On October 23, 2026 Nykode Therapeutics ASA (OSE: NYKD), a clinical stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported a trial-in-progress e-Poster highlighting the design and clinical rationale of its randomized Phase 2 Abili-T trial evaluating its lead cancer vaccine candidate, abi-suva (formerly VB10.16) with interim data expected in 2027. The e-Poster will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026, held 23 to 27 October in Madrid, Spain.

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Abili-T (NCT06016920) is an open-label, randomized Phase 2 trial of abi-suva, Nykode’s DNA-based therapeutic cancer vaccine targeting the HPV16 E6 and E7 oncoproteins, in combination with pembrolizumab 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).

The trial will enroll approximately 100 patients across approx. 50 sites in Europe and Canada. Patients will be randomized 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). Exploratory endpoints include immunogenicity and circulating tumor DNA (ctDNA) kinetics.

The randomized Abili-T trial represents an important step in the development of Nykode’s lead program, abi-suva, building on encouraging results from the earlier trials and the differentiated design of Nykode’s therapeutic cancer vaccine platform. Unlike mRNA-based HPV16 vaccine candidates, abi-suva utilizes a DNA-based approach incorporating Nykode’s proprietary antigen-presenting cell (APC)-targeting technology, designed to direct HPV16 E6 and E7 antigens to APCs and stimulate strong, durable HPV16-specific T-cell responses. In the Phase 1 VB-C-03 study abi-suva combined with pembrolizumab demonstrated a confirmed ORR of 38.5% in 13 patients 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 study also demonstrated rapid, strong and durable HPV16-specific T-cell responses. These findings support the rationale for Abili-T, which will evaluate whether adding abi-suva to pembrolizumab improves clinical outcomes compared with pembrolizumab alone.

The protocol has been approved by 8 European regulatory authorities (Norway, France, Spain, Hungary, Poland, Czech, UK and Germany) and was recently approved in Canada. The first patient was dosed in Poland in May 2026, and enrolment has since expanded across additional sites in the UK, Spain, France and Germany.

"Abi-suva is our lead clinical program, and Abili-T is a critical step in establishing its potential to improve treatment outcomes for patients with HPV16-driven head and neck cancer. With the recent approval of the study protocol in Canada we are adding a very important country to the trial," said Michael Engsig, Chief Executive Officer of Nykode Therapeutics. "While checkpoint inhibitors have transformed cancer treatment, too many patients still do not respond. Our earlier clinical findings with abi-suva have been encouraging, and Abili-T is designed to build on those results by evaluating whether our targeted cancer vaccine can enhance the benefit of pembrolizumab. Presenting the trial design at ESMO (Free ESMO Whitepaper) provides an important opportunity to engage with the oncology community as we advance this program toward its first interim efficacy readout in 2027."

Presentation details:

● Title: Abili-T: A phase 2 randomized clinical trial evaluating the therapeutic cancer vaccine abipapogene suvaplasmid in combination with pembrolizumab versus pembrolizumab for first line treatment of patients with HPV16+ PD-L1+ unresectable recurrent or metastatic oropharyngeal cancer
● Presenter: Dr. Åse Bratland, Oslo University Hospital, Norway
● Abstract/Publication number: 1675eTiP
● Date: October 23, 2026

(Press release, Nykode Therapeutics, OCT 23, 2026, View Source [SID1234673714])