On April 11, 2024 Orca Bio, a late-stage biotechnology company developing high-precision cell therapies for the treatment of cancer, autoimmune diseases and genetic blood disorders, reported new data will be presented during the 50th Annual Meeting of the EBMT in Glasgow, United Kingdom (Press release, Orca Bio, APR 11, 2024, View Source;utm_medium=rss&utm_campaign=orca-bio-to-present-positive-clinical-data-on-orca-t-at-the-50th-annual-meeting-of-the-ebmt [SID1234642014]).

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Specifically, results from a single-center open-label Phase 1 clinical trial of an expanded group of older patients (n=20) treated with Orca Bio’s lead investigational high-precision cell therapy, Orca-T, and a reduced intensity conditioning (RIC) regimen will be presented. Preliminary data with Orca-T and RIC in patients with hematologic malignancies showed encouraging rates of relapse-free survival (77%). With a median follow-up of 9.65 months, no patients have experienced relapse to date (0%), demonstrating the curative potential for Orca-T in this historically challenging to treat patient group. An earlier dataset evaluating Orca-T and RIC in this population was presented at the 2023 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

A second presentation will highlight findings from a non-randomized retrospective analysis comparing Orca-T plus single-agent tacrolimus with a standard of care allogeneic stem cell transplant (alloHSCT) plus post-transplant cyclophosphamide (PTCy)-based graft versus host disease (GvHD) prophylaxis in patients with hematologic malignancies receiving myeloablative conditioning (MAC). When compared to the historical PTCy cohort in this patient population, Orca-T offered potentially favorable rates of relapse-free survival, non-relapse mortality and overall survival. These data were previously presented at the 2024 Tandem Meetings, Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood and Marrow Transplant Research (CIBMTR).

"At Orca Bio, we continue to build clinical evidence to support the profile of Orca-T and its potential to expand life-saving treatment to patients while also reducing treatment-related risks," said Scott McClellan, M.D., Ph.D., chief medical officer at Orca Bio. "We look forward to joining top healthcare professionals from around the world at EBMT and sharing the latest findings that support the potential for Orca-T to offer a new curative solution for providers and their patients."

The EBMT abstracts are available at View Source

Details of the Orca Bio presentations follow:

Title: Phase 1 Trial Results for Patients with Advanced Hematologic Malignancies Treated with Orca-T Cell Therapy with Reduced Intensity Conditioning and Single Agent Tacrolimus

Poster Code: A121

Date and Time: Monday, April 15, 2024 at 18:00 BST

Location: Hall 3 North

Title: A Retrospective Analysis Comparing Orca-T to Post-Transplant Cyclophosphamide Based Allogeneic Hematopoietic Stem Cell Transplant in Patients with Matched Unrelated Donors Receiving Myeloablative Conditioning

Poster Code: A107

Date and Time: Monday, April 15, 2024 at 18:00 BST

Location: Hall 3 North

About Orca-T
Orca-T is an investigational high-precision allogeneic cell therapy being evaluated in clinical trials for the treatment of multiple hematologic malignancies. Orca-T includes infusions containing regulatory T-cells, CD34+ stem cells and conventional T-cells derived from peripheral blood from either related or unrelated matched donors. Orca-T is currently being evaluated in a pivotal Phase 3 clinical trial at leading transplant centers across the U.S. and has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration.