Nykode Therapeutics is halting a Phase II trial of its cancer vaccine in patients with second-line cervical cancer as it repositions its pipeline aspirations.

The Norwegian biopharma will stop the trial of VB10.16, a potentially first-in-class off-the-shelf therapeutic DNA-based cancer vaccine candidate, in recurrent/metastatic cervical cancer due to advancements in the standard of care that makes the study less viable.

The Phase II C-04 trial (NCT06099418) is a two-arm, randomised trial 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.

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

The company said it has made the decision based on several factors including timing of development activities and optimisation of financial and human resources, among others.

Nykode CEO Michael Engsig said: “We remain highly enthusiastic about the broad potential of VB10.16 to make a meaningful difference in the lives of patients with HPV-driven cancers. While we regret the impact of excluding second-line cervical cancer from our immediate pipeline, we are eager to advance VB10.16 where we see the highest likelihood of clinical efficacy and the greatest market potential.”

Nykode states the decision is expected to reduce the VB10.16 development costs by more than $25m.

VB10.16 is a potentially first-in-class off-the-shelf therapeutic DNA-based cancer vaccine candidate in development for the treatment of human papillomavirus type 16 (HPV16)-positive cancers. The candidate acts by targeting antigens to antigen-presenting cells.

Previous Phase II data (NCT04405349) for VB10.16 in advanced PD-L1 positive cervical cancer patients in combination with atezolizumab saw median overall survival (OS) exceed 25 months having not been reached in the two-year study. Median progression-free survival (PFS) was 6.3 months.

Nykode is also investigating the vaccine in an open-label, dose-finding Phase I/IIa trial (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).