Quantum Immunologics: Rodman Conference Recap

In addition, QI’s cancer immunotherapy video is available at my YouTube channel and (also embedded below) for a three-minute visual animation of the underlying technology, which is currently being evaluated in a FDA-authorized Phase I/II trial is for Stage IV Breast Cancer Patients. In addition to breast cancer, the OFA-iLRP is present in multiple cancer lines and activates the immune system to attack cancer cells on a targeted basis with less harsh side effects (e.g. transient, flu-like symptoms resulting from immune system activation) as compared to chemo or radiation therapy.

A clinical trial in patients with metastatic renal cell carcinoma (RCC, Stage IV kidney cancer) demonstrated encouraging results for QI’s approach to CI and is summarized in a journal publication available in the medical and scientific research section, entitled ‘Immunotherapy of Metastatic Renal Cell Carcinoma with Tumor Lysate-pulsed Autologous Dendritic Cells’. There is currently a poor prognosis for patients with Stage IV RCC with 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. In five of six patients tested, enhanced immune responses against OFA antigen were detected and the strongest responses against were detected in the two patients who achieved either a complete or partial response. At the time of this journal article submission, the mean follow-up was 32 months and eight patients were still alive – despite the dire prognosis of 10% survival after 24 months with conventional therapies for metastatic RCC.

Five key takeaways from QI’s presentation at the Rodman Healthcare Conference last week include the following:

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.

In addition, the possibility for using QI’s DC-based CI in conjunction with mastectomies in order to stimulate the immune system to attack residual cancer cells after surgical remove of all or part of cancerous breast tissue was discussed at the presentation. QI also outlined its earlier stage research and provisional patents surrounding OFA-based peptides which include specific protein sequences found within OFA which offer the potential for easier recognition and processing by the immune system and direct administration to patients. This would simplify the manufacturing process as an off-the-shelf process that would bypass the need for DC sensitization outside of the body (ex-vivo). QI has also discovered antibodies against specific OFA peptides which could lead to a diagnostic test for the detection of cancer.

In early July, as the first of four steps leading to an anticipated merger and name change, Mentor Capital (MNTR.PK) acquired a 20% ownership stake in QI and represents a public-traded proxy for the Company. Mentor Capital is hoping to increase its position with QI by providing liquidity at very attractive rates to the existing and future Quantum shareholders in individual transactions, by supplying Mentor Capital public-traded shares as acquisition currency in cooperative QI acquisitions, and by further funding the corporation as it moves through subsequent FDA trials.

Quantum's approach to cancer immunotherapy 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.

Dendreon (NASDAQ:DNDN) follows a similar approach for prostate cancer and has a market cap of about $3 billion as it prepares to become a commercial-stage company with an expected FDA filing for approval of Provenge (sipuleucel-T) during 4Q09, following positive Phase 3 results announced earlier this year which demonstrated an acceptable safety profile and survival benefit beyond chemo that is expected to result in FDA approval for the treatment of metastatic, androgen-independent prostate cancer.

The mechanism of action of QI’s active CI product candidate is generating a targeted and personalized immune T cell response that will fight the patient's cancer.  The OFA/iLRP-loaded mature, moDCs (monocyte-derived dendritic cells) do not have a direct cytotoxic effect as with traditional treatments such as chemo or radiation therapy. Rather, the anti-cancer effect is generated by the presentation of OFA/iLRP to activate each patient's T cells for a targeted immune response to OFA/iLRP, which is specific to the patient's cancer cells which express this marker (see additional medical and scientific publications at BioMedReports.com for more details).

This mode of action is distinct from chemotherapy, which kills not only tumor cells, but also affects normal cells such as those which divide rapidly (e.g. hair, GI tract, etc.). This approach is also different from immune-therapies that generically stimulate the immune system (e.g. cytokines such as Interleukin-2 or IL-2) or specifically target the tumor via an anti-tumor antibody (Herceptin- trastuzumab).  Because the product requires the development of an immune response after administration, there is some delay in the potential effect of the product with the generation of each patient's immune response and a clinical effect of that may take several weeks to develop, and is typically characterized by transient, flu-like symptoms rather than the harsh side effects of radiation and/or chemotherapy.

Click here for my initial overview article on both Mentor Capital and QI. In addition, Mentor Capital has recently revamped its corporate website and Facebook page to include more information on both companies and tracking data for a 10-stock Cancer Immunotherapy Index, which is updated weekly with nine-week data current through 9/11/09. Through the first nine weeks since its inception, the CI Index has posted a gain of about 58% on an equal-weight basis with ImmunoCellular Therapeutics (OTC: IMUC.OB) as the top gainer (+233%) and Dendreon as the largest market cap company (approximately $3 billion during trading today).

Disclosure: Long IMUC.OB, MNTR.PK. See my full disclaimer at MikeHavRx.com at the bottom of any page.