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Highlights
fimaChem
*Start-up activities for the RELEASE study are progressing well after the study
commenced with enrolment of the first patient in May 2019
*23 out of 40 planned clinical sites had opened for enrolment by mid-November.
While this is 10 sites less than planned and causes a temporary effect on
patient recruitment projections, the company expects site activations to be back
on track early 2020. The overall RELEASE study timelines are maintained
*The first US site was activated only recently and enrolment of the first US
patient may therefore slide into 1H 2020
*Site selection is ongoing for addition of sites in Asia in 2020, to provide
access to hospitals and key opinion leaders in a region with higher prevalence
of bile duct cancer and to enhance patient recruitment
fimaVacc
*Phase I results have been accepted for presentation at ESMO Immuno-Oncology
Congress in December 2019. The results provide proof-of-concept of the fimaVacc
vaccination technology by demonstrating the improvement of immunogenicity in
healthy volunteers
*Development strategies are being pursued in parallel, with Phase I results
being used both in direct partnering efforts and planning for clinical proof of
concept in a disease setting
*Preclinical study published in high-impact immunology journal Frontiers of
Immunology, demonstrating that therapeutic cancer vaccination with fimaVacc can
be effective independent of T-helper cell functionality
fimaNAc
*Research collaboration with AstraZeneca was extended by six months until end of
2019. The scope has been expanded to evaluate if synergies established in
oncology are transferrable to additional disease areas - further collaboration
to be evaluated in 1H 2020
*Promising response on patent application for mRNA delivery, which may generate
valuable intellectual property
Throughout the third quarter we have continued to execute against the strategic
goals we set for ourselves early in the year. The start-up activities of our
RELEASE trial are progressing, and we maintain the overall timelines we have
indicated for the trial. The current lag in site activation in this early phase
of the trial is expected to be resolved early next year and the inclusion of
Asian sites in 2020 is expected to secure patient recruitment projections,
comments Per Walday, CEO of PCI Biotech.
In parallel we continue to lay the groundwork for expanding our fimaVacc and
fimaNAc technology platform programmes. The positive initial feedback on an
important patent application on mRNA delivery and the expansion of the
collaboration with AstraZeneca are both encouraging developments for fimaNAc.
This progress has been matched with an organisational expansion and we look
forward to further enhance our strategic execution capabilities in the coming
quarters, adds Walday.
A presentation in English will be held today, Wednesday 27 November 2019, at
Oslo Cancer Cluster Innovation Park.
Time: Wednesday 27 November 2019, 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 webcast (access through link
https://webtv.hegnar.no/presentation.php?webcastId=98164537 ) 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 late stage clinical development 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 programme fimaChem consists of a pivotal 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 RNAi therapeutics, thereby addressing one of the major bottlenecks
facing this emerging and promising field.
For more information visit: www.pcibiotech.com (http://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.
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