Genetic Immunity, Inc. is a US biotechnology company. We are a privately held Delaware corporation with our main office located in Baltimore, Maryland.
We maintain research facilities in Germany, Hungary and Russia. Over the course of the last ten years we have conducted three human clinical trails of our lead product candidate, an immunotherapy vaccine for the treatment of HIV. A Phase I trial in Hungary, an NIH financed and ACTG conducted Phase I/II trial in the United States, and a Phase II trial in Germany. All three trials have demonstrated efficacy, immunogenicity, safety and optimal dosage. We are now in the process of conducting a Phase II trial in Russia in order to seek marketing approval there.
In addition, we are also working with our US regulatory expert, DJA Global Pharmaceuticals, Inc. on FDA submissions of past and upcoming clinical data in order to seek appropriate designations (fast-track, orphan drug, breakthrough therapy as available) in order to to receive clear guidance on US marketing approval.
If approved, our lead product candidate DermaVir will become the first new treatment option, a complement to antiretroviral therapy, in the fight against HIV.
We are also initiating preclinical and clinical trials of twenty different cancer indications, all based on our pDNA technology platform.
At the end of 2018 we have successfully licensed our HIV vaccine technology to Pharmadis in Russia. Then, at the beginning of 2019, we extended our collaboration by granting marketing licenses to an additional twenty cancer indications. Pharmadis will be responsible for Russian and CIS (Commonwealth of Independent States) distribution.