• New analyses from two clinical trials validate the ability of Nykode’s proprietary NeoSELECT™ platform to identify neoantigens that drive strong and durable immune responses
• VB10.NEO induced neoantigen-specific T-cell responses in 94% and 100% of participants in the phase 1/2 VB N-01 and phase 1 VB N-02 trials, respectively
• Survival analyses from the N-01 trial showed that high-quality immunogenic neoantigens prioritized by NeoSELECT™ were associated with favorable overall survival in a heterogeneous, heavily pre-treated patient population
Oslo, Norway, November 5, 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 integrated multiomics and biomarker analyses from the phase 1/2 VB N-01 (NCT03548467) and phase 1 VB N-02 (NCT05018273) clinical trials of the individualized cancer vaccine VB10.NEO, designed using Nykode’s AI-powered NeoSELECT™ platform, at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) held in National Harbor, Maryland, 5-9 November 2025.
The poster highlights the capabilities of Nykode’s proprietary AI-powered NeoSELECT™ platform, which enables individualized cancer vaccine design by integrating multiomics data to select neoantigens with a high potential to trigger clinically relevant tumor-specific immune responses.
In the phase 1/2 VB N-01 and phase 1 VB N-02 trials, VB10.NEO developed using NeoSELECT™ elicited neoantigen-specific T-cell responses in 94% and 100% of participants, respectively, across multiple solid tumor types. High-quality neoantigens prioritized by NeoSELECT™ showed enrichment of both overall and stable/amplified immunogenic responses, supporting prolonged and amplified neoantigen-specific immune responses after VB10.NEO vaccination.
“We are very proud of our in-house artificial intelligence and machine learning capabilities. It is great to see the strong performance of our immunogenicity predictions being confirmed across both clinical trials,” said Agnete Fredriksen, CSO and Co-founder of Nykode Therapeutics. “While the N-01 cohort was highly heterogeneous and patients received multiple concurrent therapies, we note a favorable association between a higher number of high-quality immunogenic neoantigens and overall survival. This encouraging signal warrants confirmation in controlled studies with more homogeneous patient populations and earlier lines of treatment.”
Poster Presentation Details
Abstract #: 117
Title: Integrative analyses of multiomics data and biomarker readout demonstrate clinical and immunological relevance of individualized vaccine design via the NeoSELECT™ platform
Session Date and Time: Friday, November 7, 2025 | 10:00 AM–7:00 PM ET
The poster will be available on the Nykode website on November 7, at: https://nykode.com/research-and-development/scientific-papers-and-presentations.
About VB10.NEO
VB10.NEO is a proprietary individualized neoantigen therapy in development for the treatment of locally advanced or metastatic solid tumors. The product is designed to be produced on-demand based on each patient’s unique neoantigen profile, identified through Nykode’s AI-powered NeoSELECTTM platform, which integrates individual patient multiomics data to select the most immunogenic neoantigens. Neoantigens are proteins generated by tumor-specific mutations not present in normal tissues and are thus an attractive target for cancer immunotherapy as they may be recognized as foreign by the immune system.
Nykode has evaluated VB10.NEO in two Phase 1 clinical trials, VB N-01 and VB N-02. VB N-01 was a first-in-human study in patients with advanced solid tumors, designed to assess safety, feasibility, and immunogenicity of VB10.NEO in combination with standard-of-care treatment, including checkpoint inhibitors. VB N-02 was a Phase 1b study conducted in heavily pre-treated patients with advanced solid tumors (median 5 prior lines of treatment), aiming to further optimize dose and regimen in combination with the checkpoint inhibitor atezolizumab (Tecentriq®).
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 abi-suva, 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 late-line r/m cervical cancer. Abi-suva 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