How it Works
inCVAX utilizes the combination of a laser treatment, followed by injection at the treated tumor site with an immunological stimulant (Protectin). The method of delivery is simple and minimally invasive (see diagram). First, any one accessible tumor is injected with laser fibers, which allows for a targeted application of heat at the tumor site. This step releases tumor-specific antigens from the cancer cells into the tissue. Second, Protectin is injected around the treated tumor site, which both activates antigen presenting cells (APCs) and facilitates the interaction between the liberated tumor antigens and the activated APCs. Once the immune system is educated a systemic, anti-tumor immune response is initiated, resulting in the elimination of not only the primary tumor but also distant metastases in patients who respond to the treatment.
Due to the significant patient need, as well as tumor accessibility during treatment, Immunophotonics will initially focus its efforts on the treatment of breast cancer. However, we anticipate expanding our focus to other therapeutic areas as quickly as possible.
How it is Unique
According to the American Cancer Society, approximately 20 percent of women diagnosed with breast cancer between 2002 and 2006, died either from the disease or from treatment of the disease. Additionally, the five-year relative survival rate for a woman diagnosed with late-stage breast cancer is approximately 23 percent. A critical issue in breast cancer therapy is that not all patients are treatable with current methodologies and those diagnosed at late stages have a poor prognosis, with even fewer valid options for treatment. And, while there have been many advances and developments in breast cancer treatment in recent years, crucial problems remain. The main problems addressed with our method are the lack of (1) an effective, (2) nontoxic, and (3) practical treatment for late-stage metastatic cancer.
The Problem of Efficacy
Many current breast cancer treatments are designed to inhibit specific pathways or processes, which may or may not be specific to the root cause of the cancer. This results in subsets of patients who may not respond to treatment because of differences in their specific disease. Chemotherapies, some of which disrupt estrogen signaling to cancer cells, have low response rates ranging from 17-34 percent. Other monoclonal antibodies, some specific to the HER2 receptor, are not effective in 70 percent of HER2+ patients and come at an enormous cost to patients, of up to $100,000 for one year of treatment. Monoclonal antibodies can be more effective when combined with other chemotherapies and surgery; however, the actual net benefits are disappointing when viewed in terms of all-cause mortality (all-cause mortality helps balance a reduced risk of death from cancer against the increased risk of death from a treatment's side effects). InCVAX has shown impressive preliminary efficacy in the treatment of metastatic cancer (breast and melanoma) patients, thus addressing one of the greatest problems in breast cancer therapy today.
The Problem of Toxicity
In addition to the lack of efficacy, one of the greatest problems in cancer therapy today is the side effects associated with the treatments available. Common side effects associated with chemotherapies include fatigue, nausea, muscle and nerve problems, hair loss, low white blood cell count, and many more ranging from mild to severe. A patient suffering from these symptoms is often unable to work and perform daily tasks, resulting in loss of income and productivity. Additionally, a recent study conducted by the National Confidential Enquiry into Patient Outcome and Death found that 27 percent of patients who died within 30 days post chemotherapy treatment had their deaths hastened or caused by chemotherapy. Our pre-clinical and preliminary clinical data indicates that inCVAX is entirely nontoxic and comes with no or minimal adverse reactions, thus allowing the patients to return to their daily activities with no or minimal loss of income.
The Problem of Practicality
An ideal cancer therapy should be transformative in its approach to treatment while maintaining ease of use. A treatment may be effective, but if physicians are reluctant to use it due to practical difficulties, the therapy is not likely to be widely employed. For example, although traditional autologous vaccines have the advantage of utilizing tumor-associated antigens for each patient (thus potentially inducing an effective systemic anti-tumor response) the production process is complex and expensive. The principal advantage with inCVAX compared to other autologous cancer vaccines is that it is an in situ autologous vaccine that, through a simple local procedure, uses whole tumor cells as the sources of tumor antigens from each individual patient without ex vivo preparation or pre-selection of tumor antigens.