•   DermaVir: HIV-specific Immune Therapy

    Our lead product candidate DermaVir is designed to boost immune response in order to kill HIV-infected cells in HIV-positive or AIDS patients whose immune system has been compromised by the virus. As antiretroviral therapy is not capable of killing HIV infected cells in the reservoir, or to cure the disease, we believe DermaVir has the potential to be a new state of the art treatment paradigm in HIV/AIDS.

    DermaVir utilizes all key elements of our Immune Therapy Platform. The API of DermaVir is a single pDNA immunogen safely expressing 15 HIV antigens, the broadest antigen repertoire seen among any of the HIV vaccine candidates to date. It is a ’pathogen-like’ nanomedicine administered topically with DermaPrep, our CE marked medical device. All elements of DermaVir's novel mechanism of action have been consistently demonstrated in vitro, in animal models (mice, rabbits, primates) and in human clinical trials.

    Through these trials, we’ve demonstrated that DermaVir exhibits its specific pharmacologic effects by intensifying the patient's immune system to kill HIV-infected cells. Three seperate trials of DermaVir, with a total of ~70 HIV-infected patients, has shown excellent safety and tolerability in all doses. We found the optimal dose for boosting HIV-specific T cell immune response and demonstrated killing of HIV-infected cells by showing a statistically significant reduction of HIV-RNA in patients as compared to Placebo.

     

    A comparison of DermaVir to existing treatment:

    Dermavir Existing HIV/AIDS Therapy

    Mechanism

    Mechanism

    • Boosts immune system to kill HIV-infected cells
    • Reconstitutes HIV-specific immunity
    • Potential for remission
    • Immune intensification may reduce HIV reservoirs (more to come)
    • Interrupts viral life cycle
    • Cannot reconstitute HIV-specific immunity
    • No remission or cure even with treatment intensification
    • Does not affect HIV-reservoirs

    Toxicity Profile

    Toxicity Profile

    • No dose-limiting toxicities
    • Toxicities limit optimal dosing and certain combination regimens

    Resistance

    Resistance

    • Immunologic resistance different from drug resistance
    • Combination of at least 3 drugs based on rapid resistance

    Treatment Schedule

    Treatment Schedule

    • 4 x per year or less
    • 1 x daily or more

    DermaVir Family For Personalized Treatment


    HIV is a highly variable virus. We found that the therapeutic effectiveness of DermaVir depends on HIV sequence replicating in the patients and the patients' genetic background. To address this challenge we have developed a DermaVir Family, a family of Products containing related HIV-specific antigen sequences characteristic for the different Clades (subtypes) of the virus. To ensure the optimal therapeutic benefit for every patient, the treating physician will enter the information on the patient's HIV sequences and genetic background (HLA) into our eMINER software. After analyzing the data, the eMINER will select the optimal DermaVir Product from the DermaVir Product Portfolio and also calculate the specific T cell epitopes that will play a role in the immune boosting of the individual patient. The treating physician can then make an educated decision for selecting the optimal Product for his/her patient and could also prescribe the proper monitoring.

    The targeted epidemics and our initial Product Portfolio are summarized in the Table below. According to UNAIDS, subtype-B presently represents approximately four million individuals (Europe, North, Central and South America, Caribbean, Australia). Our other product candidates can provide optimized treatment option for an additional 24.7 million HIV-infected individuals (2009 UNAIDS Report and HIV-1 Global Distribution, IAVI report Aug 2003).

    DermaVir Product Family Geographical Target Infected population
    DermaVir B Europe, America, Caribbean, Australia 3 million
    DermaVir C Sub-Saharan Africa, South-Asia 22.5 million
    DermaVir BC Chine 1 million
    DermaVir BF South-America 1.4 million
    DermaVir AB East-Europe 10,000
    Source: UNAIDS