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

Press release

Menlo Park, CA

November 3, 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

Oral presentation to highlight impressive results with Orca-T on relapse-free survival (RFS) at one year in the Phase 1b/2 clinical trials

Oral presentation will detail first data readout of Orca-Q in haploidentical allogeneic transplant demonstrating favorable graft-versus-host disease and relapse-free survival (GRFS) at one year in patients with hematologic malignancies

Poster presentation will demonstrate the mechanism of action of Orca-T for blood and immune reconstitution

Poster presentation to show the health economic benefit to the US healthcare system of doubling the number of patients able to achieve GRFS

MENLO PARK, CA, November 3, 2022 – 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.

Orca Bio will also share two poster presentations featuring data on immune reconstitution and elevated regulatory T cell frequencies in patients treated with Orca-T, as well as an analysis of the cost burden of allogeneic hematopoietic cell transplants and the potential value of addressing this unmet need.

Oral presentations:

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


  • Abstract Number: 265
  • Date and time: Saturday, December 10, 2022, at 2 p.m. CST
  • Location: 391-392, Ernest N. Morial Convention Center


  • Presenter: Everett Meyer, M.D., Ph.D., Associate Professor of Medicine, Division of Blood and Marrow Transplantation and Cellular Therapy, Stanford Health Care


  • Title: Orca-Q Demonstrates Favorable GvHD-and Relapse-Free Survival in Haploidentical Transplants without Post-Transplant Cyclophosphamide
  • Abstract Number: 769


  • Date and time: Monday, December 12, 2022, at 10:30 a.m. CST
  • Location: 252-254, Ernest N. Morial Convention Center


  • Presenter: Amandeep Salhotra, M.D., Associate Professor, Division of Leukemia, Department of Hematology and Hematopoietic Cell Transplantation, City of Hope


Poster Presentations:

  • Title: Rapid Immune Reconstitution and Elevated Regulatory T Cell Frequencies in Patients Treated with Orca-T
  • Abstract Number: 3408


  • Date and time: Sunday, December 11, 2022, from 6 p.m. – 8 p.m. CST
  • Location: Hall D, Ernest N. Morial Convention Center


  • Title: Estimating the Lifetime Medical Cost Burden of an Allogeneic Hematopoietic Cell Transplantation Patient and the Value of Addressing the Unmet Need
  • Abstract Number: 4865


  • Date and time: Monday, December 12, 2022, from 6 p.m. – 8 p.m. CST
  • Location: Hall D, Ernest N. Morial Convention Center

About Orca-T

Orca-T is an investigational high-precision allogeneic cellular therapy consisting of infusions containing regulatory T-cells, conventional T-cells and CD34+ stem cells derived from peripheral blood from either related or unrelated matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration and is being studied to treat multiple hematologic malignancies.


About Orca-Q

Orca-Q is an investigational allogeneic cellular therapy consisting of a single infusion containing a proprietary composition of stem and immune cells derived from peripheral blood from either related or unrelated matched, unmatched or haploidentical donors. Orca-Q is currently being studied to treat multiple hematologic malignancies in alternative donor settings, with and without GvHD prophylaxis.

About Orca Bio

Orca Bio is a clinical-stage biotechnology company developing purified, high-precision cell therapies for the treatment of cancer, autoimmune diseases and genetic blood disorders. Our investigational therapies are designed to deliver better survival rates with dramatically fewer risks than standard allogeneic stem cell transplants, like graft versus host disease and other debilitating transplant-related toxicities. At Orca Bio, we hope to not only replace patients' blood and immune systems with healthy ones, but restore their quality of life. For more information, visit www.orcabio.com and follow Orca Bio on Twitter: @orcabio.


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Investor Relations

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First Clinical Data From Ongoing Orca-T Trial Shows Significantly Improved 12-Month Graft Versus Host Disease (GvHD)-Free and Relapse-Free Survival (GRFS) in Blood Cancer Patients Receiving a Hematopoietic Stem Cell Transplant (HSCT)
Orca Bio to Present at the 44th Annual J.P. Morgan Healthcare Conference

Press release

Menlo Park, CA

January 5, 2026

Orca Bio to Present at the 44th Annual J.P. Morgan Healthcare Conference 

MENLO PARK, CA, Jan. 5, 2026  Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced that Nate Fernhoff, Ph.D., Orca Bio’s co-founder and chief executive officer, will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco, CA. 

