On December 8, 2015 Medigene AG (MDG1, Frankfurt, Prime Standard) reported that early data from two independent clinical programmes in patient groups with acute myeloid leukaemia (AML) receiving dendritic cell (DC) vaccines, prepared according to technologies licensed and developed by Medigene, show an excellent safety profile and the capacity to induce T cell responses in elderly patients unable to undergo stem cell transplantation (Press release, MediGene, DEC 8, 2015, View Source [SID:1234508484]). Schedule your 30 min Free 1stOncology Demo! Two posters were presented at the 57th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in Orlando, FL, USA, detailing early clinical results of patients with acute myeloid leukaemia (AML) treated with these next-generation DC vaccines. One poster, entitled "Next-Generation Dendritic Cell Vaccination in Postremission Therapy of AML: Results of a Clinical Phase I Trial", included data from an ongoing Phase I/II investigator initiated trial (IIT) under the direction of Prof. Marion Subklewe of the Ludwig-Maximilians-Universität (LMU) in Munich, Germany. In particular, results were presented regarding the six patients included in a Phase I proof-of-concept study who have completed vaccination lasting up to 26 weeks. The second poster entitled "AML Patients in Minimal Residual Disease Vaccinated with a Novel Generation of Fast Dendritic Cells Expressing WT-1 and PRAME Mount Specific Immune Responses That Relate to Clinical Outcome" included results from four patients treated with DCs from 5 to 16 months so far in an ongoing Compassionate Use Programme[1] under the direction of Prof. Gunnar Kvalheim at Oslo University Hospital (OUH) in Norway.
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Links to the poster abstracts:
Phase I/II IIT of LMU: View Source
Compassionate Use Programme of OUH: View Source
Prof. Marion Subklewe, Professor of Internal Medicine with special Focus on Cellular Immunotherapy at the Ludwig-Maximilian University Großhadern, Munich, explains: "Upon completion of our Phase I trial, we have obtained the first evidence that use of WT-1 and PRAME as vaccine antigens can be validated through detection of T cell responses in various patients analysed to date".
Prof. Gunnar Kvalheim, Head of Department of Cellular Therapy at the Oslo University Hospital comments on his findings so far: "We are optimistic that these results pave the way for DC vaccines as a new therapy option for patients that have high risk for disease relapse and do not qualify for stem cell transplantation. The feasibility to make good quality DC vaccines from heavily pretreated patients and the capacity of our patients to make T cell responses to one or both antigens are important early findings."
Prof. Dolores J. Schendel, Chief Scientific Officer of Medigene AG, summarizes the findings from the two ASH (Free ASH Whitepaper) reports: "We are pleased with the new information that could be derived from the preliminary assessments of the ten AML patients receiving next-generation DC vaccines in these ongoing independent studies. It was feasible to manufacture high quality DCs according to our technology that led to detectable immune responses in different patients to one or both leukaemia-associated antigens. The rapidity with which T cell responses were detected in some patients speaks to the good immunizing capacity of the DCs. These observations support the approach implemented in our own company-sponsored DC vaccine trial that was launched in March of this year at OUH."