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IndustriBioteknik
Nykode Therapeutics är verksamma inom bioteknik. Bolaget är idag specialiserade inom forskning och utveckling av immunologiska terapier och vacciner. Lösningarna används huvudsakligen för behandling av patienter med cancersjukdomar samt övriga allvarliga hälsotillstånd som kräver långsiktig behandling. Störst verksamhet återfinns inom den europeiska marknaden.
2022-09-27 06:45:00
o	Nykode's vaccine candidate boosted Spike-specific T cell responses and induced
de novo T cell responses to non-Spike antigens found across SARS-CoV-2 variants

o Nykode's Vaccibody technology combined with immunogenic T cell epitopes
selected by Adaptive Biotechnologies generated broad and CD8 dominated T cell
responses post-vaccination

o Nykode's vaccine candidate was safe and well-tolerated at all three dose
levels

Oslo, Norway, September 27, 2022 - Nykode Therapeutics ASA (OSE: NYKD), a
clinical-stage biopharmaceutical company dedicated to the discovery and
development of novel immunotherapies, today 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 results successfully demonstrate proof of concept of Nykode's VaccibodyTM
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," 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 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:

o The vaccine candidate VB10.2210 induced de novo T cell responses to all four
non-Spike antigens conserved across SARS-CoV-2 variants
o The vaccine candidate boosted a strong Spike response
o The responses were dominated by killer CD8 T cells in all subjects
o The vaccine candidate was safe and well-tolerated at all three dose levels


Additional information
Further information will be available in a slide presentation in the Investors
section of the Company's website at
https://nykode.com/investors/financial-reports-and-presentations.


About VB10.2210
VB10.2210 is a T cell focused vaccine candidate, encoding 96 clinically
validated T cell epitopes spanning a total of eight SARS-CoV-2 proteins,
including Spike. These Spike- and non-Spike T cell epitopes have been identified
and validated by Adaptive Biotechnologies using their immune medicine platform.
VB10.2210 is designed to prime T cells, potentially generating a broad immune
response against current and future variants.


About Nykode Therapeutics
Nykode Therapeutics is a clinical-stage biopharmaceutical company dedicated to
the discovery and development of novel immunotherapies for the treatment of
cancer and infectious diseases. Nykode's modular vaccine technology specifically
targets antigens to Antigen Presenting Cells, which are essential for inducing
rapid, strong and long-lasting antigen specific immune responses and eliciting
efficacious clinical responses.

Nykode's lead product candidates are VB10.16, a therapeutic vaccine for the
treatment of human papilloma virus (HPV)-16 induced malignancies which
demonstrated positive interim efficacy and safety results from its Phase 2 trial
for the treatment of cervical cancer