 

The company presentation will take place on Monday, January 12, 2026, at 7:30AM PST at the Westin St. Francis in the Mission Bay Room on the 32nd floor. 

About Orca Bio

Orca Bio is a late-stage biotechnology company developing high-precision cell therapies for the treatment of blood cancer and autoimmune diseases. The company’s manufacturing platform uses single-cell precision to create personalized cell therapy products intended to replace a patient’s diseased blood and immune system with a healthy one. At Orca Bio, we are on a mission to redefine what’s possible for patients by transforming the field of curative allogeneic cell therapy. For more information, visit www.orcabio.com.  

Trademarks or registered trademarks used in this press release are the property of their respective owners.  

Contact:

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Kelsey Grossman

media@orcabio.com

Investor Relations

Joshua Murray

ir@orcabio.com

Orca Bio Appoints Key Executives Including Steve Gavel as Chief Commercial Officer

Press release

June 4, 2025

Orca Bio Appoints Key Executives Including Steve Gavel as Chief Commercial Officer 

MENLO PARK, CA, June 4, 2025  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.


Steve Gavel has joined Orca Bio as Chief Commercial Officer after most recently serving as Senior Vice President, Global Cell Therapy Commercial Development at Legend Biotech. Orca Bio has also strengthened its broader commercial organization with the addition of several senior leaders with extensive cell therapy experience to oversee Market Access, Commercial Operations and Medical Affairs.


In addition to these key commercial appointments, Allison Frisbee has joined Orca Bio as a Senior Vice President, Legal, following roles at Kronos Bio, Jazz Pharmaceuticals and Bristol Myers Squibb, and as outside counsel to life science companies at Orrick, Herrington and Sutcliffe.


Steve Gavel - Chief Commercial Officer


Gavel brings over 30 years of experience in the biotechnology and pharmaceutical sectors, with deep expertise in the commercialization of cell and gene therapies having led strategy and execution since the earliest days of the field.


“We are thrilled to welcome Steve to the Orca Bio team. Steve is a cell therapy veteran with a proven track record of building and scaling organizations in preparation for commercialization,” said Nate Fernhoff, Ph.D., Co-founder and Chief Executive Officer at Orca Bio. “As we prepare for the commercial launch of Orca-T, Steve brings a perfect combination of background, experience and strategic vision to lead Orca Bio into this next phase of growth and maturation.”


At Legend Biotech, Gavel grew and scaled its commercial organization across multiple CAR-T therapies, including leading the successful global launch of Carvykti®, a treatment for patients with relapsed or refractory multiple myeloma. There he oversaw the global commercial development efforts including launch readiness, market access and commercial operations. Prior to Legend Biotech, Gavel led U.S. commercial strategy and development at Celgene (now Bristol Myers Squibb). Before then, he held commercial roles of increasing seniority at companies including Millennium Pharmaceuticals, IMS Health, West Pharmaceutical Services and Discovery Labs.


“I’m honored to join Orca Bio as it prepares to bring its groundbreaking cell therapy to patients with high-risk blood cancers, including acute myeloid leukemia and myelodysplastic syndrome,” said Steve Gavel, Chief Commercial Officer at Orca Bio. “The company’s pioneering team has achieved remarkable progress, and with approximately 500 patients treated on trial to date, the potential of its novel high-precision platform is already being realized. I look forward to joining the company as we work to unlock new opportunities for growth and transform the therapeutic landscape for patients with blood cancer.”


Allison Frisbee - Senior Vice President, Legal


Frisbee joins with strong experience as a legal and operations leader in the life science industry, with a focus on translating complex legal and regulatory challenges into clear, strategic solutions. Prior to joining Orca Bio, Frisbee served as the Chief Administrative Officer at Kronos Bio, where she oversaw a broad portfolio including Legal, HR, Facilities, IT and Compliance. Before joining Kronos, she held senior legal roles at Jazz Pharmaceuticals and Bristol Myers Squibb.

