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Articles from Orca Bio

Orca Bio Appoints Key Executives Including Steve Gavel as Chief Commercial Officer
Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced the appointment of senior leaders to support the company as it advances its lead investigational allogeneic T-cell immunotherapy, Orca-T®, toward potential commercial launch.
By Orca Bio · Via Business Wire · June 4, 2025
Orca Bio Announces Leadership Updates
Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced the appointment of the company’s co-founder and Chief Scientific Officer, Nate Fernhoff, Ph.D., as Chief Executive Officer (CEO), succeeding Ivan Dimov, Ph.D. In addition, co-founder and Chief Operating Officer, Jeroen Bekaert, Ph.D., has assumed the role of President.
By Orca Bio · Via Business Wire · May 12, 2025
Orca Bio Announces Positive Results from the Pivotal Phase 3 Study of Investigational Orca-T® Compared to Allogeneic Stem Cell Transplant for the Treatment of Hematologic Malignancies
Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced positive results from the pivotal Phase 3 Precision-T study of Orca-T, its lead investigational allogeneic T-cell immunotherapy, in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), high-risk myelodysplastic syndrome (MDS) and mixed-phenotype acute leukemia (MPAL). Orca-T is manufactured using highly purified regulatory T-cells, hematopoietic stem cells and conventional T-cells derived from peripheral blood from either related or unrelated matched donors.
By Orca Bio · Via Business Wire · March 17, 2025
Orca Bio’s Orca-T® Meets Primary Endpoint in the Pivotal Precision-T Phase 3 Clinical Study for Hematologic Malignancies
Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced it will present positive results from the pivotal Phase 3 Precision-T study (NCT05316701) of its investigational allogeneic T-cell immunotherapy, Orca-T, in people with hematologic malignancies at the 51st Annual Meeting of the EBMT held March 30-April 2, 2025 in Florence, Italy.
By Orca Bio · Via Business Wire · February 10, 2025
Orca Bio to Present at the 43rd Annual J.P. Morgan Healthcare Conference
Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced that Ivan Dimov, Ph.D., Orca Bio’s co-founder and chief executive officer, will present at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco, CA.
By Orca Bio · Via Business Wire · January 6, 2025
Orca Bio Presents Three-Year Survival Data with Orca-T® in Patients with Hematological Malignancies at the 66th ASH Annual Meeting
Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today presented positive long-term data on its lead investigational allogeneic T-cell immunotherapy, Orca-T, at the 66th American Society of Hematology (ASH) Annual Meeting.
By Orca Bio · Via Business Wire · December 8, 2024
Orca Bio Presents Clinical Results on Use of Orca-Q® without GvHD Prophylaxis in Patients with Hematological Malignancies at the 66th ASH Annual Meeting
Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today presented clinical findings on the use of Orca-Q, its investigational second-generation allogeneic T-cell immunotherapy, without the use of any graft versus host disease (GvHD) prophylaxis in patients with diverse hematological conditions at the 66th American Society of Hematology (ASH) Annual Meeting.
By Orca Bio · Via Business Wire · December 7, 2024
Orca Bio to Present Clinical Data on Its High-Precision Cell Therapies at the 66th American Society of Hematology Annual Meeting
Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced that new clinical data will be presented in three oral sessions at the American Society of Hematology (ASH) Annual Meeting from December 7-10 in San Diego, CA.
By Orca Bio · Via Business Wire · November 5, 2024
Orca Bio Announces Completion of Patient Enrollment for the Precision-T Phase 3 Study of Orca-T
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.
By Orca Bio · Via Business Wire · June 5, 2024
Orca Bio to Present Positive Clinical Outcomes with Orca-T in Patients with AML at 2024 ASCO Annual Meeting
Orca Bio, a biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced it will present new data at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois, from May 31–June 4. The presentation will highlight outcomes of its lead investigational allogeneic T-cell immunotherapy, Orca-T, in patients with acute myeloid leukemia (AML).
By Orca Bio · Via Business Wire · May 23, 2024
Orca Bio to Present Positive Clinical Data on Orca-T at the 50th Annual Meeting of the EBMT
Orca Bio, a late-stage biotechnology company developing high-precision cell therapies for the treatment of cancer, autoimmune diseases and genetic blood disorders, today announced new data will be presented during the 50th Annual Meeting of the EBMT in Glasgow, United Kingdom.
