On March 20, 2026 Nykode Therapeutics ASA (OSE: NYKD), a clinical stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported 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.
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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:
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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.
(Press release, Nykode Therapeutics, MAR 20, 2026, View Source [SID1234663790])