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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.

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2021-12-28 06:45:00
o	First subject dosed with Nykode Therapeutics' T cell focused SARS-CoV-2
vaccine candidate. This is part of the ongoing Phase 1/2 two-arm clinical trial
VB-D-01 designed to specifically address emerging variants of concern, including
Omicron*)
o The T cell focused vaccine candidate (VB10.2210) encodes 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
o Initial analysis indicates that no epitopes outside the Spike are affected by
the Omicron variant


Oslo, Norway, December 28, 2021 - Nykode Therapeutics AS (Euronext Growth
(Oslo): NYKD), a clinical-stage biopharmaceutical company dedicated to the
discovery and development of vaccines and novel immunotherapies, announced today
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 (NCT05069623). 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.

Siri Torhaug, Chief Medical Officer of Nykode Therapeutics, commented: "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."

Mikkel W. Pedersen, Chief Scientific Officer of Nykode Therapeutics, continued:
"The role of the cellular immune response to SARS-CoV-2 mediated by T cells
reflects untapped potential.

It has been shown that virus specific T cell responses in vaccinated human
subjects coincide with rapid protection and are associated with milder disease
in COVID-19 patients. While current Spike-based vaccine approaches generate
limited T cell responses and uncertain long-term protection, the emergence of
SARS-CoV-2 variants with a high number of mutations in the Spike protein as seen
with Omicron calls for novel T cell vaccine strategies. Nykode's vaccine
candidate VB10.2210 targets select validated T cell epitopes specific to a total
of eight SARS-CoV-2 proteins using our modular APC (Antigen Presenting
Cells)-targeted vaccine technology platform, which has been observed to drive
strong T cell responses. Our T cell based approach has the potential to generate
longer, durable immunity and resistance to emerging variants."

The T cell epitope vaccine candidate, VB10.2210, encodes a combination of
conserved and immuno-dominant 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. It is the expected substantial loss of
neutralization from antibodies that may adversely impact the overall protection
provided by available SARS-CoV-2 vaccines.

Agnete B. Fredriksen, Chief Innovation and Strategy Officer of Nykode
Therapeutics, added: "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."

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. The
Research Council of Norway supports this important development program.

Webcast
CEO Michael Engsig and other members of management will host a webcast on
January 5, 2022 at 4 p.m. CET / 10 a.m. EST to give a company update and present
its SARS-CoV-2 vaccine candidates. The live and archived webcast can be accessed
in the Investors section of the Company's website at
https://nykode.com/investors/financial-reports-and-presentations.


*)The Omicron variant of the SARS-CoV-2 virus, first identified in South Africa
on November 9, 2021, was designated a variant of concern by the World Health
Organization (WHO) on November 26, 2021. Early data suggests that Omicron
carries an increased risk of re-infection, and genetic sequence analysis has
revealed several mutations in the Spike protein, which may reduce clinical
effectiveness of current vaccines and/or therapeutic antibodies.


About Nykode Therapeutics

Nykode Therapeutics, is a clinical-stage biopharmaceutical company, dedicated to
the discovery and development of vaccines and novel immunotherapies for the
treatment cancer and infectious diseases. Nykode Therapeutics' 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 elicit efficacious clinical responses.

Its lead product candidates are VB10.16, a therapeutic vaccine for the treatment
of human papilloma virus 16 induced malignancies which is in Phase 2 for the
treatment of cervical cancer