Medigene AG: Interim 1-year clinical immune monitoring data from DC vaccine trial in AML presented at ASH 2019 Annual Meeting

Munich/ Martinsried (pta035/10.12.2019/22:00 UTC+1) Medigene AG (FSE: MDG1, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, announces that Medigene's researchers presented clinical immune monitoring data obtained during the first year of treatment from the ongoing Phase I/II clinical trial with Medigene's DC vaccine for the treatment of acute myeloid leukemia (AML) at the 61st ASH Annual Meeting (Orlando, USA).

This ongoing DC vaccine clinical trial for the treatment of AML will be completed at the end of 2019 and topline data will be reported in the beginning of 2020.

The poster presentation focused on clinical immune monitoring data from the trial. Several assay systems were used to assess the impact of the DC vaccine on T cell responses (specific for WT-1 and PRAME antigens) and other immunological parameters. Furthermore, the recurrence of WT-1-positive and/or PRAME-positive AML blasts, as well as the occurrence of AML-specific mutations in bone marrow, were investigated. The results of the 1-year interim assessment show that, upon in vitro stimulation with WT-1 or PRAME, T cells from peripheral blood of 75% (6 of 8) of relapsing patients were capable of producing the pro-inflammatory cytokine IFNgamma, while such a response was detected in only in 25% (3 of 12) of the patients in remission.

Dr. Kai Pinkernell, CMO and CDO of Medigene AG, comments: "These interim clinical immune monitoring data from our DC trial after one year of treatment shed light on the potential functionality of our vaccine. We believe that the detection of reactive T cells in peripheral blood may be linked to the concomitant presence of AML blasts in the periphery of relapsing patients. In addition, in most patients in remission the stable or decreasing levels of WT-1 and/or PRAME mRNA in the bone marrow would be consistent with a local response against AML antigens, despite a negative IFN-gamma response in peripheral blood. Further monitoring of the patients in remission in the second year of vaccination may bring further insights into the role of DC vaccination in the prevention of AML recurrence."

The poster entitled "DC Vaccination Induces Antigen Specific Immune Responses in AML Patients: A 1-Year Interim Assessment" is available at Medigene's company website at: https://www.medigene.com/technologies/abstracts

About Medigene's DC trial:
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).

Interim results:
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). After a 12-month 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 initiation of vaccination, suggesting a possible molecular relapse upon entering the study.

About Medigene's DC vaccines:
In addition to Medigene's development focus on T cell-receptor modified T cells (TCR-Ts), the Company has developed a new generation of antigen-tailored dendritic cell (DC) vaccines.
Dendritic cells (DC) can take up antigens, process them and present peptides on their surface in a form that can induce antigen-specific T cells to mature and proliferate. In this way, T cells recognize and eliminate tumor cells which bear the same antigen peptide on their surface. Dendritic cells can also induce natural killer cells (NK cells) to attack tumor cells. The scientific team of Medigene has developed new, fast and efficient methods for generating autologous (patient-specific) mature dendritic cells which have the relevant characteristics to generate very strong T cell and NK cell immune responses. The dendritic cells can be loaded with various tumor antigens to treat different forms of cancer. Since an immune response builds up over the total time of administration of the DC vaccine, this form of therapy is particularly designed for patients who suffer from a tumor disease which has been reduced to such an extent by chemotherapy that the prevention of the recurrence of the tumor disease is the main goal.

About acute myeloid leukemia (AML):
Acute myeloid leukemia is a malignant disease of the hematopoietic system, affecting mainly adults above 60 years of age. In Germany, about 3,600 cases are registered annually.
AML is caused by uncontrolled growth of dysfunctional hematopoietic precursor cells in the bone marrow. These cells prevent the generation of normal blood cells, causing a decrease in erythrocytes and platelets, for example. Typical symptoms of AML include anemia, fever, increased risk of infection, and bleeding. AML progresses rapidly and may be fatal within a few weeks or months, if untreated.
AML treatment is often started with intensive chemotherapy, followed by consolidation with or without allogeneic hematopoietic stem cell transplantation. Unfortunately, a significant proportion of patients suffer a relapse of the original disease. Depending on the biologic risk profile of the disease, age and co-morbidity the long-term survival is highly variable.

Medigene AG (FSE: MDG1, ISIN DE000A1X3W00, Prime Standard) is a publicly listed biotechnology company headquartered in Martinsried near Munich, Germany. The company is developing highly innovative immunotherapies to target various forms and stages of cancer. Medigene concentrates on the development of personalized T cell-based therapies, with associated projects currently in pre-clinical and clinical development.

For more information, please visit http://www.medigene.com

This press release contains forward-looking statements representing the opinion of Medigene as of the date of this release. The actual results achieved by Medigene may differ significantly from the forward-looking statements made herein. Medigene is not bound to update any of these forward-looking statements. Medigene® is a registered trademark of Medigene AG. This trademark may be owned or licensed in select locations only.

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