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.
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: fima Chem (enhancement of chemotherapeutics for localised treatment of cancer), fima Vacc (T-cell induction technology for therapeutic vaccination), and fima NAc (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 fima Chem 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. fima Vacc 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. fima NAc 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.
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.