“I’m thrilled to join the team at Orca Bio and help continue shaping a thoughtful, values-driven legal and compliance function,” said Allison Frisbee, Senior Vice President, Legal at Orca Bio. “It’s a privilege to partner with teams who are not only advancing transformative therapies, but leading with a deep commitment to integrity, accountability and an unwavering commitment to doing what’s right for patients.”

About Orca Bio

Orca Bio is a late-stage biotechnology company developing high-precision cell therapies for the treatment of cancer and autoimmune diseases. The company’s manufacturing platform uses single-cell precision to create proprietary, uniquely-defined products designed to replace a patient’s diseased blood and immune system with a healthy one. At Orca Bio, we are on a mission to redefine what’s possible for patients by transforming the field of curative allogeneic cell therapy. For more information, visit www.orcabio.com.

Trademarks or registered trademarks used in this press release are the property of their respective owners.

Contact:

Corporate Communications

Kelsey Grossman

media@orcabio.com

Investor Relations

Joshua Murray

ir@orcabio.com

Orca Bio Presents Encouraging Interim Clinical Data on Orca-Q in Haploidentical Allogeneic Hematopoietic Stem Cell Transplants at 64th ASH Annual Meeting

Press release

Menlo Park, CA

December 12, 2022

Orca Bio Presents Encouraging Interim Clinical Data on Orca-Q in Haploidentical Allogeneic Hematopoietic Stem Cell Transplants at 64th Annual ASH Meeting

Orca-Q is Orca Bio's investigational high-precision cell therapy designed to overcome the challenges of haploidentical allogeneic hematopoietic stem cell transplant (alloHSCT)

Interim multi-center Phase 1 clinical trial results show that Orca-Q improved graft-versus-host disease-free, relapse-free survival in haploidentical alloHSCT compared to standard of care, without the use of post-transplant cyclophosphamide

MENLO PARK, CA, Dec. 12, 2022 – 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.

The data from the ongoing clinical trial show that Orca-Q reduced the incidence and severity of graft versus host disease (GvHD) and improved graft-versus-host disease-free, relapse-free survival (GRFS) rates in 26 patients matched to haploidentical allogeneic hematopoietic stem cell donors. Unlike standard of care haploidentical allogeneic stem cell transplant (alloHSCT), Orca-Q does not require post-transplant cyclophosphamide (PTCy).

“Patients and transplant physicians are in urgent need of a novel treatment option that improves the chances of survival and the quality of that survival. This is the key limitation of haploidentical transplant, which is currently the only treatment option for the vast majority of blood cancer patients in need of a transplant,” said Amandeep Salhotra, M.D., associate professor, Division of Leukemia, Department of Hematology and Hematopoietic Cell Transplantation, City of Hope. “These results suggest Orca-Q’s promise to overcome this serious challenge by offering a novel investigational high-precision cell therapy with the potential to significantly improve patient outcomes and reduce serious transplant-related risks.”

Orca-Q is an investigational high-precision cell therapy that is a proprietary composition of enriched CD34+ stem cells combined with specific T cell subsets. The findings presented at ASH are from patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplastic syndromes (MDS) and chronic myeloid leukemia (CML) who were matched to haploidentical allogeneic donors, defined as matched across at least 4/8 but fewer than 7/8 human leukocyte antigen (HLA) loci. Historical controls from the literature of patients who received standard of care haploidentical alloHSCT with PTCy GvHD prophylaxis were used for comparison purposes1,2,3,4.

Interim results from the Phase 1 single-arm, open-label trial showed:

  • A reduction of grade 2-4 acute GvHD (aGvHD) at 6 months as compared to literature controls (13% vs 21-63%), with only one patient developing grade 3 aGvHD and no incidence of grade 4 aGvHD.


  • No patients experienced moderate-to-severe chronic GvHD (cGvHD), compared to 24%-33% in the literature control. There was only one case of mild cGvHD.
  • GRFS was 75% at one year after Orca-Q, which compares favorably to a GRFS of 46% in patients in the literature control.

