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MediGene announces details of first clinical trial in TCR cancer immunotherapy.

M2 PHARMA-March 23, 2017-MediGene announces details of first clinical trial in TCR cancer immunotherapy


Biotechnology company MediGene AG (ETR: MDG1) plans to start its first clinical trial with T-cell receptor modified T cells in late 2017, the company announced on Thursday.

The trial will involve an HLA-A2:01-restricted T-cell receptor (TCR) that targets PRAME (Preferentially Expressed Antigen in Melanoma), a well characterised tumour antigen. PRAME was first discovered in melanoma and is overexpressed in numerous solid cancer indications as well as several haematological malignancies. The TCR candidate was found to demonstrate favourable safety and efficacy in preclinical studies, MediGene explained.

Subject to regulatory approval, MediGene plans to begin a combined Phase I/II safety and feasibility trial of its TCR targeting PRAME, named MDG1011, in patients with advanced haematological diseases, particularly acute myeloid leukaemia (AML), myelodysplastic syndrome (MDS) and multiple myeloma (MM).

The Phase I part of the trial will focus on dose escalation, testing up to four dose cohorts in 3+3 design. The chosen dose will then be further tested in Phase II. This part of the trial will include a prospective control group and could potentially be extended into further malignancies.

Following approval for the clinical trials by the competent authority, MediGene will announce the final details, including trial size, study sites and timelines.

The company will present data on its selected TCR candidate at the upcoming American Association for Cancer Research (AACR) annual meeting, which will take place in Washington DC, US.

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Publication:M2 Pharma
Date:Mar 23, 2017
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