Nykode Therapeutics Highlights Robust Immunogenicity and Promising Clinical Activity for Abi-Suva at ICHNO 2026

20 Mar 2026 14:45 CET

• Encouraging preliminary efficacy was observed, with a confirmed ORR of 38.5%
(5 out of 13 PD-L1-positive patients) compared to 19.1% in the reported
historical control with standard of care (pembrolizumab monotherapy) in a
comparable first-line setting. In patients with high PD-L1 expression (CPS ≥
20), the ORR was 50.0% (3 out of 6 patients) compared to historical 23.3%.

• The overall disease control rate (DCR) was 69.2% (vs. 47.1% in the historical
control). In patients with high PD-L1 expression (CPS ≥ 20), the DCR was 100.0%
(vs. 53.4% in the historical control).

• Robust immunogenicity was demonstrated, with 100% of evaluable patients in the
6 mg and 9 mg cohorts showing HPV-16 specific T cell responses.

• The combination showed a favorable safety profile, with all abi-suva dose
levels safety cleared and only transient, manageable Grade 1–2 adverse events,
and with no treatment discontinuations or fever.

• Safety data and dose regimen are superior to recent competitor data together
with a strong efficacy profile; the data builds a strong foundation leading into
the Abili-T trial with anticipated first patient dose in the first half of 2026.


Oslo, Norway, March 20, 2026 – Nykode Therapeutics ASA (OSE: NYKD), a clinical
stage biopharmaceutical company dedicated to the discovery and development of
novel immunotherapies, today announced 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.

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:
https://nykode.com/research-and-development/scientific-papers-and-presentations/

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.


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

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