Press release

Menlo Park, CA

February 11, 2021

Orca Bio Announces Updated Orca-T Clinical Data Presented at the 2021 TCT (Transplantation & Cellular Therapy) Meetings of the American Society of Transplantation and Cellular Therapy (ASTCT) and Center for International Blood & Marrow Transplant Research (CIBMTR)

Orca-T (n=50) with single agent graft versus host disease (GvHD) prophylaxis when compared to a cohort of patients who received a standard-of-care (SOC) hematopoietic stem cell transplant (HSCT) (n=144) and two-agent GvHD prophylaxis demonstrated:


●     Improved 1-year GvHD-free and Relapse-Free Survival (GRFS) (75% vs 31%)

●     Decreased incidence of grade 2+ acute GvHD (aGvHD) at 100 days (10% vs 30%)

●     Decreased chronic GvHD (cGvHD) at 365 days (3% vs 46%)

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

Results from multi-center (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 to a cohort of patients who received a standard-of-care (SOC) hematopoietic stem cell transplant (HSCT) (n=144) and two-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 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, Ph.D., Chief Scientific Officer at Orca Bio.

“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, Ph.D., Chief Scientific Officer at Orca Bio.

About Orca-T

Orca-T is an investigational high-precision allogeneic cellular therapy consisting of infusions containing regulatory T-cells, conventional T-cells and CD34+ stem cells derived from peripheral blood from either related or unrelated matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration and is being studied to treat multiple hematologic malignancies.

About Orca Bio

Orca Bio is a clinical-stage biotechnology company developing a pipeline of high-precision allogeneic cell therapy therapies with the goal of safely and effectively replacing a patient’s diseased blood and immune system with a healthy one. Orca Bio’s products are biologic cell therapies designed to provide targeted donor cells to patients with the goal of increasing survival rates while decreasing toxicities. The company’s proprietary therapeutic and manufacturing platforms are exclusively licensed from Stanford University. For more information, visit www.orcabio.com. Follow Orca Bio on Twitter: @orcabio.

Orca Bio Media Contact:

media@orcabio.com

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