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2026-02-24 11:45:00
o Anti-tumor activity was observed with a final confirmed objective response
rate (ORR) of 38.5%.
o The data demonstrates that abi-suva elicits rapid, strong and durable
HPV16-specific T cell responses. Robust and durable T cell expansion in the
circulation was also confirmed by TCR sequencing.
o All tested doses of abi-suva in combination with pembrolizumab were well
tolerated and showed a favorable safety profile.
o Oral presentation at ICHNO on March 20, 2026.
Oslo, Norway, February 24, 2026 - Nykode Therapeutics ASA (OSE: NYKD), a
clinical-stage biopharmaceutical company dedicated to the discovery and
development of novel immunotherapies, today announces data from the phase 1
dose-escalation part of the VB-C-03 trial (N=13). The data will be further
elaborated at an oral presentation by Dr. Caroline Even, Institut Gustave
Roussy, Villejuif (Paris) at the 10th International Congress on Innovative
Approaches in Head & Neck Oncology (ICHNO) on March 20, 2026. A full abstract is
expected to be published by ICHNO before the congress.
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 1st
line unresectable recurrent or metastatic oropharyngeal head and neck cancer
patients (NCT06016920). Nykode is further advancing abi-suva development in 1st
line head and neck cancer through the Abili-T phase 2 randomized clinical trial.
The phase 1 VB-C-03 data show that anti-tumor activity was observed with a final
confirmed objective response rate (ORR) of 38.5%. The data demonstrates that
abi-suva elicits rapid, strong and durable HPV16-specific T cell responses.
Robust and durable T cell expansion in the circulation was also confirmed by TCR
sequencing. The data also demonstrate that all tested doses of abi-suva in
combination with pembrolizumab were well tolerated and showed a favorable safety
profile.
Michael Engsig, Chief Executive Officer of Nykode, commented: "The objective
response rate of 38.5% for the combination treatment compared to historical 19%
of standard of care gives us confidence in abi-suva heading into the Abili-T
trial which is investigating the same regiment in a randomized controlled
setting. This is the third trial for abi-suva indicating effect across three
different patient groups including both head and neck as well as cervical
cancer."
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 head and neck
cancer. 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