By Orca Bio · Via Business Wire · April 11, 2024
Orca Bio Presents Promising Data on Orca-T in Two Oral Presentations at the 2024 Tandem Meetings of ASTCT® and CIBMTR®
Orca Bio, a late-stage biotechnology company developing high-precision cell therapies for the treatment of cancer, autoimmune diseases and genetic blood disorders, today announced positive data on its lead investigational high-precision cell therapy, Orca-T, 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).
By Orca Bio · Via Business Wire · February 23, 2024
Orca Bio to Present at the 42nd Annual J.P. Morgan Healthcare Conference
Orca Bio, a late-stage biotechnology company developing high-precision cell therapies for the treatment of cancer, autoimmune diseases and genetic blood disorders, today announced that Ivan Dimov, Ph.D., Orca Bio’s co-founder and chief executive officer, will present at the 42nd Annual J.P. Morgan Healthcare Conference.
By Orca Bio · Via Business Wire · January 3, 2024
Orca Bio Presents Positive Data Demonstrating the Potential for Orca-T and Orca-Q to Expand Treatment to Additional Patient Groups at the 65th ASH Annual Meeting
Orca Bio, a late-stage biotechnology company developing high-precision cell therapies for the treatment of cancer, autoimmune diseases and genetic blood disorders, today announced positive new data that suggest its investigational high-precision cell therapies, Orca-T and Orca-Q, have the potential to deliver improved clinical outcomes across different age ranges, donor types and conditioning regimens relative to existing standard of care allogeneic hematopoietic stem cell transplants (alloHSCT). The results presented at the 65th American Society of Hematology (ASH) Annual Meeting showed promising data with the use of Orca Bio’s cell therapies across several patient groups where there is significant unmet medical need.
By Orca Bio · Via Business Wire · December 9, 2023
Orca Bio to Present Positive Clinical Data on its Novel High-Precision Cell Therapies at the 65th American Society of Hematology Annual Meeting
Orca Bio, a late-stage biotechnology company developing high-precision cell therapies for the treatment of cancer, autoimmune diseases and genetic blood disorders, today announced that new data will be presented at the American Society of Hematology (ASH) Annual Meeting from December 9-12 in San Diego, CA. Specifically, an oral presentation will highlight the outcomes of myeloablative Orca-T, Orca Bio’s lead investigational high-precision cell therapy, in patients over the age of 55. A second oral presentation will share updated results in an expanded group of patients with haploidentical donors treated with Orca Bio’s second investigational high-precision cell therapy, Orca-Q.
By Orca Bio · Via Business Wire · November 2, 2023
Orca Bio Presents Positive Data Reinforcing Clinical Profile of Orca-T and Orca-Q at 2023 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR
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.
By Orca Bio · Via Business Wire · February 16, 2023
Orca Bio to Present at the 41st Annual J.P. Morgan Healthcare Conference
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 that Ivan Dimov, Ph.D., Orca Bio’s co-founder and chief executive officer, will present at the 41st Annual J.P. Morgan Healthcare Conference.
By Orca Bio · Via Business Wire · January 6, 2023
Orca Bio Presents Encouraging Interim Clinical Data on Orca-Q in Haploidentical Allogeneic Hematopoietic Stem Cell Transplants at 64th ASH Annual Meeting
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 that interim clinical data from its Phase 1 multi-center trial of its second investigational cell therapy, Orca-Q, were unveiled in an oral presentation at the 64th American Society of Hematology (ASH) Annual Meeting.
By Orca Bio · Via Business Wire · December 12, 2022
Orca Bio Presents Data Demonstrating its Lead Investigational High-Precision Cell Therapy Orca-T Significantly Improved Relapse-Free Survival at 64th ASH Annual Meeting
Orca Bio, a late-stage biotechnology company developing high-precision cell therapies for the treatment of cancer, genetic blood disorders and autoimmune diseases, today presented updated positive clinical data on its lead investigational cell therapy, Orca-T, during an oral presentation at the 64th American Society of Hematology (ASH) Annual Meeting.
By Orca Bio · Via Business Wire · December 10, 2022
Orca Bio to Present Four Abstracts at the 64th American Society of Hematology Annual Meeting, Including Updated Relapse-Free Survival Data with Orca-T and the First Clinical Data for Orca-Q
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 that new clinical data will be presented at the American Society of Hematology (ASH) Annual Meeting from December 10-13. Specifically, an oral presentation will include new data on relapse-free survival with Orca Bio’s lead investigational high-precision cell therapy, Orca-T. Additionally, results from Orca Bio’s Phase 1 clinical trial of its second investigational cell therapy, Orca-Q, in patients with haploidentical donors will be presented for the first time in an oral presentation.
