Gene Mediated Cytotoxic Immunotherapy™ (“GMCI”)
Stimulation of a precise and robust “personalized” attack on cancer
GMCI is a pre-produced, readily available “off-the-shelf” immunotherapy that can be manufactured, shipped, and stored relatively inexpensively. Upon administration, it will generate a precise and robust patient specific immune response, attacking a patient’s solid tumors, distant metastases, or minimum residual disease. GMCI does not preselect or target a single tumor associated antigen (TAA) like most other targeted therapies, but rather enables the immune system itself to choose the best several TAA targets expressed by a patient’s particular tumor. By creating an immunogenic tumor microenvironment, GMCI will generate an attack against many of the patient’s dominant TAAs. Consequently, antigen escape is much less likely. The same product can be used in virtually all solid tumor indications and for all solid tumor patients.
Administration of our GMCI technology is simple and is almost always incorporated into a procedure performed within the standard of care. It consists of just a series of small gauge, relatively painless injections at the tumor site or target tissue followed by the oral administration of an activating prodrug. The initial injections deliver aglatimagene besadenovec (AdV-tk), a gene vector derived from an adenovirus, a virus typically associated with common cold symptoms. This vector was engineered so that it can only multiply in specialized laboratory cells and is used as a vehicle to deliver the thymidine kinase (tk) gene, derived from the Herpes Simplex virus, to the target cells. The target tissues and cells then produce the TK protein. Cells that multiply in the neighborhood of where the TK protein was delivered and is now expressed then become susceptible to the toxic effects of valacyclivir, the anti-herpetic medication commonly used to treat genital herpes and cold sores and marketed as Valtrex®. Administration of valacyclivir then causes a cytotoxic biochemical reaction at the site of administration that leads to the death of multiplying tumor cells, cells repairing themselves from radiation or chemotherapy damage, and endothelial cells from growing tumor vessels. A subsequent cascade of immuno-stimulatory events, including the production and recruitment of disease fighting cytokines and cancer killing T-Cells, amplified by TK’s “super-antigen” characteristics, stimulates the in situ development of a precise, patient-specific anti-tumor immune effect to combat cancer cells. As a result, massive amounts of newly created T-cells, primary weapons used by the body to fight cancer, now recognize cells expressing a patient’s unique TAAs. These T-cells will identify, attack and destroy cancer cells expressing these antigens both at the site of the tumor and anywhere else in the body. Some of these new T-cells, called memory T-cells, can remain for years, patrolling the body for remaining cancer cells and providing a durable “vaccine like” effect, resulting in the eradication of tumors in some cases or slowing their growth or spread in others.
In addition to the generation of a potent anti-cancer immune response, another advantage of GMCI is its safety. To date, GMCI has been very well tolerated with minimal and transient side effects, most commonly 24-48 hours of flu-like symptoms. Low toxicity correlates to patient tolerability and enables us to combine GMCI with already barely tolerable aggressive forms of cancer therapies, including chemotherapy, radiation and more toxic novel immunotherapies. The resulting synergy between GMCI and the toxic current standard of care allows for maximum potency and enables cancer patients to use our GMCI without the risk of having to forgo or modify a currently trusted treatment regimen. Another important result of GMCI’s low toxicity is that it is well suited for the treatment of less aggressive or slower growing cancers such as newly diagnosed prostate cancer. In patients with these cancers, side effects normally associated with many cancer treatments are unacceptable because they will dramatically decrease these otherwise healthy patients’ quality of life.
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