Oslo (Norway), 2 May 2019 – PCI Biotech (OSE: PCIB), a cancer focused clinical-stage company developing innovative therapeutics that address significant unmet medical needs today announced that the final immune response results from the fimaVacc Phase I study in healthy volunteers indicate a clear enhancement of both CD8 and CD4 T-cell responses and an improved CD8 T-cell functionality after vaccination at tolerable dose levels.
The interim clinical results previously reported that fimaVacc may enhance overall T-cell responses, especially to the HPV peptide, which is much less immunogenic than the KLH protein. The final data confirms these results, showing a substantial increase in number of T-cell responders to the HPV peptides already after two vaccinations and a clear enhancement in the T-cell responses compared to the control group. The important CD8 responses are also more robust with fimaVacc and exhibit increased functionality compared to control.
The overall clinical data cover more than 90 subjects providing clinical support of fimaVacc’s potential to enhance the cellular immune responses that are important for therapeutic effect of vaccines. This enhancement of cellular immune responses was seen at well tolerated fimaVacc dose levels, with the tolerability of fimaVacc also established across a wide range of doses. The analysis of overall T-cell responses has been done in collaboration with Oslo University Hospital, The Radium Hospital, while the analysis of CD8 T-cell responses has been done at Leiden University Medical Centre (LUMC).
Per Walday, CEO of PCI Biotech, said: "Improving immunogenicity of vaccine candidates is a main priority in the immunotherapy industry. The encouraging results of the Phase I study provide proof of concept and efficacy in terms of optimal dosing of fimaVacc in humans as well as an overall characterization of tolerability, in keeping with the target objectives of the trial and paving the way for further development in a clinical setting."
The study was designed as an open-label, antigen-adjuvant controlled study with the objectives to determine immune responses, safety and tolerability of fimaVacc in healthy volunteers. The study was performed with two model vaccines; a large immunogenic protein (KLH) and two smaller less immunogenic peptides (HPV). More than 90 subjects are included and recruitment is now stopped.
Per Walday, CEO
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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 is about to initiate a pivotal 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
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.