Patients treated with Orca-Q also experienced a low adverse event profile, suggesting Orca-Q has the potential to offer a new treatment option for patients undergoing haploidentical alloHSCT.

Today, approximately 70% of blood cancer patients do not have access to a fully matched related donor. Haploidentical transplant, which uses healthy, blood-forming cells from a partially matched donor to replace the unhealthy ones, is one of the few treatment options currently available to those without a fully matched donor. However, its use remains significantly limited because of the conditioning regimens that are required. Haploidentical transplant patients receiving higher intensity myeloablative conditioning treatments have a higher risk of cGvHD post-transplant, while patients receiving lower intensity pre-transplant conditioning have a greater risk of relapse.

“These interim results from our second clinical program demonstrate Orca-Q’s potential to overcome the challenges of haploidentical alloHSCT by providing a solution with which patients and physicians may no longer have to compromise between the risk of relapse and the risk of GvHD,” said Scott McClellan, M.D., Ph.D., chief medical officer of Orca Bio. “This novel approach, along with our growing body of clinical evidence demonstrating Orca-T’s improved GvHD and relapse-free survival rates in patients with HLA-matched donors, underscore the potential of our high-precision platforms to deliver cell therapies that can greatly expand the number of patients who receive life-saving treatment, whether their donor is a full or partial match.”

The full presentation is available on www.orcabio.com.

About Orca-Q

Orca-Q is Orca Bio's second investigational high-precision allogeneic cellular therapy to enter clinical development for hematological malignancies. Orca-Q is a proprietary composition of enriched CD34+ stem cells combined with specific T cell subsets derived from haploidentical—or partially matched—donors that are purified through Orca Bio's high-precision platform. Orca-Q is a first-in-class therapy that has the potential to improve patient outcomes and reduce the risks of graft versus host disease, without the use of post-transplant cyclophosphamide (PTCy) in patients for whom a full human leukocyte antigen (HLA) match cannot be found.

About Orca-T

Orca-T is an investigational high-precision allogeneic cellular therapy consisting of infusions containing regulatory T-cells, conventional T-cells and CD34+ stem cells derived from peripheral blood from either related or unrelated matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration and is being studied to treat multiple hematologic malignancies.

About Orca Bio

Orca Bio is a late-stage biotechnology company developing purified, high-precision cell therapies for the treatment of cancer, autoimmune diseases and genetic blood disorders. Our investigational therapies are designed to deliver better survival rates with dramatically fewer risks than standard allogeneic stem cell transplants, like graft versus host disease and other debilitating transplant-related toxicities. At Orca Bio, we hope to not only replace patients' blood and immune systems with healthy ones, but restore their quality of life. For more information, visit www.orcabio.com and follow Orca Bio on Twitter: @orcabio.

1 Gooptu, M, et al. Blood. 2021; 138 (3): 273–282. 

2 Sanz, J, et al. J Hematol Oncol. 2020; 13:46. 

3 Baker, M, et al. Biol Blood Marrow Transplant. 2016; 22; 2047-2055. 

4 Sanz, J, et al. J Hematol Oncol. 2020; 13:46.

Contact:

Corporate Communications

media@orcabio.com

Investor Relations

Joshua Murray

ir@orcabio.com

Orca Bio Presents Clinical Results on Use of Orca-Q without GvHD Prophylaxis in Patients with Hematological Malignancies at the 66th ASH Annual Meeting

Press release

Menlo Park, CA

December 7, 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-Q allogeneic T-cell immunotherapy with no GvHD prophylaxis in patients with matched donors demonstrated low rates of GvHD and non-relapse mortality

MENLO PARK, CA, December 7, 2024 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. 

Preliminary data from a subset of the multicenter Phase 1 clinical trial of Orca-Q in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myeloid leukemia (CML) and myelofibrosis (MF) showed encouraging patient outcomes without the use of GvHD prophylaxis, including low rates of GvHD, infection and non-relapse mortality (NRM) in patients with fully matched donors.

