First subject dosed in the fimaVACC phase I study

Oslo, 5 September 2016 - PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company, today announced that the first subject has been dosed in the fimaVACC phase I study to evaluate safety, tolerability and immune responses in healthy volunteers, with read-out in first half of 2017. PCI Biotech's fimaVACC programme aims to enhance the cellular immune responses important for therapeutic effect of vaccines.

The study objectives are to determine the safety, tolerability and immune responses of fimaVACC in healthy volunteers. The clinical research organisation of Covance has been chosen as strategic partner for the study, which is performed in the UK. The study design is as an open-label, antigen-adjuvant controlled study in up to 80 subjects, with estimated completion in first half of 2017.

Per Walday, CEO of PCI Biotech, said: "Improving immunogenicity of vaccine candidates is a main priority in the immunotherapy industry and we believe that the fimaVACC technology may play an important part in solving this challenge. Translation of our fimaVACC technology into man is therefore a very important milestone to establish PCI Biotech in the immunotherapy field."

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 fimaCHEM programme consists of a Phase I/II clinical 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 siRNA 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
Per Walday, CEO, pw@pcibiotech.no, Mobile: +47 917 93 429.

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