Orca-T (Orca Bio)

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, Calif.--(BUSINESS WIRE)-- Orca Biosystems, 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 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 or . 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 and follow Orca Bio on X: @OrcaBio.

NASHVILLE, Tenn.--(BUSINESS WIRE)-- Sarah Cannon Research Institute (SCRI), one of the world’s leading oncology research organizations conducting community-based clinical trials, announced today that it will highlight its latest research insights through more than 145 presentations at the 2024 American Society of Clinical Oncology (ASCO®) Annual Meeting from Friday, May 31 – Tuesday, June 4 in Chicago, Ill. Over 100 investigators from across SCRI’s network are co-authors on clinical trial updates that will be showcased at the Annual Meeting, including data from more than 65 early-phase clinical trials. “We look forward to connecting with colleagues from around the world at ASCO’s Annual Meeting to discuss the latest developments in advancing therapies for cancer patients,” says Howard A. “Skip” Burris, III, MD, President, SCRI. “The depth and breadth of clinical research being presented by SCRI experts signifies our commitment to accelerating drug development and providing greater access to cutting-edge therapies closer to home.” For a comprehensive list of abstracts and presentations, visit SCRI’s ASCO Site. To learn more about our research experts, visit our Leadership Page. Noteworthy Presentations Breast Cancer Erika Hamilton, MD, SCRI, will present “H3B-6545 in Women with Locally Advanced/Metastatic Estrogen Receptor-Positive, HER2 Negative Breast Cancer” in an oral presentation during the Breast Cancer – Metastatic Rapid Oral Abstract Session on Monday, June 3 from 11:30 a.m. - 1:00 p.m. CDT in Hall D1. Joyce O'Shaughnessy, MD, SCRI at Texas Oncology I The US Oncology Network, will deliver “Association of MammaPrint Index and 3-Year Outcome of Patients with HR+HER2- Early-Stage Breast Cancer Treated with Chemotherapy with or without Anthracycline” in an oral presentation during the Breast Cancer—Local/Regional/Adjuvant Rapid Oral Abstract Session on Friday, May 31 from 2:45 p.m. - 4:15 p.m. CDT in E451. Denise Yardley, MD, SCRI, will give the oral presentation, “Baseline Characteristics and Efficacy Endpoints for Patients with Node-Negative HR+/HER2− Early Breast Cancer: NATALEE Trial” during the Breast Cancer—Local/Regional/Adjuvant Rapid Oral Abstract Session on Friday, May 31 from 2:45 p.m. - 4:15 p.m. CDT in E451. Lung Cancer David Spigel, MD, SCRI, will discuss “ADRIATIC: Durvalumab as Consolidation Treatment for Patients with Limited-Stage Small-Cell Lung Cancer” in an oral presentation during the Plenary Session on Sunday, June 2 from 1:00 p.m. - 4:00 p.m. CDT in Hall B1. Clinical Trial Access Ishwaria Subbiah, MD, MS, SCRI, will present “5-Year Multicenter Analysis of Clinical Trial Participation and Total Cost of Care for Older Adults with Cancer” in an oral presentation during the Quality Care/Health Services Research Rapid Oral Abstract Session on Monday, June 3 from 1:15 p.m. - 2:45 p.m. CDT in S102. In addition to scientific presentations, SCRI leadership will participate in and lead ASCO sessions, including: Meredith McKean, MD, MPH, SCRI, is a discussant in the Oral Abstract Session, Melanoma/Skin Cancers, on Friday, May 31 from 2:45 p.m. - 5:45 p.m. CDT in Hall D1, where she will present “PD-1–Refractory Advanced Melanoma: How Do We Get to the Finish Line?” Dr. Burris will deliver the “Presentation and Recognition of Conquer Cancer Top Donors” in the Opening Session on Saturday, June 1 from 9:30 a.m. - 12:00 p.m. CDT in Hall B1. Dr. Hamilton will chair the Clinical Science Symposium, Next-Generation Antibody-Drug Conjugates: The Revolution Continues, and present “The ABCs of ADCs: What Does the Future Hold?” on Sunday, June 2 from 9:45 a.m. - 11:15 a.m. CDT in Hall D1. Abdul Naqash, MD, SCRI at OU Health - Stephenson Cancer Center, will chair the Oral Abstract Session, Developmental Therapeutics—Immunotherapy, on Monday, June 3 from 11:30 a.m. - 2:30 p.m. CDT in Hall D2. Andrew McKenzie, PhD, SCRI & Genospace, and Vivek Subbiah, MD, SCRI, will serve as panelists in the Case-Based Panel, Beyond Tumor Types: Advancing Tumor-Agnostic Drug Development and the Role of the Tumor Microenvironment, on Monday, June 3 from 3:00 p.m. - 4:00 p.m. CDT in Hall D2. Cesar Perez, MD, SCRI at Florida Cancer Specialists & Research Institute, will present “Emerging Data for Antibody Drug Conjugates in Head and Neck Squamous Cell Carcinoma,” during the Breaking Ground in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Novel