“With a conventional allogeneic stem cell transplant, patients typically receive a mix of strong immunosuppressive drugs to control GvHD. These can also lead to poor immune reconstitution and increase the risk of infections, organ damage and relapse,” said presenting author Mehrdad Abedi, MD, hematologist and professor of Medicine at UC Davis Comprehensive Cancer Center. “The possibility of achieving a cure without the need for preventative agents could expand the treatment landscape for patients with hematologic malignancies. While additional data is needed, these early findings suggest Orca-Q without GvHD prophylaxis may have the potential to transform our treatment approach.”

This analysis evaluated 14 patients enrolled in the HLA-identical donor dose expansion arm who received myeloablative conditioning (MAC) with Orca-Q and either busulfan, fludarabine and thiotepa (BFT) or total body irradiation-based conditioning (TBI). Across all patients, the median time to engraftment of neutrophils and platelets was 11 days and rates of GvHD and serious infections were low. In the subgroup of patients who received Orca-Q and BFT, there was no chronic GvHD of any grade and two cases of grade 2 acute GvHD. There were no cases of non-relapse mortality (NRM) reported across all 14 patients. Relapse-free survival (RFS) and overall survival (OS) were both 85% among all patients, and both 90% in the BFT population. GvHD-free, relapse-free survival (GRFS) was 77% and 90% across all patients and in the BFT group, respectively.

Across all patients, Orca-Q was manufactured reliably and delivered with vein-to-vein times of 72 hours or less across the U.S.

“Our team is inspired by the possibility of developing a product that could eliminate the need for GvHD prophylaxis while preserving safety and efficacy, a concept representing a significant advancement for hematology and beyond,” said Nate Fernhoff, PhD, co-founder and chief scientific officer at Orca Bio. “We are highly encouraged by these preliminary data which provide an early glimpse into the future therapeutic potential of Orca-Q.”

About Orca-Q

Orca-Q is Orca Bio’s second-generation investigational allogeneic T-cell immunotherapy being evaluated in clinical trials for the treatment of multiple hematologic malignancies, including in patients with haploidentical donors. Orca-Q is a proprietary composition of stem cells combined with specific T-cell subsets derived from healthy donors and engineered by Orca Bio’s high-precision platform. 

About Orca Bio

Orca Bio is a late-stage biotechnology company developing high-precision cell therapies for the treatment of cancer and autoimmune diseases. Our investigational products are designed to replace a patient’s diseased blood and immune system with a healthy one, with the goal of improving outcomes with 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.

Contact:

Corporate Communications

Kelsey Grossman

media@orcabio.com

Investor Relations

Joshua Murray

ir@orcabio.com


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)

Press release

Menlo Park, CA

February 11, 2021

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-T (n=50) with single-agent graft versus host disease (GvHD) prophylaxis when compared with a cohort of patients who received a standard-of-care (SOC) hematopoietic stem cell transplant (HSCT) (n=144) and a 2-agent GvHD prophylaxis demonstrated:

  • Improved 1-year GvHD-free and Relapse-Free Survival (GRFS) (75% vs 31%
  • Decreased incidence of grade 2+ acute GvHD (aGvHD) at 100 days (10% vs 30%)
  • Decreased chronic GvHD (cGvHD) at 365 days (3% vs 46%)

MENLO PARK, CA, February 11, 2021 – Orca Bio, a clinical-stage biotechnology company developing high-precision investigational cell therapies, today announced updated clinical data from its first-generation investigational therapy Orca-T, which was presented at the 2021 TCT Meetings of ASTCT and CIBMTR by Everett Meyer, MD, PhD, Assistant Professor of Medicine, Blood and Marrow Transplantation at Stanford University.I

Results from multicenter (NCT04013685) and single-center (NCT01660607) phase I/II trials showed that patients receiving Orca-T (n=50) with single-agent GvHD prophylaxis demonstrated improved 1-year GvHD-free and Relapse-Free Survival (GRFS) (75% vs 31%) when compared with a cohort of patients who received a standard-of-care (SOC) hematopoietic stem cell transplant (HSCT) (n=144) and 2-agent GvHD prophylaxis.

