Mendus AB announced the publication of additional Phase 1 clinical trial data on its lead development program vididencel in the peer-reviewed medical journal HemaSphere. The data supports the potential of vididencel as a novel acute myeloid leukemia (AML) maintenance therapy and provides valuable insights for the current and future clinical trials with vididencel in AML and high-risk MDS. The publication, titled ?Durable Responses and Survival in High-Risk Myelodysplastic Syndrome and Acute Myeloid Leukemia Patients Receiving the Allogeneic Leukemia-derived Dendritic Cell Vaccine DCP-001?, and written by researchers from the Amsterdam UMC, Cancer Center Amsterdam and Erasmus University Medical Center, describes the long-term follow up data and additional patient characteristics from the Phase 1 clinical trial evaluating vididencel (DCP-001) in acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS).

In the Phase 1 clinical trial 12 patients were treated with vididencel (product ID: DCP-001), six patients with AML, three patients with AML with prior MDS and three patients with MDS with excess of blasts. Seven out of twelve patients showed a response to treatment; five patients showed progression of disease. The main discriminating variables in favor of response were patients who entered the study either in complete remission or who had stable disease status and a low percentage of blasts in the bone marrow at study entry.

Importantly, there was no association found between response and disease risk classification with the majority of responding patients having an adverse cytogenetic risk profile, which is highly encouraging given the difficulty in effecting positive outcomes for these patients with a poor prognosis. In the seven responders, a median relapse free survival (RFS) of 420 days (? 14 months) and a median overall survival (OS) of 1090 days (?

36 months) was observed as compared to a median OS of 144 days in the five non-responders. The longest surviving patient experienced an RFS of 1,849 days (? 5 years) and OS of 2,160 days (?

5.9 years) after treatment with vididencel. In a subset of three patients, who initially responded to vididencel but later relapsed, post-vaccination treatment with azacitidine was evaluated and resulted in one complete remission and two partial responses. The data suggest that azacitidine and vididencel may act synergistically.