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Highlights
fimaChem
*Enrolment of patients into the RELASE study is still challenging and
fluctuating - Covid-19 has a continued negative impact on the study and with
August being a low recruitment month due to the holiday season, only five
patients were enrolled in Q3
*Three patients were enrolled into the RELEASE study in October and the company
continues to have a strong focus on recruitment, with the emphasis on regular
trial management, including overall performance evaluation and site replacement
*Thirty patients have per end of October been included in the RELEASE study and
the expected timeline for interim analysis remains 2H 2023
*Proactively pursuing strategies to address recruitment and retention, including
interactions with FDA and EMA about an alternative study design
fimaVacc
*The programme is progressing towards initiation of a Phase II clinical proof-
of-concept study, with product definition and study design clarified following
comprehensive consultations with international experts
fimaNAc
*Development plan initiated based on strategic research and collaborations,
targeting applications suited to the specific strengths of the PCI technology
Corporate
*Significantly strengthening the organisation with three highly skilled
individuals; an experienced operational leader for RELEASE, and two key
employees within clinical science and business development focusing on fimaVacc
and fimaNAc
Per Walday, CEO of PCI Biotech, comments: “The strengthening of the organisation
with three key employees has contributed positively to the progress in all
development areas, but the RELEASE study is unfortunately still affected by the
Covid-19 pandemic. Scheduling of local administration of light to the bile duct
by endoscopy remains challenging in the RELEASE study, as clinical trial sites
continue to deal with a backlog of patients. The situation is expected to
improve as the vaccination rates increase going forward. We are fully focused on
optimal study performance and progress, with attention to site performance and
proactive management of study specific risks. We are also pursuing strategic
options to address retention and recruitment, including ongoing interactions
with regulatory authorities regarding a well-prepared and rational study design
change utilising external control data in RELEASE. The initial responses from
regulatory authorities do however suggest significant challenges for using this
approach in a pivotal trial of a first line treatment. We are pleased to provide
more granularity on the next steps for fimaVacc, as product definition and study
approach has been further clarified following comprehensive interactions with
KOLs. We look forward to bringing this exciting programme with encouraging early
clinical immune response results to proof-of-concept in a combination treatment
setting with immunomodulation in solid tumours. A stronger strategic focus has
been applied to the fimaNAc programme with emphasis on specific applications
lending themselves to the strength of the PCI technology, and we continue to
pursue new and value-adding collaborative opportunities.”
The presentation will be held in English today, Wednesday 17 November 2021, at
08.30am CET (local time). The presentation can be followed as a live webcast,
access through link
https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20211117_3 or the
company’s website under “Investors - Reports and presentations - Webcasts”.
Q&A session
There will be a Q&A session at the end of the presentation and it will be
possible to post written questions through the webcast console. The presentation
will also be presented through a teleconference, mainly facilitated for
investors intending to ask questions verbally during the Q&A session.
Dial-in details for teleconference, mainly facilitated for verbal questions
during Q&A session:
If you plan to use this facility, please join the event 5-10 minutes prior to
the scheduled start time using the dial-in numbers below. A line mediator will
provide information on how to ask questions.
Norway +47 2350 2007 / Sweden +46 (0)8 5033 6574 / Denmark +45 35 15 80 49 /
United Kingdom +44 (0)330 336 9125 / United States +1 929 477 0324. If your
country is not listed, we recommend that you use the dial-in details for UK.
When prompted, provide the confirmation code or event title.
Confirmation Code: 7356590
Event title: PCI Biotech
The interim report and the presentation will also be available on www.newsweb.no
and on the company’s webpage, www.pcibiotech.com from 07:00am CET on 17 November
2021.
For further information, please contact:
Ronny Skuggedal, CFO
Email: rs@pcibiotech.no
Mobile: +47 9400 5757
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 further information, please visit: www.pcibiotech.com
(http://www.pcibiotech.com)
Contact information: PCI Biotech Holding ASA, Ullernchausséen 64, N-0379
Oslo
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.
Kilde
