PCI Biotech: First half year 2017 report and presentation
Oslo, 29 August 2017 - Please find enclosed the financial report and
presentation for second quarter and first half year 2017.
PCI Biotech reported important progress for the fimaChem programme during
1H 2017, with early promising signs of effect in Phase I. The study has also
provided encouraging interim overall survival data averaging 15.6 months per end
July 2017 (median 14.4 months), with 25% of the patients still being alive.
These promising results may be further strengthened by repeating the treatment.
Safety for repeated treatment will be investigated in a Phase I extension study
and the first patient in this study was treated in August. Regulatory
interactions to clarify the fastest way to market and subsequent preparations
for Phase II will run in parallel with the extension study, thereby minimising
time to initiation of a potential pivotal Phase II study with repeated
treatment.
Clinical translation of the fimaVacc asset is progressing with tolerability
being established and the initial results on overall T-cell responses from the
study are expected to be available during 2H 2017.
The fimaNAc programme has showed positive progress and the research
collaborations with RXi Pharmaceuticals and a top-10 pharma company have both
entered into new stages during 2017.
The rights issue completed in Q1 2017 enables PCI Biotech to progress the
fimaChem programme through regulatory interactions to determine the fastest way
to market, as well as the Phase I extension study and other preparations for
initiation of Phase II. The proceeds, together with a grant from the Norwegian
Research Council, will also cover the clinical translation of the promising
fimaVacc asset. The organisation will be strengthened with Dr Olivecrona as
Chief Medical Officer (CMO) from October 2017.
Per Walday, CEO of PCI Biotech, comments: "After the rapid initiation of the
fimaChem Phase I extension study, we now have full focus on effective completion
of this study and the regulatory interactions to clarify fastest route to
market. We are also eagerly awaiting the initial results on overall T-cell
responses from the fimaVacc Phase I study and will revert to the market as soon
as these are available."
Highlights
fimaChem
* Encouraging interim overall survival data from Phase I
* First patient treated in the Phase I extension study
fimaVacc
* Tolerability of the vaccination technology established - awaiting initial
results on overall T-cell responses
fimaNAc
* RXi Pharmaceuticals collaboration expanded into the field of immuno-oncology
* Top-10 pharma collaboration extended and entered into in vivo studies
Corporate
* Dr Hans Olivecrona appointed as Chief Medical Officer
* Completion of a fully underwritten rights issue of NOK 70 million
* Awarded up to NOK 14.3 million in public grants for further development of
the vaccination platform
A presentation in English will be held today, Tuesday 29 August 2017, at Oslo
Cancer Cluster Innovation Park.
Time: Tuesday August 29 2017, 09.00am -10.00am CEST (local time).
Venue: Jónas Einarsson aud. (2nd floor, entrance 2B), Oslo Cancer Cluster
Innovation Park, Ullernchausséen 64, Oslo.
The presentation can be followed as a live audiocast, see link
(http://webtv.hegnar.no/presentation.php?webcastId=58639798). It will be
possible to post questions through the webcast console.
About PCI Biotech
PCI Biotech is a biopharmaceutical company focusing on development and
commercialisation of novel therapies for the treatment of cancer through its
innovative photochemical internalisation (PCI) technology platform. PCI is
applied to three distinct anticancer paradigms: fimaChem (enhancement of
chemotherapeutics for localised treatment of cancer), fimaVacc (T-cell induction
technology for therapeutic vaccination), and fimaNAc (nucleic acid therapeutics
delivery).
Photochemical internalisation induces triggered endosomal release that is used
to unlock the true potential of a wide array of therapeutic modalities. The
company's lead fimaChem programme consists of a Phase I/II clinical study in
bile duct cancer, an orphan indication with a high unmet need and without
approved products. fimaVacc applies a unique mode of action to enhance the
essential cytotoxic effect of therapeutic cancer vaccines, which works in
synergy with several other state-of-the-art vaccination technologies. fimaNAc
utilises the endosomal release to provide intracellular delivery of nucleic
acids, such as mRNA and siRNA therapeutics, thereby addressing one of the major
bottlenecks facing this emerging and promising field.
For more information visit: www.pcibiotech.com
Contact information: PCI Biotech Holding ASA, Ullernchausséen 64, N-0379
Oslo
Ronny Skuggedal, CFO, rs@pcibiotech.no, Mobile: +47 9400 5757
Forward-looking statements
This announcement may contain forward-looking statements, which as such are not
historical facts, but are based upon various assumptions, many of which are
based, in turn, upon further assumptions. These assumptions are inherently
subject to significant known and unknown risks, uncertainties and other
important factors. Such risks, uncertainties, contingencies and other important
factors could cause actual events to differ materially from the expectations
expressed or implied in this announcement by such forward-looking statements.
PCI Biotech disclaims any obligation to update or revise any forward-looking
statements, whether as a result of new information, future events or otherwise.
This information is subject to the disclosure requirements pursuant to section
5 -12 of the Norwegian Securities Trading Act.