Medigene AG: Medigene achieves positive preliminary results in Phase I of Phase I/II trial of TCR-T therapy MDG1011 in blood cancers

Planegg/Martinsried (pta034/21.12.2021/15:20 UTC+1)

• MDG1011 was safe and well tolerated
• Successful individual manufacturing of MDG1011 drug product from heavily pre-treated patients with advanced-stage blood cancers
• Clinical outcome data from ongoing patient follow-up and data regarding biologic activity of the drug product expected to become available in Q1 2022

Martinsried/Munich, 21 December 2021. Medigene AG (Medigene, FSE: MDG1, Prime Standard), a clinical-stage immuno-oncology company focusing on the development of T cell immunotherapies, today announces first promising results from the Phase I part of the Phase I/II clinical trial of Medigene's T cell receptor-modified T cell (TCR-T) therapy MDG1011 in blood cancers, regarding safety, tolerability and feasibility to manufacture TCR-T drug products from highly pre-treated patients with advanced-stage blood cancers (ClinicalTrials.gov Identifier: NCT03503968).

Clinical outcome data from ongoing patient follow-up and data regarding biologic activity of the drug product from immune-monitoring analyses are expected to become available in Q1 2022.

MDG1011 is a TCR-T immunotherapy directed against the tumor antigen PRAME (PReferentially expressed Antigen in MElanoma) and was manufactured to be administered in a single intravenous dose to patients suffering from relapsed or refractory acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) or multiple myeloma (MM) who had previously undergone extensive pre-treatment with standard or experimental therapies. The multi-center, open-label, dose-escalation Phase I part of the study was conducted at 9 clinical centers in Germany. The primary objective of the 3+3 study design is to evaluate the safety and tolerability of MDG1011 and feasibility of manufacturing MDG1011 using autologous CD8+ T cells from the patients. Data cut-off point for reported results herein is 3 months post treatment.

White blood cells were harvested by leukapheresis and enriched for CD8+ T cells from 13 patients with a median age of 65 years (range of 55-80 years). The defined dose levels of 0.5, 1 or 5 million TCR-transduced T cells per kg body weight could be successfully manufactured for 12 of the 13 patients (92.3%). Four patients succumbed to disease before treatment could be administered, in line with the severity of the underlying condition of study patients. Thus, 9 patients were treated with a single intravenous administration of MDG1011.

All patients experienced adverse events, with a preponderance of treatment emergent adverse events (TEAEs) expected for the underlying malignant condition. Grade 1-2 transient cytokine release syndrome (CRS) considered attributable to MDG1011 was experienced by 2 patients, giving direct evidence for biological activity of the infused T cells. Neither immune effector cell-associated neurotoxicity syndrome (ICANS) nor dose-limiting toxicities were reported.

Prof. Simone Thomas, from the Department of Internal Medicine III of the University Hospital Regensburg and Regensburg Center for Interventional Immunology, Principal Investigator of the study: "New treatment options are urgently needed for usually elderly patients with relapsed or refractory AML or MDS after previous treatments, given the high mortality associated with progressive disease. MDG1011 appeared to be safe and well tolerated applying up to 5 million PRAME-specific TCR-transduced T cells per kg body weight, and the trial as such may open an avenue for further investigation of MDG1011."

Prof. Dolores Schendel, Chief Executive Officer and Chief Scientific Officer at Medigene: "Our special thanks go to all patients who participated in the study and to the entire study team for their efforts and contribution.

Elderly patients who have undergone multiple lines of pre-treatment and suffer from advanced hematological disease, present special challenges for successful manufacture of TCR-Ts. Therefore, we are pleased with the very high rate of success in the manufacture of the necessary numbers of CD8+ PRAME-specific TCR-positive T cells for each individual patient. Observed recoveries from cryopreserved TCR-T cells enabled simplified logistics to be used for delivery of qualified drug products to distant centers for timely application in patients.

Further data on immunological function of TCR-T cells in conjunction with signs of biological activity in vivo and potential impact on clinical outcomes over time, will be provided when current follow-up studies have been completed."

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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 PRAME

PRAME (PReferentially expressed Antigen in MElanoma) is a tumor antigen of the cancer-testis-antigen family which is over-expressed in various solid tumors. Expression in healthy tissue is limited to the testis, which itself is an immuno-privileged tissue that usually cannot be attacked by the body’s own immune cells. This makes PRAME very suitable as a target antigen for TCR-T therapies.

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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E-mail: investor@medigene.com

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