Mendus has entered into a collaboration with the Australasian Leukaemia & Lymphoma Group (ALLG) to conduct a Phase 2 clinical trial, 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.
“We are grateful to work together with ALLG to set up a randomized clinical trial testing vididencel in combination with current standard of care in AML maintenance,” says Jeroen Rovers, Chief Medical Officer of Mendus. “Mendus will benefit from ALLG’s vast expertise and extensive clinical trial network, which has played an integral role in the clinical evaluation of several therapies to improve clinical outcomes in AML at large, including oral AZA as the current standard of care in AML maintenance.”
The ALLG AMLM22 CADENCE trial
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 oral AZA as a maintenance therapy in AML. The first stage of the study will assess the safety of 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 intradermal 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.
Photo of Jeroen Rovers
