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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 fima_Vacc_ 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 fima_Vacc_ 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 fima_Vacc_ and exhibit increased functionality compared to control.

The overall clinical data cover more than 90 subjects providing clinical support of fima_Vacc_.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 fima_Vacc_ dose levels, with the tolerability of fima_Vacc_ 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 fima_Vacc_ 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.