On November 5, 2024 Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, reported that new clinical data will be presented in three oral sessions at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting from December 7-10 in San Diego, CA (Press release, Orca Bio, NOV 5, 2024, View Source;utm_medium=rss&utm_campaign=orca-bio-to-present-clinical-data-on-its-high-precision-cell-therapies-at-the-66th-american-society-of-hematology-annual-meeting [SID1234647736]).
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Three-year survival data with Orca Bio’s lead investigational allogeneic T-cell immunotherapy, Orca-T, will be presented from the multicenter Phase 1b clinical trial of patients with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and high-risk myelodysplastic syndrome (MDS). Additionally, initial feasibility, safety and efficacy data from an investigator-sponsored trial evaluating the combination of Orca-T with allogeneic CD19/CD22-CAR-T cells in patients with high-risk B-cell acute lymphoblastic leukemia (B-ALL) will be shared. In a third oral session, data from a multicenter Phase 1 clinical trial will be presented from patients treated with Orca Bio’s second-generation investigational allogeneic T-cell immunotherapy, Orca-Q, in patients with hematologic malignancies without the use of any post-treatment graft versus host disease (GvHD) prophylaxis.
"We are pleased to present exciting new data from our lead clinical programs for patients with blood cancers, including three-year follow-up with Orca-T, our lead cell therapy candidate currently being evaluated in a pivotal Phase 3 clinical trial," said Ivan Dimov, Ph.D., co-founder and chief executive officer of Orca Bio. "We also look forward to debuting the results of patients treated with Orca-Q without the use of any GvHD prophylaxis. Overall, these findings represent important progress toward our goal of delivering our high-precision approach to more patients who could potentially benefit."
The ASH (Free ASH Whitepaper) abstracts are now available at www.hematology.org. Details of the Orca Bio oral presentations follow:
Oral Session: 732. Allogeneic Transplantation: Disease Response and Comparative Treatment Studies: Finding the Ideal Donor and Graft: Going Beyond HLA
Title: Observational Comparison of Overall Survival between Phase 1b Orca-T and Registry-Based Post-Transplant Cyclophosphamide Patients
Abstract Number: 694
Date and Time: Sunday, December 8, 2024 at 5:15 PM PT
Location: San Diego Convention Center, Room 6A
Oral Session: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: B Cell-directed CAR T Cell Therapies for ALL and for Autoimmunity
Title: Safe and Effective Combination of Donor-Derived, Allogeneic CD19/CD22-CAR T Cells with Myeloablative Graft-Engineered Allo-HCT for High-Risk B-ALL
Abstract Number: 679
Date and Time: Sunday, December 8, 2024 at 4:30 PM PT
Location: Marriott Marquis San Diego Marina, Marriott Grand Ballroom 2-4
Oral Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Monitoring, Understanding and Optimizing GVHD Interventions
Title: Preliminary Safety and Efficacy of Myeloablative Orca-Q with No GvHD Prophylaxis for Treatment of Advanced Hematologic Malignancies
Abstract Number: 382
Date and Time: Saturday, December 7, 2024 at 4:45 PM PT
Location: San Diego Convention Center, Room 6CF
About Orca-T
Orca-T is an investigational allogeneic T-cell immunotherapy being evaluated in clinical trials for the treatment of multiple hematologic malignancies. Orca-T is comprised of highly purified 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 which has completed enrollment at leading transplant centers across the U.S. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration.
About Orca-Q
Orca-Q is Orca Bio’s second-generation investigational allogeneic T-cell immunotherapy being evaluated in clinical trials for the treatment of multiple hematologic malignancies, including in patients with haploidentical donors. Orca-Q is a proprietary composition of stem cells combined with specific T-cell subsets derived from healthy donors and engineered by Orca Bio’s high-precision platform.