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IndustriBioteknik
Nykode Therapeutics är verksamt inom bioteknik. Bolaget är specialiserat inom forskning och utveckling av immunologiska terapier och vacciner. Lösningarna används huvudsakligen för behandling av patienter med cancersjukdomar samt övriga allvarliga hälsotillstånd som kräver långsiktig behandling. Störst verksamhet återfinns runtom den europeiska marknaden.

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NYKD: 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

2026-10-23 08:00:00
-	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

Nykode Therapeutics ASA
Oslo Science Park
Gaustadalléen 21
N-0349 Oslo, Norway
looking statements.\
\
Contact for Nykode Therapeutics ASA:\
IR@nykode.com\
\
Nykode Therapeutics ASA\
Oslo Science Park\
Gaustadalléen 21\
N-0349 Oslo\, Norway\