As of the data cut-off, Orca-T plus single-agent GvHD prophylaxis was well-tolerated in the clinical trial, with a decreased incidence of grade 2+ acute GvHD (at 100 days: 10% vs 30%) and chronic GvHD (at 365 days: 3% vs 46%). The high-precision investigational cellular products continue to be successfully manufactured and scaled in a central facility and were delivered to patients at multiple clinical sites with a vein-to-vein time of less than 72 hours. The presentation can be viewed on the Orca Bio website.

“Orca-T continues its groundbreaking performance in our phase 1b clinical trial where it is under investigation to improve survival by preventing transplant-related mortality, aGvHD, and cGvHD,” said Nate Fernhoff, PhD, Chief Scientific Officer at Orca Bio.

“Orca-T continues its groundbreaking performance in our phase 1b clinical trial where it is under investigation to improve survival by preventing transplant-related mortality, aGvHD, and cGvHD."

Nate Fernhoff, PhD, Chief Scientific Officer at Orca Bio.

About Orca Bio

Orca Bio is a late-stage biotechnology company developing purified, high-precision cell therapies for the treatment of cancer, autoimmune diseases and genetic blood disorders. Our investigational therapies are designed to deliver better survival rates with dramatically fewer risks than the standard of care. At Orca Bio, we hope to not only replace patients' blood and immune systems with healthy ones, but restore their quality of life. For more information, visit www.orcabio.com and follow Orca Bio on Twitter: @orcabio.


Contact:

Corporate Communications

Kelsey Grossman

media@orcabio.com

Investor Relations

Joshua Murray

ir@orcabio.com


Orca Bio to Present New Clinical Data on Its High-Precision Cell Therapies at the 2026 Tandem Meetings of ASTCT® and CIBMTR®

Press release

Menlo Park, CA

January 21, 2026

Orca Bio to Present New Clinical Data on Its High-Precision Cell Therapies at the 2026 Tandem Meetings of ASTCT® and CIBMTR®

New data evaluating Orca-T® with reduced intensity conditioning versus PTCy for the treatment of hematological malignancies 
Orca-T outcomes in patients with myelodysplastic syndromes to be presented for the first time; includes retrospective comparison to PTCy 
Additional presentations will highlight the combination of Orca-T and an allogeneic CAR-T (OrCAR-T™), manufacturing and nationwide distribution data reported on Orca–T and clinical findings of Orca-Q® in patients with haploidentical donors 

MENLO PARK, CA, Jan. 21, 2026  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 two oral and seven poster sessions at the 2026 Tandem Meetings of ASTCT and CIBMTR from February 4-7 in Salt Lake City, UT. 

 

The presentations will include data on the company's pipeline of investigational allogeneic T-cell immunotherapies for the treatment of multiple hematological malignancies, including Orca-T, Orca-Q and the Orca-T and allogeneic CAR-T combination therapy, OrCAR-T. 

 

“Our presentations at this year’s Tandem Meetings reflect the growing body of evidence supporting the use of Orca-T as a precision-engineered cellular immunotherapy administered through an allogeneic stem cell transplant,” said Nate Fernhoff, Ph.D., co-founder and chief executive officer of Orca Bio. “From new data in myelodysplastic syndromes, to evaluations in reduced intensity conditioning, and a report on our ability to reliably distribute our products to patients nationwide, these findings represent our ongoing efforts to improve outcomes for the transplant community. We look forward to engaging with our peers and partners to discuss how these advancements can help redefine the treatment landscape for patients with blood cancer.” 

 

The Tandem abstracts are now available at www.tandemmeetings.com. Details of the Orca Bio presentations follow: 

 

Oral Session: Session A - Clinical Progress in GVHD Prevention, Risk Stratification, and Treatment 

Title: Interim Clinical Outcomes in Orca-T with Reduced Intensity Conditioning: An Observational Comparison to Registry-Based Post-Transplant Cyclophosphamide Patients 

Presentation ID: 7 

Date and TimeWednesday, February 4, 3:15 PM - 3:30 PM MST 

Location: Ballroom AB 

 

Oral SessionSession E - Acute Lymphoid Leukemias: Advances in CAR T and Transplant Approaches 

