Medigene AG: Academic partner Oslo University Hospital presented clinical data on compassionate use of AML DC vaccine at ASH

Martinsried/Munich (pta008/03.12.2018/07:30 UTC+1) Medigene AG announced that researchers from Oslo University Hospital presented an update on clinical compassionate use (1) data of their dendritic cell (DC) vaccine utilizing Medigene's DC vaccine technology for production. Results of five acute myeloid leukemia (AML) patients treated with dendritic cells (DCs) expressing the tumor antigens WT-1 and PRAME were presented at the 2018 American Society of Hematology (ASH) Annual Meeting in San Diego, USA.

The clinical compassionate use data were collected at the Department of Cellular Therapy at the Oslo University Hospital, Norway, under the responsibility of Prof. Gunnar Kvalheim and are independent of Medigene's ongoing company-sponsored Phase I/II DC vaccine trial. The Oslo University Hospital has an agreement with Medigene to use Medigene's patented protocol for polarized, fast DC generation at Oslo University Hospital's production facility for supply of their ongoing academic clinical studies with their DC vaccines.

Oslo University Hospital treated five AML patients in morphological remission after incomplete induction/consolidation chemotherapy using their DC vaccines. Despite chemotherapy and impaired hematopoiesis, high quality DC vaccines with essential functions were easily generated from monocytes of these patients.

The clinical results show that to date 3 of 5 patients are alive without current signs of relapse. Two patients received DC vaccines for 22 and 37 months and have been followed for 61 and 44 months respectively, since completion of chemotherapy. The third younger patient had signs of relapse and vaccination was halted after 10 months. This individual was then given allogeneic stem cell transplantation and remains in complete remission after 59 months. One further patient was vaccinated for 24 months without signs of relapse but died 27 months post chemotherapy due to unrelated heart disease. The fifth patient, who showed no T cell activity, relapsed after 12 months of vaccination and died at month 20.

This update on the compassionate use data from Oslo University Hospital was presented on a poster entitled "Immune Monitoring of Vaccine Quality and Persistence of Specific T Cell Responses in Five AML Patients Receiving Extended Dendritic Cell Vaccination Under Compassionate Use" by Iris Bigalke M.D. As announced previously, the abstract of the poster has been available at: https://ash.confex.com/ash/2018/webprogram/Paper114557.html or http://tiny.cc/0v940y

The poster with the updated data is available at Medigene's company website at https://www.medigene.com/technologies/publications/

Medigene has an ongoing company-sponsored Phase I/II trial with the company's proprietary DC vaccine, which will provide more information about vaccination against WT-1 and PRAME and its potential contribution to immune responses that might prevent or suppress disease relapse in AML patients.

About Medigene's DC vaccines: Besides 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.

Medigene is currently evaluating its DC vaccines in a company-sponsored Phase I/II clinical trial in acute myeloid leukaemia (AML).

About acute myeloid leukaemia (AML): Acute myeloid leukaemia is a malignant disease of the hematopoietic system, affecting mainly adults above 60 years of age. In Germany, about 3,600 incidences 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 blood coagulation disorder. AML progresses rapidly and may be fatal within a few weeks if untreated.

AML is treated initially with intensive chemotherapy. Another treatment option is allogeneic hematopoietic stem cell transplantation. Unfortunately, the majority of patients suffer a relapse. Only about 15 - 20% of the patients show long-term remission after conventional chemotherapy. Allogeneic hematopoietic stem cell transplantation is the only treatment option that offers a more positive prognosis.

Medigene AG (FSE: MDG1, ISIN DE000A1X3W00, Prime Standard, SDAX) 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 the focus on T cell-receptor modified T cells (TCR-Ts) and has associated projects currently in pre-clinical and clinical development.
For more information, please visit http://medigene.com

(1) Compassionate Use: Prescription of as-yet unapproved drugs outside of clinical trials in particularly severe cases where there are no treatment alternatives

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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