Data provide insights into manufacturing efficiency, logistics, and early clinical outcomes of Orca-T for patients with blood cancers
MENLO PARK, CA, November 4, 2020 – Orca Bio, a clinical-stage biotechnology company, today announced that preliminary data from the phase I/II clinical trials of Orca-T (NCT04013685 and NCT01660607) will be presented at the 62nd American Society of Hematology (ASH) Annual Meeting, to be held virtually from December 5-8, 2020. Data will be presented on manufacturing, logistics, and early clinical outcomes. Patients in the Orca-T trial are compared with a retrospective contemporaneous control group from Stanford University. Everett Meyer, MD, PhD, Medical and Scientific Director of the Cellular Therapy Facility, Stanford Health Care and Assistant Professor of Medicine, Blood and Marrow Transplantation, Stanford University, will present the data.
Orca-T is a high-precision allogeneic cell therapy under investigation to replace a conventional mobilized blood product in hematopoietic stem cell transplant (HSCT). The therapy is designed with the goal of preventing graft-versus-host disease and other transplant related complications. Orca-T is manufactured via a proprietary GMP platform in a central lab. Patients with both related donors and unrelated donors are eligible and fresh, viable products are distributed to clinical sites around the continental United States. Data supporting reliability of manufacturing and transport will also be presented.
The US Food and Drug Administration has granted Orca-T regenerative medicine advanced therapy (RMAT) and orphan drug designation to treat patients eligible for a hematopoietic stem cell transplant. The RMAT designation provides Orca Bio the avenue to receive early guidance from the FDA to steer manufacturing and clinical development.
“This therapy was originally pioneered by Dr. Everett Meyer and Dr. Robert Negrin in a single-center trial at Stanford University, and Orca Bio has further developed the Orca-T drug in a multicenter trial. Leveraging the Orca Bio manufacturing platform, we aim to provide access to this potentially curative cell therapy to patients worldwide,” said Nate Fernhoff, PhD, Chief Scientific Officer and Cofounder of Orca Bio.
Details of the presentation
- Title: Orca-T, a Precision Treg-Engineered Donor Product, Prevents Acute GvHD With Less Immunosuppression in an Early Multicenter Experience With Myeloablative HLA-Matched Transplants
- Session: 722. Clinical Allogeneic Transplantation; Acute and Chronic GvHD, Immune Reconstitution: Phase I and II Trials
- Abstract: 354
- Date and time: Sunday, December 6, 2020, 9:45 AM PT
- Presenter: Everett Meyer, MD, PhD, Stanford University
- For more information visit the 62nd ASH Annual Meeting and Exposition website