PCI Biotech Q3 2021 interim results
Oslo (Norway), 17 November 2021 – PCI Biotech
(OSE: PCIB), a cancer focused biopharmaceutical company, today
announces its interim Q3 2021 results. Please find enclosed the
report and presentation.
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, CFOEmail: rs@pcibiotech.noMobile: +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 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.
- PCI Biotech Q3 2021 Interim Report
- PCI Biotech Q3 2021 Presentation
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