Technology Platform

The HyVax Semi-Allogenic Hybrid Cell Vaccine represents a new approach to cancer and AD immunotherapy aimed at stimulating an effective cytotoxic T lymphocyte (CTL)-mediated immune response against cancer or A ß - producing cells. This approach is based on semi-allogeneic cells hybrids derived from the fusion of patient-derived cancer or white blood cells (WBC) with our patented Fo1-12 allogeneic cell line, certified for human use. Collaborative studies performed at the NCI and MUSC indicate that Fo1-12-derived hybrid cells can be easily mixed with antigenic peptides to induce an effective CTL-mediated immune response whose specificity is determined by the added peptide.

We have learned from our melanoma, adenocarcinoma and peptide-based studies that semi-allogenic cell hybrids as immunotherapeutics have numerous advantages over other immune-based technologies. Some of these advantages include:

1. The patented allogeneic cell line Fo1-12 has been engineered to express selectable markers that allow for easy selection and production of semi-allogeneic cell hybrids.  These cell hybrids are derived from the fusion of Fo1-12 with patient-derived cells.



2. The patient-tailored cell hybrids are easy and economical to produce, and we have over a 90% success rate in obtaining these hybrids from cancers of various histologies, as well as from patients-derived white blood cells from a single blood draw.  The cost to produce the hybrids is currently estimated at ~$250 per dose, or ~$4,000 for a six month-course of therapy (16 doses).  The Company believes that the production cost for the vaccines can be substantially reduced.  Even without cost savings, the Company believes that the vaccines could be priced at $10,000 to $15,000 for each 16 dose-course of therapy.



3. The cell hybrids can be produced in essentially unlimited quantities for patient treatment and can be banked and stored indefinitely under liquid nitrogen until needed.



4. The cell hybrids can express a variety of disease-specific antigens, necessary to induce an effective cell-mediated immune response. We believe that a whole-cell approach to immunotherapy will have a huge advantage over the peptide-only or single antigen approaches.



5. After treatment of over 60 cancer patients with semi-allogeneic cell hybrids, there is no evidence of any significant toxicity with up to 30 million cells per weekly dose.



6. A Master Cell Bank (MCB) of the Fo1-12 cell line has been produced under GMP conditions and has been successfully certified by a qualified testing laboratory to meet FDA requirements.  A sizable portion of the MCB is being stored off-site in a secure GMP storage facility.



7. SemiAlloGen technology falls under the umbrella of personalized medicine.  Patient-specific prevention and treatments are the inevitable result of the realization that each individual is different and predisposition to certain diseases comes with one's genetic make-up and tends to show up to varying degree in each affected family.  The awareness of personalized medicine is rapidly becoming the norm among members of the middle and upper-middle class in the US. These educated and sophisticated individuals with considerable disposable income will be the users of our products and they represent a very large market.



8. Our IP position appears to be very solid (US Patent # 6,063,375 granted on May 16, 2000), and a recent review of the claims indicates that we may need only one additional filing (use patent) to protect the use of these vaccines for AD.