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Highlights
fimaChem
*The first patient has been enrolled in the RELEASE study in South Korea, less
than three months after opening of the first study site in Asia. All the nine
planned study sites in South Korea and Taiwan are now open, with initial good
screening activity
*Several initiatives are being implemented in the RELEASE study to recoup long-
term recruitment projections. Besides going into Asia, the most important
initiative is the protocol amendment made to expand the eligible patient
population. Full approvals of the protocol amendment are received in 10 European
countries, South Korea, Taiwan and US. Seven sites are pending local ethic
approvals and the focus is now on achieving the remaining approvals
*A total of 45 RELEASE study sites are open by end-October 2020 across EU, US
and Asia and 38 of these sites are open under the new amended protocol
*The consequences of the COVID-19 pandemic and the new recruitment initiatives
for the RELEASE study cannot yet be fully established. The second wave of the
pandemic is currently sweeping over many countries, but we are seeing early
indications of increased screening activity after implementation of the new
amended protocol and the opening of Asian sites. The situation is more uncertain
in the US and the implementation of the new amendment by local ethics is still
pending at most sites, so first patient enrolled in the US may slide into 2021
*The company continues to have full focus on enrolment of patients into the
RELEASE study. The expected timeline for the planned interim analysis is
retained as a range from 2H 2022 to 1H 2023
fimaVacc
*A new research collaboration is established with DCprime to explore novel
cancer vaccination concepts. DCprime is a clinical stage, privately held cancer
immunotherapy focused company and the companies will perform an extensive
evaluation of technology compatibility and synergy based on preclinical studies.
The results will be evaluated and explored for the potential for further
development and partnership
fimaNAc
*In October 2020 PCI Biotech was informed that AstraZeneca elected not to enter
into a definitive agreement for the fimaNAC technology. Encouraging preclinical
results have continued to be achieved with the fimaNAC platform in this
collaboration and the decision not to enter into a definitive agreement is
primarily based on a strategic evaluation by AstraZeneca’s of their current
development needs. The companies will work together to publish the preclinical
results from this collaboration
Per Walday, CEO of PCI Biotech, comments: “The RELEASE screening activities have
increased since the summer and I am very pleased with the efforts and good
progress made by the organisation to ensure an optimised RELEASE study. With the
first patient already enrolled in Asia and most of the sites screening for
patients under the new amended protocol, we are now well positioned to
accelerate the RELEASE study. We are already seeing early indications of
increased screening activity, but it remains to be seen how the second wave of
the COVID-19 pandemic will affect further progress. We were disappointed that AZ
did not elect to enter into a definitive agreement. This collaboration has
however provided us with positive results and important knowhow. We are
confident in the potential of the fimaNAc technology and will use these data and
learnings to further enhance and promote the technology. We have also
established a new broad and exciting research collaboration with DCprime
spanning both fimaVacc and fimaNAc, and we look forward to exploring synergies
between our technologies.”
An online presentation in English will be held today, Wednesday 11 November
2020, at 08.30am CET (local time). The presentation can be followed as a live
webcast (access through link
https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20201111_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 asking questions
verbally 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 9125 / 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: 2202572
Event title: PCI Biotech Holding ASA Q3 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 (CET) on 11
November 2020.
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
