First patient enrolled in the AMLM22-CADENCE trial with Mendus’ product vididencel
Mendus AB ("Mendus" publ; IMMU. ST), a biopharmaceutical company focused on immunotherapies targeting tumor recurrence, today announced that the first patient has been enrolled in the AMLM22-CADENCE trial, which studies Mendus’ lead product vididencel as a novel maintenance therapy in acute myeloid leukemia (AML).
In this multi-center, randomized controlled Phase 2 trial, the Australasian Leukaemia and Lymphoma Group (ALLG) is studying vididencel as a novel AML maintenance treatment in combination with oral azacitidine (AZA), currently the only approved AML maintenance drug. In the trial, patients in first complete remission following intensive induction chemotherapy receive standard treatment with AZA or the combination of AZA + vididencel. Vididencel is administered as 4 biweekly intradermal injections, followed by 3 booster injections up to 6 months after start of treatment.
The first stage of the AMLM22-CADENCE trial will randomize 40 patients and in the second stage, efficacy of the combination will be assessed in an additional 100 patients. This trial will provide initial safety data on vididencel as add-on to current standard of care and contributes to the further expansion of the regulatory dossier.