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 (pta032/21.12.2021/15:15 UTC+1)

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.

(end)