B7.1/IL-2 Leukaemia Cell Vaccine for Non-Transplant AML RFUSIN2-AML2 (NTX)

Key Inclusion Criteria: * Diagnosis of MDS RAEB-2 or primary (de novo) or secondary AML defined according to the WHO classification either as a new diagnosis or as a relapse. * Patients for whom the optimal therapy in CR1 would be to undergo allogeneic bone marrow transplantation, but for whom this procedure is either not recommended (e.g. due to comorbidities) or not available (e.g. lack of a suitable donor). Key Exclusion Criteria: * Patients with MDS RAEB-2 or AML and favourable prognostic profile (good risk cytogenetics: t(15;17)(q22;q12\~21), inv16(p13q22)/t(16;16)(p13;q22), t(8;21)(q22;q22) or cytogenetically normal AML with NPM1 mutation and absence of Flt-3 ITD). * Patients unsuitable for standard induction chemotherapy. * Patients who have previously undergone or will be able to undergo allogeneic transplantation. * Patients who have had previous or current treatment with any form of investigational immunotherapy.