Oslo, Norway, September 29, 2023 - Nykode Therapeutics ASA (OSE: NYKD), a
clinical-stage biopharmaceutical company dedicated to the discovery and
development of novel immunotherapies, today announced the initiation of the
Phase 1/2a clinical trial. The trial evaluates VB10.16, the Company's wholly
owned off-the-shelf therapeutic cancer vaccine candidate for HPV16-positive
cancers, in combination with MSD's (Merck & Co., Rahway, NJ, USA) PD-1 inhibitor
KEYTRUDA® (pembrolizumab) in first line (1L) setting in patients with
HPV16-positive, PD-L1-positive, recurrent or metastatic head and neck squamous
cell carcinoma (HNSCC).
"Initiating the VB10.16 trial for HPV16-positive head and neck cancer, is a
significant step in our clinical strategy," said Michael Engsig, CEO of Nykode
Therapeutics. "The strong results in advanced cervical cancer patients in
VB-C-02 boost our confidence in VB10.16's potential for HPV16-positive HNSCC.
The VB-C-03 trial launch shows our commitment to expanding VB10.16 as an
innovative immunotherapy for HPV16 cancers across more indications and treatment
stages."
VB-C-03 is a Phase 1/2a open-label, dose-finding trial investigating safety,
tolerability, and efficacy. It consists of two consecutive phases, a dose
escalation phase (Phase 1) and a dose expansion phase (Phase 2a), testing
VB10.16 in doses up to 9 mg, in combination with pembrolizumab in a 1L setting
in patients with HPV16-positive, PD-L1-positive HNSCC. The trial will take place
in Europe.
"The C-03 trial is our first trial in a first line setting. We are encouraged by
the C-02 trial which showed that moving up in the treatment line may further
improve the clinical outcome. In addition, we are exclusively focusing on the
subset of patients with PD-L1+ tumors as these were found to demonstrate the
best efficacy in the C-02 trial. We will also be testing doses up to 9 mg, three
times higher than previously used. All in all, we are eager to see the potential
clinical benefit for the important head and neck cancer patient population,"
said Klaus Edvardsen, Chief Development Officer of Nykode Therapeutics.
Merck will supply KEYTRUDA, while Nykode retains all commercial rights to
VB10.16 worldwide.
Note: KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a
subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About the Phase 1/2a Trial
The open-label, dose-finding Phase 1/2a trial will evaluate the safety,
immunogenicity, and anti-tumor activity of VB10.16 in combination with MSD's
PD-1 inhibitor KEYTRUDA® (pembrolizumab) in patients with HPV16-positive,
PD-L1-positive, recurrent or metastatic head and neck squamous cell carcinoma
(HNSCC) who are eligible for pembrolizumab monotherapy. The trial consists of
two consecutive phases, a dose escalation phase (Phase 1) and a dose expansion
phase (Phase 2a). The trial will determine the biological optimal dose of
VB10.16 in combination with a fixed dose of pembrolizumab and elicited by doses
of 3 mg, 6 mg, and 9 mg VB10.16. The trial will take place in Europe. More
information is available at ClinicalTrials.gov Identifier: NCT06016920.
About VB10.16
VB10.16 is a potentially first-in-class off-the-shelf therapeutic 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 positive data from a Phase 2 trial in advanced
cervical cancer patients (NCT04405349) in combination with atezolizumab with mOS
not reached but estimated to be greater than 25 months at the time of analysis
in PD-L1+ patients. The vaccine-induced significant HPV16-specific T cell
responses were correlated with clinical responses. The candidate has also
demonstrated favorable clinical data in a Phase 1/2a trial in pre-cancerous
HPV16-induced high grade cervical intraepithelial neoplasia (HSIL