Orca Bio Presents Three-Year Survival Data with Orca-T® in Patients with Hematological Malignancies at the 66th ASH Annual Meeting

Press release

Menlo Park, CA

December 8, 2024

Orca Bio Presents Three-Year Survival Data with Orca-T® in Patients with Hematological Malignancies at the 66th ASH Annual Meeting

Three-year overall survival with Orca-T allogeneic T-cell immunotherapy was 86% for patients with AML, ALL and MDS compared to 67% in a non-randomized historical cohort of post-transplant cyclophosphamide (PTCy)
Reduced non-relapse mortality and increased relapse-free survival seen with Orca-T compared to PTCy at one-year
In a second oral presentation, early feasibility data were presented on the combination of Orca-T and allogeneic CAR-T cells in patients with high-risk B-ALL
Orca-T is being evaluated in a pivotal Phase 3 clinical trial versus a conventional allogeneic stem cell transplant with data expected in the first half of 2025

MENLO PARK, CA, December 8, 2024 – 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.

Three-Year Survival Data with Orca-T vs PTCy

The results of a three-year follow-up analysis with Orca-T plus single-agent tacrolimus (TAC) showed encouraging overall survival (OS) in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and high-risk myelodysplastic syndrome (MDS). These results also showed an improvement when compared to a historical cohort of patients receiving an allogeneic stem cell transplant (alloHSCT) with post-transplant cyclophosphamide (PTCy)-based graft versus host disease (GvHD) prophylaxis.

“With the current standard of care, physicians must carefully balance the risk of relapse with the risk of toxicities when treating patients with serious hematological malignancies, as both impact overall survival,” said presenting author Caspian Oliai, MD, medical director of the UCLA Bone Marrow Transplantation Stem Cell Processing Center. “The preliminary results with Orca-T have been promising, and now observational outcomes show sustained improvement in comparison to a similar cohort of patients who received a conventional alloHSCT with PTCy at one, two and three years. These data add to the growing body of evidence suggesting Orca-T could potentially offer an important new treatment option for patients.”

This analysis from the multicenter Phase 1b clinical trial evaluated a subset of patients (n=77) who received Orca-T with TAC. These outcomes were compared to patients from a CIBMTR literature-based cohort (n=293) who received alloHSCT with a PTCy-based GvHD prophylaxis regimen. All patients across both groups received myeloablative conditioning (MAC) and used a related or unrelated fully matched donor. These subsets of patients were selected based on disease, disease status and conditioning regimens that most closely resemble the patients enrolled in the ongoing pivotal Phase 3 clinical trial evaluating Orca-T.

The analysis included patients who had a median follow-up time of 33 months (range 5-54 months) and 24 months (range 0-53 months) in the Orca-T Phase 1b and PTCy cohorts, respectively. The OS at 12, 24 and 36 months (p=0.0021) are summarized in the table below:

Phase 1b Orca-T plus TAC OS AlloHSCT with PTCy OS
1 Year 96% (range 88%-99%; 95% CI) 82% (range 78%-87%; 95% CI)
2 Year 88% (range 78%-94%; 95% CI) 73% (range 68%-79%; 95% CI)
3 Year 86% (range 73-92%; 95% CI) 67% (range 61%-74%; 95% CI)

Further analyses of these patient subsets found Orca-T may reduce non-relapse mortality (NRM) and increase relapse-free survival (RFS) compared to PTCy. At one year, NRM was 1.4% in the Orca-T group and 7.4% in the PTCy cohort. The rate of RFS at one year was 83% and 71% for patients receiving Orca-T and PTCy, respectively. Results also found that age had no significant impact on OS at one year. For patients receiving Orca-T, OS was 95% (88%-100%) in patients under the age of 50 and 97% (92%-100%) in patients over the age of 50. For patients in the PTCy cohort, OS was 86% (81%-92%) in patients under the age of 50 and 77% (70%-85%) in patients over the age of 50. 

Across all patients in the Phase 1b trial, Orca-T was manufactured reliably and delivered with vein-to-vein times of 72 hours or less across the U.S.

“We’re pleased to present positive long-term follow-up data for Orca-T as these findings provide valuable insight into how the cell therapy performs over extended periods of time,” said Scott McClellan, MD, PhD, chief medical officer at Orca Bio. “As we eagerly await the results of our pivotal Phase 3 clinical trial evaluating Orca-T in a similar patient population, we are one step closer to gathering the information needed for BLA submission and toward potentially making a significant difference for patients.”

