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First subject dosed with Nykode’s vaccine candidate

Siri Torhaug

Nykode Therapeutics has announced that the first subject has been dosed with its T cell focused next-generation SARS-CoV-2 vaccine candidate in its VB-D-01 Phase 1/2 trial.

The T cell specific vaccine is designed to prime T cells, potentially generating a broad immune response against current and future variants. The VB-D-01 trial is a two-arm, open label, dose escalation and dose expansion study to evaluate the safety, reactogenicity and immunogenicity of both the T cell specific/VB10.2210 and the RBD/VB10.2129 vaccine candidates in healthy, previously vaccinated subjects.

“The emergence of the Omicron variant highlights the paramount need for next-generation COVID vaccines designed to be minimally impacted by future variants of concern such as Omicron. Dosing the first subject with our T cell focused vaccine candidate in this second arm of our COVID-19 vaccine trial is a remarkable milestone. We are also very pleased with the speed at which this was achieved,” says Siri Torhaug, Chief Medical Officer of Nykode Therapeutics.

The T cell epitope vaccine candidate

The T cell epitope vaccine candidate, VB10.2210, encodes a combination of conserved and immunodominant T cell epitope hotspots spanning multiple SARS-CoV-2 antigens. The vaccine candidate encodes 96 immunogenic T cell epitopes identified and validated by Adaptive Biotechnologies following analysis of more than 6,500 samples.

T cells are the adaptive immune system’s first responders to detect any pathogen. They quickly multiply and circulate in the blood to find and destroy infected cells shortly after infection, often before symptoms appear, thus preventing development of disease. In addition, T cells can “remember” prior infections and can kill pathogens if they reappear.

In contrast, the antibodies produced by the current COVID vaccines bind to the virus to prevent it from infecting cells. However, research shows that SARS-CoV-2 antibodies and to a lesser extent, T cells, produced by natural infection or current Spike-based vaccines decline over time and become off-target as the virus mutates, states the company. It is the expected substantial loss of neutralization from antibodies that may adversely impact the overall protection provided by available SARS-CoV-2 vaccines.

“Increasing evidence suggests that T cells play a key role in preventing severe and symptomatic disease in vaccine recipients and may provide protection against new and emerging virus strains.”

“Increasing evidence suggests that T cells play a key role in preventing severe and symptomatic disease in vaccine recipients and may provide protection against new and emerging virus strains. Our new T cell vaccine candidate was designed and selected in collaboration with Adaptive Biotechnologies. We believe that the combination of Adaptive’s validated T cell epitopes with our modular vaccine technology platform that drives broad CD8 T cell immune responses could result in a significantly differentiated COVID-19 vaccine and as a potential universal booster to available vaccines,” says Agnete B. Fredriksen, Chief Innovation and Strategy Officer of Nykode Therapeutics.

The VB-D-01 trial

In the VB-D-01 trial, the two vaccine candidates are being tested both in a dose escalation phase using three dose levels, and a dose expansion phase with a selected dose. Single versus two-dose administrations of each vaccine will also be explored in the dose escalation phase. This is being conducted in Norway at the Oslo University Hospital, and the Haukeland University Hospital, Bergen.

Photo of Siri Torhaug, Chief Medical Officer of Nykode Therapeutics

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