Sparks - Mendus

Mendus has announced a new strategy for its lead cancer vaccine candidate, vididencel, driven by its relatively new chief medical officer, Dr Tariq Mughal. The refreshed strategy is based on encouraging data in acute myeloid leukaemia (AML). Notably, in the Phase IIa ADVANCE II trial in high-risk AML, the majority of patients were alive and five patients passed five-year survival at a median follow-up of 48 months. While vididencel is currently being assessed in the Phase IIb CADENCE trial, exploring it in combination with oral azacitidine (the current standard of care), Mendus has now announced that it has also prepared a new Phase Ib trial to explore the potential synergy between vididencel and azacitidine plus venetoclax. Initial top-line data from both of these trials are expected mid-2026 and will guide the go-to-market strategy in AML.

Another key takeaway from the strategy update was the expansion of vididencel’s potential application as an active immunotherapy to chronic myeloid leukaemia (CML). Based on encouraging preclinical data, originally presented at American Society of Hematology 2024, Mendus has prepared a Phase Ia/Ib trial to evaluate safety and feasibility in CML patients. If the data are supportive, Mendus will proceed with a Phase IIa trial, aiming to improve treatment-free remission rates in this patient population.

In order to fund these additional clinical activities, Mendus has initiated a corporate reorganisation, including reduced headcount, which is expected to offset the additional trial costs for 2026. Should the strategy be successful, it has the potential to broaden the market opportunity for vididencel.