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Medigene reveals pivotal blood cancer therapy data

MDG1011 is a therapy which aims to improve outcomes for patients with high-risk blood cancers.

Medigene – a company concentrating on the development of T cell immunotherapies for solid tumours – has announced final phase 1 dose-escalation results from the study of its MDG1011 candidate.

The therapy concerns high-risk myeloid and lymphoid neoplasms and the results will be shared at the European Society for Blood and Marrow Transplantation (EBMT) 2023 annual meeting this week.

The MDG1011 treatment is an autologous TCR-T therapy specific for a peptide fragment of PRAME (Preferentially expressed antigen in Melanoma) – a specific tumour antigen presented on cancer cells by the human leukocyte antigen.

During the open-label research conducted at nine clinical locations throughout Germany, 13 patients – ten with acute myeloid leukaemia (AML), two with multiple myeloma (MM) and one with myelodysplastic syndrome and myeloproliferative neoplasm (MDS/MPN) – underwent leukapheresis for TCR-T cell manufacture.

Two out of nine patients showed early response on treatment at week four and one AML patient showed complete remission at week four, but disease progression was detected at week 12. Also, one patient with multilineage MDS/MPN remained stable and did not show any progression to secondary AML throughout the 12-month trial. Four patients died from their disease, with none considered related to MDG1011.

The study also showed MDG1011 TCR-T cells were present in peripheral blood (PB) among six patients within the first four weeks, with detection still possible in the MDS/MPN patient at 12 months.

Furthermore, the provision of MDG1011 was generally well tolerated by pre-treated patients, while clinical observations were backed up by the persistence of MDG1011 cells in PB and the reduction of PRAME levels in PB.

Professor Dolores Schendel, chief scientific officer at Medigene, was optimistic about the results: “We are pleased to report the end-of-trial results for the phase 1 dose escalation study of MDG1011 which showed the potential for MDG1011 in high-risk myeloid neoplasms.”

She added: “We thank all the investigators and their staff who carried out this clinical trial and are indebted to the patients and their families who participated in this first-in-human study. As we have announced previously, despite these encouraging early data, in line with our strategy to focus on solid tumours, we are currently exploring the opportunity to partner with MDG1011 for further clinical development.”