Genetic Immunity Grants Exclusive License of Therapeutic HIV Vaccine Technology to JSC Pharmadis for Russia and Commonwealth of Independent States

MOSCOW, December 18, 2018 /PRNewswire/ --

Genetic Immunity, a clinical stage biotechnology company, has granted an exclusive license of its trans-dermally delivered pDNA-based therapeutic HIV vaccine technology to Pharmadis, a Russian company with vast experience in medicine.

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Under terms of the agreement, effective immediately, Pharmadis received rights to market Genetic Immunity's HIV technology in Russia and the Commonwealth of Independent States. 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.

Upon successful completion, marketing authorization will be sought. Pharmadis is responsible for financing study costs and seeking marketing approval.

"DermaVir is the next generation of plasmid DNA-based vaccine for the treatment of chronic diseases," stated 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 continued.

The DermaVir platform contains a novel plasmid DNA that encodes most HIV genes. The vaccine is administered topically using the DermaPrep medical device.

'Proof of concept' for the immunological and anti-viral activities of DermаVir was demonstrated in infected macaques, some of them with advanced stages of SIV. Analyses of data derived from these animal trials have indicated that repeated DermaVir administration results in a cumulative strengthening of the antiviral immune response without adding significant toxicities or adverse effects.

"In addition to the Russian license, we are in the process of completing documents requested by the FDA. Once available, data obtained in Russia will be used to strengthen our US submission process," Rozsnyay added.

"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.