Positive Phase I/II trial feasibility results – Consistent high-quality DC vaccines in AML patients

Planegg/Martinsried – Medigene AG (Medigene, FSE: MDG1, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, is pleased to present production feasibility results from the dendritic cell (DC) vaccine Phase I/II clinical trial completed earlier this year in a poster at the Society for Immunotherapy of Cancer 35th Annual Meeting (SITC 2020) being held virtually on 9-14 November 2020. The poster # 271 will be available in the Virtual Poster Hall from 11-14 November 2020 from 9:00 am – 5:00 pm EST (3:00 pm – 11:00 pm CET), Q&A sessions will be held on Wednesday, 11 November 2020, 5:15 pm – 5:45 pm EST (11:15 pm – 11:45 pm CET) and on Friday, 13 November 2020, 4:40 pm – 5:10 pm EST (10:40 pm – 11:10 pm CET).

The poster # 271 entitled, “Consistent high-quality dendritic cell vaccines produced post-chemotherapy in patients with acute myeloid leukemia (AML) for use in a Phase I/II trial”, describes the production characteristics of mature DCs manufactured from monocytes isolated from the blood of AML patients who had been previously treated with intensive chemotherapy. In 15 of 20 patients only one manufacturing batch was required to produce sufficient DCs to cover all vaccinations, while only 5 patients required a second production batch.

The characteristics of the DCs produced from patients were comparable to DCs from a healthy control donor in terms of surface marker expression (CD83, CD40, CD80, CD86 and HLA-DR), cytokine production (interleukin-12), functional traits (chemokine-directed migration), in vivo activity in all patients (delayed-type hypersensitivity responses at 6 weeks) and expression of target antigens PRAME or WT-1. The consistency of the DC vaccines was notable despite patients differing in age, AML subtype, and amounts of standard chemotherapy received.

Dr. Yngvar Floisand, Head Physician of the Department of Hematology at the Oslo University Hospital and Principal Investigator of the trial, commented: “The DC vaccines produced for the patients in this study were remarkably consistent and showed an excellent immune functional profile which we believe played a role in the encouraging responses seen over the 2-year course of the study.”

Dr. Kai Pinkernell, Chief Medical Officer and Chief Development Officer at Medigene: “DC vaccines were effectively produced from blood monocytes of all patients in the trial. Importantly, with the strong success rate in production of DCs from a single apheresis, we believe this approach is acceptable to AML patients. The feasibility of the rapid production of these mature DCs and the consistency of their characteristics from patient-to-patient encourage our belief that the approach is sufficiently robust to support further development. We are pleased to see the continuation of this program with our partner, Cytovant Sciences HK Limited, a biopharmaceutical company founded by Roivant Sciences, as they progress towards clinical development in Asia.”

The poster will be available at medigene.com/technologies/abstracts from 11 November 2020, 9:00 am EST (3:00 pm CET).

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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 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.

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.

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

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Mary-Ann Chang
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