FIT Biotech Oy: FIT Biotech’s GMP facility audited and approved – the company resumes manufacturing of drug candidates

Company announcement           
August 25, 2016 at 9.45 am EET
FIT Biotech's GMP facility audited and approved - the company resumes manufacturing of drug candidates

Finnish Medicines Agency Fimea has reapproved FIT Biotech Ltd's GMP-manufacturing (Good Manufacturing Practice, GMP) license, which was withheld as previously announced. The Company started a process to resume GMP-manufacturing and renewing the GMP-license using funds received at the First North -listing. The renewal of the GMP-license enables the ramp-up of manufacturing and manufacturing of drug candidates for clinical trials as planned.

The renewed license will allow FIT Biotech to start manufacturing of its therapeutic HIV-vaccine for the EU Horizon 2020 EHVA-project where its effect will be tested in a novel treatment concept. The EHVA-project aims at controlling HIV-infection by immunotherapy. The clinical trial is a phase IIb-study that will be conducted as a multicentric trial in six European countries. FIT Biotech's candidate vaccine will be tested in 170 subjects.

The project is funded by the European Horizon 2020 programme. The project started in January 2016 and will continue until 2021. As announced earlier by FIT Biotech, the company will receive a grant amounting to approximately 1 million euros and the funds will be received in the early stage of the project.

The renewed GMP-license will also enable FIT Biotech's R&D-strategy focusing on gene based treatments. An own GMP-facility represents a strategic asset for the company enabling manufacturing of drug candidates for clinical trials.


Further information:
James Kuo
CEO, FIT Biotech Oy
Tel: +358 3 3138 7000
Certified Advisor: Translink Corporate Finance Oy, tel. +358 20 743 2790

FIT Biotech in brief

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

FIT Biotech applies GTU® technology in its drug development programmes. Application areas include cancer (gene therapy) and infectious diseases such as HIV and tuberculosis, as well as animal vaccines.

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

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