PCI Biotech

European patent for treatment of bile duct cancer with the fimaChem technology

Oslo (Norway), 16 November 2020 – PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company, today announces that the European Patent Office (EPO) has informed the company that a new European patent has been granted. The European patent covers the intended use of fimaChem in combination with gemcitabine for the treatment of cholangiocarcinoma (bile duct cancer).

Per Walday, CEO, comments: We are very happy to see this patent granted in Europe, which provides an extended protection of the intended use of fimaChem lasting several years beyond the potential market exclusivity offered by the orphan designation. Our full focus is now on the successful delivery of the global pivotal RELEASE study.

Today’s announced European patent secure protection until 2037. The patent application is still pending in US and key Asian markets.

About fimaChem            
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. 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, RELEASE, in extrahepatic bile duct cancer, an orphan indication with a high unmet need and without approved products.

RELEASE is a single randomised pivotal study with registration intent, building on encouraging results from the Phase I study. RELEASE will evaluate fimaChem in combination with the standard of care chemotherapy (gemcitabine and cisplatin) as a first line treatment, with orphan drug designation granted in both EU and the US.

Contact information:    
Per Walday, CEO            
[e-mail]
Mobile: [phone]

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.