FIT Biotech Oy: FIT Biotech has delivered the first batch of FIT-06 vaccine to EHVA clinical trials

FIT Biotech Oy

Press release 27.8.2018 at 08.30 AM EET

FIT Biotech has delivered the first batch of FIT-06 vaccine to EHVA clinical trials
FIT Biotech Ltd ('FIT Biotech', FITBIO: FN Finland) has delivered the first batch of FIT-06 vaccine from their factory in Tampere to the European HIV Vaccine Alliance (EHVA) for a clinical, phase I/II trial. FIT Biotech's vaccine candidate FIT-06 is a part of the experimental therapeutic approach whose safety and efficacy is tested with participants living with HIV. The company announced in June 2018 that the Swiss and UK pharmaceutical authorities have granted permission for initiating clinical trials.

The first delivered batch consisted of fifty (50) vaccine units. Clinical studies are expected to start during the autumn. Delivery of the next batch is due Q1/2019.

Erkki Pekkarinen, FIT Biotech's CEO comments:
'This is an important milestone in the research for therapeutic HIV vaccines by EHVA. We are proud of our role in EHVA consortium and our capacity to produce FIT-06 vaccine within the agreed timetable. Our vaccine candidate FIT-06 is the priming vaccine component in this trial and results will be very important not only to us, but first and foremost to patients who want an alternative way to control HIV rather than daily drugs.'

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 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.

For further information:
CEO Erkki Pekkarinen
Tel: [phone]
E-mail: [e-mail]
Certified Advisor: Aalto Capital Partners Oy, tel. [phone]

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 such as HIV and tuberculosis, as well as animal vaccines.

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
Principal media

DISTRIBUTION:
NASDAQ OMX Helsinki
Principal media