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Transforming immunotherapy for myeloid blood cancers

Growing evidence from completed and ongoing trials indicates that vididencel stimulates the immune system in a unique way, leading to broad tumor-directed immune responses and improved immune competence. This may be the key to resolving the main therapeutic challenges in acute myeloid leukemia (AML) and chronic myeloid leukemia (CML). A series of anticipated clinical milestones will further validate the use of vididencel in myeloid blood cancers.

The recently completed ADVANCE II Phase 2a trial delivered proof-of-concept that vididencel acts as an immunotherapy against measurable residual disease (MRD) and is associated with durable survival in AML. In the ongoing randomized Phase 2b CADENCE trial, vididencel is combined with oral azacitidine (Aza), an approved AML maintenance drug. Initial immunological data collected from the CADENCE trial demonstrated immune activation and improved immune competence in the vididencel treatment arm, in line with observations from the ADVANCE II trial. In September, Mendus announced the initiation of the Phase 1b DIVA trial evaluating vididencel in newly diagnosed AML-patients with measurable residual disease following less-intensive first-line treatment consisting of venetoclax and azacitidine (Ven+Aza). The next read-out from the first 20 patients in the CADENCE trial is expected in H1 2027, whereas topline data from the DIVA trial are expected H2 2027. The goal of these two trials is to position vididencel broadly as a post-remission immunotherapy across the first-line treatment landscape and define the optimal path to market in AML.

In CML, the primary objective of vididencel treatment is to support treatment-free remission (TFR), allowing patients to safely and successfully stop daily treatment with tyrosine kinase inhibitors (TKIs). Mendus reported a positive read-out from the first safety and tolerability stage of the VITAL-CML Phase 1b trial, following review by the Data Safety Monitoring Board (DSMB). The DSMB concluded that the combination of vididencel and tyrosine kinase inhibitor (TKI) treatment in chronic-phase CML raised no safety or tolerability concerns, supporting continuation of the trial. The VITAL-CML trial will evaluate whether vididencel can stimulate immune-mediated disease control and enable chronic-phase CML patients with suboptimal TKI responses to reach sustained deep molecular responses (DMR) and become eligible for TFR. Topline data from the trial are expected in mid-2027.

The positive VITAL-CML safety data also allow us to proceed with the VITAL-TFR2 Phase 2a trial, which is focused on establishing TFR success in patients who previously experienced a failed TFR attempt due to relapse. To support the trial, Mendus entered a collaboration with the South Australian Health and Medical Research Institute (SAHMRI), a leading Australian medical research institute, with the aim to start the trial in Q4 2026.

With a robust basis from completed trials, initial promising data from ongoing trials and a rich pipeline with multiple near-term read-outs, vididencel is optimally positioned to deliver clinical benefit and maximize commercial value. With gratitude towards our clinical collaborators and patients participating, we look forward to keeping our stakeholders informed of the progress across our clinical pipeline as we pursue our mission to transform immunotherapy for myeloid blood cancers.

Erik Manting, Ph.D.
Chief Executive Officer

*Published on November 11th 2026