Medigene AG: Further encouraging results from long-term follow-up of AML patients in DC vaccine trial

Planegg/Martinsried (pta033/08.02.2021/16:00 UTC+1) Medigene AG (Medigene, FSE: MDG1, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, presents further encouraging results from the follow-up of acute myeloid leukemia (AML) patients in Medigene's dendritic cell (DC) vaccine Phase I/II clinical trial. The results are being presented by the trial's Principal Investigator, Dr Yngvar Floisand (Head Physician of the Department of Hematology at the Oslo University Hospital) in a poster at the virtual Transplantation & Cellular Therapy (TCT) Meeting of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR) taking place on 8-12 February 2021.

The poster entitled, "Long term follow up of a 'fast-DC' immunotherapy against WT-1 and PRAME as a post-remission strategy for AML", was based on follow-up until the data cut-off date (September 2020) and provides further support for potentially lasting clinical benefits in patients who received the DC vaccine.

A total of 15 of 20 patients remained alive, with a median follow up time of 44 months (range 34 to 63 months) after the first vaccination, such that the 3-yr and 5-yr overall survival probability (OS) from the time of first vaccination was 75% each (95% confidence interval, CI: 50%-89%). For patients of 60 years of age or more, OS at 3-yr and 5-yr from the time of first vaccination was 70% (n=10, 95% CI: 33%-89%) while for those below age 60 it was 80% (n=10, 95% CI: 41%-95%). The 3-yr and 5-yr OS from the time of diagnosis was 80% (95% CI: 55%-92%) and 75% (95% CI: 50%-89%), respectively.

At the data cut-off date, the number of relapses remained stable from earlier reporting times at 2 years with a total of 9 of 20 patients relapsed. The progression-free survival probability (PFS) at 3-yr and 5-yr after first vaccination or diagnosis therefore remained unchanged at 55% (95% CI: 31%-74%). For the older patients (>= 60 years), 3-yr and 5-yr PFS was 50% (95% CI: 18%-75%) and for the younger patients (<60 years) it was 60% (95% CI: 25%-83%).

Dr. Kai Pinkernell, Chief Medical Officer and Chief Development Officer at Medigene: "We are delighted to see that after more than 3.5 years of median follow up, long-term OS and PFS results indicate a durability of the potential clinical benefits for patients receiving the DC vaccine, which also had a favorable safety/tolerability profile. Importantly, we believe the 70% long-term survival in the elderly patients is particularly encouraging."

Further development of the DC vaccine program is currently ongoing in East Asia with Cytovant Sciences HK Limited, a biopharmaceutical company founded by Roivant Sciences, and Medigene seeks partnering opportunities in other territories.

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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-T cells), 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.

Medigene
Dr. Gary Waanders, Dr. Anna Niedl
Phone: +49 89 2000 3333 01
e-mail: investor@medigene.com

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