Mendus has announced the launch of its chronic myeloid leukaemia (CML) programme for lead immunotherapy candidate, vididencel.
Preparations have been completed and regulatory clearance has been received for the Phase I VITAL-CML study, which will assess the safety and feasibility of vididencel in CML patients with suboptimal responses to tyrosine kinase inhibitors (TKIs), the standard of care for the disease.
VITAL-CML has been designed to recruit c 24 participants, and an initial top-line readout based on the first eight patients is anticipated in H226, which we believe could represent an important inflection point.
If successful, Mendus plans to proceed with a subsequent Phase IIa trial (called VITAL-TFR2). While the primary focus for vididencel is in acute myeloid leukaemia (AML), in our view, the expansion into CML is promising and has the potential to significantly broaden its application, which may translate to a sizeable commercial opportunity.