AFFiRiS AG - Encouraging Results From Phase I Studies of two Alzheimer's Candidate Vaccines Trigger a EUR 10 Million Milestone Payment

Wednesday, October 21, 2009 General News
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VIENNA, Austria, October 20 AFFiRiS AG today announcedthat the primary endpoints have been met for the Phase I clinical studies ofits two Alzheimer's vaccines AD01 and AD02, which demonstrated favourablesafety and tolerability profiles. These results trigger a 10 million EURmilestone payment from licensee GlaxoSmithKline Biologicals.

All 48 patients treated in these studies were given four vaccinationswhich were well tolerated and no serious side effects associated with thevaccine candidates were observed.

The results demonstrate the potential value of the AFFITOME(R)technology, which forms the platform for both of these vaccines and couldresult in a generation of highly specific vaccines. While analysing theclinical outcome in detail the company, together with GSK Biologicals isprogressing to the next development stage. AFFiRiS AG is also usingAFFITOME(R) technology to develop vaccines for Parkinson's disease,atherosclerosis and four other indications.

Affinity to Success

Commenting on the results, AFFiRiS' CEO, Dr. Walter Schmidt, said: "Thisinitial demonstration of safety and tolerability is an outstanding milestonein our joint efforts with GSK Biologicals to develop a therapeuticAlzheimer's vaccination. However, the results also highlight the potentialcapability of our AFFITOME(R) technology, which forms the basis for the twovaccine candidates. This technology is also the platform for our six othervaccine programmes, including Parkinson's and atherosclerosis currently underdevelopment. The results not only represent an important milestone in thedevelopment of our Alzheimer's vaccination but also confirm our basicstrategy. We will be investing all of this milestone payment in our researchand development projects."

In October 2008 AFFiRiS concluded a licensing agreement with GSKBiologicals on jointly developing the Alzheimer's vaccines AD01 and AD02.Comprising total payments of up to EUR 430 million upon successfulcommercialisation, and the progress that has now been achieved is a keymilestone in the collaboration. As part of this agreement, GSK Biologicalshas gained access to the AFFITOME(R) technology of AFFiRiS, in the field ofAlzheimer vaccination.

In other indications AFFiRiS retains the exclusive rights to thistechnology. In summary, the AFFITOME(R) technology delivers short syntheticpeptides that mimic functionally highly specific original structures such asthose of antigens. This can be used to generate vaccines - particularlyimportant with Alzheimer's vaccines - that lead to the formation ofantibodies which target only detrimental derivatives of human proteins andleaving their healthy precursor forms alone.

Success for Both Vaccine Candidates

The clinical studies to test the two therapeutic Alzheimer's vaccineswere conducted in Vienna, Austria, using two different peptide antigens. 24patients with mild to moderate stage of the disease were recruited for eachof the two studies. Each patient received four vaccinations at four-weeklyintervals. Both groups were divided into two subgroups of 12 patients whoreceived the vaccine with or without an adjuvant. Commenting on the results,Dr. Frank Mattner, CSO of AFFiRiS AG, said: "All 48 patients were able tocomplete the study without any problems, with the data now evaluateddemonstrating acceptable tolerability of vaccine candidates AD01 and AD02.None of the 48 participants in the studies showed any indications ofmeningoencephalitis or other autoimmune reactions that have caused severeproblems for other Alzheimer's vaccine candidates. We are now analysing theimmunological data and results of the cognitive tests in detail."

AFFiRiS AG (as at October 2009):

Based on its proprietary patent position AFFiRiS AG develops tailor-madepeptide-vaccines against Alzheimer's, Atherosclerosis, Parkinson's andanother four diseases with unmet medical need and attractive markets.Alzheimer's disease is currently the lead indication and recently two vaccinecandidates have completed the phase I clinical testing. In October 2008, thecompany closed a licensing deal with GlaxoSmithKline Biologicals on itsAlzheimer's vaccine program. The contract foresees payments of up to EUR 430million. AFFiRiS currently has 60 highly-qualified employees and recentlyextended its facilities at the Campus Vienna Biocenter, Austria, up to 1,700square meters ( at AFFiRiS AG: Agnes Meyer Karl-Farkas-Gasse 22 1030 Vienna Austria T +43-1-798-15-75-39 E W Copy Editing & Distribution: PR&D - Public Relations for Research & Education Campus Vienna Biocenter 2 1030 Vienna Austria T +43-1-505-70-44 E W


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