Mendus presented data on immune responses following vididencel administration

Mendus announced on Monday that new data had been presented at the European Hematology Association conference. According to the release, confirmed T cell responses following vididencel administration were strongly correlated with overall survival in the ADVANCE II trial. The new data supports previous results that vididencel may lead to long-term survival benefit in patients with acute myeloid leukemia (AML) although confirming this requires further research. Vididencel’s potential is next explored in the Phase II CADENCE trial in combination with the standard of care oral azacitidine.

Immune activation by vididencel correlated with overall survival

According to the data presented at the conference, 17 out of 20 patients in the ADVANCE II trial showed T cell responses to tumor antigens following vididencel administration. These responses were strongly correlated with prolonged survival. All patients (9/20) with confirmed T cell responses (i.e. at least two independent responses to the same antigen) were alive at the data readout. The responses also correlated with complete or partial eradication of the residual cancer cells (or Measurable Residual disease MDR). In addition to T cell responses, numbers of B cells also correlated with overall survival suggesting that B cells may play a part in mediating the possible survival benefit. These data improve our understanding of the mechanisms of immune activation following vididencel treatment in the ADVANCE II trial. Confirmation of whether vididencel leads to prolonged survival in patients with AML still requires further research.

Next in line for vididencel: the CADENCE trial

The next step for vididencel is the Phase II AMLM22-CADENCE trial to study vididencel in combination with standard-of-care as AML maintenance therapy. To our understanding, patient recruitment for the trial has already started by Mendus’ partner Australasian Leukaemia and Lymphoma Group ALLG. The first stage of the trial will enroll 40 patients, half of whom will receive vididencel in combination with standard-of-care oral azacitidine (Onureg®) and half of whom will receive Onureg® only. An additional 100 patients are planned to be enrolled in the second stage. We expect a data readout from the first stage in mid-2025.

In parallel, the company is also building readiness for a pivotal-stage trial in AML by H2’25. This includes upscaling vididencel manufacturing in partnership with NorthX Biologics, which according to Mendus is progressing on schedule and within budget. We believe the CADENCE data readout and pivotal-stage readiness are achievable with the financing already in place.