Activartis Develops Dendritic Cell-Based Therapeutic Cancer Vaccine in Phase II

Novel, IP-protected approach mobilises immune system

Results from multi-centre phase II clinical study expected in 2012

Duesseldorf, Germany and Vienna, Austria, October 27, 2011 / B3C newswire / - Activartis GmbH - former Trimed Biotech GmbH - is developing a cancer immunotherapy concept which is currently in phase II clinical trials. Initially directed against aggressive brain cancer, it will in principle be applicable to all types of cancerous diseases. It therefore has blockbuster potential. The therapeutic platform combines a completely novel proprietary and IP-protected approach - the utilisation of a bacterial danger signal in combination with the patient's tumour antigens - with a proven successful concept (dendritic cells) to mobilise the patients' immune system to combat the disease.

CEO Thomas Felzmann, MD, will present his company at this year´s Bio Europe in Düsseldorf [November 1, 2011 at 4:15 pm (level 2, room 28)].

The Vienna-based company is privately held by the founder and AOP Orphan Pharmaceuticals AG, an Austrian pharmaceuticals company specialising in the development and commercialisation of drugs for rare and orphan diseases.

Active, individualised, DC-based cancer immune therapy
The Activartis proprietary technology platform focuses on dendritic cells (DCs), the key regulatory elements of the immune system. To trigger an immune response against tumour cells, the immune system's tolerance of cancer cells must be overridden. By presenting a bacterial danger signal (LPS, lipopolysaccharide) in combination with the patient's tumour antigens to the patient's dendritic cells, Activartis' therapeutic agent tricks the cells into recognising the tumour as dangerous, which triggers an immune reaction to the tumour antigens. The DCs then activate tumour-specific T cells (including the killer T cells that attack tumour cells) to destroy tumour tissue. The Activartis therapeutic concept is the first active immune therapy that activates release of the immune modulatory cytokine interleukin 12 (IL-12), a signalling molecule that is of central importance in polarising an immune response based on killer T-cell activity. The proprietary technology involved is part of a trend-setting approach to individualised medicine. Utilising the patient's own tumour tissue, Activartis aims to mobilise the patients' immune system to develop a tailored immune response to their specific tumour, in order to recognise and destroy the disease. The therapy is in principle therefore applicable to all cancerous diseases.

Benefits of Activartis technology platform
Autologous dendritic cell therapies represent a major milestone in the development of cancer immune therapy, and a paradigm shift in cancer treatment. In April 2010, the FDA approved the first autologous dendritic cell therapy for the treatment of advanced prostate cancer. However, the use of an antigen specific to a particular tumour means that it cannot be used against other cancers. The technology is also highly dependent on antigen selection, and is exposed to the potential variability of cancers in different patients.

The Activartis cancer vaccine technology eliminates these drawbacks by employing a more advanced technology, which uses the complete spectrum of tumour antigens unique to an individual patient's cancer.

The handling and logistics requirements for Activartis therapeutic agents are simpler and less complicated to manage. The agents may be frozen, conserved and shipped, meaning that a patient's whole course of treatment can be produced at one time. Outpatient treatment of the patients is completed in minutes.

Results of phase II clinical trials against GBM expected in 2012
Currently, Activartis is testing its therapy in a randomised, open-label, 2-arm, multi-centre, phase II clinical study of glioblastoma multiforme (GBM) at eight clinical institutions in Austria, including three university hospitals. GBM is the most aggressive and lethal form of brain cancer. The disease often progresses rapidly, and prognosis is nearly always poor (median survival is approximately 14 months). The primary objective of the study is progression-free survival, with overall survival as the secondary goal. The interim results of the study are expected to be available in the second half of 2012.

Search for industry partner after phase II study
The safety and efficacy of Activartis' therapeutic agent has been demonstrated in four phase I pilot studies including more than 100 patients with different indications (brain, bone, kidney, prostate cancer, and a heterogenous selection of paediatric cancers). Clinical development is backed by AOP Orphan Pharmaceuticals, an Austrian pharmaceuticals company that acquired Activartis in 2006. The partners plan to apply for orphan drug designation. Following successful completion of phase II, Activartis and AOP Orphan are planning to collaborate with an industrial partner who will co-sponsor phase III clinical development, manufacturing, registration and market launch as well as the clinical development of Activartis DC cancer vaccine technology for further indications.