Medigene AG

Medigene reports financial & business results for the first six months of 2019

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Martinsried/Munich (pta006/07.08.2019/07:30) - August 07, 2019. Medigene AG (FSE: MDG1, Frankfurt, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, today reported on their business performance and financial results for the first half of 2019. In the first six months of 2019, the Company made additional advances in their immunotherapy programs and reported a significant revenue increase, primarily due to the partnerships with bluebird bio and Roivant/Cytovant. Medigene confirms the financial guidance for the fiscal year 2019.

"In the first half of 2019, we reported on clinical progress for three TCR therapy projects. Importantly, we initiated patient treatment in our ongoing study with Medigene's first TCR therapy, MDG1011. We also commenced preparations for the Phase I trial of our second TCR therapy, MDG1021, with Leiden University Medical Center, scheduled to start in 2020. Additionally, our partner bluebird bio announced its intention to start a Phase I clinical trial in 2020 with the first TCR from our partnership. Also, Medigene was able to present promising clinical interim results from our DC vaccine trial," said Prof. Dolores Schendel, CEO/CSO of Medigene AG. "In addition, we established an important strategic partnership with Roivant/Cytovant for cellular therapies in Asia which will enable us to bring much needed treatment alternatives to this patient population. We are very pleased with the progress we have made this year and look forward to making further advancements with our proprietary immunotherapy programs as well as with those of our partners in the coming months."

Major events since the beginning of 2019:
- In June, Medigene presented an interim analysis from its ongoing Phase I/II clinical trial with dendritic cell (DC) vaccines in acute myeloid leukemia (AML) patients at the congress of the European Hematology Association (EHA). The completion of the ongoing trial is scheduled for the end of 2019, following a two-year treatment period.
- In May, Medigene entered into a clinical trial agreement for its second T cell receptor (TCR) immunotherapy MDG1021 with Leiden University Medical Center. The Phase I clinical trial using an HA-1-specific TCR is scheduled to start in 2020 as Medigene's second company-sponsored clinical TCR-T trial.
- In May, Medigene's partner bluebird bio presented preclinical data for the first TCR candidate from the Medigene collaboration. The data demonstrated a high antigen sensitivity of the MAGE-A4-TCR, with strong recognition of tumor cell lines and durable tumor elimination in a subcutaneous in vivo melanoma model. Additionally, the data showed functional responses in both CD8+ and CD4+ T cell populations, demonstrating that addition of the CD8 co-receptor will not be needed for use of this MAGE-A4-TCR in solid tumors. bluebird bio intends to commence clinical development of the TCR targeting the MAGE-A4 tumor antigen in 2020; bluebird bio may potentially combine this highly active TCR with other technologies to enhance T cell function in solid tumor microenvironments in next generation programs.