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FIT Biotech Oy: EHVA clinical trial authorization granted for testing FIT-06 in UK

(June 26, 2018)

FIT Biotech Oy                                                            

Company release 26.6.2018 at 8:30 AM EET

EHVA clinical trial authorization granted for testing FIT-06 in UK

FIT Biotech Oy ("Company", FITBIO: FN Finland) today announced that the UK medical authorities have granted the European HIV Vaccine Alliance (EHVA) the permission to start a phase I/II clinical trial. In this trial, FIT Biotech's HIV vaccine candidate FIT-06 is a part of a regimen whose safety and efficacy are tested in the UK with participants living with HIV. This trial is part of a multicentric trial with study sites in six European countries, sponsored by INSERM-ANRS (French National Institute of Health and Medical Research) and is expected to start during 2018. FIT Biotech announced earlier in June 2018 that equivalent clinical trial authorization was granted in Switzerland.



Worldwide, almost 37 million people are living with HIV and approximately 2 million new infections occur every year. The Company's clinical stage candidate FIT-06 aims to contribute to addressing challenges of standard therapies that include restricted access to medication, continuous patient retention in lifelong therapy, social stigma and potentially serious side effects. There is a need to provide a safer and more cost-effective alternative to current HIV therapies, and the FIT-06 vaccine is part of the EHVA arsenal that could represent an important element in this strategy.

CEO Erkki Pekkarinen comments: "The process is proceeding as planned and the UK has now granted the clinical trial authorization after Switzerland. We are extremely proud to be a part of the EHVA consortium. Our vaccine candidate FIT-06 is the priming vaccine component in this trial and results will be very important not only to us, but also to the immunotherapy field, as we are evaluating immune markers associated with the control of HIV."

FIT BIOTECH OY
Board of Directors

For further information:
CEO Erkki Pekkarinen
Tel: +358 44 027 0080
E-mail: [email protected]

Certified Advisor: Aalto Capital Partners Oy, tel. +358 40 587 7000

About FIT Biotech
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 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.

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

About EHVA
The European HIV Alliance (EHVA) is a five-year project funded by the European Union's Horizon 2020 Research and Innovation Programme designed to foster the development of an effective vaccine. The EHVA encompasses 39 partners, each with the expertise to promote a comprehensive approach to the development of an effective HIV vaccine. The international alliance, which includes academic and industrial research partners from all over Europe, as well as sub-Saharan Africa and North America, will work to discover and progress novel vaccine candidates through the clinic (www.ehv-a.eu).

DISTRIBUTION:
Nasdaq Helsinki
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