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2022-02-11 06:45:00
  • Nykode Therapeutics has reached the enrollment target of 50 patients in its VB C-02 trial for the treatment of advanced cervical cancer
  • Interim efficacy and safety data expected in 1H 2022

OSLO, Norway, Feb. 11, 2022 (GLOBE NEWSWIRE) -- Nykode Therapeutics AS (Euronext Growth (Oslo): NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of vaccines and novel immunotherapies, today announced the completion of patient enrollment in the Phase 2 study of VB10.16, Nykode’s lead cancer vaccine candidate, in combination with Roche’s checkpoint inhibitor atezolizumab for the treatment of advanced cervical cancer. VB10.16 is a potentially first-in-class off-the-shelf therapeutic HPV16 cancer vaccine designed to induce strong HPV16 specific T cell responses for the treatment of HPV16-positive cancers.

“We are pleased to report the completion of patient enrollment in our ongoing Phase 2 trial of VB10.16, our wholly owned product candidate for the treatment of cervical cancer,” said Michael Engsig, CEO of Nykode Therapeutics. “This is an important inflection point for Nykode as we advance our lead candidate through the clinic. After successfully enrolling 50 patients across trial sites in six countries, we look forward to reporting interim efficacy and safety data from the first patients in the first half of 2022. In parallel, we are exploring the possibility of evaluating VB10.16 in other HPV-driven cancers, including head and neck cancer.”

VB C-02 is a multi-center, open-label Phase 2 trial of patients with advanced or recurrent, non-resectable HPV16-positive cervical cancer. Almost 20 European sites in six European countries were engaged in enrolling patients in the trial. Nykode has previously reported positive interim safety data from the trial.

Siri Torhaug, Chief Medical Officer of Nykode Therapeutics, commented: “Cervical cancer is a leading cause of death for women. It is an indication which continues to have a high unmet medical need with limited response to standard of care treatment in an advanced setting. We are very happy to have reached this important milestone for our lead cancer vaccine VB10.16 and look forward to continuing the development program. We are thankful for the patients, their families, the investigators and the trial site personnel who have made this trial possible.”

Additional information about the Phase 2 trial is available at clinicaltrials.gov (NCT04405349).

Nykode Therapeutics
Nykode Therapeutics is a clinical-stage biopharmaceutical company dedicated to the discovery and development of vaccines and novel immunotherapies for the treatment of cancer and infectious diseases. Nykode’s modular vaccine technology specifically targets antigens to Antigen Presenting Cells, which are essential for inducing rapid, strong and long-lasting antigen specific immune responses and eliciting efficacious clinical responses.

Nykode’s lead product candidates are VB10.16, a therapeutic vaccine for the treatment of human papilloma virus 16 induced malignancies which is in Phase 2 for the treatment of cervical cancer; and VB10.NEO, a cancer neoantigen vaccine, which is exclusively out licensed to Genentech and is in Phase 1b for the treatment of locally advanced and metastatic tumors and Phase 1/2a for the treatment of melanoma, lung-, head and neck, renal-, and bladder cancer. Additionally, Nykode has initiated a Phase 1/2 trial in 2021 with its two next-generation COVID-19 vaccine candidates.

The Company has collaborations with Roche, Genentech and Nektar Therapeutics within oncology, a multi-target collaboration with Regeneron within oncology and infectious diseases and a collaboration with Adaptive Biotechnologies for COVID-19 T cell vaccine development.

Nykode Therapeutics’ shares are traded on Euronext Growth (Oslo), a trading platform operated by Euronext, the leading Pan-European market infrastructure. The ticker code is NYKD. Further information about Nykode Therapeutics may be found at http://www.nykode.com.

Contact for Nykode Therapeutics AS:

CEO Michael Engsig
Nykode Therapeutics AS

Nykode Therapeutics AS

Oslo Science Park
Gaustadalléen 21
N-0349 Oslo, Norway

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.