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Nykode announces positive Phase 1/2 results

Nykode Therapeutics has announced clinical results from the open label, dose escalation trial of its 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 results successfully demonstrate proof of concept of Nykode’s Vaccibody platform’s ability to induce a powerful immune response by delivering selected antigens to Antigen Presenting Cells,” stated Klaus Edvardsen, Chief Development Officer of Nykode Therapeutics. “Importantly, our vaccine, which incorporates T cell epitopes selected by Adaptive Biotechnologies, induced killer CD8 T cell responses against non-Spike antigens conserved across all major variants of concern, in addition to generating a broad and strong T cell response to the Spike antigen in healthy individuals. Further, the trial supports the favorable safety profile of our Vaccibody technology as observed in previous trials.”

“I am very excited with these results, which also demonstrate the value of our strategic partnership with Adaptive and the synergistic potential of our technologies in the clinic.”

“I am very excited with these results, which also demonstrate the value of our strategic partnership with Adaptive and the synergistic potential of our technologies in the clinic,” said Michael Engsig, Chief Executive Officer of Nykode Therapeutics. “We will further assess the evolution of the pandemic and the overall regulatory environment in order to determine the next steps for VB10.2210. Beyond COVID, and based on the successful proof of concept results, we are now exploring additional opportunities to encode Adaptive discovered T cell epitopes in Nykode’s technology with the potential to treat other diseases with high unmet medical need.”

The trial

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.

Photo: iStock

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