Venturing into vaccines

TapImmune taps Crucell’s cell line for vaccine development

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BELLEVUE, Wash.—TapImmune Inc. will use Crucell's PER.C6cells for the development of immunotherapeutic vaccines for cancer andinfectious diseases under a licensing agreement with Crucell N.V.


According to TapImmune chairman Dr. Glynn Wilson, the PER.C6cell line is ideally suited for the development and large-scale manufacturingof the company's TAP vaccine products for preclinical and clinical studies andultimately, commercial products of a multitude of biopharmaceuticals. In theuse of recombinant vaccines using adenoviral vectors, PER.C6 cells do notgenerate replication competent adenoviruses, making it the state-of-the-artplatform for the large-scale production of adenoviral vectors for clinicalapplications.


In addition, Dr. Wilson notes that the PER.C6 cell lineprovides a robust and scaleable process in a suspension culture that allows rapiddevelopment times. Crucell will provide TapImmune with technical assistance andsupply of know-how on the use of the PER.C6 cells. TapImmune is solelyresponsible for all preclinical studies. Crucell has the first right tonegotiate a license to TapImmune's infectious disease vaccine and vaccineadjuvant products.


Crucell was formed when a small biotech company in Leidencalled IntroGene, which collaborated with scientists from Leiden University toinvent and develop the PER.C6 technology, teamed up with another Dutch biotechcompany: U-BiSys, the inventor and developer of an efficient approach to thediscovery of monoclonal antibodies. Crucell embarked on a larger mission in2006, when it acquired the Swiss vaccine maker Berna Biotech and SBL Vaccines ofSweden. With these acquisitions, Crucell now bills itself as the largestindependent vaccine company in the world. Its PER.C6 cell line is thebest-documented cell line for vaccine development to date and has been used byMerck, Novartis and other major vaccine producers. Its extensive BiologicsMaster File at the U.S. Food and Drug Administration (FDA) can becross-referenced by licensees, resulting in simplification and acceleration ofthe IND filing and approval process.


TapImmune Inc. is a biotechnology company specializing inthe development of cell-based immunotherapeutics and vaccines in the areas ofoncology and infectious disease. The company's lead product candidate, theAdhTAP vaccine enhancer is designed to restore and augment antigen presentationand subsequent recognition and killing of cancer cells by the immune system.The company is currently planning the development AdhTAP for the commencementof clinical manufacturing and toxicology studies.


TapImmune is also developing a TAP-based prophylacticvaccine that initial tests indicate may increase the efficacy of targetedprophylactic vaccines by up to 1000 times.

TapImmune was formed based on technology developed inBritish Columbia by professor Wilfred Jeffries. His team demonstrated in animalstudies using mice that when TAP1 and TAP2 are downregulated the immune systemdoesn't recognize—and attack— cancer cells. Next, enhancing the normal level ofTAP was shown to prevent infectious disease, in this case small pox, reducingthe 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 andis putting together a new board and management team.


The plan is to use the company's patented IP to engineerrestoration of TAP expression, which in turns restores the assembly offunctional MHC class 1 molecules and the cells' ability to notify the immunesystem of the presence of cancer cells. The immune system kills cells that haveantigenic MHC class 1 restricted antigens on their surface. The technologyprovides several competitive advantages, Wilson states. It is not restricted byan individual's genetics or to any specific tumor or pathogen-associated antigen,making it applicable to many types of cancers and microbial pathogens. TAP isnormally expressed in all cells and is complementary and synergistic with otherimmunotherapeutics and microbial vaccines.


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