Nykode Therapeutics ASA Announces Positive Results from the Phase 1/2 Open Label, Dose Escalation Trial of its T Cell Focused SARS-CoV-2 Vaccine Candidate

Nykode Therapeutics ASA announced positive clinical results from the Phase 1/2 open label, dose escalation trial of Nykode's T cell focused pan-SARS-CoV-2 vaccine candidate (VB10.2210) in healthy individuals who were previously vaccinated with an approved mRNA vaccine. T cell responses were analyzed by ex vivo ELISpot up until day 35. VB10.2210 induced broad and strong T cell responses, dominated by killer CD8 T cells, against both Spike- and non-Spike antigens.

It was safe and well-tolerated at all three dose levels. Approved vaccines are based on Spike, a protein subject to high immune selection pressure and mutation frequency. By contrast, VB10.2210 is designed to induce T cell responses against epitopes from seven additional antigens that are highly conserved across previous and existing SARS-CoV-2 variants.

Nykode's candidate is therefore expected to retain efficacy independent of future Spike mutations and would not need to be updated for future variants of concern. The open label Phase 1/2 trial, VB-D-01 (NCT05069623), is a two-arm trial to evaluate the safety, reactogenicity and immunogenicity of VB10.2210 in healthy, previously vaccinated individuals. 34 participants were enrolled and received at least one dose of VB10.2210 and 24 participants across the three dose levels were evaluable for immunogenicity analysis.

The vaccine candidate VB10.2210 encodes both Spike- and non-Spike T cell epitopes, identified and validated by Adaptive Biotechnologies. The immune response was assessed using five different peptide pools including the relevant epitopes from each of the following antigens: Spike, Membrane Glycoprotein (M), Nucleocapsid Protein (N), Orf1ab+Orf3+Orf10 and Orf7. Highlights: The vaccine candidate VB10.2210 induced de novo T cell responses to all four non-Spike antigens conserved across SARS-CoV-2 variants.

The vaccine candidate boosted a strong Spike response. The responses were dominated by killer CD8 T cells in all subjects. The vaccine candidate was safe and well-tolerated at all three dose levels.