PCI Biotech fourth quarter and preliminary full year 2021 results
Oslo (Norway), 18 February 2022 – PCI Biotech
(OSE: PCIB), a cancer focused biopharmaceutical company, today
announces its interim Q4 and preliminary full-year 2021 results.
Please find enclosed the report and presentation.
Highlights
fimaChem*The
RELEASE trial was closed to recruitment in January 2022 due to
changes in the competitor situation that renders the trial
challenging to complete and potentially inadequate for approval
*Approximately 30% of the 41 enrolled patients
will continue to receive study treatments for up to 6 months,
enabling a swift wind-down of the trial
*The trial results will be analysed to evaluate
how the data can be utilised going forward
fimaVacc*The
programme is progressing towards initiation of a Phase II clinical
proof-of-concept study, with product definition and overall study
design clarified following comprehensive consultations with
international experts
*US patent granted for the use of fimaVACC in
combination with immune checkpoint inhibitors
fimaNAc*Focused development plan
initiated based on strategic research and collaborations, targeting
applications suited to the specific strengths of the PCI
technology
*Encouraging data on enhanced delivery of mRNA
for various medical applications 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
*In January 2022, PCI Biotech entered into a
preclinical collaboration with the South Korean company MDimune,
developing innovative drug delivery technologies for modifying
cellular and disease processes
Corporate*Significantly
strengthened the organisation with three highly skilled
individuals; an experienced clinical operational leader, and two
key employees within clinical science and business development
focusing on fimaVACC and fimaNAC
2021
in review - managing RELEASE and preparing
the ground for fimaVACCA
lot of effort was put into accelerating the RELEASE study in bile
duct cancer last year, as the Covid-19 pandemic continued to have a
strong negative impact on study progress with fluctuating
recruitment through the year. The strong efforts resulted in
enhanced screening and enrolment of bile duct cancer patients
towards the end of the year, with the ambitious target of 12
patients included per quarter being reached in Q4. However, the
clinical performability and business opportunity for the RELEASE
programme changed radically when a clinical pivotal study with an
immune checkpoint inhibitor reported overall positive results, with
clinically meaningful benefit on progression free survival and
overall survival. The results presented at ASCO GI in January 2022
showed significant clinical benefit in the RELEASE patient
population. This is expected to quickly change the standard of care
for these patients. These results are positive news for patients
but will unfortunately render the RELEASE study challenging to
complete, and the study was therefore terminated late January 2022.
Stopping RELEASE was a hard decision to make and we would like to
thank all contributors to the study. It has been a tremendous
effort, not least by the enrolled patients, the clinical sites, and
our investors, willing to contribute to the benefit of future
patients and their relatives. We are now focusing on a swift and
cost-effective closing of the study, whilst ensuring that any
potential residual value is captured. The fimaVACC programme is
progressing towards manufacturing of a defined vaccine product and
the next clinical phase. It is now the lead programme in the
company and a group of international expert investigators has been
established to support the development. The aim is to combine the
fimaVACC technology with relevant immunomodulation therapy,
initially focusing on the most apposite indication before a
potential broadening of the deployment of this versatile platform.
To this end, another important patent was added to the fimaVACC IP
portfolio by the US granting a patent covering combination with
relevant immune checkpoint inhibitors. Positive collaborative data
for the fimaNAc technology for intracellular delivery of nucleic
acid therapeutics were presented last year. These data have helped
boosting further interest in the fimaNAc technology and two
collaborations were initiated with South Korean companies. Last
year, a strategic review of the fimaNAc technology and
collaborative opportunities resulted in the initiation of a focused
development plan targeting applications suited to the specific
strengths of the technology. The organisation was also reinforced
with specific expertise to support the further development of both
fimaVACC and fimaNAc.
***A presentation in English will be held today,
Friday 18 February 2022, at Oslo Cancer Cluster Innovation
Park.
Time: Friday 18 February, 08:30am – 09:30am CET
(local time).Venue: Jónas Einarsson aud. (2nd floor, entrance 2B),
Oslo Cancer Cluster Innovation Park, Ullernchausséen 64, Oslo.
The presentation can be followed as a live
webcast, access through link
https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20220218_2
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 40682 0620 /
Denmark +45 7876 8490 / United Kingdom +44 203 7696 819 /
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:
Quarterly Report - Q4
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 18 February
2022.
For further information, please contact:Ronny
Skuggedal, CFOEmail: rs@pcibiotech.noMobile: +47 9400 5757
About PCI
Biotech PCI
Biotech is a biopharmaceutical clinical stage development company
focusing on development and commercialisation of novel therapies
for the treatment of cancer through its innovative photochemical
internalisation (PCI) technology platform. PCI induces triggered
endosomal release that is used to unlock the true potential of
therapeutic modalities.
The company’s lead programme fimaVACC aims to
enhance immunotherapy in cancer, by triggered endosomal release of
antigens or nucleic acids encoding antigens, or immunostimulatory
factors. Enhancement of relevant immune responses with protein- and
peptide-based vaccines were successfully demonstrated in humans
through an extensive Phase I study in healthy volunteers and a
Phase II study is in planning with the aim to demonstrate
enhancement of immunotherapy for treatment of solid tumours. In the
fimaNAC programme endosomal release is utilised 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 Q4 2021 Interim Report
- PCI Biotech Q4 2021 Presentation
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