FIT Biotech focusing on gene therapy

The Board of Directors of the Finnish biotechnology company FIT Biotech Oy (NASDAQ: FITBIO) has reviewed the company's on-going development projects and made a strategic decision to develop applications for gene therapy besides vaccine development. The decision is based on the good results of the functionality of the GTU® technology already achieved, as well as the significant market need for gene therapies. Gene therapies have the potential to considerable commercial opportunities. In December FIT Biotech filed a patent application related to use of GTU® technology in gene therapy.

Gene therapy aims at finding a simple way to safely and cost-efficiently produce therapeutic or preventive antibodies in the human body. FIT Biotech will initiate the commercialisation of gene therapy applications upon obtaining additional data and when corresponding industrial rights are secured. FIT Biotech's GTU® technology platform provide a good foundation for opening a new development path.

"Gene therapy is a market segment that grows fast. Biological drugs are increasingly replacing chemical drugs, and in particular, the use of drugs for gene therapy is expected to grow significantly. FIT Biotech, thanks to its gene therapy development projects, is excellently positioned to commercialise this potential. Shifting the strategic focus increasingly into gene therapy will enable efficient utilisation of the company's patented GTU® technology when developing antibodies and gene vaccines", says Rabbe Slätis, Chairman of the Board, FIT Biotech.

Development of the therapeutic vaccine against bovine papilloma virus and Ebola did not meet with company's objectives.  Of the development projects that the company disclosed in the listing prospectus published on May 29, 2015 in connection with its IPO these two vaccine projects will be discontinued. However, development of the applicability of these drug candidates for gene therapy will be continued.
Development of other projects will proceed as planned. FIT Biotech's patented cutting edge GTU® technology facilitates quick and efficient transfer of genes into target cells.

Henceforth FIT Biotech's development project portfolio comprises:

1.    GTU® gene therapy
In gene therapy, that is, treating or preventing a disease through gene transfer, the aim is to transport the desired genes to human somatic cells where they start to produce therapeutic or preventive proteins. FIT Biotech's objective is to develop enabling applications for gene therapy. The company is presently conducting preclinical studies to obtain proof-of-concept for the patented GTU® technology in gene therapy. The studies have so far produced positive results that support the company's expectation of the efficacy of the technology.

2.    GTU® genetic vaccines
With its GTU® vaccines, the company focuses particularly on the prevention and treatment of diseases in areas where treatments do not exist at the moment, or where medical treatments have poor efficacy or safety. Examples of such areas are a therapeutic tuberculosis vaccine, HIV immunotherapy and animal vaccines.

3.    Research collaboration
Besides direct licensing agreements, the company aims to enter research agreements as a stepping stone for final licence agreements. The company is a member of the EU Horizon 2020 research consortium developing a new type of treatment for HIV. FIT Biotech manufactures the test vaccines in its own production facility approved by the Finnish Medicines Agency.


More information:
Rabbe Slätis
Chairman of the Board, FIT Biotech Oy
Telephone: +358 40 840 6749
Email: rabbe.slatis@fitbiotech.com

Certified Advisor: Translink Corporate Finance Oy, telephone +358 20 743 2790

FIT Biotech Oy in brief
FIT Biotech Oy is a biotechnology company established in 1995. The company develops and licenses its patented GTU® (Gene Transport Unit) vector technology for new-generation medical treatments. GTU® is a gene transport technology that meets a significant medical challenge in the usability of gene therapy and DNA vaccines.

FIT Biotech presently applies the GTU® technology to its drug development programmes. Examples of application areas include cancer (gene therapy), infectious diseases, such as HIV and tuberculosis, and animal vaccines.

FIT Biotech shares are listed on the First North Finland market maintained by Nasdaq OMX Helsinki Oy.

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