Mendus AB (publ) announced Human Research Ethics Committee (HREC) approval to initiate the AMLM22-CADENCE trial, which studies Mendus' lead product vididencel as a novel maintenance therapy in acute myeloid leukemia (AML). Following positive Phase 2 monotherapy data from the ongoing ADVANCE II trial with vididencel in AML patients with measurable residual disease (MRD), Mendus announced a collaboration with the Australasian Leukaemia and Lymphoma Group (ALLG) to expand the clinical development of vididencel in December 2023. Mendus and ALLG will study vididencel as a novel AML maintenance treatment in combination with oral azacitidine (AZA), currently the only approved AML maintenance drug, in a multi-center, randomized controlled Phase 2 trial (AMLM22-CADENCE).

In the AMLM22-C ADENCE trial, patients in first complete remission following high-intensity chemotherapy will receive standard treatment with AZA or the combination of AZA + vididencel. Vididencel will be administered as 4 biweekly intradermal injections, followed by 3 booster injections up to 6 months after start of treatment. The first stage of the trial will randomize 40 patients and in the second stage, efficacy of the combination will be assessed in an additional 100 patients.

This approach will enable safety evaluations and assessment of the therapy. By the end of 2023, Mendus and ALLG had completed the preparations for the start of the trial, with the CADENCE protocol domain submitted to the Human Research Ethics Committee (H REC) within the ALLG AMLM22 platform. On March 27, 2024, Mendus and ALLG announce that HREC approval was granted, allowing for clinical site initiation and start of enrolment of the trial in April 2024.

Based on positive FDA feedback, safety data from the AML22-CADENCE trial can be used for the global registration dossier for vididencel in AML in the second half of 2025, based on trial protocol development and large-scale GMP manufacturing of vididencel.