Sparks - Mendus

Mendus has initiated the Phase Ib DIVA trial, evaluating vididencel in combination with venetoclax and azacitidine (Ven+Aza) in newly diagnosed acute myeloid leukaemia (AML) patients with measurable residual disease (MRD) who are considered unfit for intensive induction chemotherapy or transplantation. The 24-patient, single-arm study is designed to confirm safety, assess immune activity and determine whether vididencel can reduce MRD following first-line Ven+Aza treatment. Strategically, DIVA aims to broaden vididencel’s post-remission positioning beyond patients treated with intensive chemotherapy, complementing the ongoing Phase IIb CADENCE study and addressing the growing population achieving remission with less-intensive regimens. A first safety readout from six patients is expected in H127, followed by initial top-line data from the full 24-patient cohort in H227, providing two clear clinical catalysts next year. If the study demonstrates that vididencel can be safely combined with Ven+Aza while driving immune activation and lowering residual disease, it would provide proof-of-concept for a broader role for the therapy across the AML post-remission setting.