By Orca Bio · Via Business Wire · November 3, 2022
Orca Bio Expands Manufacturing Capabilities to Develop and Commercialize its Precision Cell Therapies
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 the expansion of its current manufacturing capabilities with the construction of a new 100,000-square-foot commercial facility in Sacramento, CA. This facility will support the late-stage clinical development and commercialization of Orca Bio’s precision cell therapies, including Orca-T, which is currently being evaluated in a Phase 3 registrational trial.
By Orca Bio · Via Business Wire · September 8, 2022
Orca Bio Announces the Precision-T Phase 3 Study is Open and Enrolling Patients at Transplant Centers Across the U.S.
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 Precision-T, its pivotal Phase 3 study, is open, enrolling and treating patients at clinical trial sites including Stanford Health Care, City of Hope, Winship Cancer Institute of Emory University, Sarah Cannon Research Institute, Ronald Reagan UCLA Medical Center and Oregon Health & Science University. Precision-T is expected to enroll approximately 174 patients at more than 20 transplant centers across the U.S.
By Orca Bio · Via Business Wire · August 2, 2022
Orca Bio to Present New Clinical Data on Orca-T at the European Hematology Association 2022 Congress
Orca Bio, a clinical-stage biotechnology company developing purified, high-precision cell therapies for the treatment of cancer, genetic blood disorders and autoimmune diseases, today announced that new clinical data on its lead investigational high-precision cell therapy, Orca-T, will be shared in an oral presentation at the hybrid European Hematology Association (EHA) Congress from June 9-17, 2022, in Vienna, Austria.
By Orca Bio · Via Business Wire · May 12, 2022
Orca Bio Presents Positive Data Reinforcing Clinical Profile and Manufacturing Reliability of Orca-T at 2022 Transplantation & Cellular Therapy ASTCT and CIBMTR Tandem Meetings
Orca Bio, a clinical-stage biotechnology company developing purified, high-precision cell therapies for the treatment of cancer, genetic blood disorders and autoimmune diseases, today announced that positive new data were presented at the 2022 Transplantation & Cellular Therapy ASTCT and CIBMTR Tandem Meetings in Salt Lake City, Utah.
By Orca Bio · Via Business Wire · April 25, 2022
Orca Bio to Present at the 40th Annual J.P. Morgan Healthcare Conference
Orca Bio, a clinical-stage biotechnology company developing purified, high-precision cell therapies for the treatment of cancer, autoimmune diseases and genetic blood disorders, today announced that Ivan Dimov, Ph.D., Orca Bio’s chief executive officer and co-founder, will present at the 40th Annual J.P. Morgan Healthcare Conference.
By Orca Bio · Via Business Wire · January 6, 2022
Positive Clinical Results from More than 100 Patients Treated with Orca Bio’s Lead Investigational High Precision Cell Therapy Presented at 63rd ASH Annual Meeting
Orca Bio, a clinical-stage biotechnology company developing purified, high-precision cell therapies for the treatment of cancer, autoimmune diseases and genetic blood disorders, today announced positive clinical data on its lead investigational cell therapy, Orca-T, were presented at the American Society of Hematology (ASH) Annual Meeting. The data presented on 109 patients with at least 90 days of follow-up in combined data from the Phase 1b and Phase 2 trials showed significantly higher graft-versus-host disease-free, relapse-free survival (GRFS) rates compared to patients who received standard of care.
By Orca Bio · Via Business Wire · December 11, 2021
Orca Bio to Present New Clinical Data on Orca-T at the 63rd American Society of Hematology Annual Meeting
Orca Bio, a clinical-stage biotechnology company developing purified, high-precision cell therapies for cancer, autoimmune and genetic blood disorders, today announced that new data will be presented from a single-center Phase 2 trial and a multi-center Phase 1b trial at the American Society of Hematology (ASH) Annual Meeting. Specifically, pooled data from patients treated with Orca-T, an investigational high-precision cell therapy product being studied in patients with hematologic malignancies, will be shared in an oral presentation. Additionally, results of Orca-T in a subset of patients with myelofibrosis from those same trials will be shared in a poster presentation.
By Orca Bio · Via Business Wire · November 4, 2021