Duyuru • May 23
Nykode Therapeutics ASA Highlights New Data in Two Poster Presentations At the 2025 Asco Annual Meeting Nykode Therapeutics ASA 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. 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, Oslo, Norway. In patients with persistent, recurrent, or metastatic HPV16-positive cervical cancer, VB10.16 combined with ateolizumab 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. Induction of neoantigen-specific immune responses by VB10.NEO in combination with atezolizeumab in heavily pretreated patients with advanced solid tumors: Final analysis of the phase 1b VB N-02 trial. Presenter: Seebastian Ochsenreither, Charite University of Medicine Berlin Comprehensive Cancer Center, Berlin, Germany. VB10.NEO Inc, VB10. NEO, Nykode's personalized cancer neoantigen vaccine, in combination with atezoluzumab, induced neoantigen-specific immune response. 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 IFNg 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.N NEO in combination with atezolizing a median PFS reached before2 months, limiting the opportunity for comprehensive assessment of long-term immune response and clinically meaningful responses. V B10.NEO in combination With atezolizumab demonstrated a favorable safety profile. These results support further development of VB10.NEO In additional solid tumor settings. Duyuru • Apr 23
Nykode Therapeutics AS announces Annual dividend Nykode Therapeutics AS announced Annual dividend of NOK 1.0000 per share, ex-date on May 27, 2025 and record date on May 28, 2025. Duyuru • Feb 28
Nykode Therapeutics ASA Announces Preclinical Data Highlighting its Immune Tolerance Platform's Ability to Modulate Multiple Key Immune Components in Autoimmune Disease Nykode Therapeutics ASA announced new preclinical findings reinforcing the unique mechanism of action and potential of its APC-targeted immune therapy platform in treating autoimmune diseases. Important new data show that Nykode's APC-targeted constructs increase antigen-specific regulatory T cells, which are known to downregulate an unwanted immune response, while simultaneously reducing antigen-specific effector T cells that drive inflammation. Furthermore, new data show that Nykodes's APC-targeted construct can reduce the generation of antigen-specific IgG autoantibodies, thereby shaping also the humoral component of the immune response, which is known to be involved in many autoimmune conditions. These changes suggest that the therapy works effectively through multiple arms of the antigen-specific immune system to promote its effectiveness and support its potential as a future therapy for autoimmune disorders, allergy and organ transplant rejection. Furthermore, new data show the data have been generated using MOG and PLP-1 antigens, which are applicable in chronic and relapsing-remitting EAE models. The Company remains committed to advancing its immune tolerance platform and further exploring the clinical potential of APC-targeted therapy for autoimmune diseases, allergies, and organ transplant rejection. Duyuru • Jan 08
Nykode Therapeutics ASA Announces Publication of Phase 2 VB-C-02 Data Confirming Prolonged Benefit and Definitive Vaccination Effects Nykode Therapeutics ASA announced the publication of a manuscript entitled Safety and efficacy of the therapeutic DNA- based vaccine VB10.16 in combination with atezolizumab in persistent, recurrent or metastatic HPV16- positive cervical cancer: a multicenter, single-arm phase 2a study in the peer-reviewed BMJ "Journal for ImmunoTherapy of Cancer" (JITC). The trial investigated the use of Nykode's wholly owned off-the- shelf therapeutic cancer vaccine candidate VB10.16 in combination with Roche's checkpoint inhibitor atezolizumab in patients with persistent and recurrent or metastatic HPV16-positive cervical cancer. As previously communicated, the published results confirm prolonged clinical benefits and indicate a potential synergistic treatment effect of VB10.16 in combination with atezolizumab compared to what has previously been reported for checkpoint inhibitor monotherapy. In this analysis the remaining patients were followed for up to 24 months, compared to at least 12 months in the previously reported data cut-off. The trial demonstrated an ORR of 19.1% in the efficacy population. With the extended 12-month follow- up period to the end of the trial, both mPFS and mOS increased compared to what has previously been reported, reaching 4.3 months and 21.3 months, respectively. In the subpopulation of PD-L1-positive patients (n=24) the ORR increased to 29.2% resulting in further improved mPFS and mOS of 6.3 months and 24.7 months, respectively. Among PD-L1-positive patients with one prior line of SATC (n=15), the ORR increased to 40.0%, and mPFS and mOS further improved to 15.8 months and not reached, respectively. VB-C-02 is a multi-center, single arm, open-label Phase 2 trial to assess the efficacy, immunogenicity and safety of VB10.16 in combination with the PD-L1 inhibitor atezolizumab in patients with advanced or recurrent, non-resectable human papillomavirus type 16 (HPV16)-positive cervical cancer. Patients received treatment with VB10.16 in combination with atezolizumab for up to one year. The trial enrolled 52 patients at sites in Europe. Additional information about the VB-C-02 trial is available at clinicaltrials.gov (NCT04405349). VB10.16 is a potentially first-in-class off-the-shelf therapeutic DNA-based cancer vaccine candidate in development for the treatment of HPV16-positive cancers. The cancer vaccine is designed based on Nykode's VaccibodyTM technology platform of targeting antigens to antigen presenting cells. VB10.16 has reported promising data from a Phase 2 trial in advanced PD-L1 positive cervical cancer patients (NCT04405349) in combination with atezolizumab The candidate has also demonstrated favorable clinical data in a Phase 1/2a study in pre-cancerous HPV16-induced high grade cervical intraepithelial neoplasia (HSIL; CIN 2/3) demonstrating a statistically significant correlation of immune responses and clinical responses. Nykode is currently investigating VB10.16 in VB-C-03, an open-label, dose-finding Phase 1/2a trial evaluating VB10.16 in combination with MSD's PD-L1 inhibitor KEYTRUDA® (pembrolizumab) in patients with HPV16-positive, PD-L1-positive, recurrent, or metastatic head and neck squamous cell carcinoma (HNSCC). Cervical cancer is the fourth leading cause of cancer death in women worldwide and is most frequently diagnosed between the ages of 35 and 44. Each year around 600,000 women are diagnosed with cervical cancer worldwide. Almost all cases are caused by human papillomavirus (HPV) infection and HPV16 accounts for more than half of all cervical cancer cases. Approximately 80% of patients with cervical cancer have squamous cell carcinoma and most other patients have adenocarcinomas. Cervical cancer is often curable when detected early and effectively managed, but treatment options are more limited in advanced disease stages or when the cancer has spread. One of the emerging challenges within oncology is the virus-induced cancer types, with Human Papillomavirus (HPV) being one of the most prominent. There are several types of high-risk HPV causing cancers, HPV16 being one of the most common, with more than 130,000 new cases in the U.S. and EU per year. Using a therapeutic cancer vaccine targeted specifically towards the HPV16 infected cells in the tumors, such as Nykode's cancer vaccine VB10.16, represents a novel immunotherapeutic treatment option. By combining a therapeutic cancer vaccine with the checkpoint inhibitors and/or other general immune therapies, the tumors can be attacked by the cancer-specific T cells from several angles with the aim of improving patient outcomes. 
