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Sparks commentary - Mendus

Healthcare

Sparks - Mendus

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Mendus_resized
Mendus (OMX: IMMU) – VITAL-CML clears first safety hurdle
Published by Arron Aatkar, PhD

Mendus has reported a positive readout from the first stage of its Phase Ib VITAL-CML trial, with the data safety monitoring board (DSMB) identifying no safety or tolerability concerns in the eight patients who completed four doses of vididencel alongside standard tyrosine kinase inhibitor (TKI) therapy. The result clears the way for the study to progress its evaluation of whether vididencel can deepen molecular responses in suboptimal TKI responders, potentially enabling more patients to achieve treatment-free remission (TFR). VITAL-CML has enrolled 12 out of a planned 24 participants, with additional readouts expected in Q426 and initial top-line data from the full cohort targeted for mid-2027. Importantly, the positive safety assessment also enables Mendus to initiate the Phase IIa VITAL-TFR2 study in patients who have previously failed a TFR attempt, which is scheduled to start in Q426, consistent with prior guided timelines.

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