Nykode Therapeutics Presents Promising Immunotherapy Data for HPV16-Positive Cancer and Solid Tumors at ASCO 2025
Key Insights
Nykode Therapeutics has presented new clinical data at ASCO 2025 for two cancer immunotherapy candidates, VB10.16 and VB10.NEO (search), both showing robust immune responses when combined with atezolizumab.
VB10.16 demonstrated durable clinical responses in HPV16-positive cervical cancer (search) patients, with stronger T cell responses associated with reduced systemic immunosuppression during treatment.
VB10.NEO (search), a personalized cancer neoantigen vaccine, induced neoantigen-specific immune responses in 100% of heavily pretreated solid tumor patients, with de novo responses in 85% and durable T cell clone expansion in 82%.
Nykode Therapeutics has unveiled promising new data from two clinical trials evaluating its cancer immunotherapy candidates at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The presentations highlighted the potential of the company's targeted immunotherapy platform in inducing robust immune responses across multiple tumor types.
The clinical-stage biopharmaceutical company presented findings for two candidates—VB10.16 and VB10.NEO (search)—both administered in combination with atezolizumab (Tecentriq®). The data demonstrated encouraging results in heavily pre-treated patient populations with favorable safety profiles.
"These new data add to the growing body of clinical evidence supporting our vaccine candidates VB10.NEO (search) 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."
VB10.16 Shows Promise in HPV16-Positive Cervical Cancer
The first poster presentation, titled "Integrative analysis of VB10.16 and atezolizumab in advanced HPV16-positive cervical cancer (search): Linking biomarker insights to clinical outcomes," was presented by Kristina Lindemann from Oslo University Hospital.
The VB C-02 trial demonstrated that VB10.16 combined with atezolizumab induced durable clinical responses in patients with persistent, recurrent, or metastatic HPV16-positive cervical cancer (search). Notably, stronger HPV16-specific T cell responses were associated with reduced systemic immunosuppression during treatment.
The researchers also found that tumor microenvironment (TME) characteristics were associated with higher response rates. These findings emphasize the importance of identifying the right patient population and understanding treatment effects on systemic immunosuppression, highlighting the promise of this combination therapy for further exploration.
VB10.NEO Demonstrates Strong Immune Response in Solid Tumors
The second poster, "Induction of neoantigen-specific immune responses by VB10.NEO (search) in combination with atezolizumab in heavily pretreated patients with advanced solid tumors: Final analysis of the phase 1b VB N-02 trial," was presented by Sebastian Ochsenreither from Charité University of Medicine Berlin.
VB10.NEO (search), Nykode's personalized cancer neoantigen vaccine, showed impressive immunological activity when combined with atezolizumab. Neoantigen-specific immune responses were observed in 100% of patients, with de novo immune responses in 85% of patients, as measured by in vitro stimulated IFN ELISpot. Additionally, 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, with a median of 5 prior therapy lines and predominantly low or negative PD-L1 (search) expression. This resulted in a median progression-free survival (PFS) reached before 2 months, limiting the opportunity for thorough assessment of long-term immune responses and clinically meaningful responses.
Nevertheless, VB10.NEO (search) in combination with atezolizumab demonstrated a favorable safety profile, supporting further development in additional solid tumor settings.
Nykode's Immunotherapy Platform
Nykode's modular immunotherapy technology specifically targets antigens to antigen presenting cells (search) (APCs), which have been shown to induce broad, strong, and long-lasting antigen-specific immune responses in cancer that correlate with clinical responses.
VB10.16, a therapeutic immunotherapy for HPV16-induced malignancies, has already demonstrated favorable safety and efficacy results from its Phase 2 trial for cervical cancer (search) treatment and is currently being further developed for head and neck cancer (search).
VB10.NEO (search), an individualized cancer neoantigen immunotherapy, has been investigated in two trials with more than 10 different indications.
Beyond oncology, Nykode is also utilizing its APC-targeted technology to create an immune tolerance platform for potential use in autoimmune disorders, organ transplant rejections, anti-drug antibody reactions, and allergy.
The detailed posters from the ASCO presentations will be available on the Nykode website on May 30, providing further insights into these promising immunotherapy approaches.