Combining Orca Bio Approach with CAR-T Technology

A second oral presentation highlighted initial feasibility, safety and efficacy data from an investigator-sponsored Phase 1 clinical trial evaluating OrCAR-T, a platform that combines the Orca Bio technology with CAR-T technology. This presentation highlighted data following treatment with Orca-T and allogeneic CD19/CD22 CAR-T cells in patients with high-risk B-cell acute lymphoblastic leukemia (B-ALL).

B-ALL remains incurable for many patients despite treatment with an alloHSCT or autologous CAR-T cells, which can also lead to serious complications including GvHD, infections and CAR-related toxicities. Preliminary results for 10 patients treated with OrCAR-T who reached the primary endpoint of 42 days post-treatment showed neutrophil and platelet engraftment at 14 days. At a median follow up of 381 days (range 61-762 days, including 6 patients with >12 months of follow-up) across three dose escalation levels (1x106 CAR+ cells/kg; 2x106 CAR+ cells/kg; 3x106 CAR+ cells/kg), there were no cases of acute or chronic GvHD, no grade 3 or greater cytokine release syndrome and no neurotoxicity observed. 

These early findings suggest a single treatment that combines a high-precision cell therapy like Orca-T with specific CAR-T cells has the potential to benefit patients with a range of hematologic diseases.


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 Precision-T, a pivotal Phase 3 clinical trial, which has completed enrollment at leading transplant centers across the U.S. Orca-T 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 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

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Joshua Murray

ir@orcabio.com

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Orca Bio to Present at the 43rd Annual J.P. Morgan Healthcare Conference

Press release

Menlo Park, CA

January 6, 2025

Orca Bio to Present at the 43rd Annual J.P. Morgan Healthcare Conference

MENLO PARK, CA, January 6, 2025 – 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.

The company presentation will take place on Monday, January 13, 2025, at 8:00AM PST at the Westin St. Francis in the Golden Gate 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 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

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Orca Bio Presents Promising Data on Orca-T in Two Oral Presentations at the 2024 Tandem Meetings of ASTCT® and CIBMTR®

Press release

Menlo Park, CA

February 23, 2024

Orca Bio Presents Promising Data on Orca-T in Two Oral Presentations at the 2024 Tandem Meetings of ASTCT® and CIBMTR®

Orca-T, Orca Bio’s lead investigational high-precision cell therapy, showed favorable rates of relapse-free survival, non-relapse mortality and overall survival when compared to a non-randomized, historical cohort of post-transplant cyclophosphamide (PTCy) in a retrospective analysis 
Orca-T demonstrated similar results in older and younger patients with hematologic malignancies undergoing myeloablative conditioning
Orca-T is currently being evaluated in a pivotal Phase 3 clinical study at transplant centers across the U.S. for the treatment of multiple hematologic malignancies

MENLO PARK, CA, Feb. 23, 2024 – 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). 

In the first of two oral presentations, findings from a retrospective analysis compared historical outcomes between Orca-T and a standard of care allogeneic stem cell transplant (alloHSCT) plus post-transplant cyclophosphamide (PTCy)-based graft versus host disease (GvHD) prophylaxis in patients with hematologic malignancies receiving myeloablative conditioning (MAC). Within the non-randomized cohorts of varying conditioning regimens and disease types, Orca-T demonstrated favorable results across clinical outcomes including relapse-free survival (RFS), non-relapse mortality (NRM) and overall survival (OS).

“When treating hematological malignancies, physicians are often faced with compromising between the risk of relapse and the risk of serious toxicities, all of which can impact overall patient survival,” said Alexandra Gomez-Arteaga, MD, Assistant Professor of Medicine at Weill Cornell Medicine, hematologist oncologist in the Bone Marrow Transplant and Cellular Therapy Program at NewYork-Presbyterian/Weill Cornell Medical Center, and presenting author. “While advances in prophylaxis agents have demonstrated improvements in reducing the rate of graft versus host disease, the findings of this retrospective analysis suggest Orca-T may also provide benefits across key survival metrics, further highlighting the importance of identifying novel approaches that may offer enhancements across all patient outcomes.”

