PCI Biotech: Successful Phase I fimaVacc vaccination proof of concept study to be published in Frontiers in Immunology

Oslo (Norway), 23 November 2020 – PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company, today announced that the results from the successful Phase I proof of concept study for the fimaVacc technology is accepted for publication in Frontiers in Immunology, a high impact immunology journal. The article title is "Photochemical internalization enhanced vaccination is safe, and gives promising cellular immune responses to an HPV peptide-based vaccine in a phase I clinical study in healthy volunteers” and the abstract of the publication is available through this link: https://www.frontiersin.org/articles/10.3389/fimmu.2020.576756/abstract.

The open label Phase I study in more than 90 healthy volunteers was completed in 2019 and conducted to assess the safety, tolerability and immune response to fimaVacc with intradermal vaccination. The overall results provide proof-of-concept by demonstrating that fimaVacc enhances the immune responses to peptide and protein based vaccines in healthy volunteers. The results further support fimaVacc’s potential to enhance the cellular immune responses that are especially important for therapeutic effect of vaccines. Moreover, the study shows that fimaVacc can be safely employed in humans.

Per Walday, CEO of PCI Biotech, comments: We are delighted to publish the fimaVacc Phase I data in a high-impact immunology journal. The results of this study showed that employment of fimaVacc provided a substantial increase in the number of subjects exhibiting a T-cell response to an HPV peptide based vaccine. An improved CD8+ T-cell response was also seen with fimaVacc, which is a highly sought-after feature of therapeutic vaccination technologies. We now look forward to disseminating these results and move the fimaVacc technology into a disease 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). The results show a substantial increase in number of T-cell responders to HPV peptides already after two vaccinations and a clear enhancement in the T-cell responses compared to the control group. The employment of fimaVacc increased the number of subjects exhibiting a T-cell response to the HPV peptide vaccine about 10-fold over what was achieved with the vaccine and adjuvant (Hiltonol) combination without fimaVacc. Moreover, the use of fimaVacc seemed to result in a more consistent and multifunctional CD8+ T-cell response.

The study was performed in collaboration with international experts, including staff at the Department of Medical Oncology at Leiden University Medical Centre (LUMC) under the leadership of Professor Sjoerd van der Burg. The Phase I study and the general development of the fimaVacc technology is supported by a grant from the Research Council of Norway (Forskningsrådet).

Contact information:    
Per Walday, CEO            
pw@pcibiotech.no
Mobile: +47 917 93 429

About PCI Biotech         
PCI Biotech is a biopharmaceutical late stage clinical development 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.

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.