Nykode Therapeutics has dosed the first participant in Phase I/II VB-D-01 clinical trial of its T cell-specific Covid-19 vaccine candidate in unvaccinated individuals.
The shot can potentially prime T cells, thereby eliciting a wide-ranging immune response against present as well as future viral variants.
The open-label, two-arm dose-escalation and dose-expansion trial is designed to assess the safety, reactogenicity and immunogenicity of both the T cell-specific/VB10.2210 and the RBD/VB10.2129 vaccine candidates in healthy subjects.
Supported by the Research Council of Norway, the trial is being carried out in Norway at the Oslo University Hospital and the Haukeland University Hospital, Bergen.
In the dose-escalation portion, three dose levels of both the vaccines will be explored while the dose-expansion segment will analyse a selected dose.
Furthermore, single as well as two doses of both vaccines will be evaluated in the dose-escalation phase.
The VB10.2210 vaccine encodes a mixture of conserved as well as immuno-dominant T cell epitope hotspots covering various antigens of the SARS-CoV-2 virus.
It encodes 96 immunogenic T cell epitopes of eight viral proteins, including Spike.
According to preliminary analysis, no epitopes outside the Spike were impacted by the Omicron variant of the SARS-CoV-2 virus.
Nykode Therapeutics chief scientific officer Mikkel Pedersen said: “While current Spike-based vaccine approaches generate limited T cell responses and uncertain long-term protection, the emergence of SARS-COV-2 variants with a high number of mutations in the Spike protein as seen with Omicron calls for novel T cell vaccine strategies.
“Nykode’s vaccine candidate VB10.2210 targets select validated T cell epitopes specific to a total of eight SARS -CoV-2 proteins using our modular Antigen Presenting Cells-targeted vaccine technology platform, which has been observed to drive strong T cell responses.”
In November this year, Vaccibody was rebranded to Nykode after signing an approximately $1bn deal.