First therapeutic vaccine for HIV indication

Our lead product candidate DermaVir® is designed to boost natural immune responses to kill HIV-infected cells in patients with compromised immunity. As current antiretroviral therapy is incapable of killing HIV-infected cells in the reservoirs or providing a cure, we believe DermaVir® has the potential to be a new state-of-the-art HIV/AIDS treatment.

Our lead product candidate DermaVir® is designed to boost natural immune responses to kill HIV-infected cells in patients with compromised immunity. As current antiretroviral therapy is incapable of killing HIV-infected cells in the reservoirs or providing a cure, we believe DermaVir® has the potential to be a new state-of-the-art HIV/AIDS treatment.

Through the clinical studies we demonstrated that DermaVir® has a specific immunological effect by boosting the immune system to kill HIV-infected cells. Three clinical studies with DermaVir®, enrolling a total of ~70 HIV-infected patients, showed excellent safety and tolerability in all doses. We found the optimal dose for boosting HIV-specific T-cell immune responses and demonstrated the killing of HIV-infected cells by showing a statistically significant reduction of HIV-RNA in patients treated with the optimal dose of DermaVir® compared to placebo.

In addition to the three completed clinical trials, we are working on initiating a Phase III study in Russia or East Africa in 200 patients.

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Pre-clinical

Multiple studies using different animal models (rats, pigs, rabbits, monkeys) demonstrated that DermaVir® is safe and well tolerated. Even in the highest dose, we did not find any related toxicity.

HIV / AIDS

Once a lethal pandemic, human immunodeficiency virus (HIV) has now taken the form of a chronic condition. As of 2021, according to WHO 38.4 million were living with HIV [1]. The incidence of new HIV infections globally is approximately 1.5 million each year. The majority of these people living with HIV/AIDS have a life expectancy comparable to healthy adults. With appropriate ART treatment HIV may remain a chronic condition and the progression to AIDS is rare. However, ART is not available to everyone; and chronic therapy is still flawed by several side-effects. Thus, many PLWHA have a poor quality of life and suffer from high morbidity and mortality. Approximately 50% demonstrate a pattern of cognitive, motor, and behavioral dysfunction.

Although combination ART has enabled tremendous progress in suppressing HIV replication, it fails to eliminate HIV latently infected cells, and infected individuals remain HIV positive for life, despite an undetectable viral load. Lifelong ART is required to maintain the control of virus replication, which may result in significant problems, including long-term toxicity and high costs.

Therefore, novel therapeutic strategies are urgently needed to eliminate the viral reservoir in the host for HIV cure. It has been recently shown that the size of the viral reservoir is inversely correlated with the frequency of HIV-specific central-memory T cells. These data suggested that combination ART in conjunction with therapeutic vaccination aimed at expanding the HIV-specific T cell pool with central-memory features bears the potential to accelerate clearance of the viral reservoir.

Immunotherapies

Immunotherapies seek to cure diseases by manipulating, strengthening, or suppressing the immune system. They represent one of the most exciting innovations in recent decades for treating diseases such as cancer. Immunotherapies can potentially be used to treat infectious and autoimmune diseases, chronic inflammation, and to support transplantations.

HIV—being attacks the immune system which makes it a potential target for immunotherapies. DermaVir® vaccine developed by Genetic Immunity, Inc. is a promising candidate immunotherapy, also suitable for platform technology. By the pDNA construct we can effectively target other diseases as well like infections, allergy and even certain types of cancer.