On March 1, 2019 Applied DNA Sciences Inc. (NASDAQ: APDN) ("Applied DNA"), a leader in large-scale PCR-based DNA manufacturing, reported that LineaRx, Inc. ("LineaRx"), its wholly-owned subsidiary focused on next-generation biotherapeutics, will ship TK7 and ConTRT amplicons to Takis/Evvivax next week as part of the companies’ Joint Development Agreement ("JDA") entered into in September 2018 (Press release, Applied DNA Sciences, MAR 1, 2019, View Source [SID1234533907]).
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Per the JDA, LineaRx and Takis/Evvivax will jointly develop linear DNA expression amplicons for TK7 and ConTRT, two of Takis/Evvivax’s anti-cancer vaccine candidates, utilizing LineaRx’s validated linear DNA technology. Linear DNA amplicons carrying the DNA sequences for Takis/Evvivax vaccine candidates will be delivered to pre-clinical animal models via Takis/Evvivax’s proprietary electroporation technology.
In 2018, LinearRx and Takis/Evvivax’s collaboration showed immunogenicity in mice that were vaccinated with linear DNA against the human protein telomerase that is over-expressed in more than 85% of all cancers. "This year we are using ConTRT, an improved version of our telomerase vaccine and a unique personalized approach which includes an epitope-prediction pipeline and a delivery strategy to achieve an extremely effective cancer vaccine over what has been done previously," said Dr. Luigi Aurisicchio, CEO of Takis/Evvivax. "Each expression amplicon will undergo rigorous quality subject matter testing, immunogenicity testing, followed by a tumor challenge, with results planned for publication later this year."
"Our collaborations with Takis/Evvivax and other therapy developers are helping to validate LineaRx’s novel technology as a viable alternative to bacterially-produced plasmids, with the potential for increased patient safety and reduced costs, using new quality control protocols for large-scale PCR production at LineaRx. We believe that linear DNA and the establishment of new quality attributes for this new therapeutic field will change the way gene and immune therapies will be performed," stated Dr. James Hayward, president and CEO of Applied DNA. "Our implementation of testing for new quality attributes will support our preparation to approach FDA to seek approval for clinical study. Our know-how in the fields of therapeutic linear DNA production and the standardized PCR platforms in use at LineaRx enable us to create novel expression amplicons. We are extremely pleased with the progress we are making with Takis/Evvivax under our JDA."