Mendus AB announced that the company has entered into a collaboration with the Australasian Leukaemia & Lymphoma Group (ALLG) to conduct a Phase 2 clinical trial, ALLG AMLM22 CADENCE, evaluating its lead product candidate vididencel in combination with oral azacitidine (AZA) as a potential novel maintenance treatment in acute myeloid leukemia (AML). Mendus and ALLG expect to obtain all approvals required for the start of the CADENCE trial before the year-end. Mendus and ALLG plan to initiate the ALLG AMLM22 CADence trial as an adaptive, randomized, multi-center Phase 2 trial consisting of two stages, which will evaluate vididencel in combination With AZA in 40 patients randomized to either receive vididencel + AZA or AZA alone.

In the second stage, the efficacy of the combination will be assessed in an additional 100 patients. Vididencel will be administered as four biweekly intraradermal injections, followed by 3 booster injections up to 6 months after start of treatment. Mendus and ALLG have completed the preparations for the start of the CADence trial in the ALLG AMLM22 adaptive platform, with the CADENCE protocol domain submitted to the central ethical committee of participating hospitals.

Upon committee approval, the trial will be open for enrolment. An update of the currently ongoing ADVANCE II monotherapy Phase 2 trial evaluating vididencel as a maintenance treatment for AML patients with measurable residual disease (MRD) will be presented at the American Society of Hematology Conference (ASH 2023).