Nykode Therapeutics Announces Advances in Clinical Pipeline and Research

• On-track to leverage promising Phase 2 cervical cancer data with FDA clearance to start a potentially registrational trial in 2023, and expansion into head and neck, two areas with high unmet need.
  
• Previously un-published data from both VB10.16 and VB10.NEO, substantiates the long-lasting immune responses which supports development opportunities in both advanced and earlier treatment settings.
• Partnership with Regeneron moving closer to lead selection and preliminary “breaking tolerance” data.
• Compelling data across different autoimmune disease models opens a commercially attractive new therapeutic vertical.

OSLO, Norway, Sept. 20, 2023 (GLOBE NEWSWIRE) -- Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, announces significant advances in its clinical pipeline and research at the Capital Markets Day in New York.

“We are excited to lay out our path to building shareholder value through a focused strategy to develop VB10.16 in advanced cancer with a significant further upside in early-stage cancer. We today present additional data from both our VB10.16 and VB10.NEO programs supporting a differentiated durable immune response,” said Michael Engsig, CEO of Nykode Therapeutics.

“Further, our unique targeted vaccine technology has great potential within autoimmune disorders, which affect around every tenth person globally. We have established proof of concept in different autoimmune disease models, and this breakthrough presents a substantial additional potential commercial opportunity for Nykode.”

VB10.16: Therapeutic vaccine candidate for human papilloma virus (HPV) 16+ cancers with strong clinical data

• Additional VB-C-02 data supporting a differentiated long-lasting and clinically relevant immune response.
• VB-C-04 trial design: Potentially registrational phase 2 trial in recurrent/metastatic (R/M) cervical cancer progressing on 1st line standard of care (SOC) (pembrolizumab + chemotherapy +/- bevacizumab). IND approval received from FDA and on track to be initiated Q4 2023.
• VB-C-03 trial design: Phase 1/2a trial. Combination treatment of VB10.16+pembrolizumab in 1st line HPV16+ R/M HNSCC. On track to be initiated in Q3 2023.