AC Immune Therapy chosen for groundbreaking Alzheimer´s Disease Trial in Colombia and USA

SBA Member News, 16.05.2012

AC Immune SA, today announced that the anti-Abeta antibody crenezumab will be tested in a first-ever prevention trial in cognitively healthy individuals who are destined to develop Alzheimer´s disease because of their genetic history. Crenezumab was discovered by AC Immune and exclusively out-licensed in 2006 to Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY). The groundbreaking study – the world’s first to investigate whether an anti-amyloid treatment can stave off the disease – is being run by a collaboration of the US National Institutes of Health (NIH), the Banner Alzheimer´s Institute (BAI), the University of Antioquia in Colombia and Genentech. Prof. Andrea Pfeifer, CEO of AC Immune commented: "We are proud that this antibody developed from our technology platform has been chosen to be the first drug candidate ever to be investigated in a prevention trial in Alzheimer´s disease. Scientists agree that promising experimental drugs should be tested years before a person is diagnosed with this terrible disease. We are delighted that our partner Genentech is taking this clinical leadership as part of the landmark Alzheimer’s Prevention Initiative.” “We are honored by this recognition of our company’s leading role in finding innovative therapies for one of the world’s most pressing medical burdens; it validates Switzerland’s pre-eminence as a center for biotechnology excellence,” continued Prof. Pfeifer. Currently, most Alzheimer’s treatments are being tested in patients with mild to moderate stage disease after a person has been diagnosed and has lived with Alzheimer’s symptoms for some years already. Many in the clinical and scientific community believe that by the time memory begins to slip and other thinking problems emerge, too much damage may already have occurred for some treatments, such as those focusing on amyloid, to be effective. They suspect that these potential therapies must instead be started before the onset of symptoms. About the Alzheimer´s prevention trial The USD 100 million trial is the cornerstone of a new international collaborative, the Alzheimer’s Prevention Initiative (API), formed to accelerate the evaluation of promising but unproven prevention therapies and led by Drs. Eric M. Reiman and Pierre Tariot from the BAI. It will study the experimental anti-amyloid antibody treatment called crenezumab in approximately 300 people from an extraordinarily large extended family in Colombia, who shares a rare genetic mutation that typically triggers Alzheimer’s symptoms around age 45. The trial will also include a small number of individuals in the United States. A key characteristic of this group of patients is that they have a predictable onset and near certainty of disease compared to sporadic Alzheimer’s disease. The trial is designed to determine whether the drug can reduce participants’ chances of developing the disease’s disabling and irreversible symptoms, preserve memory and thinking abilities, and slow the progression of Alzheimer’s biomarkers. If the treatment’s effects on brain imaging and other biological measurements of the disease are shown to predict its clinical benefit, the study could establish a much more rapid way to test future therapies. NIH has awarded a USD 16 million, five-year grant for the study, and BAI has committed USD 15 million in philanthropic funds. Genentech will contribute the major share of funding, in addition to providing study drug and clinical and operational expertise integral to the design and conduct of the study. Given the importance of the trial, data and findings will be shared publicly after its completion to help the entire Alzheimer’s research community find faster ways to test promising prevention therapies. For more information, please visit the Banner/Genentech News Release The Banner Alzheimer´s Institute Genentech The Alzheimer´s Prevention Initiative The US National Institutes of Health About crenezumab (former names RG7412, MABT5102A) Crenezumab, an anti-Abeta antibody, was discovered and humanized by AC Immune through its proprietary SupraAntigenTM technology and is being developed at Genentech under an exclusive licensing agreement with AC Immune. Preclinical studies suggest that crenezumab may bind to amyloid proteins and clear them from the brain. It has been studied in both healthy individuals and people with Alzheimer’s and currently is being evaluated in a Phase II clinical study in patients with mild to moderate symptoms. No significant safety issues have been detected to date. The drug was selected for this prevention trial with guidance from an expert advisory panel. About the licensing agreement In 2006 AC Immune closed an exclusive out-licensing agreement for its anti-Abeta program with Genentech, under which Genentech develops the anti-Abeta antibody crenezumab for the treatment of Alzheimer´s disease. Genentech has full ownership and global responsibility for clinical development, manufacturing and commercialization of the antibody, including all regulatory activities. In return, AC Immune received an upfront payment, and two milestone payments upon the start of Phase I and Phase II respectively. In addition AC Immune obtained funding through a research collaboration that was successfully concluded after three years in 2009. The contract provides potential revenues of over USD 300 million for AC Immune through payments upon successful completion of clinical and regulatory milestones in Alzheimer´s disease and additional applications. Additionally, upon commercialization of a product AC Immune will receive royalties. The start of this new clinical trial does not trigger any payments to AC Immune. About AC Immune SA AC Immune SA is a Swiss-based biopharmaceutical company and a leader in Alzheimer´s disease drug development. AC Immune develops innovative therapeutics with “best in class” potential against Alzheimer´s Disease and other conformational diseases along three axes: vaccines, antibodies and small molecules. The anti-Abeta antibody (Crenezumab) for passive immunization is partnered with Genentech and is in Phase II development. The company continues to develop in house the small molecule ACI-91 and the vaccine ACI-24 in Phase II and Phase I/IIa clinical development respectively. These three clinical programs are focused on Alzheimer’s disease, and are backed by a rich portfolio of preclinical compounds. The therapeutic molecules are also leveraged for Alzheimer´s disease diagnostic and other central nervous system and non-CNS diseases, such as Glaucoma. Since its foundation in 2003, AC Immune has raised CHF 64 million from private investors.



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