IVAC: Individualized vaccines for the treatment of malignant melanoma

IVAC: Individualized vaccines for the treatment of malignant melanoma

Currently available treatments for cancer are based either on non-specific mechanisms of action or are directed against commonly expressed targets on tumor. So far only a rather small fraction of patients benefits from these available drugs. The main reason for failure of available treatments in the majority of cancer patients is the heterogeneity of individual patients and tumors.

In order to address the remaining high unmet medical need in oncology and to acknowledge the heterogeneity of the disease, the Ci3-project seeks to develop individualized mutanome-vaccines (IVAC® Mutanome) that constitute patient-specific cancer treatments targeting immunogenic mutations expressed in the patient’ own tumor.

Scientifically, IVACs are based on the fact that each individual tumor carries a number of non-synonymous mutations. The number of mutations depends on the tumor-type. For malignant melanoma the average number of somatic, non-synonymous mutations is between 100 to 120. Some of the genetic alterations can be recognized by the immune system, and may represent ideal antigens which are not subject to tolerance mechanisms of the immune system. Technologically, IVACs are based on methods for next-generation sequencing (NGS) which have recently become available, making it possible to analyze an entire genome in a very short time and at acceptable costs. The partner TRON uses NGS as a starting point to develop optimized processes for identifying immunogenic mutations. After applying bioinformatics algorithms and running confirmatory tests, this leads to the design of a customized vaccine. The partner BioNTech RNA Pharmaceuticals has an innovative RNA technology platform which enables manufacturing of variant vaccine preparations for use in patients (GMP-manufacturing), within few weeks at reasonable costs. Only the combination of unique know-how, proprietary approaches and the high-performance technologies of both partners allow the development of individualized tumor vaccines and the sophisticated translation of this approach into the hospital. Currently, both partners are strengthening their efforts to seamlessly link the IVAC-processes, so as to establish a value chain for the manufacture of a specific vaccine which would allow a patient-specific IVAC-drug to become available within several weeks.

The first pioneering clinical trial to test the safety of IVAC MUTANOME vaccines for the treatment of malignant melanoma has started end of 2013. First Proof of Concept results are expected in 2015. The approach to develop individual cancer immunotherapies as described in this project, bears a high potential to become a novel treatment for malignant melanoma.

Type 

  • Leuchtturmprojekt

Keywords 

  • personalized medicine
  • Individualized tumor therapies
  • Tumor vaccines
  • RNA vaccines
  • Mutanome Vaccines

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