Nykode Therapeutics Announces New Interim Data from the VB-C-03 Trial Showing Encouraging Anti-Tumor Activity and Tolerability of Abi-suva (VB10.16)
• Anti-tumor activity was observed with a final confirmed objective response rate (ORR) of 38.5%.
• The data demonstrates that abi-suva elicits rapid, strong and durable HPV16-specific T cell responses. Robust and durable T cell expansion in the circulation was also confirmed by TCR sequencing.
• All tested doses of abi-suva in combination with pembrolizumab were well tolerated and showed a favorable safety profile.
• Oral presentation at ICHNO on March 20, 2026.
Oslo, Norway, February 24, 2026 – Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, today announces data from the phase 1 dose-escalation part of the VB-C-03 trial (N=13). The data will be further elaborated at an oral presentation by Dr. Caroline Even, Institut Gustave Roussy, Villejuif (Paris) at the 10th International Congress on Innovative Approaches in Head & Neck Oncology (ICHNO) on March 20, 2026. A full abstract is expected to be published by ICHNO before the congress.
The VB-C-03 trial is investigating abi-suva in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in 1st line unresectable recurrent or metastatic oropharyngeal head and neck cancer patients (NCT06016920). Nykode is further advancing abi-suva development in 1st line head and neck cancer through the Abili-T phase 2 randomized clinical trial.
The phase 1 VB-C-03 data show that anti-tumor activity was observed with a final confirmed objective response rate (ORR) of 38.5%. The data demonstrates that abi-suva elicits rapid, strong and durable HPV16-specific T cell responses. Robust and durable T cell expansion in the circulation was also confirmed by TCR sequencing. The data also demonstrate that all tested doses of abi-suva in combination with pembrolizumab were well tolerated and showed a favorable safety profile.
Michael Engsig, Chief Executive Officer of Nykode, commented: “The objective response rate of 38.5% for the combination treatment compared to historical 19% of standard of care gives us confidence in abi-suva heading into the Abili-T trial which is investigating the same regiment in a randomized controlled setting. This is the third trial for abi-suva indicating effect across three different patient groups including both head and neck as well as cervical cancer.”
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. KEYTRUDA® has been supplied by MSD for the VB-C-03 trial according to the clinical trial collaboration and supply agreement between Nykode and MSD.
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: IR@nykode.com
Nykode Therapeutics ASA Oslo Science Park Gaustadalléen 21 N-0349 Oslo, Norway