Mendus is forging ahead with vididencel, its primary clinical asset, aiming to address a market niche: the acute myeloid leukaemia (AML) maintenance setting. The company is gearing up to launch the Phase II CADENCE combination trial assessing its lead cancer vaccine candidate, vididencel, in combination with oral azacitidine (Onureg), the only approved AML maintenance drug, to prevent relapse after remission for AML patients. This study is being conducted in collaboration with the Australasian Leukaemia and Lymphoma Group, leveraging Mendus's local expertise and clinical trial network. During a recent business update, management indicated that the company has received positive feedback from the FDA regarding late-stage development. Mendus expects to commence a global registrational trial in H225, with manufacturing to be guided through the alliance with NorthX Biologics and large-scale Good Manufacturing Practice (GMP) batches expected from mid-2025. The CADENCE trial is on track to start recruiting patients in April 2024.Den vollständigen Artikel lesen ...
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