Medigene Provides Results for Fiscal Year 2019 and Outlook

Conference call on 26 March 2020 at 4pm CET (Frankfurt) / 11am EDT (New York)

MARTINSRIED, Germany and MUNICH, Germany, March 26, 2020 (GLOBE NEWSWIRE) -- Medigene AG (MDG1, Frankfurt, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies for the treatment of cancer, today published its financial results and Annual Report for the 2019 financial year and its outlook for the current 2020 financial year. The full version of the Annual Report 2019 can be downloaded here: http://www.medigene.com/investors-media/reports-presentations/

Company highlights in 2019 and since period end:

T cell receptor-modified T cell therapies (TCR-Ts)

• Medigene commences treatment of patients in the Phase I/II trial of its first TCR-T immunotherapy MDG1011 against several blood cancers and opens additional clinical trial sites.
  
  
• MDG1021 from Leiden University Medical Center (LUMC) was selected as next clinical TCR-T development candidate for testing in patients with relapsed or persistent hematologic malignancies after allogeneic hematological stem cell transplantation (allo-HSCT).
  
  
• Medigene developed the inducible Medigene TCR (iM-TCR) and in-licensed the PD1-41BB switch receptor from Helmholtz Zentrum München (HMGU) for an improved safety and activity of Medigene's TCR-T candidates and future applications in solid tumors.

Dendritic cell (DC) vaccine

• Medigene completed the Phase I/II clinical trial of the DC vaccine in AML patients in December 2019 and reported positive final 2-year topline results in January 2020. These results were consistent with the 12-month interim analysis presented in 2019.

Partnerships

• Medigene and Roivant Asia Cell Therapy Holdings Ltd. (a subsidiary of Roivant Sciences Ltd.) on behalf of Cytovant Sciences Co. Ltd. entered into a strategic license and cooperation agreement for cell therapies in Asia. Medigene received an upfront payment of US $10 m and is eligible to receive potential development, regulatory, and commercial milestone payments.
  
  
• bluebird bio Inc. presented preclinical data on the first therapeutic TCR-T candidate arising from the Medigene collaboration targeting the tumor antigen MAGE-A4 which is expressed by a variety of solid tumor types. bluebird bio announced its intention to start clinical development of the MAGE-A4 TCR-T candidate in 2020.
  
  
• The remaining rights to the non-core product Veregen and the complete stock of the corresponding active pharmaceutical ingredient were sold to the German pharmaceutical company Aresus Pharma GmbH.