Adamis Pharmaceuticals TeloB-VAX vaccine is composed of the patients' own circulating B lymphocytes harboring a unique patented engineered plasmid DNA. The transfection procedure is "spontaneous", requiring no facilitating molecules or devices. After 60 minutes of incubation with the plasmid, the cells can be re-infused back into the patient. In studies conducted to date, TeloB-VAX cancer vaccine induces a potent cellular immune response against the first truly common cancer antigen, the telomerase reverse transcriptase (TERT).
Telomerase is an enzyme that adds DNA sequence repeats (e.g., "TTAGGG") to the 3' end of DNA strands in the telomere regions of chromosomes at every cell division. Telomerase confers the immortality trait that converts normal cells into cancer cells and prevents the erosion of telomeres and end-to-end chromosomal fusion. As such, telomerase is over-expressed in the vast majority of differentiated cancer cell types. Importantly, telomerase is also necessary for self-renewal of cancer stem cells and cancer cell progenitors. Based on the foregoing, TERT is an antigen expressed in both differentiated and progenitor cancer cells making vaccination against TERT a potentially effective measure to induce an immune response against cancer cells at both stages of differentiation.
In a Phase 1 study completed at the University of California, San Diego, in castrate resistant prostate cancer (CRPC) patients, this vaccine was safe, non-toxic and immunogenic. A single immunization using transgenic lymphocytes induced a specific CD8 T cell response against a dominant TERT peptide. Two injections of TeloB-VAX, spaced one month apart, was shown to increase the response against TERT. More important, the T cells induced post vaccination were shown to specifically kill prostate cancer cells.
Currently Adamis is planning a Phase 2 study in CRPC patients. The study will be conducted at UCSD and at the University of Wisconsin Carbone Cancer Center.
If successfully developed, Adamis believes the technology offers certain significant advantages over the existing FDA approved vaccine, Provenge. Some of the advantages include: 1) prolonged antigen presentation by B cells (5 days) as compared to the short presentation time by dendritic cells (12 hours), 2) a unique patented technology using a universal cancer antigen (marker) that is increased in approximately 85% of all tumors, 3) induces an immune response after a single injection, 4) no need for complicated culture procedures (easy to manufacture), 5) much fewer steps, and 6) lower cost.
If future clinical trials are successful, TeloB-VAX may very well be called a "universal cancer vaccine" that could induce immunity against multiple cancer types as well as targeting the specific cancer stem cell.