Two vaccines for Alzheimer’s disease found safe in first-in-man studies: AFFiRiS

AFFiRiS to receive 10 m EUR milestone payment from licensee GlaxoSmithKline Biologicals

AD01 and AD02, two investigative vaccine candidates against Alzheimer’s disease have been found safe in clinical studies conducted by AFFiRiS AG.

Alzheimer vaccine candidates AD01 and AD02 have met the primary endpoints for the Phase I clinical studies, which demonstrated favourable safety and tolerability profiles.

AFFiRiS AG will now receive a 10 million EUR milestone payment from licensee GlaxoSmithKline Biologicals.

AFFiRiS entered into a licensing agreement with GSK Biologicals on jointly developing the Alzheimer’s vaccines AD01 and AD02 in October 2008.

GSK Biologicals has gained access to the Affitome technology of AFFiRiS, in the field of Alzheimer vaccination, as part of this agreement.

AFFiRiS’ Affitome technology delivers short synthetic peptides that mimic functionally highly specific original structures such as those of antigens. This can be used to generate vaccines – particularly important with Alzheimer’s vaccines – that lead to the formation of antibodies which target only detrimental derivatives of human proteins and leaving their healthy precursor forms alone.

AFFiRiS retains the exclusive rights to this technology in other indications.

GSK Biologicals is expected to make total payments of up to EUR 430 million upon successful commercialisation.

Alzheimer vaccine candidates AD01 and AD02 were given to 48 patients. All the patients were given four vaccinations which were well tolerated and no serious side effects associated with the vaccine candidates were observed.

“This initial demonstration of safety and tolerability is an outstanding milestone in our joint efforts with GSK Biologicals to develop a therapeutic Alzheimer’s vaccination,” stated AFFiRiS’ CEO, Dr Walter Schmidt.

The clinical studies to test Alzheimer vaccine candidates AD01 and AD02 were conducted in Vienna, Austria, using two different peptide antigens.

24 patients with mild to moderate stage of the disease were recruited for each of the two studies. Each patient received four vaccinations at four-weekly intervals. Both groups were divided into two subgroups of 12 patients who received the vaccine with or without an adjuvant.

None of the 48 participants in the studies showed any indications of meningoencephalitis or other autoimmune reactions that have caused severe problems for other Alzheimer’s vaccine candidates.

Alzheimer vaccine candidates AD01 and AD02 results demonstrate the potential value of the Affitome technology, which forms the platform for both of these vaccines and could result in a generation of highly specific vaccines.

AFFiRiS AG is also using Affitome technology to develop vaccines for Parkinson’s disease, atherosclerosis and four other indications.

AFFiRiS AG develops tailor-made peptide-vaccines against Alzheimer’s, atherosclerosis, Parkinson’s and another four diseases with unmet medical need and attractive markets.

Alzheimer’s disease is currently the lead indication and recently two vaccine candidates have completed the phase I clinical testing.

Alzheimer’s Disease

Alzheimer’s disease is a progressive brain disorder that gradually destroys a person’s memory and ability to learn, reason, make judgments, communicate and carry out daily activities.

Alzheimer’s is a leading cause of dementia.Alzheimer’s disease may result from the build-up of toxic beta-amyloid peptides in the brain.

As Alzheimer’s disease progresses, individuals may also experience changes in personality and behavior, such as anxiety, suspiciousness or agitation, as well as delusions or hallucinations.