Sparks - Mendus

Mendus has presented updated five-year follow-up from the completed Phase IIa ADVANCE II trial of vididencel in measurable residual disease (MRD) positive acute myeloid leukaemia (AML), alongside an update on the ongoing Phase Ib VITAL-CML study. All ADVANCE II patients remaining in long-term follow-up have now reached five-year survival, with median follow-up extending to 60 months. Translational analyses continue to support vididencel’s proposed mode of action, with immune-cell clustering at injection sites confirming local immune activation that translated into systemic immune responses associated with durable clinical remissions. The safety profile also remains favourable, with no product-related serious adverse events reported and treatment-related effects primarily comprising transient, mild to moderate injection-site reactions.

In chronic myeloid leukaemia (CML), VITAL-CML enrolment has reached 13 of the planned 24 patients (versus 12/24 reported in September), following successful completion of the initial eight-patient safety and tolerability stage. No new efficacy data were disclosed, with initial early molecular response data still expected in Q426 and top-line results from the full cohort anticipated in mid-2027. Preclinical work presented alongside the clinical update showed that vididencel stimulated CML-directed immune responses and was compatible with standard-of-care tyrosine kinase inhibitors.

Overall, the update is incrementally supportive of Mendus’s clinical strategy for vididencel, reinforcing the durability and mechanistic evidence established in AML, while VITAL-CML continues to progress towards its first molecular response readout.