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Orca Bio Unveils Promising Clinical Data in Hematology Showcase

Orca Bio Unveils Promising Clinical Data in Hematology Showcase

Orca Bio Showcases Innovative Data at Renowned Hematology Meeting

Orca Bio, an innovative biotechnology company based in Menlo Park, is committed to advancing the field of high-precision cell therapy. This dedication has culminated in the exciting announcement that new clinical data will be shared during three key oral sessions at the upcoming American Society of Hematology (ASH) Annual Meeting.

Key Data to Be Presented

Among the highlights of Orca Bio's presentation is the three-year survival data associated with its lead investigational therapy, Orca-T. This data arises from a multicenter Phase 1b clinical trial focused on patients diagnosed with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), and high-risk myelodysplastic syndrome (MDS). Remarkably, additional initial feasibility, safety, and efficacy data from an investigator-sponsored study that combines Orca-T with allogeneic CD19/CD22-CAR-T cells for patients with high-risk B-cell acute lymphoblastic leukemia (B-ALL) will also be revealed.

More About the Clinical Trials

Furthermore, details from another multicenter Phase 1 clinical trial showcasing the use of Orca Bio’s next-generation therapy, Orca-Q, will be unveiled. This trial pertains to patients suffering from hematologic malignancies who did not require any post-treatment graft-versus-host disease (GvHD) prophylaxis.

“We are thrilled to showcase promising new data documenting our lead clinical programs targeting blood cancers,” stated Ivan Dimov, Ph.D., co-founder and CEO of Orca Bio. He expressed optimism regarding the findings, particularly the three-year follow-up data from Orca-T, which is currently being studied in a pivotal Phase 3 clinical trial. “Moving forward, we are eager to present results from patients treated with Orca-Q, showcasing the absence of GvHD prophylaxis. Overall, these findings mark significant strides towards our mission of making our high-precision approach accessible to more patients,” he explained.

Details of the Oral Sessions

The ASH Annual Meeting promises to be an insightful occasion, with abstracts now available for attendees. Below are the details of the Orca Bio presentations:

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 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 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 at 4:45 PM PT
Location: San Diego Convention Center, Room 6CF

The Science Behind Orca-T

Orca-T, a remarkable investigational allogeneic T-cell immunotherapy, is currently undergoing evaluation in clinical trials targeting various hematologic malignancies. The therapy is composed of a highly purified population of regulatory T-cells, CD34+ stem cells, alongside conventional T-cells, all sourced from matched donors. As of now, Orca-T is being assessed in a pivotal Phase 3 clinical trial that has successfully completed its enrollment phase across top transplant centers in the U.S. Moreover, it has been recognized by the U.S. Food and Drug Administration with Regenerative Medicine Advanced Therapy (RMAT) designation.

Insights into Orca-Q

The second-generation investigational treatment, Orca-Q, is designed as a follow-up to the success of Orca-T and continues to be evaluated for its efficacy in treating multiple hematologic malignancies. This innovative therapy utilizes a proprietary blend of stem cells paired with specialized T-cell subsets derived from healthy donors. Utilizing Orca Bio's high-precision platform, Orca-Q showcases the company's commitment to enhancing patient treatment options.

About Orca Bio

As a late-stage biotechnology company, Orca Bio aims to develop high-precision cell therapies specialized in addressing cancer and autoimmune diseases. Their investigational products focus on replacing patients' diseased blood and immune systems with healthier alternatives, ultimately enhancing treatment outcomes with reduced risks compared to conventional methods. With a cutting-edge manufacturing platform, Orca Bio harnesses single-cell precision to craft proprietary products that may revolutionize allogeneic cell therapy. Their mission is to elevate cell therapies, making them both more effective and safer, while redefining the future of medical treatment.

Frequently Asked Questions

What is the primary focus of Orca Bio's research?

Orca Bio specializes in high-precision cell therapies aimed at treating cancer and autoimmune disorders.

What types of therapies does Orca Bio offer?

The company offers investigational treatments such as Orca-T and Orca-Q for hematologic malignancies.

Where will the ASH Annual Meeting be held?

The Annual Meeting will take place at the San Diego Convention Center.

How significant is the data being presented by Orca Bio?

The presented data reflects three-year survival metrics and early feasibility findings crucial for blood cancer treatments.

What is the overarching goal of Orca Bio's therapies?

The goal is to improve patient outcomes with safer, high-precision therapeutic options.

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