Quantum Immunologics (QI) is a privately held company that is dedicated to improving the treatment outcome and quality of life for cancer patients through the research, development, and commercialization of innovative, cost-effective therapeutic and diagnostic products. QI's scientific approach links the immunogenic and invasive properties of malignant cancers with a specific protein known as oncofetal antigen immature laminin receptor protein (OFA) that is uniquely expressed on cancer cells, but not found on normal cells outside of early fetal development.
QI'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 as it prepares to become a commercial-stage company with the possible early to mid 2010 launch of Provenge (sipuleucel-T), following positive Phase 3 results announced earlier this year. Provenge is derived from a patient's own immune system (dendritic cells, hence the name Dendreon) and is poised (upon FDA approval) to become the first of a new class of therapeutics called active cellular immunotherapies (ACI) which are sometimes referred to as cancer vaccines (even though treatments such as Provenge are not designed to prevent the disease like Gardasil or Cervarix, which are designed to prevent HPV infection that is associated with cervical cancer).
The FDA-authorized Phase I/II clinical trial for QI is described in full detail at the ClinicalTrials.gov website with the official title posted as, "Phase I/II Vaccine Study With Autologous Dendritic Cells Loaded With Oncofetal Antigen/iLRP (immature laminin receptor protein) in Patients With Metastatic Breast Cancer." The University of South Alabama serves as a collaborator while the trial is sponsored by QI with a ClinicalTrials.gov identifier of NCT00879489. The Phase I/II clinical trial is structured as an open label, single-arm, interventional treatment study designed to assess both efficacy and safety in a single, combined trial. Combining Phase I/II into a single study saves about six months and $1 million from the clinical development process and reflects optimism toward the prospects for the Company's experimental cancer immunotherapeutic.
The study will be accomplished by collecting dendritic cells (APCs) from the each patient's blood using a machine to which the patient is connected through two small cannula placed into arm. The APCs will be manipulated in the lab with human recombinant oncofetal antigen (OFA/iLRP) and then injected into the skin of patients (intradermal administration). There will be a series of three monthly skin injections, administered at four-week intervals. The Company hopes to induce a safe, targeted anti-cancer response by this method and the outcome measures for the study will include toxicity/safety, response, survival, immunological monitoring, and time to disease progression. 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).
The study utilizes an antigen that is found only on cancer cells and is not detected on normal tissue. The molecule is known as oncofetal antigen or OFA because it is only found on cancer cells and early-stage fetal cells/embryos in the womb. Because OFA is unique to cancer, the Company believes OFA could be used to train the patients' own immune system to mount a targeted attack of cancer cells which express this antigen. Although OFA has been found in large concentrations on all cancer types, it was found to be especially abundant in breast cancers. A study published in a medical journal (Blood. 2003;102:4416-4423) stated that it has been documented in previous rodent and human studies that OFA-iLRP is an immunogenic protein that can specifically activate both T and B lymphocytes, making it an ideal antigen for immunotherapeutic strategies directed against all types of human cancer.
The Phase I/II clinical trial is designed to examine the inherent immune response in breast cancer patients directed towards OFA/iLRP and whether this immune response could be amplified and modified through actively vaccinating using autologous (patient-derived) OFA/iLRP-pulsed dendritic cells which are re-injected into cancer patients. OFA/iLRP is the chosen target for this immunotherapy product candidate because it has been found to be expressed in all human cancers examined so far, including myeloid + lymphoid leukemias, lymphomas, renal cell (kidney) carcinomas, prostate cancer, breast cancer, lung cancer, melanoma, squamous cell carcinoma, and ovarian cancer.
The mechanism of action of this active cancer immunotherapy product candidate is to generate 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 radiation therapy or chemo. 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.
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.