• Encouraging preliminary efficacy was observed, with a confirmed ORR of 38.5% (5 out of 13 PD-L1-positive patients) compared to 19.1% in the reported historical control with standard of care (pembrolizumab monotherapy) in a comparable first-line setting. In patients with high PD-L1 expression (CPS ≥ 20), the ORR was 50.0% (3 out of 6 patients) compared to historical 23.3%.
• The overall disease control rate (DCR) was 69.2% (vs. 47.1% in the historical control). In patients with high PD-L1 expression (CPS ≥ 20), the DCR was 100.0% (vs. 53.4% in the historical control).
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• Robust immunogenicity was demonstrated, with 100% of evaluable patients in the 6 mg and 9 mg cohorts showing HPV-16 specific T cell responses.
• The combination showed a favorable safety profile, with all abi-suva dose levels safety cleared and only transient, manageable Grade 1–2 adverse events, and with no treatment discontinuations or fever.
• Safety data and dose regimen are superior to recent competitor data together with a strong efficacy profile; the data builds a strong foundation leading into the Abili-T trial with anticipated first patient dose in the first half of 2026.
Oslo, Norway, March 20, 2026 – Nykode Therapeutics ASA (OSE: NYKD), a clinical stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, today announced that Dr. Caroline Even (Institut Gustave Roussy, Paris) presented Phase 1 dose escalation results from the VB-C-03 study on behalf of the investigators at the 10th International Congress on Innovative Approaches in Head & Neck Oncology (ICHNO), 19-21 March 2026, in Seville, Spain.
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 first-line unresectable recurrent or metastatic (r/m) oropharyngeal head and neck cancer (OPC) patients (NCT06016920). Nykode is further advancing abi-suva development in first-line r/m OPC through the Abili-T phase 2 randomized clinical trial.
Three cohorts of participants (N = 13) with HPV16-positive, PD-L1-positive r/m OPC received either 3, 6 or 9 mg of abi-suva in combination with pembrolizumab. All abi-suva dose levels were safety-cleared in accordance with prespecified criteria.
Encouraging preliminary efficacy signals were observed in the trial. The confirmed objective response rate (ORR) was 38.5%, compared with a reported historical ORR of 19.1% for pembrolizumab monotherapy in a comparable first-line patient population with CPS ≥1 (KEYNOTE-048). The overall disease control rate (DCR) was 69.2% (vs. 47.1% in the historical control). Notably, among participants with high PD-L1 expression (CPS ≥ 20), an ORR of 50.0% (vs. 23.3%) and a DCR of 100.0% (vs. 53.4%) were observed.
Robust immunogenicity was also demonstrated, with 100% of evaluable participants in the 6 mg and 9 mg dose cohorts showing HPV16-specific T-cell immune responses.
“These data provide important evidence that abi-suva is doing what it is designed to do — generate strong HPV16-specific immune responses while showing encouraging early clinical activity. These data along with the dose regimen points to a strong competitive profile which strengthens our confidence in the randomized Abili-T trial slated to start in the first half of this year.” commented Agnete Fredriksen, CSO and Co-founder of Nykode Therapeutics.
The combination demonstrated a favorable safety profile, with treatment-emergent adverse events largely limited to transient, manageable Grade 1–2 events. No treatment-emergent adverse events led to treatment discontinuation or death. Of note, no fever, chills, or flulike symptoms were observed.
The presentation will be available after the session at the Company’s Webpage: Scientific papers and presentations - Nykode
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 first line head and neck cancer with the randomized Abili-T trial with interim results within 2027. 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
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