Gene Transfer Vaccine for Malignant Melanoma

A vaccine against malignant melanoma that is based on gene transfer by adeno-associated viruses (AAV) is now in a phase I/II clinical trial. The trial, in several European countries, will include patients who have been diagnosed with melanoma stage IV and have undergone immunotherapy and chemotherapy without results.

To produce the vaccine, the tumor is excised and immune-activating genes are introduced into the tumor cells in a laboratory. After treatment stops the further growth of the tumor cells, the modified cells are administered to the patient. The transfer is performed using nonpathogenic adeno-associated viruses. The vaccine was jointly developed by MediGene AG (Munich, Germany) and Aventis Pharma (Frankfurt, Germany). Under the terms of an agreement between the two companies, MediGene is responsible for the development of the AAV technology, while both firms oversee the planning and realization of phase I and phase II clinical studies. Aventis is responsible for the phase III clinical trials, registration, and marketing.

"The key problem of any cancer therapy is the tolerance of the immune system towards metastases,” said Johanna Holldack, M.D., chief operating officer of MediGene. "With this vaccine we expect to enable the immune system to identify and eliminate all metastases.”



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