MENLO PARK, CA, February 11, 2021 – Orca Bio, a clinical-stage biotechnology company developing high-precision investigational cell therapies, today announced updated clinical data from its first-generation investigational therapy Orca-T, which was presented at the 2021 TCT Meetings of ASTCT and CIBMTR by Everett Meyer, MD, PhD, Assistant Professor of Medicine, Blood and Marrow Transplantation at Stanford University.I

Results from multicenter (NCT04013685) and single-center (NCT01660607) phase I/II trials showed that patients receiving Orca-T (n=50) with single-agent GvHD prophylaxis demonstrated improved 1-year GvHD-free and Relapse-Free Survival (GRFS) (75% vs 31%) when compared with a cohort of patients who received a standard-of-care (SOC) hematopoietic stem cell transplant (HSCT) (n=144) and 2-agent GvHD prophylaxis.

As of the data cut-off, Orca-T plus single-agent GvHD prophylaxis was well-tolerated in the clinical trial, with a decreased incidence of grade 2+ acute GvHD (at 100 days: 10% vs 30%) and chronic GvHD (at 365 days: 3% vs 46%). The high-precision investigational cellular products continue to be successfully manufactured and scaled in a central facility and were delivered to patients at multiple clinical sites with a vein-to-vein time of less than 72 hours. The presentation can be viewed on the Orca Bio website.

“Orca-T continues its groundbreaking performance in our phase 1b clinical trial where it is under investigation to improve survival by preventing transplant-related mortality, aGvHD, and cGvHD,” said Nate Fernhoff, PhD, Chief Scientific Officer at Orca Bio.