information: Submission of a clinical trial application
Announcement: submission of a clinical trial application
Company: Medigene (Germany)
mechanism: cell therapy. MDG1011 has been developed with Medigene's TCR technology for adoptive T-cell therapy. This echnology aims at arming the patient's own T cells with tumor-specific T-cell receptors (TCRs). The receptor-modified T cells are then able to detect and efficiently kill tumor cells. This immunotherapy approach attempts to overcome the patient's tolerance towards cancer cells and tumor-induced immunosuppression by activating and modifying the patient's T cells outside the body (ex vivo).
TCR therapy is developed to utilize a higher number of potential tumor antigens than other T cell-based immunotherapies, such as chimeric antigen receptor T cell (CAR T) therapy.
Disease: advanced hematological diseases, namely acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and multiple myeloma (MM)
area: Cancer - Oncology
- • On July 10, 2017, Medigene announced that the company has filed a clinical trial authorization application (CTA) to begin its first clinical trial with its proprietary T-cell receptor- (TCR) modified T cells as an immunotherapy to treat a range of blood cancer indications. The CTA was submitted to the German authority Paul-Ehrlich-Institute (PEI) .
- Medigene expects to start this trial by year end 2017.
- Medigene intends to start a combined Phase I/II safety and feasibility clinical trial of its TCR therapy MDG1011, subject to regulatory approval. MDG1011 targets PRAME and will be evaluated in patients with advanced hematological diseases, namely acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and multiple myeloma (MM). The final study design will be made available after CTA approval by PEI. To date, no clinical trials utilizing TCR- modified T cells have been conducted in Germany.
- The CTA submission triggers a final milestone payment of € 2.0 million from Medigene AG to the former contributing shareholders of Medigene Immunotherapies (formerly: Trianta Immunotherapies) within the next five months. Medigene intends to settle this payment through the issuance of new shares from authorized capital. The milestone payment was an agreed part of the purchase price for the acquisition of Trianta in January 2014. With this third and final milestone payment, the total purchase price of approximately € 10 million will have been entirely settled.