Dr. Nicolas Mach
Geneva University Hospital

Every patient is unique. Every cancer is unique.   Anti-tumor immunotherapy combines cells from a patient’s tumor with a vaccine designed to stimulate the patient’s immune system. This treatment method has been used successfully in a small percentage of patients with advanced cancers such as melanoma, squamous cell lung cancer, bladder cancer, gastric and head and neck cancers.

Granulocyte Macrophage Colony-stimulating Factor (GM-CSF) is a human protein involved in the immune response to almost all cancers. It is an adjuvant, or booster, that helps immunotherapy to be more effective when it is administered in small doses. But once administered, it is quickly absorbed and loses its effectiveness. The challenge has been to find a way to continuously deliver these small doses in combination with the tumor’s antigens.

This research group is testing a new medical encapsulation technology (MVX-ONCO-1) that is basically a time-release capsule placed under the skin at the vaccine site so the immunotherapy will have sustained effectiveness. Trial studies with these capsules have been promising. This particular six month study will evaluate 39 patients with head and neck squamous cell carcinoma. [Awarded 2015]

 

Clinical Summary
Cancer is the leading cause of death in most developed countries and a major cause of morbidity around the world. Many deadly cancers are 5 of 13 diagnosed at an advanced stage despite preventive measures. The vast majority of individuals suffering from cancer with local infiltration or metastasis will die from their malignancy within 3 years despite the currently available therapies. New treatments for advanced malignant cancers are critically needed. In the recent years novel anti-tumor immunotherapy strategies has led to interesting clinical benefit in a significant portion of patients with advanced refractory cancers in several tumor types: melanoma, squamous cell lung cancer, bladder cancer, gastric, head and neck cancer. MVX-ONCO-1 is an innovative anti-cancer immunotherapy with unique specificity: Therapy is individualized and can be applied to any cancer type. Every tumor is unique with its own set of molecular/genetic alterations, generating abnormal proteins. Each anomaly is a potential target (antigen) for an efficient immune system. In addition to the right targets, potent tumor specific active immunotherapy needs very strong immune booster, or adjuvant, in order to efficiently stimulate the immune system. MVXONCO-1 is an investigational medicinal product (IMP) that combines patient specific targets and a potent adjuvant (GM-CSF) in a subcutaneous (sc) formulation. The specific antigens are obtained from the patient's own cancer cells harvested from the primary tumor or a metastasis. The adjuvant is release locally at the vaccine site in a controlled, standardized manner for several days. To fulfill such requirement, MVX-ONCO-1 uses a small capsule containing a cell-line producing stable level of the adjuvant protein. The initial data is showing a very good safety/feasibility profile and some interesting clinical activity, this study will allow the evaluation of MVX-ONCO-1 in a multi-centric, Phase 2 efficacy study in Switzerland. [Awarded 2015]