IRW-PRESS: Medigene AG: Medigene AG: Medigene presents new data on the reproducible production of TCR-T cells from the MDG1011 program
Corporate announcement for the capital market
Planegg/Martinsried (pta021/08.11.2022/15:00) – Medigene AG (Medigene, FWB: MDG1, Prime Standard), an immuno-oncology company with clinical projects focused on the development of differentiated T-cell-targeted cancer therapies, today presents presented new data on the reproducible production of TCR-T cells in elderly, heavily pretreated blood cancer patients at the Cell UK Conference, taking place in London on November 7th and 8th, 2022. The presentation (in English) can be found on the Medigene website: https://www.medigene.de/technologies/abstracts
MDG1011 is an autologous TCR-T therapy specific for a peptide fragment of the tumor antigen PRAME (PReferentially expressed antigen in MElanoma) presented on cancer cells by the human leukocyte antigen HLA-A2. Manufacturing MDG1011 presented challenges for some participants in a phase I dose escalation study (NCT03503968 (https://clinicaltrials.gov/ct2/show/NCT03503968)) because these patients had blood cancers, were heavily pretreated, and were elderly . All of these are factors that can affect the quality of T cells. Leukapheresis was performed to obtain the patient-specific T cells for the production of MDG1011. Blood cancer cells were found in high concentrations in the blood of several patients, which can affect the production process and the purity of the finished MDG1011 drugs. Nevertheless, using a semi-automated, modular manufacturing process, TCR T cells could be produced for twelve out of thirteen patients, which corresponds to a success rate of 92%. Evaluation of immunoreactivity showed high anti-tumour activities for all MDG1011 end products as a potential marker for efficacy.
Production of MDG1011 and functional activity
The patients underwent leukapheresis and CD8+ T cells were enriched and cryopreserved for use in the production of MDG1011. After thawing and activation, the PRAME-specific T-cell receptor was introduced into the CD8-positive T-cells by retroviral gene transfer. Expansion and cryopreservation of TCR-T cells allowed later shipment to the appropriate clinical centers where they could be thawed and administered to patients as a single infusion. GMP manufacturing and quality control processes and subsequent immunoassay of the thawed MDG1011 end products demonstrated the following:
* Successful generation of highly enriched CD8+ TCR-T cells despite high variability in leukapheresis-derived starting materials. The MDG1011 end products did not show any residual blood cancer cells.
* Sufficient production of TCR T cells expressing the PRAME-specific T cell receptor for a phase I dose escalation study of MDG1011
* High viability of MDG1011 in all phases of the production process both before and after cryopreservation
* Polyfunctional cytokine secretion and killing of tumor cell lines after antigen-specific stimulation in vitro for all MDG1011 products
* Preserve various subsets of T cells during the manufacturing process of MDG1011 products, including stem memory T cells, central memory T cells and other effector memory T cells.
Overall, MDG1011 could be reproducibly produced with variable starting material from older, heavily pretreated patients with blood cancer. The TCR T cells showed excellent viability after thawing and antigen-specific polyfunctional cytokine secretion was observed in all MDG1011 products prepared from matched patients.
Prof. Dolores Schendel, Chief Scientific Officer at Medigene: “The manufacture of functionally effective MDG1011 products is crucial for the clinical benefit in the treatment of patients. We are pleased that we can also do this for MDG1011 products, which are used for elderly patients with relapsing or refractory blood cancers, with a very high success rate. The robust process resulted in highly purified, high-quality, polyfunctional CD8+ TCR-T cells. The blood cancer insights obtained here provide important insights for our development of novel TCR-T therapies for patients with solid tumors.”
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About Medigene
Medigene (FWB: MDG1) is a late-stage preclinical immuno-oncology company focused on the discovery and development of differentiated, next-generation cell therapies to improve the quality of life of cancer patients. With an end-to-end technology platform built on multiple proprietary and exclusive product improvement and product development technologies, Medigene aims to develop leading-edge T-cell receptor-modified T-cell (TCR-T) therapies that both optimized in terms of safety and effectiveness. Medigene’s strategy is aimed at developing product candidates both for its own pipeline and for partnerships. Further information at https://www.medigene.de
About Medigene’s TCR-Ts
T cells are at the heart of Medigene’s therapeutic approaches. With the help of Medigene’s immunotherapies, the patient’s own defense mechanisms are to be activated and T cells prepared to fight tumor cells. Medigene’s therapies aim to equip the patient’s own T cells with tumor-specific T cell receptors (T cell receptor, TCR). The resulting TCR-T cells should be able to recognize and efficiently destroy tumor cells.
This immunotherapeutic approach tries to overcome the existing tolerance towards the cancer cells and the tumour-induced suppression of an immune response in the patient. For this purpose, the patient’s T cells are activated outside the body, genetically modified with tumor-specific TCRs and then multiplied. This means that a large number of specific T cells that can fight the tumor can be made available to patients within a short period of time.
About PRAME
PRAME (PReferentially expressed antigen in MElanoma) is a tumor antigen from the cancer testis antigen family that is overexpressed in various solid tumors. Expression in healthy tissues is restricted to the testes, which is itself an immune-privileged tissue that cannot normally be attacked by the body’s immune cells. This makes PRAME very suitable as a target antigen for TCR-T therapies.
This release contains certain forward-looking statements. These reflect Medigene’s position as of the date of this announcement. The results actually achieved by Medigene may differ significantly from the statements made in the forward-looking statements. Medigene is not obliged to update forward-looking statements. Medigene® is a trademark of Medigene AG. This mark may be owned or licensed in select countries.
For reasons of easier readability, no gender-specific differentiation is made. Corresponding terms apply to both genders in terms of equal treatment.
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Sender: Medigene AG
Address: Lochhamer Strasse 11, 82152 Planegg/Martinsried
Country Germany
Contact: Medigene PR/IR
Phone: +49 89 2000 3333 01
Email: [email protected]
Website: www.medigene.de
ISIN(s): DE000A1X3W00 (Share)
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