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PCI Biotech: US patent for the vaccine technology (fimaVacc) in combination with checkpoint inhibitors

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Oslo (Norway), 31 May 2021 – PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company, today announces that the U.S. Patent and Trademark Office (USPTO) has informed the company that a new US patent will be granted 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
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

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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