funding the current Phase 2 study in AD and plan to do so in the subsequent clinical phases of the programs,
from our financial resources. In the field of diagnostics, the parallel development of therapeutic compounds and companion diagnostics
is of growing importance to the pharmaceutical industry. The development timeframe of a PET diagnostic agent is significantly shorter
than for a therapeutic product providing the prospect for potential diagnostic product revenues to be realized quicker than potential
therapeutic product revenues. Our Morphomer platform is particularly well suited to generate molecules for use in the development
of companion diagnostics.