U.S. biotechnology company Genetic Immunity has granted an exclusive license of its trans-dermally delivered plasmid DNA-based therapeutic HIV vaccine technology to Russian company Pharmadis, the two firms said in a statement.
Under the agreement, Pharmadis received rights to market Genetic Immunity’s HIV technology in Russia and the Commonwealth of Independent States (CIS). As part of the agreement, to qualify for Russian marketing approval, a new clinical study will be conducted in Moscow. Up to 200 patients will be enrolled in the study, expected to start in H1-2019 and to be completed in H1-2020, the companies said.
“DermaVir is the next generation of plasmid DNA-based vaccine for the treatment of chronic diseases,” said Viktor Rozsnyay, CEO of Genetic Immunity. “We are very excited to partner with Pharmadis, one of the most professional medical companies in Russia, and are confident that together we can bring our HIV technology to the market.”
“We look forward to facilitating the upcoming trial and hope for a positive outcome. Once approved in Russia, our therapeutic vaccine can be a significant addition to the treatment repertoire available to effectively combat HIV,” Rozsnyay added.
“In addition to the Russian license, we are in the process of completing documents requested by the U.S. Federal Drug Administration (FDA). Once available, data obtained in Russia will be used to strengthen our U.S. submission process,” he said.
“We are glad to begin cooperation with Genetic Immunity. We consider DermaVir potentially as the most revolutionary plasmid DNA-based therapeutic vaccine,” stated Nikolai Kovalev, Managing Director of Pharmadis.