Title: Mature Outcomes from the Phase I Trial of Orca-T and Allogeneic CD19/CD22 CAR-T cells for Adults with High-Risk B-ALL 

 Presentation ID: 31 

Date and TimeThursday, February 5, 3:15 PM - 3:30 PM MST 

Location: Ballroom AB 

 

Poster SessionMyeloid Neoplasms Including Relapse – Clinical 

TitleClinical Outcomes in Myelodysplastic Syndrome Patients Treated with Orca-T or Post-Transplant Cyclophosphamide Patients: A Registry-Based Comparison 

 Presentation ID: 534  

Date and TimeThursday, February 5, 6:30 PM - 8:00 PM MST 

Location: Poster Hall AB 

 

Poster SessionCell and Gene Therapy – Clinical 

TitleScalable Manufacturing and Nationwide Distribution of Orca-T: A Precision-Engineered Allogeneic Immune Cell Therapy  

 Presentation ID: 161 

Date and TimeThursday, February 5, 6:30 PM - 8:00 PM MST 

Location: Poster Hall AB 

 

Poster SessionGVHD Clinical – Prevention and Treatment 

TitleClinical Outcomes in Orca-T and Registry-Based Post-Transplant Cyclophosphamide Patients: An Observational Comparison 

 Presentation ID: 366 

Date and TimeThursday, February 5, 6:30 PM - 8:00 PM MST 

Location: Poster Hall AB 

 

Poster SessionGVHD Clinical – Prevention and Treatment 

TitlePreliminary Safety and Efficacy of Myeloablative Orca-Q in Patients with Haploidentical Donors 

 Presentation ID: 345 

Date and TimeThursday, February 5, 6:30 PM - 8:00 PM MST 

Location: Poster Hall AB  

 

Poster SessionConditioning Regimens 

TitleSingle Center Phase 1b Study of Orca-T Following Escalated Doses of Total Marrow and Lymphoid Irradiation (TMLI) in Patients with Acute Leukemia or MDS 

 Presentation ID: 172 

Date and TimeThursday, February 5, 6:30 PM - 8:00 PM MST 

Location: Poster Hall AB 

 

Poster SessionHealth Services and Barriers to Access 

TitleOrca-T Demonstrates Favorable Quality of Life and Healthcare Resource Use Compared to Standard AlloHSCT Plus Tac/MTX for GVHD Prevention in a Randomized phase 3 Clinical Trial (Precision-T) 

 Presentation ID: 402 

Date and TimeThursday, February 5, 6:30 PM - 8:00 PM MST 

Location: Poster Hall AB 

 

Poster SessionHealth Services and Barriers to Access 

TitleCost-Effectiveness of Orca-T Vs Allo-HCT with Conventional GVHD Prophylaxis for the Treatment of Advanced Hematologic Malignancies in the United States 

 Presentation ID: 401 

Date and TimeThursday, February 5, 6:30 PM - 8:00 PM MST 

Location: Poster Hall AB 

About Orca-T

Orca-T is an investigational allogeneic T-cell immunotherapy under evaluation for the treatment of multiple hematologic malignancies including acute leukemias and myelodysplastic syndromes. Orca-T is composed of highly purified regulatory T-cells, hematopoietic stem cells and conventional T-cells derived from either related or unrelated matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation for the prevention of graft versus host disease or death in patients eligible for hematopoietic stem cell transplant from the U.S. Food and Drug Administration (FDA). The Biologics License Application (BLA) for Orca-T is currently under Priority Review with the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of April 6, 2026.   

About Orca Bio

Orca Bio is a late-stage biotechnology company developing high-precision cell therapies for the treatment of blood cancer and autoimmune diseases. The company’s manufacturing platform uses single-cell precision to create personalized cell therapy products intended to replace a patient’s diseased blood and immune system with a healthy one. At Orca Bio, we are on a mission to redefine what’s possible for patients by transforming the field of curative allogeneic cell therapy. For more information, visit www.orcabio.com.  

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Contact:

Corporate Communications

Kelsey Grossman

media@orcabio.com

Investor Relations

Joshua Murray

ir@orcabio.com