Prof Dr Bjørn Tore Gjertsen of the University of Bergen and Haukeland University Hospital in Norway gave the presentation. He is a principal investigator of both trials.

ADVANCE II

ADVANCE II, a Phase 2a trial, enrolled twenty AML patients with persistent measurable residual disease after intensive chemotherapy. All patients still in long-term follow-up have now reached five-year survival, at a median follow-up of 60 months. Vididencel-induced immune responses were associated with durable remissions in the majority of patients. There were no product-related serious adverse events, and the main side effects were transient, mild to moderate injection-site reactions.

“The completed ADVANCE II trial has demonstrated the principle of immune-mediated control of residual disease and revealed that vididencel-induced immune responses were associated with durable clinical remissions,” says Gjertsen. “Building on proof-of-concept in AML, we have now expanded the clinical development of vididencel into CML with the aim of enabling more patients to achieve successful treatment-free remissions.”

The Phase 1b VITAL-CML trial

The Phase 1b VITAL-CML trial is evaluating whether vididencel can deepen molecular responses in patients with a suboptimal response to tyrosine kinase inhibitors. Its initial safety stage of eight patients has been completed, and thirteen of a planned twenty-four patients are now enrolled. Initial data on early molecular responses are expected in Q4 2026, with topline results in mid-2027.