Oslo, Norway, May 23, 2025 – Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, today announced 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) Annual Meeting in Chicago, Illinois.
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.
The posters will be available on the Nykode website on May 30, at: https://nykode.com/research-and-development/scientific-papers-and-presentations.
About Nykode Therapeutics
Nykode Therapeutics is a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies with a focus on the treatment of cancer and autoimmune diseases. Nykode’s modular immunotherapy technology specifically targets antigens to antigen presenting cells (APC), which have been shown to induce a broad, strong and long-lasting antigen specific immune response in cancer, which correlates with clinical responses.
Nykode’s lead product candidates are VB10.16, a therapeutic immunotherapy for the treatment of HPV16 induced malignancies which demonstrated favorable safety and efficacy results from its Phase 2 trial for the treatment of cervical cancer. VB10.16 is currently being further developed in head and neck cancer. VB10.NEO, an individualized cancer neoantigen immunotherapy, has been investigated in two trials with more than 10 different indications.
Nykode is also utilizing its APC-targeted technology to create an immune tolerance platform for the potential use in autoimmune disorders, organ transplant rejections, anti-drug antibody reactions and allergy.
Nykode Therapeutics’ shares are traded on the Oslo Stock Exchange (OSE: NYKD). Further information about Nykode Therapeutics can be found at http://www.nykode.com.
Forward-looking statements for Nykode Therapeutics
This announcement and any materials distributed in connection with this announcement may contain certain forward-looking statements. By their nature, forward-looking statements involve risk and uncertainty because they reflect the company's current expectations and assumptions as to future events and circumstances that may not prove accurate. A number of material factors could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements.
Contact for Nykode Therapeutics ASA:
Alexandra Deschner, Head of IR
Nykode Therapeutics ASA
IR@nykode.com
Nykode Therapeutics ASA
Oslo Science Park
Gaustadalléen 21
N-0349 Oslo, Norway