The analysis further compared a subgroup of 48 patients from Orca Bio’s multi-center Phase 1b trial who received a MAC Orca-T with single-agent tacrolimus (TAC) and a conditioning regimen of busulfan, fludarabine and thiotepa (BFT) which is being used in the pivotal Phase 3 clinical study of Orca-T, with 61 patients from the CIBMTR literature-based cohort who received an alloHSCT with a combination of PTCy, calcineurin inhibitor (CNI) and mycophenolate mofetil (MMF). The analysis included patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) who had a median follow-up time of 15 months and 12 months in the Orca-T and PTCy cohorts, respectively. The outcomes at 12 months are summarized in the table below:

Orca-T with BFT/TAC Standard alloHSCT with CNI/MMF/PTCy
RFS 86% 63%
NRM 0% 17%
OS 100% 76%

In a second oral presentation, results were shared from a subgroup analysis of Orca Bio’s ongoing multi-center Phase 1b clinical trial of patients with AML, MDS and acute lymphocytic leukemia (ALL) who received Orca-T and BFT conditioning. The findings demonstrated Orca-T’s potential ability to deliver similar outcomes in older patients (55+ years of age, n=25) and younger patients (18-54 years of age, n=39) undergoing MAC. Notably, Orca-T delivered similar results across RFS (84.8% in younger patients and 82.3% in older patients), NRM (0% in both groups) and OS (100% and 95.5% in the younger and older patient groups, respectively). Across all patients, Orca-T continued to be manufactured reliably and delivered with vein-to-vein times of 72 hours or less across the U.S. These data were previously presented at the 65th American Society of Hematology (ASH) Annual Meeting in December 2023.

“We are pleased to present findings that reinforce the potential for Orca-T to address the balancing act that providers encounter when working to achieve a lasting cure while reducing toxicities,” said Scott McClellan, MD, PhD, Chief Medical Officer at Orca Bio. “The ability of Orca-T to potentially treat the disease while also lowering treatment-related mortality, including for patients of a more advanced age, could arm physicians with an important new therapeutic option. We look forward to continued investigation of Orca-T in our randomized Phase 3 study, Precision-T.”

About Orca-T

Orca-T is an investigational high-precision allogeneic cell therapy being evaluated in clinical trials for the treatment of multiple hematologic malignancies. Orca-T includes infusions containing 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 Twitter: @OrcaBio.

Contact:

Corporate Communications

Kelsey Grossman

media@orcabio.com

Investor Relations

Joshua Murray

ir@orcabio.com

Visit our newsroom
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

Press release

Menlo Park, CA

December 9, 2023

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-T, Orca Bio’s lead investigational high-precision cell therapy, showed similar results in older patients undergoing myeloablative conditioning as seen in younger patients across disease control, non-relapse mortality and overall survival
Orca-T in older patients given a reduced intensity conditioning regimen demonstrated curative potential with no incidence of relapse and encouraging relapse-free survival
Orca-T showed positive results in patients with intermediate to high-risk myelodysplastic syndrome
Orca-Q, Orca Bio’s second investigational high-precision cell therapy, showed encouraging data in graft-versus-host-disease-free and relapse-free survival in patients with a haploidentical donor without the use of post-transplant cyclophosphamide 

MENLO PARK, CA, Dec. 9, 2023 – 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.

Orca-T in Older Patients with Myeloablative Conditioning

Results highlighted in an oral presentation showed Orca-T’s ability to deliver similar outcomes in older patients undergoing myeloablative conditioning (MAC) as younger patients. Notably, Orca-T delivered similar results across disease control, non-relapse mortality (NRM) and overall survival (OS).

“While the use of MAC offers the best chance of a cure, it also increases life-threatening complications in older patients receiving standard of care alloHSCT,” said presenting author Caspian Oliai, M.D., medical director of the UCLA Bone Marrow Transplantation Stem Cell Processing Center. “These latest findings suggest a cell therapy like Orca-T, which has the potential to offer a cure while reducing toxicity and lowering treatment-related mortality, may allow older patients to better tolerate MAC. This approach could expand curative treatment to older patients who might not be offered a MAC regimen today, and potentially provide physicians with an important new option in our ongoing efforts to balance the risk of relapse with transplant-related side effects.”

In a subgroup analysis, 64 patients from Orca Bio’s ongoing multi-center Phase 1b clinical trial who received Orca-T and busulfan, fludarabine and thiotepa (BFT) conditioning for the treatment of acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), mixed phenotype leukemia, chronic myeloid leukemia (CML) and myelodysplastic syndromes (MDS) were divided into two age groups: 18-54 years of age (n=39), and 55 years of age and older (n=25). With a median follow-up of 12 months, the following outcomes were reported: 

  • Relapse-free survival (RFS) was 84.8% in younger patients and 82.3% in older patients.
  • NRM was 0% in both groups.
  • OS was 100% and 95.5% in the younger and older patient groups, respectively.
  • Events of grade 3-4 acute graft versus host disease (GvHD) and moderate-to-severe chronic GvHD were low across the younger group (0 and 3, respectively) and older group (1 and 3, respectively).

