Mendus has announced the initiation of the Phase 1b DIVA trial evaluating vididencel in combination with venetoclax and azacitidine in patients with newly diagnosed acute myeloid leukemia (AML).
The study will focus on patients with measurable residual disease (MRD) following first-line treatment with venetoclax plus azacitidine (Ven+Aza) who are considered unsuitable for intensive induction chemotherapy. According to Mendus, preparations for the study have been completed, and all required regulatory approvals have been obtained.
The trial is led by Professor Andrew Wei at the Peter MacCallum Cancer Centre in Melbourne, Australia, and is supported by the Olivia Newton-John Cancer Research Institute (ONJCRI). Mendus agreed with ONJCRI earlier in 2026 to support the development and execution of the study.
The DIVA Trial
DIVA, short for Dendritic cell Immune activation combined with Venetoclax and Azacitidine, is a single-arm Phase 1b study expected to enroll 24 patients.
Eligible participants will have newly diagnosed, transplant-ineligible, MRD-positive AML and be in first complete remission (CR1) or a partial form of complete remission, including CRh or CRi, within 120 days of starting venetoclax plus azacitidine.
The study’s primary objectives include:
- evaluating the safety of adding vididencel to Ven+Aza
- assessing immune activity associated with vididencel treatment; and
- determining whether treatment can reduce measurable residual disease.
The first safety analysis involving 6 patients is expected in the first half of 2027, while initial topline results from the full 24-patient cohort are anticipated in the second half of 2027.
Expanding Vididencel’s Role in AML
Vididencel is an investigational active immunotherapy designed to stimulate immune-mediated control of residual cancer cells following first-line AML treatment.
Mendus is developing the therapy as a post-remission immunotherapy to target residual disease that may contribute to subsequent relapse. The DIVA study expands this development strategy to patients achieving remission after less-intensive Ven+Aza therapy rather than intensive induction chemotherapy.
Tariq Mughal, Chief Medical and Scientific Officer at Mendus, highlighted the challenge posed by leukemia stem and progenitor cells that can persist after treatment:
“A major challenge in the treatment of AML is the elimination of leukemia stem and progenitor cells.”
Mendus said the study is intended to explore whether immune activation with vididencel can help address residual disease and reduce the risk of AML relapse.
Vididencel Across the AML Treatment Landscape
The DIVA trial complements Mendus’ ongoing AMLM22-CADENCE Phase 2b trial, which is also led by Professor Wei. CADENCE is evaluating vididencel in combination with oral azacitidine following intensive chemotherapy, including patients regardless of MRD status.
Earlier Phase 2 development of vididencel in the ADVANCE II trial evaluated the immunotherapy in patients with AML and persistent MRD after intensive treatment. Mendus has reported durable remissions associated with vididencel-induced immune responses in that study.
By studying vididencel following both intensive chemotherapy and venetoclax-based first-line therapy, Mendus is seeking to broaden its potential role as a post-remission treatment across different AML patient populations.
Vididencel has received Orphan Drug Designation in both the United States and the European Union, as well as FDA Fast Track Designation.
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