PCI Biotech Holding — Earnings Release 2017

Sep 12, 2017

PCI Biotech: Initial clinical results from Phase I indicate that vaccination with fimaVACC enhances cellular immune responses

PCI Biotech: Initial clinical results from Phase I indicate that vaccination with fimaVACC enhances cellular immune responses

Oslo (Norway), 12 September 2017 - PCI Biotech (OSE: PCIB), a cancer focused

clinical-stage company developing innovative therapeutics that address

significant unmet medical needs today announced that the first immune response

results from the fimaVacc Phase I study in healthy volunteers indicate enhanced

overall T-cell responses at tolerable dose levels.

The clinical data cover more than 50% of the planned subjects in the ongoing

dose finding part of the study and provide initial clinical support of

fimaVacc's potential to enhance the cellular immune responses that are important

for therapeutic effect of vaccines. The dose finding will continue to establish

maximum tolerated dose and further explore the efficacy of fimaVacc. The study

remains on track for completion by first half of 2018.

Per  Walday,  CEO  of  PCI  Biotech,  said: "Improving immunogenicity of vaccine

candidates is a main priority in the immunotherapy industry. We believe that the

fimaVacc technology may play an important part in solving this challenge and the

initial immune response results in the Phase I study are encouraging. We look

forward to the completion of this study, aiming for clinical translation of the

promising preclinical results with the fimaVacc technology. "

The objectives of the Phase I study are to determine safety, tolerability and

immune responses of fimaVacc in healthy volunteers. The study is designed as an

open-label, antigen-adjuvant controlled study in up to 110 subjects.

Contact information:

Per Walday, CEO

pw@pcibiotech.no

Mobile: +47 917 93 429

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 clinical 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 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.