Nykode Therapeutics Announces FDA Approval of IND for VB-C-04, a Trial of VB10.16 in HPV16-Positive Cervical Cancer

• FDA approval of IND for VB-C-04 trial.
  
• Nykode to further elaborate on trial design and development strategy at upcoming capital markets day in New York on September 20.
  

OSLO, Norway, Sept. 05, 2023 (GLOBE NEWSWIRE) -- 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 (Tecentriq¹) 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.

¹Tecentriq 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 Vaccibody 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; CIN 2/3) demonstrating a statistically significant correlation of immune responses and clinical responses.