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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.
2022-12-06 16:45:00
Oslo, Norway, December 6, 2022 - Nykode Therapeutics ASA (OSE: NYKD), a
clinical-stage biopharmaceutical company dedicated to the discovery and
development of novel immunotherapies, today announced that it has entered into a
clinical collaboration and supply agreement with MSD (Merck & Co., Inc., Rahway,
NJ, USA), to evaluate Nykode's wholly-owned lead candidate, VB10.16, in
combination with MSD's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in a Phase
1/2a trial in patients with HPV16-positive head and neck cancer.

VB10.16 is an off-the-shelf therapeutic cancer vaccine specifically designed to
treat HPV16-induced malignancies. The candidate has reported interim data from a
Phase 2 trial in heavily pre-treated cervical cancer patients (NCT04405349). The
analysis demonstrated a favorable safety profile, with responses observed in
both PD-L1 positive and negative patients (ORR 27% and 17%, respectively). The
vaccine-induced significant HPV16-specific T cell responses were associated with
clinical responses.

"We are thrilled to collaborate with MSD, a global leader in immuno-oncology,
and to work with their highly experienced and talented scientific team," stated
Agnete Fredriksen, Chief Business Officer & Co-founder of Nykode Therapeutics.
"We see great potential for Nykode's cancer vaccine in combination with MSD's
anti-PD-1 therapy to generate a potent immune response in head and neck cancer
and provide a meaningful clinical benefit for patients with late-stage disease."

The open-label, dose-finding Phase 1/2a trial will evaluate the safety,
immunogenicity, and anti-tumor activity of VB10.16 in combination with KEYTRUDA
in patients with unresectable recurrent or metastatic HPV16-positive head and
neck squamous cell carcinoma. The trial is anticipated to begin enrollment in
Europe during the first half of 2023.

Under the terms of the agreement, Merck will supply KEYTRUDA. Nykode retains all
commercial rights to VB10.16 worldwide.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of
Merck & Co., Inc., Rahway, NJ, USA.


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