HA-1-specific T cell receptor therapy(MediGene AG)

It’s been several months since Medigene AG laid out plans to devote itself to solid tumors. In keeping with that promise, the German biotech said Thursday that it’s cutting an early-stage TCR-T therapy for relapsed or refractory blood cancer patients — after researchers blamed the pandemic in part for their failure to dose any patients in the first seven months of a Phase I trial. The candidate, MDG1021, was licensed from the Leiden University Medical Center at the end of 2018, about a year after Medigene out-licensed its AAV-like particle tech to focus on T cells and immunotherapy. It targets a specific, immunogenic form of the antigen HA-1, which is expressed on cells of the hematopoietic system. The idea is that if the patient’s blood cells, — and thus lymphoma or leukemic cells — carry the immunogenic version of the HA-1 antigen and the donor stem cells do not, MDG1021 TCR-T cells would fight the patient’s cancer cells while allowing the donor cells to repopulate the patient’s blood forming system. MDG1021 entered a Phase I trial in patients with relapsed or persistent blood cancers after allogeneic hematopoietic stem cell transplantation (allo-HSCT) back in July. But Medigene saw a long road ahead, so it veered off in a different direction — putting part of the blame on Covid-19. The company’s stock slipped 4% on the news. “We believe the challenges of recruiting patients for this program have been exacerbated under the prevailing pandemic conditions and that this situation is unlikely to improve substantially over the coming months, leading us to this difficult decision,” chief medical and development officer Kai Pinkernell announced. No patients have been dosed since recruitment opened for a Phase I trial in July, Pinkernell said in a call with investors on Thursday morning. Medigene still has a few other TCR-T candidates up its sleeve, including MDG1011, which CEO Dolores Schendel says is “front and center” at the clinical level. That candidate’s in an ongoing Phase I trial in AML and MDS. There’s also an undisclosed candidate in development with bluebird bio, and a program in development with Cytovant, a biotech launched by Sinovant and Roivant. As for MDG1021, Medigene says it’s in discussions to return the development and commercialization rights to LUMC.