On May 7, 2026 Nykode Therapeutics ASA (OSE: NYKD), a clinical stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported the dosing of the first patient in Abili-T, a randomised Phase II clinical trial evaluating abi-suva (formerly VB10.16) in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD1 therapy, KEYTRUDA (pembrolizumab) versus pembrolizumab alone as first-line treatment for patients with HPV16-positive, PD-L1-positive recurrent or metastatic head and neck squamous cell carcinoma (1L r/m HNSCC).
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The initiation of Abili-T marks a pivotal milestone in Nykode’s clinical development programme and reinforces the Company’s strategy to advance abi-suva as a targeted immunotherapy for the significant unmet medical need that exists in HPV16-driven cancers.
"Initiating the first patient in the Abili-T trial is an important step forward for Nykode and most importantly for patients with first-line recurrent/metastatic head and neck squamous cell carcinoma who continue to have significant unmet medical needs," said Michael Engsig, Chief Executive Officer at Nykode Therapeutics. "Abi-suva is designed to generate strong and durable HPV16-specific immune responses and we look forward to generating data in a randomized setting. We are grateful to the clinical investigators and patients participating in this study."
"There is a significant unmet need for patients with HPV16-driven head and neck cancer, particularly in the first-line setting," said Åse Bratland, Coordinating Investigator of the Abili-T trial, The Norwegian Radium Hospital, Oslo University Hospital. "Abi-suva is designed to generate a targeted and durable immune response and combining it with pembrolizumab may offer a meaningful new approach for these patients. We are hopeful that this study will provide important insights and, ultimately, lead to improved outcomes."
Abili-T is a randomised, open-label, multicentre Phase II trial evaluating abi-suva in combination with pembrolizumab versus pembrolizumab alone as first-line treatment in patients with HPV16-positive, PD-L1-positive recurrent or metastatic head and neck squamous cell carcinoma (1L r/m HNSCC).
The trial will enroll approximately 100 patients across 40 sites in Europe and Canada. Patients will be randomised to receive either abi-suva in combination with pembrolizumab or pembrolizumab alone. The primary endpoints are progression-free survival (PFS) and objective response rate (ORR). Secondary endpoints include duration of response (DOR), disease control rate (DCR), and overall survival (OS).
The Abili-T trial follows the successful completion of three prior clinical studies with abi-suva, VB-C-01, VB-C-02 and VB-C-03, which established the safety and tolerability of abi-suva as monotherapy and in combination with checkpoint inhibitors and demonstrated a strong and durable clinical effect in patients with advanced HPV16-driven cancers.
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 Abili-T trial according to the clinical trial collaboration and supply agreement between Nykode and MSD.
Disease Background and Market Opportunity
The combined incidence of HPV16-positive HNSCC in the EU and US is approximately 63,000 new cases annually and the incidence of HPV16-driven HNSCC is rising.
Despite recent advances in immuno-oncology, patients with recurrent or metastatic HNSCC continue to face a significant unmet medical need. Current standard of care achieves an objective response rate of 19% and a median overall survival of 12.3 months. The majority of treatments currently in development for HNSCC are focused on HPV-negative disease, leaving the HPV16-positive patient population particularly underserved.
Beyond HNSCC, abi-suva has the potential to address a broader HPV16-driven cancer population including cervical, anal, vulvar and penile cancers with an annual incidence of approximately 134,000 patients annually in Europe and the US. This broader opportunity is supported by the clinical data generated in the VB-C-02 trial, which demonstrated strong and durable clinical effects in advanced cervical cancer patients, and in the VB-C-01 demonstrating a promising efficacy and favorable safety profile and confirmed the induction of robust HPV16-specific T-cell responses in pre-cancerous lesions (CIN).
(Press release, Nykode Therapeutics, MAY 7, 2026, View Source [SID1234665339])