PCI Biotech to present Phase I fimaVacc results at ESMO Immuno-Oncology 2019

Oslo, Norway, December 12, 2019 PCI Biotech (OSE:PCIB), a clinical-stage company developing innovative therapeutics that address significant unmet medical needs, today announced that it will present results from the successful fimaVacc Phase I proof of concept study in healthy volunteers at the ESMO Immuno-Oncology Congress 2019 being held December 11-14, 2019 at Palexpo in Geneva, Switzerland.

PCI Biotech’s research collaborator, Oslo University Hospital represented by Dr. Pål Selbo, will present the poster during the poster display session Thursday, December 12, from 12:15 to 13:15 local time (CET). The presented results provide proof of concept of the fimaVacc vaccination technology by demonstrating the improvement of immunogenicity in a healthy volunteer study completed in May 2019.

The poster named “109P - Phase I clinical study for validation of fimaporfin-based photochemical internalisation: A novel technology for enhancing cellular immune responses important for therapeutic effect of peptide-and protein-based vaccines” will be made available on PCI Biotech’s website (www.pcibiotech.com ) under “Other presentations”.

About fimaVacc              
This novel vaccine technology 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. The fimaVacc programme aims to enhance the cellular immune responses that are important for the therapeutic 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 today’s vaccines often fail to generate such responses. One of the main reasons is likely insufficient delivery of vaccine antigens to the appropriate presentation pathway in the immune cells. The fimaVacc technology has the potential to effectively enhance vaccine presentation through these pathways.

About PCI Biotech         
PCI Biotech is a biopharmaceutical 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.

Contact information:   
PCI Biotech Holding ASA, Ullernchausséen 64, N-0379 Oslo, Norway. www.pcibiotech.com      
Ronny Skuggedal, CFO, [e-mail] , Mobile: [phone].

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.