Medigene AG: PRAME expression and HLA genotype screening in AML and MDS patients

Poster at ASH Annual Meeting 2020, 5-8 December 2020

Planegg/Martinsried (pta045/07.12.2020/16:00 UTC+1) Medigene AG (Medigene, FSE: MDG1, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, is pleased to present results from a patient and healthy donor screening assessment of the expression of PRAME and HLA-genotype in a poster at the virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition on 5-8 December 2020. This screening analysis was conducted in parallel with the ongoing Phase I/II clinical trial of MDG1011.

The screening evaluated the expression of mRNA encoding the tumor antigen PRAME in acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) patients (N=165) and further determined the frequency of the HLA-A*02:01 genotype in these patients and in healthy donors (N=141).

Some 48% of the patients were determined to express PRAME and 55% were HLA-A*02:01 positive. Double-positive patients i.e. positive for both PRAME and HLA-A*02:01, were 27% of the total. Amongst the healthy donors, 48% were found to be HLA-A*02:01 positive.

In parallel, the frequency of specific HLA-A types in healthy donors was analyzed. The analysis revealed that the five most common HLA-A types (HLA-A*02:01, HLA-A*01:01, HLA-A*03:01, HLA-A*24:02, and HLA-A*11:01) were present in 88% of the healthy volunteers. These results suggest that most of the population could be addressed by T cell receptors (TCRs) specific for antigen targets presented on these HLA types.

Dr. Kai Pinkernell, Chief Medical Officer and Chief Development Officer at Medigene: "Having seen how many patients express both PRAME and HLA-A*02:01, we expect that a significant portion of patients might ultimately be eligible to receive our TCR-T cell product MDG1011.

And importantly, as shown by the frequency analysis of HLA-A types, broader coverage of a substantial proportion of a patient population could be achieved by using combinations of TCR-T cells restricted by a relatively small number of HLA-A types. Medigene has the TCR platform to efficiently identify TCRs specific for antigen targets presented on diverse HLA types, giving us the ability to ultimately address a wider patient population."

Poster details:

Title	PRAME mRNA Expression in AML/MDS and HLA Genotype Analysis: Impact on Population Coverage and Design of TCR-Based Immunotherapies
Number	2881
Authors	Richard Addo, MD, PhD, Kathrin Davari, PhD, Silke Raffegerst, PhD, Dolores Schendel, PhD, Kai Pinkernell, MD, Simone Thomas, MD
Presenter	Dr. Richard Addo, Medigene
Session	617. Acute Myeloid Leukemia: Biology, Cytogenetics, and Molecular Markers in Diagnosis and Prognosis: Poster III Monday, 7 December 2020, 7:00 am - 3:30 pm PT (Monday, 7 December 2020, 4:00 pm - Tuesday, 8 December 2020, 12:30 am 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 www.medigene.com

About Medigene's TCR-Ts
TCR-T technology arms a patient's own T cells with tumor-specific T cell receptors. The T cell receptor-modified T cells (TCR-T cells) are then able to detect and efficiently kill tumor cells. This immunotherapy approach attempts to overcome the patient's tolerance towards cancer cells and tumor-induced immunosuppression by activating and modifying the patient's T cells outside the body (ex vivo).

Medigene is conducting a first Phase I/II clinical trial of its TCR-T candidate MDG1011 in the blood cancer indications AML and MDS as well as a second Phase I clinical trial of MDG1021 in patients suffering from relapsed or persistent blood cancer after allogeneic (non-self) hematopoietic stem cell transplantation (allo-HSCT). In addition, Medigene is establishing a pipeline of TCRs and has collaborations with bluebird bio, Inc. and Cytovant Sciences HK Ltd. addressing solid tumor indications.

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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