Nykode Therapeutics to Present Trial-in-Progress Poster Highlighting the Design of the Phase 2 Abili-T Trial of Lead Cancer Vaccine Abi-Suva at ESMO Congress 2026
- Abili-T trial progressing well, on track for first interim data expected in 2027 - Study approved in Canada
Oslo, Norway, October 23, 2026 - Nykode Therapeutics ASA (OSE: NYKD), a clinical stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, today announced 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) Congress 2026, held 23 to 27 October in Madrid, Spain.
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 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
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
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