Vis børsmeldingen
Highlights
fimaChem
*Increased screening and enrolment to RELEASE in Q1 after implementation of the
amended protocol and the opening of Asian sites. The full effect of these
initiatives is not expected until the Covid-19 situation improves further
*The first US patient was enrolled in the RELEASE study in April
*Continued focus on enrolment of patients into the RELEASE study, with the
emphasis going forward being on regular trial management, including performance
evaluation and replacement of underperforming sites
*The expected timeline for the planned interim analysis remains in the range
from 2H 2022 to 1H 2023
fimaVacc
*Successful Phase I vaccination proof of concept study published in the high
impact immunology journal, Frontiers in Immunology, demonstrating that fimaVacc
enhances the immune response to peptide- and protein-based vaccines in healthy
volunteers. The focus going forward is utilising the Phase I results in
partnering efforts and planning for clinical proof-of-concept in a disease
setting
fimaNAc
*Encouraging data on enhanced delivery of mRNA for various medical applications
was presented at the UK based 12th Annual RNA Therapeutics Virtual Conference in
February 2021
*In May 2021, PCI Biotech entered into an extensive research collaboration with
the South Korean company OliX Pharmaceuticals, a leading developer of RNAi
therapeutics
Per Walday, CEO of PCI Biotech, comments: “We have seen a good increase in
patient screening and enrolment into the RELEASE study in Q1 2021, which is
encouraging and supports the relevance of our study optimisation efforts. We
expect to see the full force of these modifications when the healthcare systems
are no longer afflicted by the pandemic. The situation has been difficult in the
US, but an increase in activity during Q1 resulted in the first patient being
enrolled in April. We are now fully focused on optimal study performance and
progress, with the attention to site performance and management of study
specific risks. For fimaVacc, we were pleased to see the successful proof-of-
concept study published in the high impact immunology journal, Frontiers in
Immunology. The focus going forward is utilising these results in partnering
efforts and planning for clinical proof-of-concept in a disease setting. We were
proud to present the strong collaborative fimaNAc data at a relevant
international conference in February. We will be using these results to draw
further attention and interest among relevant players within nucleic acid
therapeutics. The broad and exciting collaboration recently announced with OliX
Pharmaceuticals in South Korea signifies the strengths of our data and we look
forward to exploring synergies between our technologies.”
An online presentation in English will be held today, Friday 7 May 2021, at
08.30am CEST (local time). The presentation can be followed as a live webcast,
access through link https://channel.royalc
(https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20210507_1)a
(https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20210507_1)st.com/hegn
armedia/#!/hegnarmedia/20210507_1
(https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20210507_1) 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 2100 2610 / Sweden +46 (0)8 5033 6574 / Denmark +45 35 15 80 49 /
United Kingdom +44 (0)330 336 9105 / United States +1 929-477-0402. 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: 5592549
Event title: PCI Biotech Q1 2021 Conference Call
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 (CEST) on 7 May
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
