Despite the setbacks and pitfalls experienced by early-stage pioneers in the cancer immunotherapy / therapeutic cancer vaccine space such as Cell Genesys, Favrille, and Genitope; recent advancements and study results are encouraging while Dendreon (NASDAQ: DNDN) awaits a FDA decision that is expected by May 2010 for its prostate cancer vaccine, Provenge, which is poised to become the first active cellular immunotherapy approved by the Agency to harness a patient's own immune system in the fight against the disease.
Last week, a group of Harvard bioengineers and immunologists reported encouraging preclinical results for a novel delivery mechanism for therapeutic cancer vaccines that utilizes tiny plastic disks embedded with tumor-specific antigens and implanted under the skin to mobilize the immune system to attack melanoma (skin cancer) tumors in mice. The implants utilized in this study were made of an FDA-approved biodegradable polymer that is just 8.5 millimeters in diameter and highly porous (90% air) to make them highly permeable for interaction with cells of the immune system.
Quantum Immunologics (QI) is a privately held, clinical-stage company that is engaged in the research, development, and production of innovative therapeutic and diagnostic products that are based on the universal cancer antigen (oncofetal antigen or OFA) that also had news last week in the form of a pact with Auburn to develop a cancer immunotherapy product for use in animals.
The BioMedReports.com research download section and the ProActive News Room Landing page for QI have been updated to reflect my new 27-page profile report for QI and an overview of other cancer vaccines in development, following news last week of a collaboration agreement with Auburn University to bring its novel cancer immunotherapy to the veterinary market. The parties have agreed to form a new, independently-funded and jointly-owned company to accomplish its goal with operations expected to commence by mid-2010.
Favorable growth trends for the pet and animal care industry are outlined below and the pact with a leading veterinary university further validates QI's leadership role as an innovator of cancer therapeutics / diagnostics based on the OFA antigen as a universal bio-marker of the disease in both humans and animals.
1.) total pet industry spending in the U.S. is estimated at $45.4 billion in 2009, which includes $12.2 billion in vet care spending;
2.) according to the 2009-2010 National Pet Owners Survey, 62% of U.S. households own a pet, which equates to 71.4 million homes;
3.) the worldwide market for animal healthcare, excluding bulk feed and nutrition products, is expected to reach just under $20 billion in 2008, experiencing growth of 26% from 2003.
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 follows a similar approach for prostate cancer as it prepares to become a commercial-stage company with a pending FDA decision for Provenge (sipuleucel-T) expected by 5/1/10, 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 also referred to as therapeutic cancer vaccines.
Highlights from QI's investor presentations in New York City earlier this month include an expectation for preliminary data from the ongoing Phase I/II FDA-authorized trial during 1Q10, which will include comparing medical imaging scans before treatment with QI's OFA cancer vaccine at 90-day intervals to monitor tumor size with the goal of achieving either stable disease or improvement (i.e. tumor shrinkage). Contingent on the initial results, QI expects to begin discussions with the FDA to expedite the start of a much larger pivotal (i.e. a study designed to obtain FDA approval) Phase 2b/3 clinical trial and is also working on R&D initiatives to improve and refine the OFA technology for the upcoming study such as isolating specific regions within OFA that elicit a targeted immune response against cancer cells.
Currently, QI has enrolled eight patients in the ongoing Phase I/II clinical trial, with a goal of completing the enrollment of all 27 patients by the end of 1Q10 (31-March) - at which time preliminary data is expected from the initial cohort of patients that are already enrolled in the study and receiving treatments. The study is open to women who have been diagnosed with Stage IV / Metastatic Breast Cancer and the treatment is free to eligible participants. While the inherent risks of developing an innovative therapeutic cancer vaccine cannot be eliminated, several key points make the risk / reward ratio favorable for early-stage investors in QI that accept the privately held status and speculative nature of such an investment.
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 with just three patients, but the Agency recommended a combination Phase I/II trial to expedite the clinical development process.
