FIT Biotech’s GTU® technology offers the possibility to express the gene of interest in a population of proliferating cells for extended periods of time taking advantage of the viral function for partitioning provided by the E2 protein and multimeric E2 binding sites. Additionally, GTU® carries an E2-dependent transcriptional activation function for expression of the gene of interest. These unique properties confer an enhanced immunogenicity profile of the selected antigens as demonstrated within a variety of preclinical studies conducted in small (mice) as well as large animals (swine and non-human primates). Furthermore, the safety and immunogenicity profile of the GTU® technology was evaluated in various Phase I/II clinical trials conducted in Europe and South Africa.
Data generated from preclinical and clinical studies attracted the interest of different international networks such us ANRS, HVTN and ACTG which are exploring the GTU® technology in different collaborative partnerships.
The main idea in HIV vaccine development has been to use genetic immunization in order to obtain a strong cell mediated immune response against the HI virus, special emphasis has been put on the development of DNA plasmids suitable to be used in the vaccination. During this process, a highly effective DNA plasmid, GTU® (Gene Transport Unit) was developed and protected by FIT Biotech. Patent for GTU® is issued in Europe and USA. The GTU® technology offers a possibility to express the gene of interest in a population of proliferating cells for extended periods of time. Experiments using tissue culture cells as a model indicate that the functions of GTU® increase the expression of gene of interest up to two orders of magnitude compared to regular CMV based expression vectors under the same conditions.
The GTU® is meant to be used as a transfer vector for biological therapeutics in humans. For most purposes, an antibiotic resistance gene is commonly used as a selection marker for the production of the plasmid in the bacteria. However, in cases where the goal is to generate a product in high yield for administration to patients such as a DNA vaccine, the use of antibiotic resistance genes in the plasmids raises concerns. Therefore FIT has developed new auxotrophic GTU® based vectors, and developed efficient production process for such vector types. FIT Biotech has patented this auxotrophic selection system worldwide.
FIT Biotech’s most advanced vaccine is the therapeutic HIV vaccine. The vaccine has been tested in a phase II trial in South Africa and has been proven safe,well tolerated and having a significant impact in declining the viral load and increasing the CD4 cell counts, thus suggesting its use as a potent therapeutic agent, Further HIV therapeutic clinical studies are conducted in collaboration with Imperial College, London, United Kingdom, and ANRS, France.
Due to its versatile features the GTU® Technology can be used for a variety of vaccine and gene therapy based applications thus facilitating the development of several innovative biotechnological products. TB, Malaria and Dengue Fever vaccine developments are in the discovery phase and being developed in collaboration with international networks.