Nykode Therapeutics Announces Clinical Collaboration with MSD to Evaluate VB10.16 in Combination With KEYTRUDA® (pembrolizumab) in Patients with HPV16-Positive Head and Neck Cancer

06 Dec 2022 16:45 CET

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; and VB10.NEO, an individualized cancer
neoantigen vaccine, which is exclusively out-licensed to Genentech, a member of
the Roche Group. Additionally, Nykode is conducting a Phase 1/2 trial with
next-generation COVID-19 vaccine candidates.

The Company’s partnerships include Genentech within oncology, a multi-target
collaboration with Regeneron within oncology and infectious diseases and a
collaboration with Adaptive Biotechnologies for COVID-19 T cell vaccine
development.

Nykode Therapeutics’ shares are traded on the Oslo Stock Exchange (OSE: NYKD).
Further information about Nykode Therapeutics may be found at
http://www.nykode.com.


Forward-looking statements for Nykode Therapeutics
This announcement and any materials distributed in connection with this
announcement may contain certain forward-looking statements. By their nature,
forward-looking statements involve risk and uncertainty because they reflect the
company's current expectations and assumptions as to future events and
circumstances that may not prove accurate. A number of material factors could
cause actual results and developments to differ materially from those expressed
or implied by these forward-looking statements.


Contact for Nykode Therapeutics ASA:

Chief Business Officer, Agnete Fredriksen
Nykode Therapeutics ASA
IR@nykode.com

Nykode Therapeutics ASA
Oslo Science Park
Gaustadalléen 21
N-0349 Oslo, Norway

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577496_221206 Nykode PR HNC MSD Supply Agreement - FINAL (1).pdf