On May 22, 2025 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported the presentation of new data from two clinical trials evaluating its cancer immunotherapy candidates — VB10.16 and VB10.NEO, both in combination with atezolizumab (Tecentriq), — at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois (Press release, Nykode Therapeutics, MAY 22, 2025, View Source [SID1234653312]).
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The two posters highlight the potential of Nykode’s targeted immunotherapy platform in inducing robust immune responses in heavily pre-treated patient populations across multiple tumor types, with encouraging safety profiles.
"These new data add to the growing body of clinical evidence supporting our vaccine candidates VB10.NEO and VB10.16," said Agnete Fredriksen, CSO and Co-founder of Nykode Therapeutics. "The quality of the immune responses seen in both trials and the increased understanding of the relation between the immune responses and patient characteristics—reinforce the potential of our APC-targeted technology and help define the best path forward for these promising assets."
Sunday, June 1, 2025 | 9:00 AM–12:00 PM
CT Abstract #: 5538
Title: Integrative analysis of VB10.16 and atezolizumab in advanced HPV16-positive cervical cancer: Linking biomarker insights to clinical outcomes.
Presenter: Kristina Lindemann, Department of Gynecological Oncology, Oslo University Hospital & Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway
Session Type and Title: Poster Session – Gynecologic Cancer
Poster Board Number: 436
• In patients with persistent, recurrent, or metastatic HPV16-positive cervical cancer, VB10.16 combined with atezolizumab induced durable clinical responses. • The VB C-02 trial demonstrated that stronger HPV16-specific T cell responses were associated with reduced systemic immunosuppression during treatment. • Tumor microenvironment (TME) characteristics are associated with higher response rates. • These findings support the importance of identifying the right patient population as well as elucidating the treatment effect on the systemic immunosuppression and highlights the promise of VB10.16 in combination with atezolizumab, warranting further exploration.
Monday, June 2, 2025 | 1:30 PM–4:30 PM CT
Abstract #: 2639
Title: Induction of neoantigen-specific immune responses by VB10.NEO in combination with atezolizumab in heavily pretreated patients with advanced solid tumors: Final analysis of the phase 1b VB N-02 trial.
Presenter: Sebastian Ochsenreither, Charité University of Medicine Berlin Comprehensive Cancer Center, Berlin, Germany Session Type and Title: Poster Session – Developmental Therapeutics – Immunotherapy
Poster Board Number: 286
• VB10.NEO, Nykode’s personalized cancer neoantigen vaccine, in combination with atezolizumab, induced neoantigen-specific immune responses. • Neoantigen-specific immune responses were observed in 100% of the patients and de novo immune responses were observed in 85% of patients, as measured by in vitro stimulated IFNγ ELISpot. • Expansion of durable T cell clones was seen in 82% of patients, suggesting persistence of the immune response. • The trial enrolled heavily pre-treated patients across more than 10 indications, a median of 5 prior therapy lines and predominantly low or negative PD-L1 expression resulting in a median PFS reached before 2 months, limiting the opportunity for thorough assessment of long-term immune responses and clinically meaningful responses. • VB10.NEO in combination with atezolizumab demonstrated a favorable safety profile. • These results support further development of VB10.NEO in additional solid tumor settings.