MDG1021 / Medigene - LARVOL DELTA

FOCUS ON SOLID TUMORS - DISCONTINUATION OF MDG1021 DEVELOPMENT PROGRAM (MediGene Press Release) - "The Executive Management of Medigene AG...with approval of the Supervisory Board decided today that, consistent with the company's recent decision to focus its development efforts on solid tumors, the MDG1021 development program is to be discontinued....Recruitment for the Phase I clinical trial of the T cell receptor-modified T cell (TCR-T) therapy MDG1021 directed against the antigen HA-1 in patients suffering from relapsed or persistent blood cancers after allogeneic (non-self) hematopoietic stem cell transplantation, which was initiated at the Leiden University Medical Centre (LUMC) in the Netherlands in mid-2020, will be put on hold with immediate effect. Discussions are ongoing with the LUMC regarding the potential assumption of the sponsorship role by the LUMC with continuation of the study under LUMC's responsibility and return of the development and commercialization rights to the HA-1-specific TCR acquired from LUMC in November 2018."

Clinical • Discontinued • Enrollment status • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Multiple Myeloma • Myelodysplastic Syndrome • Myelofibrosis • Myeloproliferative Neoplasm • Oncology

Medigene enters Phase I clinical development with its TCR-T immunotherapy MDG1021 in hematological cancers (GlobeNewswire) - "Medigene...has received approval from the Dutch regulatory authority (the Central Committee on Research Involving Human Subjects, CCMO) to begin a first clinical trial of MDG1021. MDG1021, which targets the antigen HA-1, thus becomes Medigene’s second proprietary T cell receptor-modified T cell (TCR-T) immunotherapy candidate to enter clinical development. The Phase I study of MDG1021 will be initiated at the Leiden University Medical Center (LUMC), the Netherlands, and will enroll patients suffering from relapsed or persistent blood cancers after allogeneic (non-self) hematopoietic stem cell transplantation (allo-HSCT), an area with high unmet medical need."

New P1 trial • Hematological Malignancies • Oncology

Medigene reports financial & business results for the first six months of 2019 (MediGene Press Release) - "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...In addition, Medigene continues its successful collaboration with bluebird bio and expects to make further progress on TCR candidate discovery. bluebird bio announced to commence clinical development in solid tumors with the first TCR from this partnership (a TCR targeting MAGE-A4) in 2020."

Clinical • Enrollment open • Licensing / partnership • New P1 trial