Medigene expands patent protection of its technologies in key markets, the USA and Europe

Planegg/Martinsried - Medigene AG (Medigene, FSE: MDG1, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, was granted patents around certain technologies in significant territories including both the USA and Europe. Patent applications in further jurisdictions are pending.

TCR library (US10,858,760)
This US patent (a member of the same patent family was granted in Europe in 2019, EP3303591), covers Medigene's T cell receptor (TCR) building block library that enables rapid reconstruction and testing of newly discovered human TCR sequences.

The two TCR protein chains, alpha and beta, together determine the specificity of the TCR. The patent covers a library comprising 92 TCR constructs (including all 45 different TCR alpha chains and all 47 different TCR beta chains) that are needed as starting materials for recombinant expression of any TCR of interest. The constructs also include design elements for flexible exchange of any other TCR region and adaptor sequences that enable reconstructed TCRs to be shuttled into recipient T cells by different means.

This library enables rapid high-throughput reconstruction of large numbers of candidate TCRs specific for selected antigens and provides tools to reconstitute TCRs specific for mutations on a patient-individualized basis. Efficient reconstitution of many TCRs in parallel enables those sequences with the best functionality to be rapidly identified and selected for TCR-T cellular therapeutics.

CrossTAg-1 (EP3394247A1)
The European Patent Office intends to grant a European patent covering the CrossTAg-1 technology (patents covering this technology have also been granted in Japan, Australia and New Zealand last year, JP6676759, AU2016374873 and NZ741954).

This technology allows cross-presentation of antigens on both class I and II Major Histocompatibility Complex (MHC) molecules (also called "Human Leukocyte Antigens", HLA, in humans) thereby stimulating both killer T cells and helper T cells, respectively. These major T cell subsets play key roles in immune responses, including those against cancer.

The CrossTAg-1 technology directs short peptides from an antigen to be effectively processed by cellular pathways for both class I and class II HLA presentation. Thus, Medigene also believes that using the CrossTAg technology could potentially improve T cell responses to mRNA-based vaccines.

CrossTAg-2 (US10,882,891)
The CrossTAg-2 patent now granted in the US (also granted in Japan, Australia and New Zealand last year, JP6697562, AU2016374874, NZ741955) covers the use of the CrossTAg technology in dendritic cells (DCs) and DC vaccines. The use of this technology ensures that, in addition to killer T cells, helper T cells are also effectively stimulated against specific targets allowing for the broadest immune activation.

Medigene Immunotherapies GmbH and the biomedical research center Helmholtz Zentrum München are co-applicants for the mentioned CrossTAg patents which fall under the main license agreement in place with Helmholtz Zentrum München.

Prof. Dolores J. Schendel, CEO/CSO of Medigene: "Medigene's growing patent estate reflects the wide applicability of its ongoing innovation and scientific excellence across the field of therapeutic T cells. Building the patent estate covering these technologies in key commercial markets is of core importance to protecting the value of our investments in innovation. We believe our technologies could provide important benefits to deal with the constant challenges facing clinical medicine in solid tumors and infectious diseases."

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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.

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.

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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