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LandNorge
ListaOB Match
SektorHälsovård
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.
2022-10-26 16:30:00
o	VB10.NEO induced a T cell response in 95% of the patients, including expansion
of both novel and pre-existing T cells

o The responses were broad, and the majority of the encoded neoepitopes were
immunogenic and induced a CD8 T cell response

o Multiple vaccinations boosted the breadth and magnitude of the immune response

o Most T cell responses were maintained for at least one year

o The data supports the APC-targeted Vaccibody platform's unique ability to
induce broad and long-lasting immune response, including CD8 T cells with the
desired profile known to kill tumor cells

o VB10.NEO was generally safe and well-tolerated in patients with solid tumors

Oslo, Norway, October 26, 2022 - Nykode Therapeutics ASA (OSE: NYKD), a
clinical-stage biopharmaceutical company dedicated to the discovery and
development of novel immunotherapies, today announced the presentation of
positive preliminary safety and immunogenicity results from its Phase 1/2a study
of VB10.NEO, a proprietary individualized therapeutic DNA cancer vaccine, in
patients with locally advanced or metastatic solid tumors. The data will be
presented today at the Neoantigen-Based Therapies Summit in Boston,
Massachusetts. Nykode is developing VB10.NEO worldwide in partnership with
Genentech, a member of the Roche Group.

Michael Engsig, Nykode's Chief Executive Officer, stated: "I am thrilled with
these clinical data which confirm our position at the forefront of the fully
individualized cancer immunotherapy field. We believe individualized
neoantigen-based immunotherapies will transform the treatment of cancer, and we
are excited to continue the journey with our partners at Genentech, a global
leader in immuno-oncology."

Klaus Edvardsen, Nykode's Chief Development Officer, stated: "The data presented
today show that VB10.NEO induces a broad, strong and long-lasting CD8 T cell
response against patient-specific tumors, in addition to being safe and
well-tolerated in combination with other anti-cancer treatments. The data
continue to substantiate our differentiated platform technology and support its
huge potential within individualized cancer treatments. We are happy to have
such strong partners as Genentech for continued development."

Summary of Safety Results
41 patients were dosed with VB10.NEO. The data show that VB10.NEO was generally
safe and well-tolerated in patients with solid tumors when administered in
combination with various anti-cancer treatments. The most common adverse events
reported were fatigue (34%) and diarrhea (27%). The observed adverse events are
generally consistent with the known safety profiles of checkpoint inhibitors,
chemotherapy, as well as other targeted cancer therapies, with no overt signs of
add-on toxicity.

Summary of Immunogenicity Results
22 patients were included in the interim analysis. Blood samples were collected
at baseline, week 11, 22, 34 and 54, to assess immune response to individual
neoepitopes by ELISpot.
o A neoantigen-specific immune response was observed in all patients (ranging
from 3-20 neoepitopes)
o A vaccine-induced T cell response was observed in 95% of patients, inducing
expansion of both novel and pre-existing T cells
o The responses were broad and the majority of the neoepitopes included in the
vaccines were immunogenic
o Polyfunctional Th1 CD4 and Tc1 CD8 T cell responses were observed
o Ranging from 53% to 100% (or 85% on average) of the neoepitopes induced a CD8
T cell response. Cytotoxic CD8 T cells are known to be important for killing
tumor cells
o The breadth and magnitude of immune response increased upon multiple
vaccinations
o Responses to the majority of the neoepitopes were maintained for at least one
year


Additional information
More details on the results 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 the Phase 1/2a Trial
VB N-01 is an open-label first-in-human Phase 1/2a study to evaluate safety,
feasibility and efficacy of multiple dosing with individualized VB10.NEO or
VB10.NEO and bempegaldesleukin (NKTR-214) immunotherapy in patients with locally
advanced or metastatic melanoma, NSCLC, clear renal cell carcinoma, urothelial
cancer or squamous cell carcinoma of head and neck, who did not reach complete
responses with current standard of care immune checkpoint blockade. More
information is available at clinicaltrials.gov: identifier NCT03548467.


About VB10.NEO
VB10.NEO is a proprietary individualized DNA-based neoantigen vaccine in
development for the treatment of locally advanced or metastatic solid tumors
under an exclusive, worldwide clinical collaboration with Genentech, a member of
the Roche group. The vaccine is designed to be produced on-demand according to
the neoantigen profile of an individual patient. Neoantigens are proteins
generated by tumor-specific mutations not present in normal tissues and are thus
an attractive target for cancer immunotherapy as they may be recognized as
foreign by the immune system.

Nykode is currently conducting two clinical studies evaluating VB10.NEO: VB N-01
and VB N-02. VB N-01 is an open-label Phase 1/2a basket study to evaluate the
safety and efficacy of multiple dosing with VB10.NEO in patients with locally
advanced or metastatic cancer (NCT03548467). VB N-02 is an open-label Phase 1B,
dose-escalation study of the safety- and antigen-specific immune responses
elicited by VB10.NEO in combination with Roche's checkpoint inhibitor
atezolizumab in patients with locally advanced and metastatic tumors
(NCT05018273).


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