Therapies Beyond PD-L1 Immunotherapy Education Session on Tuesday, June 4 from 8:00 a.m. - 9:15 a.m. CDT in S100a. Additional Poster Presentations with SCRI First Authors Saturday, June 1 “Validation of PD-L1 as a Predictive Biomarker of Response in Operable Gastroesophageal Adenocarcinoma: A Meta-Analysis and Meta-Regression of Neoadjuvant Chemoimmunotherapy Trials,” Antonella Cammarota, MD, SCRI at HCA Healthcare UK, 1:30 p.m. - 4:30 p.m. CDT, Hall A. “Phase 1 Trial Safety and Efficacy of Ragistomig, a Bispecific Antibody Targeting PD-L1 and 4-1BB, in Advanced Solid Tumors,” Gerald Falchook, MD, SCRI at HealthONE, 9:00 a.m. - 12:00 p.m. CDT, Hall A. “NALIRIFOX versus Nab-Paclitaxel and Gemcitabine in Treatment-Naïve Patients with Metastatic Pancreatic Ductal Adenocarcinoma: Updated Overall Survival Analysis with 29-Month Follow-Up of NAPOLI 3,” Maen Hussein, MD, SCRI at Florida Cancer Specialists & Research Institute, 1:30 p.m. - 4:30 p.m. CDT, Hall A. “Safety and Preliminary Efficacy of EIK1001 in Combination with Atezolizumab in Participants with Advanced Solid Tumors,” & “Preliminary Results from a Phase 1 Study of AC699, an Orally Bioavailable Chimeric Estrogen Receptor Degrader, in Patients with Advanced or Metastatic Breast Cancer,” Manish Patel, MD, SCRI at Florida Cancer Specialists & Research Institute, 9:00 a.m. - 12:00 p.m. CDT, Hall A. “Results from Phase 1a/1b Analyses of TTX-080, a First in Class HLA-G Antagonist, in Combination with Cetuximab in Patients with Metastatic Colorectal Cancer and Head and Neck Squamous Cell Carcinoma,” Susanna Ulahannan, MD, MMEd, SCRI at OU Health - Stephenson Cancer Center, 9:00 a.m. - 12:00 p.m. CDT, Hall A. “Phase 1/2 Study of NGM707, an ILT2/ILT4 Dual Antagonist Antibody, in Advanced Solid Tumors: Interim Results from Dose-Escalation,” Judy Wang, MD, SCRI at Florida Cancer Specialists & Research Institute, 9:00 a.m. - 12:00 p.m. CDT, Hall A Sunday, June 2 “Trastuzumab Deruxtecan vs Trastuzumab Emtansine in Patients with HER2+ Metastatic Breast Cancer: Updated Survival Results of DESTINY-Breast03,” Dr. Hamilton, 9:00 a.m. - 12:00 p.m. CDT, Hall A. Monday, June 3 “Subcutaneous Epcoritamab Administered Outpatient for Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma: Results from Phase 2 EPCORE NHL-6," David Andorsky, MD, SCRI at Rocky Mountain Cancer Centers I The US Oncology Network, 9 a.m. - 12 p.m. CDT, Hall A “MYTX-011 in Patients with Previously Treated Locally Advanced or Metastatic NSCLC: Initial Dose Escalation Results in The Phase 1 KisMET-01 Study,” Melissa Johnson, MD, SCRI, 1:30 p.m. - 4:30 p.m. CDT, Hall A. “Clinical Activity and Safety of Naptumomab Estafenatox and Docetaxel in Patients with Checkpoint Inhibitor –Pretreated Advanced/Metastatic Non-Small Cell Lung Cancer: Preliminary Results of a P2 Trial,” Tim Larson, MD, SCRI at Minnesota Oncology I The US Oncology Network, 1:30 p.m. - 4:30 p.m. CDT, Hall A. “Treatment of Acute Myeloid Leukemia with Orca-T,” Jeremy Pantin, MD, SCRI at TriStar Centennial, 9:00 a.m. - 12:00 p.m. CDT, Hall A. “Safety and Tolerability of Durvalumab + Carboplatin/Paclitaxel Followed by Durvalumab ± Olaparib in Patients with Newly Diagnosed Advanced or Recurrent Endometrial Cancer in the DUO-E/GOG-3041/ENGOT-EN10 Trial,” Jessica Thomes Pepin, MD, SCRI at Minnesota Oncology I The US Oncology Network, 9:00 a.m. - 12:00 p.m. CDT, Hall A. “OPTec: A Phase 2 Study to Evaluate Outpatient Step-Up Administration of Teclistamab, a BCMA-Targeting Bispecific Antibody, in Patients with Relapsed/Refractory Multiple Myeloma,” Robert Rifkin, MD, SCRI at Rocky Mountain Cancer Centers I The US Oncology Network, 9:00 a.m. - 12:00 p.m. CDT, Hall A. “Clinical Trial Participation and End-of-Life Care Among Older Adults: A Multi-Center Longitudinal Observational Cohort Analysis of 121,717 Patients with Cancer,” Dr. I. Subbiah, 9:00 a.m. - 12:00 p.m. CDT, Hall A. “Performance of Comprehensive Genomic Profiling versus Single Gene Testing in Guideline-Recommended Biomarker Selection in Non-Small Cell Lung Cancer,” Dr. V. Subbiah, 1:30 p.m. - 4:30 p.m. CDT, Hall A. About Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI joined with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 750 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA today. SCRI’s research network brings together more than 1,300 physicians who are actively enrolling patients into clinical trials at more than 250 locations in 24 states across the U.S. Learn more about our research offerings. View source version on businesswire.com: Contacts Becca Gelman Becca.Gelman@scri.com Source: Sarah Cannon Research Institute View this news release online at: