The combination therapy failed to achieve the efficacy threshold required to advance to stage II.

CV301 is Bavarian Nordic’s cancer immunotherapy candidate, while atezolizumab is a checkpoint inhibitor being developed by Roche.

Stage I of the Phase II trial, which was sponsored by Bavarian Nordic, was performed in 27 patients across two cohorts. The first cohort assessed the combination as first-line treatment in urothelial bladder cancer patients who cannot receive cisplatin-containing chemotherapy.

The second cohort involved second-line therapy of participants who received prior cisplatin-based chemotherapy treatments.

Though clinical efficacy was observed in multiple participants, both cohorts did not meet the pre-defined clinical efficacy criteria to expand patient recruitment into stage II.

Bavarian Nordic president and CEO Paul Chaplin said: “While the results of this study are disappointing, they contribute to our overall understanding of our platform and provide important learnings to refine our approach to equip the body’s immune system with more weapons to fight cancer from within.”

The company is studying a combination of CV301 and checkpoint inhibitors in investigator-sponsored Phase II studies for colorectal and pancreatic cancers.

Bavarian Nordic also announced plans to focus on the development of its BN-Brachyury vaccine candidate, along with its new immuno-oncology strategy of intravenous and intratumoral administration.

BN-Brachyury is undergoing a Phase II trial for advanced chordoma. The company noted that the first stage of this trial demonstrated clinical activity, which in turn facilitated expanded enrolment.

Final results from the trial are expected to be available by late next year.

Bavarian Nordic is also planning for a separate trial of an intravenous formulation of BN-Brachyury.