Oslo (Norway), 26 March 2020 – 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 April 2020. The US patent covers the use of fimaVacc in combination with a new important class of vaccine adjuvants called toll like receptor agonists.

Toll like receptor agonists (TLR agonists) is a diverse class of molecules that can be used for enhancing immune responses to several types of vaccines. TLR agonists have similarities to molecules present in various types of infectious agents, like viruses and bacteria, and can act as adjuvants to alert the immune system of a possible infection, thereby activating the immune system. The combination of TLR agonists with PCI Biotech’s vaccine technology, fimaVacc, has been shown to be effective for enhancing cellular immune responses that are important for the effect both of therapeutic and prophylactic vaccines. The US patent to be granted in April 2020 gives broad coverage for the combination of TLR agonists with the fimaVacc technology.

TLR agonists represent a new important class of vaccine adjuvants that are being developed with many new vaccine candidates. This US patent is therefore important for PCI Biotech’s partnering efforts and it also provides intellectual property of importance for our ability to potentially generate an internal future vaccine pipeline, said 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 and 2014. Today’s announced US patent secure protection until 2035 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, to enhance the cytotoxic effect 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.

Effective induction of cytotoxic T-cells will be critical to realise the huge potential of therapeutic cancer vaccines, and is also important for vaccination against some viral and parasitic infections, but vaccines often fail to generate such responses. 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.

This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.