Orca Bio to Present Positive AML Outcomes with Orca-T at 2024 ASCO Meeting

Orca Bio, a biotechnology firm specializing in high-precision cell therapies, is set to present compelling new data at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The event will be held in Chicago, Illinois, from May 31 to June 4. The focus will be on the outcomes of Orca Bio's leading investigational allogeneic T-cell immunotherapy, Orca-T, in treating patients with acute myeloid leukemia (AML).

AML, the most prevalent acute leukemia in adults, poses a significant health threat with an estimated 20,800 new cases and almost 11,200 deaths annually in the United States alone. Traditional treatments, such as allogeneic hematopoietic stem cell transplants, carry considerable risks, which limit their curative potential for many patients. Dr. Rawan Faramand from Moffitt Cancer Center highlighted the potential of Orca-T to mitigate these risks, offering a curative option with lower treatment-related mortality.

The promising results come from a new subanalysis of an ongoing multi-center Phase 1b single-arm trial. This study involved 37 AML patients with a median age of 51 and a median follow-up period of 14 months. All participants underwent myeloablative conditioning with busulfan, fludarabine, and thiotepa before receiving Orca-T and single-agent graft versus host disease (GvHD) prophylaxis using tacrolimus. The findings are noteworthy: at the 12-month mark, relapse-free survival was 82.5% and overall survival was 100%, while non-relapse mortality was 0%. The safety profile for Orca-T was consistent with the broader Phase 1b population, showing no new safety concerns. Additionally, Orca-T was reliably manufactured and delivered within 72 hours across the U.S.

Scott McClellan, Chief Medical Officer at Orca Bio, expressed optimism about the data being presented at ASCO, emphasizing the potential of Orca-T to meet a significant unmet need in AML treatment. The new findings support Orca Bio's mission of expanding life-saving treatments to patients with limited options.

The details of the presentation are as follows:
- Title: Treatment of Acute Myeloid Leukemia with Orca-T
- Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
- Abstract Number: 6552
- Poster Code: 111
- Date and Time: June 3, 2024, from 9 AM to 12 PM CDT
- Location: Oncology Professionals Hall

Orca-T, an investigational therapy, is being evaluated in clinical trials for various hematologic malignancies. It includes infusions of highly purified regulatory T-cells, CD34+ stem cells, and conventional T-cells sourced from either related or unrelated donors. Orca-T is currently in a pivotal Phase 3 clinical trial across major U.S. transplant centers and has received the Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration.

Orca Bio, the company behind Orca-T, is a late-stage biotechnology firm focused on developing high-precision cell therapies for cancer, autoimmune diseases, and genetic blood disorders. The company aims to replace diseased blood and immune systems with healthy ones, offering significantly better outcomes with fewer risks than current standard treatments. Orca Bio's innovative manufacturing platform uses single-cell precision to create proprietary products that could redefine the future of allogeneic cell therapy.

Orca Bio remains dedicated to making curative cell therapies more effective and safer, aiming to break through current limitations and set new standards in the field.

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