Failures of previous vaccination methods
In spite of two centuries of vaccine development, many parasitic, bacterial and viral diseases, such as Chagas, malaria, tuberculosis and hepatitis C, and cancers have eluded protection through vaccines. Modern times have also brought new diseases, such as COVID-19, HIV, SARS, MERS, cytomegalovirus, dengue, malaria which similarly have evolved to evade protection or treatment using vaccines.
There are two types of vaccines: prophylactic and therapeutic:
Prophylactic or preventative vaccines: Only two such vaccines for cancer are currently in use, and neither directly prevents cancer. Instead, the vaccines work by killing viruses that may lead to cancer. The human papillomavirus (HPV) vaccine, for example, targets potent strains of HPV that cause the majority of cervical, throat, anal and several other cancers. The hepatitis B vaccine is designed to help prevent some cases of liver cancer. These vaccines prevent viruses that cause inflammation that may lead to cancer
Therapeutic or treatment vaccines: These are designed to stimulate the immune system to attack cancer cells. Two therapeutic cancer vaccines are now in use: Sipuleucel-T (Provenge®), which was approved for treatment of advanced prostate cancer; and, the Bacillus Calmette–Guérin (BCG) vaccine, which was originally developed for prevention of tuberculosis and has since been approved to treat bladder cancer.
Traditional vaccines are designed to incorporate a piece or inactivated whole infectious organism or tumor (called an “antigen”) and introduce the antigen to the immune system as a means to educate the immune system to respond to a subsequent exposure to live organism. Often the selected vaccine antigens are formulated together with an “adjuvant”. The adjuvant is selected in order to enhance the immune response to the antigen, which many times are weakly immunogenic.
We believe the previous lack of success in developing effective prophylactic and therapeutic cancer vaccines and vaccines to prevent or treat modern viral infections is because simple re-exposure of tumor or viral antigens to the same immune system that failed to originally protect against the disease, only serves to amplify the original failed response.
Albert Einstein stated:
“The definition of insanity is doing the same thing over and over again, but expecting different results."
A therapeutic cancer vaccine must elicit a new and different immune response upon re-exposure to the tumor or viral infection. Importantly, this new response must then become imprinted upon the immune system in a manner that allows it to dominate over the resident failed response. This is a process known as “immunomodulation”. For this reason, our novel vaccines are referred to as “immunomodulatory vaccines” to distinguish them from traditional vaccines.
Our immune system has two arms that provide us with protection from disease. One arm is the humoral immune system which produces antibodies. The other is the cellular immune system which has a variety of cell types capable of directly killing transformed (cancerous) or infected cells. Our unique immunomodulatory vaccines harness the power of the cellular immune system, while traditional vaccine approaches focus on humoral immunity. In the case of cancer and modern viruses, such as COVID-19, HIV and Hepatitis C, cellular immunity is the most desired immune response.