Medigene AG: Positive final 2-year topline data in completed DC vaccine Phase I/II trial in AML patients

Planegg/Martinsried (pta015/10.01.2020/14:20 UTC+1) 10 January 2020. Medigene AG (Medigene, FSE: MDG1, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, today publishes topline results from its completed open-label Phase I/II clinical trial of Medigene's autologous dendritic cell (DC) vaccine in 20 patients with acute myeloid leukemia (AML). The study was conducted at the Oslo University Hospital, Norway. Data were collected shortly after completion of the clinical trial, i.e. after 24 months of vaccination and follow-up of all patients.

The trial's primary outcome measures assessing 1) the feasibility of DC vaccine manufacturing/administration, and 2) its safety/tolerability over 2 years, were successfully achieved. The DC vaccinations were well tolerated with no serious adverse events (SAEs) related to the treatment.

The secondary outcome measures evaluating key clinical parameters show that after 24 months of treatment overall survival rate (OS) was 80% (16 of 20 patients, 95% confidence interval (CI): 55 to 92%) and progression free survival rate (PFS) was 55% (11 of 20 patients, 95% CI: 31 to 74%).

In the current AML treatment paradigm, patients 60 years of age or older are often ineligible for hematopoietic stem cell transplantation and have poorer treatment outcomes. This group accounted for 50% of patients in this trial (risk groups good, intermediate, poor: 4, 4, 2) and an excellent OS of 80% (8 of 10 patients, 95% CI: 41 to 95%) and a PFS of 50% (5 of 10 patients, 95% CI: 18 to 75%) was observed at 24 months. In the patient group younger than 60 years of age (risk groups good, intermediate, poor: 9, 1, 0), also an excellent OS of 80% (8 of 10 patients, 95% CI: 41 to 95%) and a PFS of 60% (6 of 10 patients, 95% CI: 25 to 83%) was observed at 24 months.

As disclosed at the time of the 12-months interim analysis in December 2018, in patients where disease relapsed, most cases (5 out of 8) occurred within the first 80 days after the start of the vaccination. These early relapses were investigated by molecular mutational analysis which suggested that some relapses had already begun on a molecular level at the time of entry into the study.

More detailed data and analyses will be presented at upcoming scientific conferences.

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