OncoVAX®'s development at our cGMP manufacturing facility involves processing and sterilizing the resected tumor over a six hour period using proprietary methods. The result is four doses of a metabolically active vaccine which are frozen to simplify storage and shipping, a logistical advantage not feasible for other autologous cancer vaccines. The cells are then irradiated to prevent further cancerous growth upon reinjection. With proper handling, these cells are effective for up to a year.
The personalized vaccine is then sent to the patient’s hospital, where it is kept frozen until the patient is ready to be inoculated. This is typically four to five weeks after surgery.
When a patient is ready to be inoculated, the hospital pharmacist will thaw the vaccine and add a proprietary formulation of Bacillus Calmette-Guerin (BCG) to enhance the immune response. The first and second injections are prepared with BCG, while the third and fourth consist only of patient-specific cancer cells.
BCG was originally developed as a vaccine against tuberculosis, prepared from a strain of live bovine tuberculosis bacillus. It has been FDA-approved as an immunological therapy against non-muscle invasive bladder cancer for over a decade. Adding BCG to the vaccine tricks the immune system into thinking the patient’s own tumor cells are also harmful infectious agents. This stimulates the body’s immune response against the minimal residual disease leftover after surgery.