Updated results from the European ADVANCE II Phase 2 trial continue to demonstrate robust relapse-free and overall survival benefit in a high-risk AML population, based on the presence of persistent measurable residual disease (MRD) following IC. At a median follow-up of 55 months, 13 out of 20 patients treated with vididencel were still alive, with 8 patients having passed 5-year follow-up and estimated 5-year overall survival standing at 63%. Immunological data tracked with survival and no associations with tumor genetics were observed, confirming that vididencel acts as an active immunotherapy against residual disease across different subtypes of AML. The poster presented at ASH is available on the Mendus website, please visit this link.

Vididencel is currently being studied in combination with oral azacitidine to improve relapse-free and overall survival for patients with or without MRD following IC in the ongoing Australian AMLM22-CADENCE randomized Phase 2b trial, led by Prof. Andrew Wei (Peter MacCallum Cancer Center, Melbourne, Australia). Based on the registration trial for oral azacitidine, the overall 5-year survival for this patient population is below 30% (26.5% for oral aza versus 20.1% for placebo 1). The study design of the trial was presented at ASH by the Australasian Leukaemia and Lymphoma Group, as the sponsor of the trial.
1Wei et al., Am J Hematol. (2023); 98:E84–E87

For elderly patients unfit for IC, the introduction of venetoclax in combination with azacitidine has led to significant improvements in overall survival versus azacitidine alone in this patient population. At ASH, data were presented from the pivotal randomized PARADIGM trial 2<, comparing ven+aza with conventional IC in newly diagnosed fit adults with AML. The favorable outcomes reported for ven+aza over IC in this fit patient population are expected to support a wider use of ven+aza as first-line treatment in AML. Mendus is therefore preparing the DIVA Phase 1b combination trial, which will study safety and feasibility of vididencel in combination with ven+aza to address this growing patient population. The DIVA trial will also be led by Prof. Wei and is anticipated to start in the first half of 2026.
2Fathi et al., Blood (2025) 146 (Supplement 1): 6.

“Increasing clinical evidence supports the expanding use of ven-aza to treat newly diagnosed fit adults with AML, particularly with release of the provocative data from the PARADIGM trial presented at ASH this year”, said Prof. Andrew Wei. “We therefore look forward to studying vididencel immunotherapy in patients treated with ven-aza, next to the ongoing combination trial with oral aza in the post-IC setting.”

Mendus had previously communicated its updated clinical strategy, aimed at further expanding the addressable patient population in the AML treatment landscape and with chronic myeloid leukemia (CML) as a new indication.

“The continued strong proof-of-concept data of the ADVANCE II trial presented at ASH confirm the potential of vididencel as a safe, efficacious and broadly applicable active immunotherapy in AML,” said Mendus Chief Medical and Scientific Officer, Prof. Tariq Mughal. “The evolution of first-line treatment of AML, driven by the clinical success of ven-aza, is now also an integral part of our development strategy. This will allow us to define the optimal go-to-market strategy and global registration trial for vididencel in AML, while we are entering CML as an additional indication. These steps will significantly expand the addressable patient population and market potential for vididencel.”

About vididencel
Vididencel is an off-the-shelf, active immunotherapy designed to stimulate immune control of residual disease and improve disease-fee and overall survival following first-line treatment of tumors with a high recurrence rate. In clinical trials, vididencel treatment was safe, tolerable and associated with durable clinical remissions in high-risk acute myeloid leukemia (AML). Vididencel comprises irradiated leukemic-derived dendritic cells that are administered via simple intradermal injection. The product is manufactured using a proprietary cell line and scalable manufacturing process, which does not require patient material or genetic engineering. Vididencel has a strong regulatory dossier, including an EMA ATMP manufacturing certificate, Orphan Drug Designation (US + EU) and Fast Track Designation (US). Based on positive proof-of-concept data demonstrating that vididencel acts as an active immunotherapy in AML, Mendus is developing vididencel as a broadly applicable immunotherapy in AML and chronic myeloid leukemia (CML).