Quantum Immunologics (QI) (privately held) is dedicated to improving the treatment outcome and quality of life for cancer patients through the research, development, and production of innovative therapeutic and diagnostic products that are based on the universal cancer antigen (oncofetal antigen or OFA). Quantum’s integrated approach to the treatment, diagnosis, and monitoring of cancer is being developed to create novel, individualized products and services that offer a greatly reduced cost, a high rate of efficacy, and minimal side effects compared to conventional treatments such as radiation or chemotherapy.
Quantum's approach to cancer immunotherapy is similar to Dendreon (NASDAQ: DNDN) and involves sensitizing the dendritic cells from a patient's own blood to recognize and direct the body's immune system to attack breast cancer sites in a targeted effort to eradicate or stabilize the disease. This approach does not involve breast surgery (e.g. complete or partial removal of breast tissue), chemotherapy, or radiation - with the goal of eliciting a targeted immune response directed at cancer cells which may prove to be more effective and safer (i.e. a few days of temporary flu-like symptoms following treatment as the immune system attacks the cancer cells) than existing treatments.
The FDA recently issued draft guidance that included considerations for companies conducting clinical studies of therapeutic cancer vaccines / immunotherapy product candidates (commonly referred to as simply cancer vaccines). Cancer vaccines are recognized as foreign antigens by the body upon administration and induce an active immune response that is mediated by cytotoxic T cells through the adaptive immune system’s antigen presenting cells (APCs) known as dendritic cells (DCs).
In addition, clinical trials of cancer vaccines typically involve multiple vaccinations over the course of a given study and the longer timeline for the generation of an effective immune response against the targeted cancer cells must be considered when designing a study protocol in terms of duration and primary outcomes. The entire PDF report issued by the FDA is available at the ProActive News Room landing page for QI and includes several relevant considerations for the Company’s OFA-iLRP cancer vaccine product candidate.
The FDA draft guidance includes considerations for studying cancer vaccines in patients that are newly-diagnosed or with early-stage disease in order to select individuals with a more robust immune system response since they are not afflicted with later-stage, widespread disease and have not endured extensive treatment with radiation and / or chemotherapy.
However, a clinical trial conducted in Europe that included patients with metastatic renal cell carcinoma (RCC, Stage IV, late-stage kidney cancer) demonstrated encouraging results for QI’s OFA-iLRP based DC cancer vaccine and is summarized in a journal publication at the Company’s News Room page: Immunotherapy of Metastatic Renal Cell Carcinoma with Tumor Lysate-pulsed Autologous Dendritic Cells ( Clinical Cancer Research Vol. 8, 3369–3376, November 2002).
Furthermore, there is evidence that OFA-iLRP plays a vital role in tumor invasiveness and metastasis, which would involve patients with late-stage disease. Based on historical data and medical / scientific journal publications, QI estimates that over 85% of patients with Stage IV metastatic breast cancer (which is the subject population of the ongoing Phase I/II trial) express OFA-iLRP as compared to approximately 44% of breast cancer patients as a whole. Based on previous study results and the fact that OFA-iLRP is not expressed on healthy tissues; QI anticipates that safety will not be an issue in the current clinical trial and OFA-iLRP has been detected in over 500 different cancer types.
There is a poor prognosis for patients with this type of late-stage kidney cancer that has already spread to other parts of the body such as the lungs, including an average survival time of about one year and a 10% survival rate two years after diagnosis. However, in this study two of 27 evaluable patients achieved a complete response with any evidence of their disease disappearing while one patient had an objective partial response. Seven patients had stable disease while the remaining 17 patients had progressive disease.
Five key takeaways from QI's presentation at the Rodman Healthcare Conference in September 2009 are outlined below.
1.) Because of their belief in QI, the Company's entire management and science team is working for either stock-based compensation only or at reduced salaries + stock compensation.
2.) QI originally filed with the FDA for authorization to conduct a Phase I safety trial, but the Agency recommended a combination Phase I/II trial to expedite the clinical development process. Phase I = 3 patients (safety); Phase II = 24 patients (safety and efficacy); patients will receive three OFA-loaded activated DC injections under the skin at monthly intervals to evaluate safety/toxicity, immune response (induction of OFA specific T-lymphocytes), objective clinical responses, time to disease progression, and survival.
3.) QI's FDA-Authorized Phase I/II Trial focusing on DC immunotherapy that targets OFA-iLRP for Stage IV breast cancer patients is underway with preliminary results expected in January 2010 and final data expected by May 2010.
4.) QI is the exclusive licensee of various patent rights in the U.S., Europe and other countries for the use of OFA to diagnose, monitor, and treat multiple types of cancer. The OFA/iLRP patents are the by-product of 20 years and $30 million of research at The University of South Alabama Medical & Science Foundation and were primarily funded by the National Institute of Health's (NIH) National Cancer Institute (NCI).
5.) The market niche for a successful CI treatment approach for breast cancer is several billion dollars based on estimated pricing of $60,000 per treatment (consisting of three injections at monthly intervals) based on the following American Cancer Society statistics: (a) 2009 estimated U.S. deaths from breast cancer = 40,610; (b) 2007 estimated worldwide deaths from breast cancer = 464,854; (c) 2009 estimated new cases of breast cancer in U.S. = 194,280; and (d) estimated new breast cancer cases worldwide in 2007 = 1.3 million.
Disclosure: No positions.
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