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

Orca-T in Older Patients with Reduced Intensity Conditioning 

Additional data from a single-center open-label Phase 1 clinical trial presented at ASH looked at the outcomes of older patients treated with Orca-T and a reduced intensity conditioning (RIC). These patients were found to be unfit for a MAC regimen due to the significant risks associated with it, particularly in older age. At 12 months, patients treated with a RIC Orca-T (n=15) saw no observable compromise in curative outcomes, with no patients experiencing relapse (0%). Patients also saw encouraging RFS (79%) and a low incidence of both grade 3-4 acute and chronic GvHD (0% and 7%, respectively).

Collectively, these findings support the potential for Orca-T to treat older patients with hematological malignancies, whether they are given a MAC or RIC regimen, with no new safety signals reported.

Orca-T in Patients with MDS

New data was also presented on the performance of Orca-T in patients with intermediate to high-risk MDS. Current treatments for MDS aren’t often curative, and many patients relapse or become resistant to first-line treatment. There remains an unmet need for new, more effective but tolerable strategies to manage MDS.

In this subgroup from the ongoing multi-center Phase 1b clinical trial, Orca-T demonstrated promising results in this patient population (n=16). At one year, RFS with Orca-T was 94%. No patients experienced grade 3-4 acute GvHD, and moderate-to-severe chronic GvHD occurred in two patients. The rates of NRM and OS with Orca-T were 0% and 94%, respectively.

Orca-T is currently being evaluated in a pivotal Phase 3 clinical study for the treatment of AML, ALL and MDS at leading transplant centers across the U.S.

Orca-Q for Patients with Haploidentical Donors

In an oral presentation, Orca Bio shared updated data from a multi-center Phase 1 clinical trial of its second high-precision cell therapy, Orca-Q, in patients with a haploidentical donor without the use of post-transplant cyclophosphamide (PTCy).

“Orca-Q is a first-in-class therapy that has the potential to improve patient outcomes and reduce the risk of graft versus host disease without the use of PTCy,” said presenting author Samer Srour, M.D., M.S., Department of Stem Cell Transplantation and Cellular Therapy at The University of Texas MD Anderson Cancer Center. “While PTCy has increased the use of haploidentical HSCTs, it can bring a myriad of risks and toxicities that we didn’t experience with Orca-Q. These updated results in an expanded group of patients continue to support Orca-Q’s promise to overcome the challenges of haploidentical stem cell transplant by providing a solution where patients and physicians may no longer have to compromise between the risk of relapse and the risk of GvHD.”

The positive outcomes from an expanded group of 33 patients with AML, ALL and CML support Orca-Q as a potential treatment option for patients with a haploidentical donor. With a median of 375 days follow-up, updated safety and efficacy data include:

  • No patients experienced moderate-to-severe chronic GvHD (0%). 
  • There was one event of grade 3 acute GvHD and no grade 4 acute GvHD. 
  • NRM was 9%.
  • RFS, GRFS and OS at one year were 82%.

Additionally, no new safety signals were identified. The estimated incidence of CTCAE grade 2 and greater than grade 3 infections at one year were 9% and 15%, respectively. 

“At Orca Bio, we understand the challenges providers face in achieving the right balance in offering blood cancer patients the best option for a cure with optimal quality of life,” said Ivan Dimov, Ph.D., co-founder and chief executive officer of Orca Bio. “We are pleased to present these latest findings at ASH that add to our growing body of clinical evidence which underscore the potential of our novel high-precision platform to expand potentially life-saving treatment to more patient groups who could benefit.”

The full ASH presentations will be made available on www.orcabio.com.

About Orca-T

Orca-T is an investigational high-precision allogeneic cell therapy being evaluated in clinical trials for the treatment of multiple hematologic malignancies. Orca-T includes infusions containing 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-Q

Orca-Q is an investigational high-precision allogeneic cell therapy being evaluated in clinical trials for the treatment of hematologic malignancies 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. Orca-Q has the potential to improve patient outcomes and reduce the risks of toxicities without the use of post-transplant cyclophosphamide (PTCy) in patients unable to identify a full human leukocyte antigen (HLA) match. 

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 Twitter: @OrcaBio.

