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early June 2021. The US patent covers the use of fimaVacc in combination with
immune checkpoint inhibitors (ICIs).
The use of ICIs has revolutionised cancer immunotherapy, as this class of drugs
may induce long-lasting effects in those patients responding to treatment.
Unfortunately, most patients do not respond to ICI therapy and different
treatment combination strategies are explored with the aim to increase the
number of patients responding. Combining ICIs with therapeutic cancer vaccines
that induce relevant immune responses against the tumour cells is regarded as
one of the most promising strategies. The patent that soon will be granted in
the US covers the use of PCI Biotech’s fimaVacc vaccination technology in
combination with important classes of ICIs and an important type of
immunological adjuvants (a class of so-called Toll like receptor agonists).
“Increasing the response rates to ICI’s is one of the pharma industry’s main
priorities in cancer and therapeutic cancer vaccination is a rational approach
to this aim. The fimaVacc technology has delivered encouraging immune responses
in early phase clinical trials and this US patent provides relevant intellectual
property for the further development of this technology.” said Dr. Per Walday,
CEO of PCI Biotech.
As part of PCI Biotech’s strategy for applying the PCI technology for
therapeutic cancer vaccines, several global patent applications were filed in
2013-2016. Today’s announced US patent secure protection until 2036 and this
patent application is still pending in Europe and key Asian markets.
About fimaVacc
This novel vaccine technology applies a unique mode of action, triggered
endosomal release of antigens or antigen-encoding nucleic acids, to enhance
immune responses essential for therapeutic cancer vaccines as well as for
several types of vaccines against viral and parasitic infections. fimaVacc works
in synergy with several other state-of-the-art vaccination technologies, and is
especially effective in combination with some types of TLR agonists. The
fimaVacc programme aims to enhance the cellular immune responses that are
important for the therapeutic and prophylactic effect of vaccines, and the
fimaVacc technology has proven excellent preclinical efficacy with protein- and
peptide-based vaccines. The technology has shown particularly strong CD8 T-cell
immune responses, which are important for therapeutic vaccination, as well as
enhanced helper (CD4) T-cell and antibody responses.
PCI Biotech successfully translated the vaccination technology into humans
through a Phase I study in healthy volunteers that was completed in May 2019.
The study covered more than 90 subjects and established the tolerability of
fimaVacc across a wide range of doses. The immune results provided proof-of-
concept and demonstrates fimaVacc’s potential to enhance overall T-cell
responses, by demonstrating improvement of the immunogenicity of vaccines in
healthy volunteers.
The results from the successful Phase I proof of concept study for the fimaVacc
technology were recently published 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
publication is available through this link:
https://www.frontiersin.org/articles/10.3389/fimmu.2020.576756/full
Effective induction of proper cellular immune responses will be critical to
realise the huge potential of therapeutic cancer vaccines, and is also important
for vaccination against some viral and parasitic infections. With present
technologies vaccines often fail to generate such responses, and especially
cytotoxic T-cell responses are often inappropriate. Insufficient delivery of
vaccine antigens to the appropriate presentation pathway in the immune cells may
be one of the main reasons for weak cytotoxic T-cell responses. The fimaVacc
technology has the potential to effectively enhance vaccine presentation through
these pathways.
Contact information:
Per Walday, CEO
pw@pcibiotech.no (mailto: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.
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