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Mendus and the Australasian Leukaemia & Lymphoma Group Collaborate to Broaden Clinical Trials Investigating Vididencel as a Maintenance Treatment for AML

Thursday, December 07, 2023

Mendus AB ("Mendus" publ; IMMU.ST), a biopharmaceutical company specializing in immunotherapies for tumor recurrence, has recently disclosed a partnership with the Australasian Leukaemia & Lymphoma Group (ALLG) for the initiation of a Phase 2 clinical trial named ALLG AMLM22 CADENCE. This trial is set to assess Mendus's lead product candidate, vididencel, in combination with oral azacitidine (AZA) as a potential innovative maintenance treatment for acute myeloid leukemia (AML). Anticipating approval before the year-end, Mendus and ALLG express their gratitude for the collaboration and emphasize the significance of testing vididencel alongside the existing standard of care in AML maintenance.

Dr. Jeroen Rovers, Chief Medical Officer of Mendus, emphasizes the value of partnering with ALLG, leveraging their extensive clinical trial network and expertise, which has been pivotal in evaluating various AML therapies, including oral AZA.

Professor Dr. Andrew Wei, Head of the Acute Myeloid Leukemia program at the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, underscores the potential of novel and minimally toxic approaches to enhance the efficacy of maintenance therapy in improving clinical outcomes for AML patients. The ongoing ADVANCE II study has indicated vididencel's safety, tolerability, and its potential as a therapeutic candidate for patients in first remission.

The ALLG AMLM22 CADENCE trial is planned as an adaptive, randomized, multi-center Phase 2 trial with two stages. The first stage will focus on assessing the safety of vididencel in combination with AZA in 40 patients, while the second stage will evaluate the combination's efficacy in an additional 100 patients. Vididencel will be administered through biweekly intradermal injections, followed by three booster injections up to six months after the initiation of treatment.

Preparations for the CADENCE trial, submitted to the central ethical committee of participating hospitals, have been completed. Once approved, the trial will open for enrollment. An update on the ongoing ADVANCE II monotherapy Phase 2 trial of vididencel as a maintenance treatment for AML patients with measurable residual disease (MRD) is anticipated to be presented at the American Society of Hematology Conference (ASH 2023).



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