Mendus announces initial immunological data from CADENCE and VITAL-CML indicating vididencel improves immune competence across indications

• Vididencel-induced immune responses activate multiple compartments of the immune system based on initial samples from the ongoing CADENCE and VITAL-CML trials

• The data are consistent with earlier observations from the completed ADVANCE II and ALISON trials, indicating vididencel improves immune competence across indications

Mendus AB ("Mendus" publ; IMMU.ST), a biopharmaceutical company focused on immunotherapies for myeloid blood cancers, today announced the initial immune data based on samples collected in the ongoing CADENCE and VITAL-CML trials. The data indicate vididencel improves immune competence across indications.

“We are encouraged by the initial immunological data collected from the ongoing CADENCE and VITAL-CML trials, which confirm the observations from the completed ADVANCE II trial in acute myeloid leukemia and ALISON trial in ovarian cancer”, said Mendus CEO Erik Manting. “The data suggests that vididencel modulates multiple compartments of the immune system and improves immune competence, which may be relevant to control residual disease. Longer-term follow-up of the ongoing trials will be required to assess the effect of vididencel treatment on disease, with multiple read-outs expected in 2027.”

The AMLM22-CADENCE (CADENCE) trial (N=40) is an ongoing randomized Phase 2b combination trial with oral azacitidine (oral-Aza), an approved drug for maintenance therapy following high-intensity chemotherapy in newly diagnosed acute myeloid leukemia (AML). Analysis of samples collected from 13 patients (7 in the vididencel+oral-Aza and 6 in the oral-Aza arm) revealed that patients treated with vididencel had a better preserved CD8+ effector/CD4+ helper T cell ratio and demonstrated a downward trend in regulatory (suppressor) T cells. Levels of LAG3+ (exhausted) T cells also went down, whereas there was an upward trend in memory B cells and memory NK cells, which have been associated with improved survival in AML. Combined, the data confirm that vididencel improves immune competence in a randomized trial setting. The CADENCE trial data will be presented by the principal investigator, Dr Victoria Ling, during the Scientific Meeting of the Australasian Leukaemia and Lymphoma Group (ALLG) held November 10-13. A first read-out (N=20) to determine whether vididencel added to oral-Aza in AML maintenance reduces risk of disease progression compared to oral-Aza alone is expected H1 2027.

The VITAL-CML Phase 1b trial (N=24) studies vididencel in patients with a suboptimal response to standard-of-care treatment with tyrosine kinase inhibitors (TKIs). Immune data based on samples collected from 7 evaluable patients showed an initial encouraging trend in select immunological markers for regulatory T cells, NK cells and specific T cell subsets. A sustained deepening of molecular disease based on BCR::ABL1 levels in the blood was not yet apparent in in the trajectories shown (~8–18 weeks, unequal follow-up), with one patient showing a trend toward deep molecular response (DMR) in the last sample collected at week 18. Longer follow-up will be needed to establish a potential immune effect on molecular disease following vididencel treatment in this specific patient population. Topline data are expected in mid-2027. Mendus had previously communicated successful completion of the safety and tolerability stage of the VITAL-CML trial and start of preparations for the VITAL-TFR2 trial that will evaluate vididencel to support treatment-free remission (TFR) in patients with a previously failed TFR attempt. Mendus and academic collaborators from the Bergen University Hospital will present the initial immune data from the VITAL-CML trial during the 68^th American Society of Hematology conference. The abstract titled “Single-cell immune and signaling profiling of vididencel immunotherapy in chronic phase CML” will be presented during Poster Session 631: Myeloproliferative Syndromes and Chronic Myeloid Leukemia: Basic and Translational, held 6-8pm CST on December 13, 2026.