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Venturing into vaccines
According to TapImmune chairman Dr. Glynn Wilson, the PER.C6 cell line is ideally suited for the development and large-scale manufacturing of the company's TAP vaccine products for preclinical and clinical studies and ultimately, commercial products of a multitude of biopharmaceuticals. In the use of recombinant vaccines using adenoviral vectors, PER.C6 cells do not generate replication competent adenoviruses, making it the state-of-the-art platform for the large-scale production of adenoviral vectors for clinical applications.
In addition, Dr. Wilson notes that the PER.C6 cell line provides a robust and scaleable process in a suspension culture that allows rapid development times. Crucell will provide TapImmune with technical assistance and supply of know-how on the use of the PER.C6 cells. TapImmune is solely responsible for all preclinical studies. Crucell has the first right to negotiate a license to TapImmune's infectious disease vaccine and vaccine adjuvant products.
Crucell was formed when a small biotech company in Leiden called IntroGene, which collaborated with scientists from Leiden University to invent and develop the PER.C6 technology, teamed up with another Dutch biotech company: U-BiSys, the inventor and developer of an efficient approach to the discovery of monoclonal antibodies. Crucell embarked on a larger mission in 2006, when it acquired the Swiss vaccine maker Berna Biotech and SBL Vaccines of Sweden. With these acquisitions, Crucell now bills itself as the largest independent vaccine company in the world. Its PER.C6 cell line is the best-documented cell line for vaccine development to date and has been used by Merck, Novartis and other major vaccine producers. Its extensive Biologics Master File at the U.S. Food and Drug Administration (FDA) can be cross-referenced by licensees, resulting in simplification and acceleration of the IND filing and approval process.
TapImmune Inc. is a biotechnology company specializing in the development of cell-based immunotherapeutics and vaccines in the areas of oncology and infectious disease. The company's lead product candidate, the AdhTAP vaccine enhancer is designed to restore and augment antigen presentation and subsequent recognition and killing of cancer cells by the immune system. The company is currently planning the development AdhTAP for the commencement of clinical manufacturing and toxicology studies.
TapImmune is also developing a TAP-based prophylactic vaccine that initial tests indicate may increase the efficacy of targeted prophylactic vaccines by up to 1000 times.
TapImmune was formed based on technology developed in British Columbia by professor Wilfred Jeffries. His team demonstrated in animal studies using mice that when TAP1 and TAP2 are downregulated the immune system doesn't recognize—and attack— cancer cells. Next, enhancing the normal level of TAP was shown to prevent infectious disease, in this case small pox, reducing the vaccine required by two to three orders of magnitude, Wilson states.
At the time, he adds, TapImmune was "riding on the edge" with little cash. Wilson joined the company, cleaned up the balance sheet and is putting together a new board and management team.
The plan is to use the company's patented IP to engineer restoration of TAP expression, which in turns restores the assembly of functional MHC class 1 molecules and the cells' ability to notify the immune system of the presence of cancer cells. The immune system kills cells that have antigenic MHC class 1 restricted antigens on their surface. The technology provides several competitive advantages, Wilson states. It is not restricted by an individual's genetics or to any specific tumor or pathogen-associated antigen, making it applicable to many types of cancers and microbial pathogens. TAP is normally expressed in all cells and is complementary and synergistic with other immunotherapeutics and microbial vaccines.