Medigene AG: Data validating TCR-Ts targeted to ovarian tumor-specific "dark matter" antigen to be presented at SITC

Planegg/Martinsried (pta029/09.11.2021/14:00 UTC+1) * Data show highly tumor specific TCR-T activation in vitro
* Medigene authors to receive "best paper" award

Martinsried/Munich, 9 November 2021. Medigene AG (Medigene, FSE: MDG1, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, will present new data on the [i]in vitro[/i] validation of a "dark matter" ovarian tumor-specific antigen. The data will be presented as a poster at the Society for Immunotherapy of Cancer's (SITC) 36th Annual Meeting being held in Washington, DC, USA, on 10 to 14 November 2021.

The SITC poster shows [i]in vitro[/i] validation of T cell therapies that combine T cell receptors (TCRs) recognizing a "dark matter" ovarian tumor-specific antigen with CD8+ T cells from healthy donors. Using T cells from three different donors, TCR transgenic T cells were activated by cells from ovarian tumor-derived organoids but not by cells from cultures of normal ovarian tissue.

Medigene's "dark matter" antigens are derived from non-exomic regions of the genome that are not transcribed in normal cells but are transcribed in cancer cells. The ovarian tumor-specific antigen used is one of 47 "dark matter" antigens specific to solid tumors identified in Medigene's ongoing exclusive collaboration with the University of Montréal investigating "dark matter" antigens in a variety of cancer types. Under the collaboration, Medigene will select a number of antigens on which it wishes to retain rights for future development.

Prof. Dolores Schendel, Chief Executive Officer and Chief Scientific Officer at Medigene: "These data illustrate why Medigene investigates tumor-specific "dark matter" antigens for directing the company's TCR-T cell therapies. The "dark matter" antigens are not present in normal, non-tumorous tissues. Using them as target for the TCRs in our TCR-T cells potentially allows us to design tumor-specific agents. Across three different T cell donors, responses from Medigene's TCR-T cells to cultured ovarian tumor cells are orders of magnitude higher than those against cultured normal ovarian cells. The consistent pattern of differentiated activation is very encouraging. We are pleased to share these data with the immunotherapy community at SITC."

The poster can be found on Medigene's website after the end of the conference: https://www.medigene.com/technologies/abstracts

JITC's Immune Cell Therapies and Immune Cell Engineering Best Paper Award

Separately, SITC has selected the paper "Development of a CD8 co-receptor independent T-cell receptor specific for tumor-associated antigen MAGE-A4 for next generation T-cell-based immunotherapy" from Medigene and its collaboration partner bluebird bio, Inc. (now: 2seventy bio, Inc.) to receive the Journal for ImmunoTherapy of Cancer's Award for Best Immune Cell Therapies and Immune Cell Engineering Paper. Co-lead authors Dr. Kathrin Davari and Dr. Tristan Holland will receive the award at SITC's Annual Meeting Awards Ceremony on Saturday, 13 November 2021.

Prof. Schendel: "We are extremely proud that the quality of our scientific work has been so highly recognized by this award. I would like to personally congratulate once again all my colleagues and our cooperation partner and thank them for the always wonderful and constructive work. Each and every day, it is a great pleasure to see how our projects are progressing and I look forward to many more publications."

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About Medigene

Medigene AG (FSE: MDG1, ISIN DE000A1X3W00, Prime Standard) is a publicly listed biotechnology company headquartered in Planegg/Martinsried near Munich, Germany. With its scientific expertise, Medigene is working on the development of innovative immunotherapies to enhance T cell activity against solid cancers in fields of high unmet medical need. Medigene's pipeline includes preclinical as well as clinical programs in development.

Medigene's strategy is to develop its own therapies towards clinical proof-of-concept. In addition, the Company offers selected partners the opportunity to discover and develop therapies on the basis of its proprietary technology platforms. In return for such partnerships, Medigene expects to receive upfront and milestone payments as well as research and development funding and royalties on future product sales.

For more information, please visit https://www.medigene.com

About Medigene's TCR-Ts

T cells are at the center of Medigene's therapeutic approaches. With the aid of Medigene's immunotherapies the patient's own defense mechanisms are activated, and T cells harnessed in the battle against cancer. Medigene's therapies arm the patient's own T cells with tumor-specific T cell receptors (TCRs). The resulting TCR-Ts should thereby be able to detect and efficiently kill cancer cells.

This approach to immunotherapy aims to overcome the patient's tolerance to cancer cells and tumor-induced immunosuppression by activating the patient's T cells outside the body, genetically modifying them with tumor-specific TCRs and finally multiplying them. In this way, large numbers of specific T cells are made available to patients to fight the cancer within a short period of time.

About Medigene's collaboration with the University of Montréal on "dark matter" tumor-specific antigens

In January 2020, Medigene entered into a research collaboration on novel cancer antigens for highly specific immunotherapies with the University of Montréal (UdeM) and IRICoR, a pan-Canadian drug discovery research commercialization center. UdeM's research team, led by Drs. Claude Perreault and Pierre Thibault at the Institute for Research in Immunology and Cancer (IRIC), provided Medigene with tumor-specific antigens (TSAs) stemming from non-coding regions of the DNA ("dark matter") which they discovered using their proprietary platform, as novel targets for various cancer indications, particularly for solid tumors. Medigene received an option to exercise an exclusive and worldwide license to develop and commercialize T cell receptors (TCRs) against up to 5 of these novel dark matter cancer antigens.

[i]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.[/i]

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