Medigene AG: Detailed analysis from Medigene's completed Phase I/II DC vaccine in AML patients presented orally at ASH 2020

Planegg/Martinsried (pta007/07.12.2020/08:00 UTC+1) Medigene AG (Medigene, FSE: MDG1, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, is excited to announce that an oral presentation of results from the Phase I/II clinical trial of its dendritic cell (DC) vaccine in acute myeloid leukemia (AML) patients was given by the study's Principal Investigator Dr. Yngvar Floisand at the virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition on Saturday, 5 December 2020.

The single center, open-label Phase I/II trial (NCT02405338) treated 20 AML patients with an autologous DC vaccine expressing WT-1 and PRAME antigens for up to 2 years and was completed earlier this year. The previously reported topline results showed an excellent safety and feasibility profile and encouraging overall survival (OS: 80% at 2 years, including patients over 60 years of age) and progression free survival (PFS: 55% at 2 years).

The more detailed analysis of the results from the study show that elevated T cell activation markers in the bone marrow appear to be associated with disease remission. In contrast, higher mutational load of various genes in the leukemia cells was associated with disease relapse.

Dr. Yngvar Floisand, Head Physician of the Department of Hematology at the Oslo University Hospital and Principal Investigator of the trial, commented: "New treatment options are desperately needed for patients with AML. The disease progresses rapidly and may be fatal within a few weeks or months, if untreated. The treatment of AML patients using autologous DC vaccines in this study provided encouraging results over the 2-year course of the study and as we continue to follow-up patients we remain excited by their overall performance."

Dr. Kai Pinkernell, Chief Medical Officer and Chief Development Officer at Medigene: "We are pleased to see the results of this trial given in an oral presentation at ASH. We hope to see a continuation of the encouraging results carried forward in future developments with the next clinical trial to be conducted by our partner, Cytovant Sciences HK limited, a biopharmaceutical company founded by Roivant Sciences. We would like to reiterate our thanks to the patients and our collaborators for their participation in the clinical trial."

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About Medigene
Medigene AG (FSE: MDG1, Prime Standard, ISIN DE000A1X3W00) 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 www.medigene.com

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)
AML 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.

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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