Medigene AG: Medigene publishes topline interim data from ongoing Phase I/II clinical trial with DC vaccines in AML patients

Martinsried/Munich (pta028/19.12.2018/21:40 UTC+1) Medigene AG (FWB: MDG1, Prime Standard, SDAX) publishes interim clinical results from its ongoing company-sponsored Phase I/II clinical trial of a dendritic cell (DC) vaccine in 20 patients with acute myeloid leukemia (AML). The primary objectives of the study are the safety and feasibility of this active immunotherapy with the patient-derived DCs produced according to Medigene's proprietary technology.

The topline data released today is from a period of one year of vaccination of all patients and represents an interim dataset after half of the treatment period.

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. 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).

The vaccinations were well tolerated with no serious adverse events (SAEs) related to the treatment. The most common adverse events (AEs) were injection site related, accounting for 35% of all AEs and mild in nature (Grade 1). The feasibility of the manufacture of the dendritic cell vaccine in these chemotherapy-pretreated subjects was already presented earlier this year (abstract AACR). Link to poster: https://www.medigene.de/fileadmin/download/abstracts/180414_AACR_2018_Poster_DC_vaccine_Medigene.pdf

After a 12-months treatment period, the overall survival was 89% (18 of 20 patients, 95% confidence interval: 61 to 97%) and the progression free survival was 60% (12 of 20 patients, 95% confidence interval: 36 to 78%). Most relapses, 5 out of 8, occurred within the first 80 days after the start of the vaccination, out of which the 2 deaths were in patients with relapses on days 45 and 64, which could point to a starting relapse upon entering the study.

The completion of the ongoing trial is scheduled for the end of 2019 following a two-year treatment period.

Medigene intends to present the detailed data from the interim analysis at a scientific conference in the near future.

Contact Medigene
Julia Hofmann, Dr. Robert Mayer
Tel.: +49 - 89 - 20 00 33 - 33 01
Email: investor@medigene.com

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Emitter:	Medigene AG Lochhamer Straße 11 82152 Planegg Germany
Contact Person:	Julia Hofmann, Head of Public and Investor Relations
Phone:	+49 89 200033-3301
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