Genetic Immunity

Address: Berlini str. 47-49, H-1045Budapest,Hungary

Tel: +36 1 272 0364

Web: http://www.geneticimmunity.com/GI00.html

Company description

Genetic Immunity is a privately held US/Hungarian clinical-stage biotechnology company focusing on the discovery, development and commercialization of a new class of immunotherapeutic biologics (‘Immune Therapies’ or ‘Therapeutic Vaccines’) for the treatment of chronic viral infections, cancer and allergy. Our Immune Therapies are designed to intensify or boost specific immune responses to modify or control these presently incurable diseases. We believe that our Products will allow people to live a better and longer life.

Our proprietary Immune Therapy Platform Technology includes the plasmid DNA-based antigen design, nanomedicine formulation and topical administration targeting antigens to dendritic cells. Our technologies support the rapid and cost-effective development of original biologic Products for several indications and provide tools for the selection of an optimal treatment for every patient based on his disease and genetic background.

Our lead Product candidate for the treatment of HIV/AIDS, referred to as ‘DermaVir’, is a therapeutic HIV vaccine effective in boosting immune responses that kill HIV-infected cells. Our Phase I and Phase II clinical trials demonstrated boosting of HIV-specific T cells and specific killing of HIV-infected cells that are not eliminated by current antiretroviral drugs. DermaVir has an excellent safety profile similar to vaccines used in healthy adults and children. The goal of DermaVir immune intensification is to modify HIV disease, decrease antiretroviral drug exposure while maintaining undetectable HIV-RNA levels and achieve a remission (functional cure) in HIV-infected patients.

Our pipeline product candidate with animal proof of concept, for the treatment of Chlamydia infection, is referred to as ‘ChlamyDerm’ and our allergen-specific immunotherapy is referred to as ‘DermAll’. ChlamyDerm decreased the amount of infected cells together with infection-associated inflammation in mice experiments. DermAll decreased the allergic symptoms by balancing allergen-specific immune responses in mice experiments. Other pipeline candidates for virus-associated cancers and warts are in discovery phase.

Products and services

There are four principal components that comprise our comprehensive Immune Therapy platform technology which are designed to work in conjunction to treat and/or control chronic infectious diseases, cancer and allergy, as follows:

1.Our Active Pharmaceutical Ingredients (API):
We have been designing (ANTIGENeering) our APIs to be specific, safe and effective. It consists of a single plasmid DNA (pDNA) immunogen ANTIGENeered to express several antigens, to contain molecular safety features and to release Virus Like Particles (VLP+) in the body of the patients. API with these crucial properties is not feasible with protein or peptide antigens.

2.Nanomedicine – our Product platform:
Our Products are referred here as the ‘nanomedicine’ according to their unique biophysical and biological features. Our APIs are formulated with our novel polymer excipient to synthetic ‘pathogen-like’ nanoparticles. The nanomedicine formulation is essential to achieve potent antigen expression from the pDNA and antigen presentation by dendritic cells. This is critical for the intensification of antigen-specific immune responses in people with chronic diseases.

3.DermaPrep – our topical administration platform:
We have developed DermaPrep medical device for targeted in vivo delivery of our nanomedicine Products to the dendritic cells of the lymph nodes via the Langerhans cells. We obtained the Marketing Approval in the European Union (CE Mark) for our DermaPrep device.

4.IT – Applied information technology:
IT innovations have been supporting the discovery, development, manufacturing, and personalized treatment processes of Genetic Immunity. These include the rational antigen design, clinical trial and data management and matching the patients with the optimal Immune Therapy Product.