Nykode hits early-stage goals for pan-variant COVID shot, but future plans murky

Nykode Therapeutics has taken aim at the holy grail of COVID-19 shots: a pan-variant vaccine that would eliminate the need for redesigning vaccines every time a new dominant variant comes around. Early data show the biotech's vaccine candidate hit its main goals in a phase 1/2 trial, which was centered on assessing safety. It remains unclear whether the company plans to advance the asset.

The Norwegian biotech—formerly known as Vaccibody—posted proof-of-concept data today demonstrating its COVID-19 vaccine candidate was safe and well tolerated at three dose levels, while also inducing T-cell responses. Primary endpoints of the study measured frequency, incidence and severity of adverse events. No dose-limiting adverse events, serious adverse events or adverse events of special interest were reported, according to Nykode.

Approved COVID-19 vaccines such as Moderna’s shot and Pfizer-BioNTech’s jab are based on the spike protein, which can be subject to high immune selection pressure and mutation frequency. Nykode’s investigational pan-SARS-CoV-2 shot, dubbed VB10.2210, doesn’t focus solely on the spike.

VB10.2210 was developed via Nykode's strategic collaboration with Adaptive Biotechnologies for COVID-19 T-cell vaccine development. The shot is designed to prime T cells using Nykode’s Vaccibody technology platform combined with 96 immunogenic T-cell epitopes (both spike and non-spike) that were selected by Adaptive Biotechnologies. The aim is to develop a vaccine that maintains efficacy regardless of future spike mutations and wouldn’t need to be updated for new emerging variants.

The open-label, dose-escalating phase 1/2 trial assessed VB10.2210 across three dose levels among 24 healthy individuals who had already received an approved mRNA vaccine. T-cell responses were analyzed by ex vivo ELISpot up until Day 35.

Nykode found VB10.2210 prompted broad and strong T-cell responses, dominated by killer CD8 T cells, against both spike and non-spike antigens.    

“We will further assess the evolution of the pandemic and the overall regulatory environment in order to determine the next steps for VB10.2210,” said Nykode CEO Michael Engsig. “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.”