MaaT013 fecal microbiotherapy modulates key gastro-intestinal and immunological processes involved in GvHD pathogenesis in vitro and in vivo

Background

Acute graft-vs.-host disease (aGvHD) is a life-threatening complication of allogeneic hematopoietic cell transplantation (allo-HCT), where allogeneic donor T cells recognize recipient tissues as foreign and damage them. Gut microbiota disruption following allo-HCT has been associated with increased aGvHD incidence, severity, and mortality. Growing clinical evidence suggests the efficacy of fecal microbiotherapy to restore a healthy and diverse gut microbiota and to treat aGvHD. MaaT013 (Xervyteg®), a standardized allogeneic fecal microbiotherapy derived from pooled healthy human fecal microbiota, has demonstrated efficacy in mitigating steroid-refractory aGvHD in the Phase 2 HERACLES trial, and is currently being evaluated in the pivotal ARES trial in ruxolitinib-resistant aGvHD with gastrointestinal involvement.