PCI Biotech: Third quarter 2017 report and presentation
Oslo, 28 November 2017 - Please find enclosed the financial report and
presentation for third quarter 2017.
Granting of orphan status from the FDA was an important milestone for the
fimaCHEM programme during Q3 2017, as was the inclusion of the first patient in
the Phase I study extension exploring the potential for repeated treatment in
Phase II. The orphan status recognises the therapeutic benefits we seek to bring
to the bile duct cancer patients in need of better local treatments. Regulatory
interactions to clarify the fastest way to market continued during the quarter
and are expected to be completed by end 2017.
The initial results from the the fimaVACC Phase I study indicate enhanced
overall T-cell responses at tolerable dose levels. The results also suggest
that vaccination with the fimaVACC technology provides both early responses and
high response rates, which are two highly sought-after features of vaccination
platforms. Notably, the best responses are seen at the lowest dose level tested.
Further expansion of the Phase I study is therefore planned to investigate even
lower doses.
The alliances in the fimaNAc programme have showed positive progress and the
research collaboration with a top-10 pharma company entered into a new stage (in
vivo) in Q3 2017.
Per Walday, CEO of PCI Biotech, comments: "The extension of fimaChem Phase I is
progressing according to plan. Our focus is now on finalisation of the
regulatory interactions and progression of all activities leading to start of
the next development phase. From the fimaVacc Phase I study we have received
promising initial clinical results suggesting that vaccination with this
technology is characterised by several important and highly sought-after
features for vaccination platforms. We are therefore intensifying this work and
further expanding the study to explore optimal conditions for vaccination."
Highlights
fimaChem
* Granted US Orphan Drug Designation
* Phase I extension study progressing according to plan
fimaVacc
* Promising interim clinical results from Phase I suggesting enhancement of
several parameters of importance for vaccination
* Expanding the clinical Phase I study to identify optimal dosing
fimaNAc
* Extension of the top-10 pharma collaboration
Corporate
* Strengthened management team further by the appointment of Dr Hans
Olivecrona as Chief Medical Officer
A presentation in English will be held today, Tuesday 28 November 2017, at Oslo
Cancer Cluster Innovation Park.
Time: Tuesday November 28 2017, 08.30am -09.30am CET (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 (access through link Q3
2017 Audiocast or the company's website under "Investors - Reports and
presentations - Webcasts"). 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.