FIT Biotech is a Finnish clinical phase biopharma company with over 20 years of history in biological drug development. The Company is focused on development and commercialization of its proprietary technology platform: Gene Transport Unit (GTU®). Currently, the Company employs 12 persons (+CEO) and has an experienced management as well as an internationally recognized scientific advisory board
The GTU® (Gene Transport Unit) technology offers the possibility to express genes 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 E2-dependent transcriptional activation function for expression of the gene of interest.
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 FIT Biotech has developed and patented an antibiotic free manufacturing method to avoid antibiotic residues in the final product.
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 poses safety concerns. Therefore FIT has developed new auxotrophic GTU® based vectors and developed efficient production processes for such vector types.
FIT Biotech has validated its proprietary GTU® Technology for licensing in terms of clinical efficacy and safety. It can be applied in DNA vaccines and gene therapy. FIT Biotech has developed the novel DNA technology taking advantage of the specific properties of the E2 – a transcriptional regulator derived from bovine papilloma virus (BPV). E2 has a dual role in the function of the vector: first, it enhances the transcription and expression of any cloned antigen; and second, by binding simultaneously to stretches of BPV origin also present in the vector, and to chromatin, it assures that the plasmid is not lost during mitosis in dividing cells.
The segregation/partitioning function of the papilloma virus is used by the virus in the processes of initial viral replication and during establishment of latent infection. The E2 protein mediated compartmentalisation of the viral genome to the chromatin may play an important role in the maintenance and gene expression of the viral genome throughout cell differentiation, until the terminal differentiation, which induces expression of late viral genes. Therefore, the partitioning/ segregation function, which is transferred into GTU®, can be beneficial for the establishment of expression of therapeutic gene in the differentiating tissue.’’
It is assumed that this feature is crucially important for gene therapy. All the above features confer the versatility of the GTU® technology which can be used in a variety of applications in research & development of vaccines and gene therapies.
|FIT Biotech at a glance