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Beskrivning

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.
2024-03-21 07:00:00
o	Updated survival data from Phase 2 trial (C-02) in advanced cervical cancer
affirm prolonged benefits and indicate a synergistic treatment effect of
Nykode's VB10.16 and atezolizumab (Tecentriq®).

o New analysis closely mirrors previously reported positive outcome. At the time
of the updated analysis, observation time for remaining patients was at least 24
months compared to at least 12 months at the previous reported outcome.

o Updated C-02 survival data support the accelerated development of VB10.16,
including the potential US pivotal trial C-04 in recurrent or metastatic
cervical cancer, and advancing of the program into earlier stages of cervical
cancer and expanding into head and neck cancer.

o Nykode will present detailed data in a future scientific publication and at a
forthcoming conference.

Oslo, Norway, March 21, 2024 - Nykode Therapeutics ASA (OSE: NYKD), a
clinical-stage biopharmaceutical company dedicated to the discovery and
development of novel immunotherapies, today announced key conclusions from the
updated analysis from the Phase 2 VB-C-02 trial. The trial investigates the use
of Nykode's wholly-owned off-the-shelf therapeutic cancer vaccine candidate
VB10.16 in combination with Roche's checkpoint inhibitor atezolizumab in
patients with recurrent or metastatic HPV16-positive cervical cancer.

The updated results, which closely mirror the previously reported positive C-02
outcomes, affirm prolonged benefits and indicate a synergistic treatment effect
of VB10.16 plus atezolizumab compared to the historical controls of monotherapy
with checkpoint inhibitors. The updated analysis' observation time for the
remaining patients was at least 24 months, compared to at least 12 months at the
previously reported outcome.

"I am thrilled with these data which yet again underscore the strength of our
Nykode technology. The strength and durability of the clinical response points
to a unique and highly differentiated therapy and we continue our efforts to
bring VB10.16 to patients as fast as possible. We are more confident than ever
in the transformative potential of Nykode's immunotherapies," said Michael
Engsig, CEO.

"Today's update is a significant milestone not just for the VB-C-02 trial but
for the entire VB10.16 development program and Nykode's technology platform at
large," stated Klaus Edvardsen, Chief Development Officer. "The extended
survival and sustained efficacy we're observing compared to historical data on
atezolizumab monotherapy underscore our confidence in VB10.16 and the upcoming
potentially registrational trial."

Nykode has a focused strategy to develop VB10.16, including a potentially US
registrational trial C-04 in recurrent/metastatic cervical cancer and a C-03
trial in first-line head and neck cancer, two areas with a high unmet medical
need. The company is also planning to move VB10.16 into early-stage cervical
cancer.

Nykode is committed to advancing the field of immunotherapy and sharing its
research findings with the broader scientific community in line with their
publication guidelines. To this end, the company will present the detailed data
from the Phase 2 VB-C-02 trial in a future scientific publication and at a
forthcoming medical conference.

Nykode wishes to thank the patients, their families and the investigators for
their participation and contribution to the VB-C-02 trial.

About the VB-C-02 trial
VB-C-02 is a multi-center, single arm, open-label Phase 2 trial to assess the
efficacy, immunogenicity and safety of VB10.16 in combination with the PD-L1
inhibitor atezolizumab in patients with advanced or recurrent, non-resectable
HPV16-positive cervical cancer. Patients received treatment with VB10.16 in
combination with atezolizumab for up to one year. The trial enrolled 52 patients
at sites in Europe. Additional information about the VB-C-02 trial is available
at clinicaltrials.gov (NCT04405349).

About VB10.16
VB10.16 is a potentially first-in-class off-the-shelf therapeutic DNA-based
cancer vaccine candidate in development for the treatment of human
papillomavirus type 16 (HPV16)-positive cancers. The cancer vaccine is designed
based on Nykode's VaccibodyTM technology platform of targeting antigens to
antigen presenting cells. VB10.16 has reported promising data from a Phase 2
trial in advanced PD-L1 positive cervical cancer patients (NCT04405349) in
combination with atezolizumab with mOS not reached, but greater than 25 months
at the time of analysis. The vaccine-induced significant HPV16-specific T cell
responses that were correlated with clinical responses. The candidate has also
demonstrated favorable clinical data in a Phase 1/2a study in pre-cancerous
HPV16-induced high grade cervical intraepithelial neoplasia (HSIL