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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.