The DIVA trial will evaluate vididencel as an immunotherapy in newly diagnosed AML patients treated with venetoclax and azacitidine (Ven+Aza). The trial is part of the updated clinical strategy communicated in the second half of 2025, which aims to position vididencel broadly as a post-remission therapy in AML to enable durable clinical remissions and improve long-term survival. The agreement with ONJCRI marks the formal start of the DIVA trial preparations, for which ONJCRI will act as sponsor and coordinator.

Mendus is currently studying vididencel in AML patients who have undergone intensive chemotherapy (IC), in the ADVANCE II single-agent Phase 2a trial and the AMLM22-CADENCE Phase 2b combination trial with oral azacitidine. To address the growing patient population treated with less intensive first-line therapy comprising Ven+Aza, Mendus is preparing the DIVA Phase 1b trial to evaluate vididencel as an immunotherapy in newly diagnosed AML patients who are ineligible for IC.

In elderly patients unfit for intensive chemotherapy, Ven+Aza has demonstrated significant improvements in overall survival compared to Aza alone. In addition, growing clinical evidence suggests favorable treatment outcomes with Ven+Aza versus IC in newly diagnosed fit AML patients, supporting adoption of Ven+Aza as a first-line treatment across AML patient populations. Safety and feasibility data from the DIVA trial will allow Mendus to position vididencel broadly in the evolving first-line treatment landscape driven by the clinical success of Ven+Aza. These data, combined with data from the ongoing trials in the post-IC setting and the evolution of the AML treatment landscape, will inform the optimal registration trial for vididencel.

The Phase 1b DIVA trial will enroll 24 patients and evaluate vididencel as a post-remission immunotherapy in newly diagnosed patients with AML treated with Ven+Aza. The trial will be conducted in Australia, where Mendus operates via its local subsidiary, Mendus Australia Pty Ltd, enabling access to attractive R&D tax incentives. The trial will be led by Prof. Andrew Wei (Peter MacCallum Cancer Centre, Melbourne, Australia), who also acts as principal investigator of the AMLM22-CADENCE trial sponsored by the Australasian Leukaemia and Lymphoma Group (ALLG). The DIVA trial is planned to commence mid-2026.