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Highlights
fimaChem
*The implementation of the amended protocol and the opening of Asian sites
provided increased screening and enrolment to RELEASE in Q1, but the activity
declined significantly in Q2 with only three patients included. The expected
timeline for the interim analysis for potential accelerated approval is revised
to 2H 2023
*Recruitment in Q3 started stronger with four patients included in July and the
company continues to focus on enrolment of patients into the RELEASE study, with
the emphasis on regular trial management, including overall performance
evaluation and site replacement
*First US patient enrolled in the RELEASE study
*Orphan drug designation granted in South Korea
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
*US patent granted for the use of fimaVacc in combination with immune checkpoint
inhibitors
fimaNAc
*Encouraging data on enhanced delivery of mRNA for various medical applications
was presented at the UK based 12th Annual RNA Therapeutics Virtual Conference
*Established extensive research collaboration with the South Korean company OliX
Pharmaceuticals, a leading developer of RNAi therapeutics
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 organisation has been focused on
the implementation of all the initiatives to recoup delays to the RELEASE study
inflicted by the Covid-19 pandemic. On the positive side, South Korea has
contributed strongly to the recruitment in 2021. Asia is a region with higher
prevalence of bile duct cancer and South Korea is a key market in this region.
The granting of orphan drug designation for fimaporfin in South Korea was an
important step in the development of fimaChem for bile duct cancer and a
recognition of the therapeutic benefits we seek to bring to the patients. The
pandemic situation is however still fluid in 2021 and we have seen fluctuating
recruitment this year, which unfortunately means that we need to revise our
estimated timelines. 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. The focused efforts needed for RELEASE during the pandemic
has unfortunately reduced available resources for fimaVacc and fimaNAc. We have
strong confidence in the commercial potential of all our programmes and have
therefore strengthened the organisation significantly, with three highly skilled
employees that will play key roles in driving the progress of all programmes.
For fimaVacc, the US patent granted for the use in combination with immune
checkpoint inhibitors (ICI’s) provides important intellectual property for the
further development of this programme. Increasing the response rates to ICI’s is
a main priority in the pharma industry and therapeutic cancer vaccination is a
rational approach to this aim, with well-suited characteristics of the fimaVacc
technology. For fimaNAc, we were pleased to announce a broad and exciting
collaboration with OliX Pharmaceuticals in South Korea, and we continue to
pursue new and value-adding collaborative opportunities.”
An online presentation in English will be held today, Tuesday 31 August 2021, at
08.30am CEST (local time). The presentation can be followed as a live webcast,
access through link
https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20210831_1
(https://channel.royalcast.com/hegnarmedia/) 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 2195 6342 / Sweden +46 4 0682 0620 / Denmark +45 7876 8490 / United
Kingdom +44 20 3769 6819 / United States +1 646 787 0157. 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: 436187
Event title: PCI Biotech Holding conference call Q2
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 31
August 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 considered to be inside information pursuant to the EU
Market Abuse Regulation and is subject to the disclosure requirements pursuant
to section 5-12 of the Norwegian Securities Trading Act. This stock exchange
announcement was published by Ronny Skuggedal, CFO, PCI Biotech Holding ASA, on
31 August 2021.
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