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LandNorge
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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.
2021-11-03 16:30:00
o  First subject dosed in Vaccibody's SARS-CoV-2 sponsored clinical trial to
specifically address emerging SARS-CoV-2 variants of concern

o Two-arm clinical trial to dose previously vaccinated subjects in a
first-in-human phase 1/2 trial, VB-D-01. Additional primary and therapeutic
applications may be considered in the future

o Vaccibody sponsored trial aims to develop two candidate vaccines:
o Second-generation vaccine that encodes the receptor binding domain (RBD)
derived from the beta variant of concern (VB10.2129), fully owned by Vaccibody
o Third-generation vaccine, a T cell based vaccine that encodes validated T
cell epitopes spanning multiple SARS-CoV-2 antigens (VB10.2210) identified by
the Adaptive Biotechnologies immune medicine platform

o Open label, dose escalation and dose expansion trial enrolling up to 160
previously vaccinated subjects at trial sites in Norway

o First infectious disease clinical program using Vaccibody's vaccine platform

o Vaccibody continues its infectious disease programs addressing other
pathogens


Oslo, Norway, November 3, 2021 - Vaccibody AS (Euronext Growth (Oslo): VACC), a
clinical-stage biopharmaceutical company dedicated to the discovery and
development of vaccines and novel immunotherapies, announced today the
initiation of its VB-D-01 Phase 1/2 trial (NCT05069623) and the first subject
dosed using VB10.2129. The trial is a two-arm, open label, dose escalation and
dose expansion study to evaluate the safety, reactogenicity and immunogenicity
of both the RBD/VB10.2129 and the T-cell based/VB10.2210 vaccine candidates in
up to 160 healthy, already vaccinated subjects.

Each vaccine candidate will be tested in both 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.

The second generation RBD vaccine candidate, VB10.2129, is designed using the
B1.351 (Beta) variant of concern and tailored to generate RBD-specific antibody
and T cell immunity. The third generation T cell epitope vaccine candidate,
VB10.2210, encodes immunodominant T cell epitopes that have been identified and
validated by Adaptive Biotechnologies using its immune medicine platform.
Adaptive's validated T cell epitopes span multiple SARS-CoV-2 antigens and have
been selected based on Adaptive's comprehensive mapping of the T cell response
to SARS-CoV-2 using more than 6,500 samples.

In preclinical models, the second generation RBD/VB10.2129 vaccine candidate,
has demonstrated rapid, strong and long-lasting antibody responses induced after
vaccination. Antibodies were detected as early as day 7 following a single, low
dose (1ug) vaccination. Strong responses with >106 endpoint titer have been
shown across key variants of concern. These results confirm previously published
pre-clinical results from Vaccibody's first-generation vaccine directed against
the original WA1/2020 strain. Following a single dose, the T cell
epitope/VB10.2210 vaccine candidate also induces early, strong T cell responses
against HLA-specific epitopes in humanized HLA transgenic mice. These
encouraging preclinical data further validate Adaptive's T cell epitope mapping
and selection to inform the design and development of Vaccibody's VB10.2210
vaccine candidate and Vaccibody's vaccine's ability to induce CD8 T Cell
responses to these epitopes.

Siri Torhaug, Chief Medical Officer of Vaccibody said, "We are excited to have
dosed the first subject in our COVID-19 vaccine trial. Our two next-generation
RBD and T-cell based vaccine candidates are designed to respond to existing and
potentially future emerging variants of concern that are characterized by
increased transmissibility and/or infectivity and have been shown to reduce the
effectiveness of an antibody response. Antibodies generated by available
vaccines have been shown to wane over time. While our initial focus for both
candidates is as booster vaccine for currently available vaccines, in the future
we may consider additional primary and therapeutic applications."

Michael Engsig, Chief Executive Officer of Vaccibody continued, "Our T cell
vaccine candidate encodes the Adaptive Biotechnologies validated T cell epitopes
and takes full advantage of the great work delivered through our newly formed
collaboration. The technologies from both companies are highly complementary.
This clinical trial is also the first time that Vaccibody uses its modular
vaccine technology platform against an infectious disease." Michael Engsig
added, "Vaccibody's infectious disease programs targeting other pathogens
outside SARS-CoV-2 continues as planned."

The VB-D-01 trial is being conducted in Norway at Oslo University Hospital and
Haukeland University Hospital, Bergen. In addition, The Research Council of
Norway is supporting this important development program.


About Vaccibody
Vaccibody AS, is a clinical-stage biopharmaceutical company, dedicated to the
discovery and development of vaccines and novel immunotherapies for the
treatment cancer and infectious diseases. Vaccibody'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 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