Affiris AG of Vienna has announced that the primary endpoints have been met for the Phase I clinical studies of its two Alzheimer’s vaccines AD01 and AD02, triggering a €10 million milestone payment from the licensee GlaxoSmithKline.
All 48 patients treated in these studies were given four vaccinations which were well tolerated and no serious side effects associated with the vaccine candidates were observed.
The company says the results demonstrate the potential value of its Affitome technology. While analysing the clinical outcome in detail, the company, together with GSK, is progressing to the next development stage. Affiris is also using Affitome to develop vaccines for Parkinson's disease, atherosclerosis and four other indications.
Walter Schmidt, CEO, said the initial demonstration of safety and tolerability is an important milestone. “The results also highlight the potential capability of our Affitome technology, which [...] is also the platform for our six other vaccine programmes, including Parkinson's and atherosclerosis currently under development. We will be investing all of this milestone payment in our research and development projects.”
It is just a year since Affiris concluded a licensing agreement with GSK in which it could receive total payments of up to €430 million upon successful commercialisation.
The 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 mop up only detrimental derivatives of human proteins, leaving their healthy precursors alone.