Medigene AG

Interim analysis from ongoing Phase I/II clinical trial with DC vaccines in AML patients presented at EHA

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Martinsried/Munich (pta009/17.06.2019/07:30) - -
- Very good feasibility for manufacture of vaccines from patient-derived cells
- Excellent safety and tolerability profile
- Encouraging data on overall survival and progression-free survival
- Mutational load analysis may allow patients to be stratified in future clinical trials.

Medigene AG (FWB: MDG1, Prime Standard) announced today that clinical data from the interim analysis of the ongoing Phase I / II clinical trial with Medigene's DC vaccine for the treatment of acute myeloid leukemia was presented during the annual congress of the European Hematology Association (EHA) taking place from 13 - 16 June in Amsterdam.

The poster presented was entitled "Interim Analysis of a WT-1 and PRAME ` Fast-DC´ vaccine shows safety as active immunotherapy for the prevention of AML relapse". The primary objectives of the study enrolling 20 AML patients are the safety and feasibility of this active immunotherapy with patient-derived DCs produced according to Medigene's proprietary technology.

The data presented was generated over a period of one year of vaccination of all patients representing an interim dataset after half of the treatment period. Topline data of this interim analysis was already published on 19 December 2018, demonstrating a very good feasibility for manufacture of the vaccines as well as an excellent safety profile and encouraging data on overall survival and progression-free survival (Link to press release: http://tiny.cc/f2377y).

In addition, the data presented at EHA included details about the mutational load status of patients who relapsed.

Clinical trial outline: A total of 20 subjects (median age 59, range 24 to 73) with AML (risk groups good, intermediate, poor: 13, 5, 2), in morphologic complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) after induction or consolidation therapy, not eligible for allogeneic hematopoietic stem cell transplantation, were enrolled into this safety and feasibility Phase I/II trial, vaccinated and followed up for 12 months at the interim analysis timepoint. Subjects in this trial had AML that was positive for Wilms Tumor-1 (WT-1) antigen with or without positivity for Preferentially Expressed Antigen in Melanoma (PRAME). Vaccination with dendritic cells, presenting the antigens WT-1 and PRAME, was carried out monthly, with a higher frequency within the first 6 weeks. AML diagnoses had been established with a median of 9.8 months before the first vaccination (range 4.5 to 17.5 months), and the last chemotherapy infusion had been performed at a median of 6.9 months (range 2 to 14.8 months).