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Orca Bio Announces Updated Orca-T Clinical Data Presented at the 2021 TCT (Transplantation & Cellular Therapy) Meetings of the American Society of Transplantation and Cellular Therapy (ASTCT) and Center for International Blood & Marrow Transplant Research (CIBMTR)

Orca Bio Announces Completion of Patient Enrollment for the Precision-T Phase 3 Study of Orca-T

Precision-T over-enrolled with 187 total patients at 19 clinical trial sites across the U.S.

Topline results expected in 1H 2025

MENLO PARK, CA, June 5, 2024 – Orca Bio, a biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced that it has completed enrollment in the pivotal Precision-T Phase 3 clinical study.

A randomized, open-label multicenter study, Precision-T (NCT05316701) is evaluating the safety and efficacy of Orca Bio’s lead investigational allogeneic T-cell immunotherapy, Orca-T, compared to a standard of care allogeneic hematopoietic stem cell transplant (alloHSCT) in patients with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and high-risk myelodysplastic syndrome (MDS). Orca-T is a donor-derived product designed to replace a patient’s diseased blood and immune system with a healthy one.

“Completing enrollment in our multicenter Phase 3 study of Orca-T is an important milestone toward our ultimate goal of delivering a potentially life-saving product to patients who have long had to settle for a standard of care that carries significant risks,” said Ivan Dimov, Ph.D., co-founder and chief executive officer of Orca Bio. “We’re immensely grateful to the patients, their families and the trial site investigators who participated in our study, and look forward to sharing pivotal data in the near future with the broader blood cancer community.”

The primary endpoint of the Precision-T study is the rate of survival free from moderate-to-severe chronic graft versus host disease (GvHD). Secondary endpoints include time to moderate-to-severe chronic GvHD, graft-versus-host-disease and relapse-free survival (GRFS) and overall survival. Topline results from the study are expected in the first half of 2025. The study has enrolled 187 patients, exceeding the original target of 174 patients.

Orca-T is designed to deliver improved outcomes for patients while overcoming the limitations of standard alloHSCT, which carries the risk of serious complications and treatment-related mortality. Orca-T uses highly purified regulatory T cells with the goal of reducing the tradeoff between the risk of relapse and the risk of serious toxicity, a primary objective of the cell therapy field. Orca-T has demonstrated promising results in early single-arm trials which were recently presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting the Annual Meeting of the EBMT, the 2024 Tandem Meetings of ASTCT® and CIBMTR® and the American Society of Hematology (ASH) Annual Meeting.

More information about the Precision-T study can be found at www.precisiontstudy.com or www.clinicaltrials.gov.

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 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.

About Orca Bio

Orca Bio is a late-stage biotechnology company developing high-precision cell therapies for the treatment of cancer, autoimmune diseases and genetic blood disorders. Our investigational products are designed to safely replace a patient’s diseased blood and immune system with a healthy one, delivering significantly better outcomes with dramatically fewer risks than the standard of care. Our manufacturing platform uses single-cell precision to create proprietary, uniquely-defined products that have the potential to transform allogeneic cell therapy. At Orca Bio, our mission is to make curative cell therapies both more effective and safer, and in doing so, push past the field’s current boundaries and redefine its future. For more information, visit www.orcabio.com and follow Orca Bio on X: @OrcaBio.

Contact:

Corporate Communications

Kelsey Grossman

media@orcabio.com

Investor Relations

Joshua Murray

ir@orcabio.com

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Orca Bio Presents Positive Data Reinforcing Clinical Profile of Orca-T and Orca-Q at 2023 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR

Three oral presentations showcase clinical evidence for Orca Bio’s promising pipeline of early- and late-stage high-precision cell therapies

Orca-T demonstrated high relapse-free survival in recipients with fully matched donors and early potential in patients with mismatched donors

Orca-Q showed improved graft-versus-host disease-free, relapse-free survival in patients with haploidentical donors

MENLO PARK, CA, February 16, 2023 – Orca Bio, a late-stage biotechnology company developing high-precision cell therapies for the treatment of cancer, genetic blood disorders and autoimmune diseases, today announced data from the company’s investigational high-precision cell therapy programs, Orca-T and Orca-Q, were presented in three oral presentations at the 2023 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR.

