OSSM-007 / Ossium Health - LARVOL DELTA

Tissue Distribution and Pharmacokinetics of Repeatedly Intravenously Dosed Mesenchymal Stem Cells in Severely Immunocompromised Mice (TCT-ASTCT-CIBMTR 2024) - "We conducted a biodistribution study in mice to (1) determine the total body exposure and persistence of OSSM-007 with intravenous administration at a dose of 2 million cells/mouse and (2) to determine the effects of IFNg priming by comparing to unprimed MSC (OSSM-001). Furthermore, incubation with IFNg (OSSM-007) did not appear to have a noticeable impact on the biodistribution or persistence of BM-MSC administered intravenously. Combined with contemporaneous tumorigenicity and toxicity study, these results indicate that systemic exposure of multiple OSSM-007 doses that are equivalent to 4.8 billion/60 kg patient is transient and safe."

PK/PD data • Preclinical • Acute Graft versus Host Disease • Aplastic Anemia • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Oncology • Transplantation • IFNG

Establishing Safety of a Novel Mesenchymal Stem Cell Therapy to Support a First-in-Human Dose Escalation Study in Steroid-Refractory aGVHD Patients (TCT-ASTCT-CIBMTR 2024) - "In conclusion, the no observable adverse effect level (NOAEL) with repeated intravenous infusion of OSSM-007 was approximately 80 million/kg or 100 million/kg average weight (male or female mice, respectively), which is equivalent to nearly 5 Billion cells/60 kg patient. This study establishes the safety of repeated high doses of OSSM-007 to support pending clinical trials in adult SR-aGVHD patients."

Clinical • P1 data • Acute Graft versus Host Disease • Aplastic Anemia • Fibrosis • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Oncology • Transplantation • IFNG

Ossium Health Awarded $3.46M in Funding from the California Institute of Regenerative Medicine (CIRM) to Advance the Development of OSSM-007 for the Treatment of Steroid-Refractory Acute Graft versus Host Disease (GVHD) (Businesswire) - "Ossium Health, Inc. announced today that the California Institute of Regenerative Medicine (CIRM) has awarded the company a $3.46M Clinical Stage Research Program (CLIN1) grant to support the continued clinical development of OSSM-007, Ossium’s interferon-gamma primed mesenchymal stem cell product, for the treatment of steroid-refractory acute graft versus host disease (GVHD). This funding will support and accelerate pre-clinical and manufacturing activities for OSSM-007, with plans to initiate clinical study activities by the end of 2023."

Financing • New trial • Acute Graft versus Host Disease • Graft versus Host Disease • Immunology