Advantagene’s approach, Gene Mediated Cytotoxic Immunotherapy (GMCI™), is an innovative and versatile platform technology that can be applied to a variety of solid tumors. It generates a tumor-specific vaccine that yields a systemic anti-tumor response from an “off-the-shelf” product—using established manufacturing processes. With more than 400 patient doses, GMCI™ has an established safety profile lacking the side effects typically associated with current cancer therapies. Furthermore, GMCI™ is synergistic with the effects of radiation, surgery, or chemotherapy, thus improving patient outcomes by improving treatments that make up the current standard of care-not interrupting therapies currently trusted by physicians and patients.
GMCI™ generates a systemic effect against residual tumor cells and occult micrometastases.
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Administration consists of an intra-tumoral injection of AdV-tk followed by an anti-herpetic prodrug (e.g., valacyclovir). AdV-tk plus prodrug cause death of tumor cells, cells damaged by radiation or chemotherapy and endothelial cells from growing tumor vessels.
As a result of complex interactions including the mode and context of cell death, viral delivery, and superantigen-like properties of the transgene itself, a potent immuno-stimulatory effect is generated. The convergence of released tumor antigens from tumor cell death, danger-signals secondary to virion injection, recruitment of antigen presenting cells (APC) secondary to acute inflammation, and stimulation of T-cell proliferation by local IL-2 and IL-12 secretion driven by the superantigen properties of the TK protein, provide the milieu for in-vivo generation of a potent anti-tumor systemic vaccine effect.
Local anticancer therapies, like surgery and radiation, are ineffective if they fail to eradicate every tumor cell and cannot be used in the treatment of metastasis. Chemotherapy is often limited by systemic toxicity.
GMCI™ does not replace the current standard of care, but instead works with current therapies for a targeted approach. In addition GMCI™ offers the goal of engaging the immune system to prevent and attack metastases.