Positive data on Orca-T was presented from the single-center Phase 2 and multi-center Phase 1b trials of patients with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndromes (MDS) and other hematological malignancies. Outcomes with Orca-T appeared to be further enhanced in patients who received a conditioning regimen of busulfan, fludarabine and thiotepa (BFT). At 12 months, the 71 patients in the Orca-T BFT subgroup reported no non-relapse mortality (0%), and high rates of relapse-free survival (87%), graft-versus-host disease-free, relapse-free survival (GRFS) (81%) and overall survival (94%). These data were previously presented at the 64th American Society of Hematology (ASH) Annual Meeting in December 2022.

In a second oral presentation, new data highlighted how expanding the donor pool may help address disparities in access to transplant. Today, approximately 70% of blood cancer patients do not have access to a fully matched related donor, and the likelihood of a patient finding a matched unrelated donor in the U.S. is as low as 29% for some ethnic backgrounds. While the use of human leukocyte antigen (HLA) mismatched donors has increased access to treatment for these patients undergoing allogeneic hematopoietic stem cell transplant (alloHSCT), clinical outcomes have also been associated with significantly worse overall survival, disease-free survival, treatment-related mortality and acute graft versus host disease (aGvHD). In a small cohort (n=8), Orca-T demonstrated promising results in patients with HLA mismatched (7/8) donors, including no cases of severe GvHD or non-relapse mortality and 100% overall survival to date. While this early data is encouraging, more studies of Orca-T in this patient population are ongoing and will provide additional clinical data in this setting.

"As we continue to enroll patients in our pivotal Phase 3 trial of Orca-T, we are extremely encouraged by its continued potential to improve relapse-free and overall survival rates,” said Ivan Dimov, Ph.D., co-founder and chief executive officer of Orca Bio. “Beyond its promise to enhance outcomes and reduce deadly, transplant-related risks, this early evidence that Orca-T may improve clinical outcomes in patients who can’t find a fully matched donor is an important step toward our ultimate goal of offering a safe and effective treatment to all patients who may benefit.”

Orca Bio also presented findings from a Phase 1 multi-center trial of its second investigational cell therapy, Orca-Q, showing that patients with haploidentical – or half-matched – allogeneic hematopoietic stem cell donors, experienced no moderate-to-severe chronic GvHD (0%) and an improved GRFS rate (75%). Orca-Q is a proprietary composition of enriched CD34+ stem cells combined with specific T cell subsets derived from haploidentical donors. Unlike standard of care haploidentical alloHSCT, Orca-Q does not require post-transplant cyclophosphamide (PTCy). These data were also previously presented at the ASH Annual Meeting.

“A haploidentical stem cell transplant is currently the only curative treatment option available for the majority of blood cancer patients who lack a matched donor, but providers often find themselves balancing the risk of relapse and the risk of debilitating side effects like GvHD, infections and other toxicities,” said Samer Srour, M.D., Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center. “These interim findings show patients treated with Orca-Q experienced improved outcomes with significantly fewer transplant-related toxicities, suggesting this novel cell therapy could help to address this critical unmet medical need.”

Links to the abstracts follow:

Oral Presentation Title: Precision-Engineered Cell Therapy Orca-T Demonstrates High Relapse-Free Survival at 1 Year While Reducing Graft-Versus-Host Disease and Toxicity

Oral Presentation Title: Orca-T, a High-Precision Cell Therapy, for the Treatment of Hematologic Malignancies in Patients with 7/8 Mismatch Donors

Oral Presentation Title: Orca-Q Demonstrates Favorable GvHD-and-Relapse-Free Survival with Haploidentical Donors without Post-Transplant Cyclophosphamide

Poster Presentation Title: Estimating the Current and Future Costs and Health Outcomes of Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HCT)