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publication in Frontiers in Immunology, a high impact immunology journal. The
article title is “Photochemical internalization enhanced vaccination is safe,
and gives promising cellular immune responses to an HPV peptide-based vaccine in
a phase I clinical study in healthy volunteers” and the abstract of the
publication is available through this link:
https://www.frontiersin.org/articles/10.3389/fimmu.2020.576756/abstract.
The open label Phase I study in more than 90 healthy volunteers was completed in
2019 and conducted to assess the safety, tolerability and immune response to
fimaVacc with intradermal vaccination. The overall results provide proof-of-
concept by demonstrating that fimaVacc enhances the immune responses to peptide
and protein based vaccines in healthy volunteers. The results further support
fimaVacc’s potential to enhance the cellular immune responses that are
especially important for therapeutic effect of vaccines. Moreover, the study
shows that fimaVacc can be safely employed in humans.
Per Walday, CEO of PCI Biotech, comments: We are delighted to publish the
fimaVacc Phase I data in a high-impact immunology journal. The results of this
study showed that employment of fimaVacc provided a substantial increase in the
number of subjects exhibiting a T-cell response to an HPV peptide based vaccine.
An improved CD8+ T-cell response was also seen with fimaVacc, which is a highly
sought-after feature of therapeutic vaccination technologies. We now look
forward to disseminating these results and move the fimaVacc technology into a
disease setting.
The study was designed as an open-label, antigen-adjuvant controlled study with
the objectives to determine immune responses, safety and tolerability of
fimaVacc in healthy volunteers. The study was performed with two model vaccines;
a large immunogenic protein (KLH) and two smaller less immunogenic peptides
(HPV). The results show a substantial increase in number of T-cell responders to
HPV peptides already after two vaccinations and a clear enhancement in the T-
cell responses compared to the control group. The employment of fimaVacc
increased the number of subjects exhibiting a T-cell response to the HPV peptide
vaccine about 10-fold over what was achieved with the vaccine and adjuvant
(Hiltonol) combination without fimaVacc. Moreover, the use of fimaVacc seemed to
result in a more consistent and multifunctional CD8+ T-cell response.
The study was performed in collaboration with international experts, including
staff at the Department of Medical Oncology at Leiden University Medical Centre
(LUMC) under the leadership of Professor Sjoerd van der Burg. The Phase I study
and the general development of the fimaVacc technology is supported by a grant
from the Research Council of Norway (Forskningsrådet).
Contact information:
Per Walday, CEO
pw@pcibiotech.no
Mobile: +47 917 93 429
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)
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.
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