o FDA approval of IND for VB-C-04 trial.
o Nykode to further elaborate on trial design and development strategy at
upcoming capital markets day in New York on September 20.
Oslo, Norway, September 5, 2023 - Nykode Therapeutics ASA (OSE: NYKD), a
clinical-stage biopharmaceutical company dedicated to the discovery and
development of novel immunotherapies, today announced FDA approval of its
investigational new drug (IND) application for the Phase 2 clinical trial. The
trial is designed to evaluate VB10.16, the Company's wholly owned off-the-shelf
therapeutic cancer vaccine candidate for HPV16-positive cancers, in combination
with Roche's PD-L1 inhibitor atezolizumab (Tecentriq®) in patients with
HPV16-positive, PD-L1-positive, recurrent or metastatic cervical cancer. Nykode
is on track to initiate the trial in the fourth quarter of 2023.
"We are excited to open the IND for the C-04 trial with VB10.16. It is an
important milestone," said Michael Engsig, CEO of Nykode Therapeutics. "We look
forward to presenting the trial design and the overall VB10.16 development
strategy at our Capital Markets Day in New York on September 20, 2023."
Atezolizumab is supplied by Roche. Nykode retains all commercial rights to
VB10.16 worldwide.
Tecentriq® is a registered trademark of the Roche Group.
About VB.1016
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 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 study in pre-cancerous HPV16-induced
high grade cervical intraepithelial neoplasia (HSIL