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Est. tid*
2027-02-24 07:00 Bokslutskommuniké 2026
2026-11-25 07:00 Kvartalsrapport 2026-Q3
2026-08-26 07:00 Kvartalsrapport 2026-Q2
2026-05-27 07:00 Kvartalsrapport 2026-Q1
2026-05-15 N/A X-dag ordinarie utdelning NYKD 0.00 NOK
2026-05-13 N/A Årsstämma
2026-02-25 - Bokslutskommuniké 2025
2026-01-21 - Extra Bolagsstämma 2026
2025-11-24 - Kvartalsrapport 2025-Q3
2025-08-27 - Kvartalsrapport 2025-Q2
2025-05-28 - Kvartalsrapport 2025-Q1
2025-05-27 - X-dag ordinarie utdelning NYKD 1.00 NOK
2025-05-26 - Årsstämma
2025-04-23 - Extra Bolagsstämma 2025
2025-02-26 - Bokslutskommuniké 2024
2024-11-27 - Kvartalsrapport 2024-Q3
2024-08-21 - Kvartalsrapport 2024-Q2
2024-05-21 - X-dag ordinarie utdelning NYKD 0.00 NOK
2024-05-16 - Årsstämma
2024-05-14 - Kvartalsrapport 2024-Q1
2024-02-28 - Bokslutskommuniké 2023
2023-11-15 - Kvartalsrapport 2023-Q3
2023-08-23 - Kvartalsrapport 2023-Q2
2023-05-16 - Kvartalsrapport 2023-Q1
2023-05-12 - X-dag ordinarie utdelning NYKD 0.00 NOK
2023-05-11 - Årsstämma
2023-02-28 - Bokslutskommuniké 2022
2022-11-23 - Kvartalsrapport 2022-Q3
2022-08-24 - Kvartalsrapport 2022-Q2
2022-05-16 - Kvartalsrapport 2022-Q1
2022-05-13 - X-dag ordinarie utdelning NYKD 0.00 NOK
2022-05-12 - Årsstämma
2022-03-31 - Bokslutskommuniké 2021
2021-12-22 - Extra Bolagsstämma 2021
2021-11-17 - Kvartalsrapport 2021-Q3
2021-08-26 - Kvartalsrapport 2021-Q2
2021-05-12 - Kvartalsrapport 2021-Q1
2021-05-06 - X-dag ordinarie utdelning NYKD 0.00 NOK
2021-05-05 - Årsstämma
2021-04-21 - Bokslutskommuniké 2020
2020-11-17 - Kvartalsrapport 2020-Q3
2020-08-27 - Kvartalsrapport 2020-Q2
2020-07-07 - Split NYKD 1:5
2020-07-06 - Extra Bolagsstämma
2020-05-12 - Kvartalsrapport 2020-Q1
2020-04-22 - Extra Bolagsstämma

Beskrivning

LandNorge
ListaOslo Bors
SektorHälsovård
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 inom den europeiska marknaden.

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2026-05-07 13:54:51
Oslo, Norway, May 7, 2026 - Nykode Therapeutics ASA (OSE: NYKD), a clinical
stage biopharmaceutical company dedicated to the discovery and development of
novel immunotherapies, today confirmed 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-PD-1 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).

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).


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