Nykode discontinues Phase II cancer vaccine trial as it restructures its pipeline

Nykode Therapeutics will use the vaccine primarily in other HPV16-positive cancers, including advanced cervical cancer and recurrent metastatic head and neck cancer. Image credit: Getty Images / Lucy Boynton,

Nykode Therapeutics is pausing a Phase II trial of its cancer vaccine in second-line cervical cancer patients to refocus its product pipeline.

The Norwegian biopharmaceutical company will discontinue the study of VB10.16, a potentially first-off-the-shelf therapeutic DNA-based cancer vaccine candidate, for the treatment of recurrent/metastatic cervical cancer, as advances in standard of care make the study less feasible.

Phase II study C-04 (NCT06099418) is a two-arm, randomized study evaluating the efficacy and safety of VB10.16 alone or in combination with Roche's Tecentriq (atezolizumab) in patients with HPV16-positive, PD-L1-positive recurrent or metastatic cervical cancer.

Ongoing studies of the candidate in other cancers positive for human papillomavirus type 16 (HPV16), including advanced cervical cancer and recurrent metastatic head and neck cancer, will continue.

The company stated that the decision was made based on several factors, including, among others, the timing of development activities and the optimization of financial and human resources.

Michael Engsig, CEO of Nykode, said: “We remain extremely excited about the great potential of VB10.16 to significantly improve the lives of patients with HPV-related cancers. While we regret excluding second-line therapy for cervical cancer from our immediate pipeline, we are committed to advancing VB10.16 where we see the greatest likelihood of clinical efficacy and the greatest market potential.”

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According to Nykode, the decision is expected to reduce development costs for VB10.16 by more than $25 million.

VB10.16 is a potential first-in-class therapeutic DNA-based cancer vaccine candidate being developed to treat cancers positive for human papillomavirus type 16 (HPV16). The candidate works by targeting antigens to antigen-presenting cells.

Previous Phase II data (NCT04405349) for VB10.16 in patients with advanced PD-L1-positive cervical cancer in combination with atezolizumab showed a median overall survival (OS) of over 25 months, which was not reached in the two-year study. The median progression-free survival (PFS) was 6.3 months.

Nykode is also investigating the vaccine in an open-label, dose-finding Phase I/IIa study (NCT06016920) evaluating VB10.16 in combination with MSD's PD-1 inhibitor Keytruda (pembrolizumab) in patients with HPV16-positive, PD-L1-positive, recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).