Press release

Menlo Park, CA

November 4, 2020

Orca Bio Announces Oral Presentation of Orca-T Clinical Data at the 62nd American Society of Hematology (ASH) Annual Meeting

--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 to a retrospective contemporaneous control group from Stanford University. Everett Meyer, M.D., Ph.D., 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.

"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.” (Nate Fernhoff, Ph.D.)

The U.S. 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, Ph.D., Chief Scientific Officer and Co-Founder 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 a.m. PT

Presenter: Everett Meyer, M.D., Ph.D., Stanford University

For more information, visit the 62nd ASH Annual Meeting and Exposition website

About Orca Bio

Orca Bio is a clinical-stage biotechnology company developing a pipeline of high-precision allogeneic cell therapy products. Orca Bio’s products are designed with the goal of safely and effectively replacing a patient’s diseased blood and immune system with a healthy one. 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.

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