Contact:

Corporate Communications

Kelsey Grossman

media@orcabio.com

Investor Relations

Joshua Murray

ir@orcabio.com

Visit our newsroom
Orca Bio to Present Positive Clinical Data on Orca-T at the 50th Annual Meeting of the EBMT

Press release

Menlo Park, CA

April 11, 2024

Orca Bio to Present Positive Clinical Data on Orca-T at the 50th Annual Meeting of the EBMT

Presentations include data from an expanded group of older patients treated with Orca Bio’s investigational high-precision cell therapy, Orca-T, and reduced intensity conditioning

MENLO PARK, CA, April 11, 2024 – 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.

Specifically, results from a single-center open-label Phase 1 clinical trial of an expanded group of older patients (n=20) treated with Orca Bio’s lead investigational high-precision cell therapy, Orca-T, and a reduced intensity conditioning (RIC) regimen will be presented. Preliminary data with Orca-T and RIC in patients with hematologic malignancies showed encouraging rates of relapse-free survival (77%). With a median follow-up of 9.65 months, no patients have experienced relapse to date (0%), demonstrating the curative potential for Orca-T in this historically challenging to treat patient group. An earlier dataset evaluating Orca-T and RIC in this population was presented at the 2023 American Society of Hematology (ASH) Annual Meeting.

A second presentation will highlight findings from a non-randomized retrospective analysis comparing Orca-T plus single-agent tacrolimus with a standard of care allogeneic stem cell transplant (alloHSCT) plus post-transplant cyclophosphamide (PTCy)-based graft versus host disease (GvHD) prophylaxis in patients with hematologic malignancies receiving myeloablative conditioning (MAC). When compared to the historical PTCy cohort in this patient population, Orca-T offered potentially favorable rates of relapse-free survival, non-relapse mortality and overall survival. These data were previously 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). 

“At Orca Bio, we continue to build clinical evidence to support the profile of Orca-T and its potential to expand life-saving treatment to patients while also reducing treatment-related risks,” said Scott McClellan, M.D., Ph.D., chief medical officer at Orca Bio. “We look forward to joining top healthcare professionals from around the world at EBMT and sharing the latest findings that support the potential for Orca-T to offer a new curative solution for providers and their patients.”

The EBMT abstracts are available at https://www.ebmt.org/. 

Details of the Orca Bio presentations follow:

Title: Phase 1 Trial Results for Patients with Advanced Hematologic Malignancies Treated with Orca-T Cell Therapy with Reduced Intensity Conditioning and Single Agent Tacrolimus 

Poster Code: A121

Date and Time: Monday, April 15, 2024 at 18:00 BST

Location: Hall 3 North

Title: A Retrospective Analysis Comparing Orca-T to Post-Transplant Cyclophosphamide Based Allogeneic Hematopoietic Stem Cell Transplant in Patients with Matched Unrelated Donors Receiving Myeloablative Conditioning

Poster Code: A107

Date and Time: Monday, April 15, 2024 at 18:00 BST

Location: Hall 3 North


About Orca-T

Orca-T is an investigational high-precision allogeneic cell therapy being evaluated in clinical trials for the treatment of multiple hematologic malignancies. Orca-T includes infusions containing 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 Twitter: @OrcaBio. 

Contact:

Corporate Communications

Kelsey Grossman

media@orcabio.com

Investor Relations

Joshua Murray

ir@orcabio.com


Visit our newsroom
Orca Bio to Present Positive Clinical Outcomes with Orca-T in Patients with AML at 2024 ASCO Annual Meeting

Press release

Menlo Park, CA

May 23, 2024

Orca Bio to Present Positive Clinical Outcomes with Orca-T in Patients with AML at 2024 ASCO Annual Meeting

Relapse-free survival and overall survival were 82.5% and 100% at 12 months, respectively, in 37 patients with AML, an aggressive form of blood cancer

Non-relapse mortality at 12 months was 0%

Orca-T is currently being evaluated in a pivotal Phase 3 clinical trial at leading treatment centers across the U.S.

MENLO PARK, CA, May 23, 2024 – 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). 

AML is an aggressive form of blood cancer and the most common acute leukemia in adults. There are an estimated 20,800 new diagnoses and nearly 11,200 deaths in the U.S. each year.

“Today, only a fraction of adults diagnosed with AML undergo curative treatment with standard of care allogeneic hematopoietic stem cell transplant due to the serious and life-threatening risks often associated with it,” said Rawan Faramand, M.D., assistant member of Blood and Marrow Transplant and Cellular Immunotherapy at Moffitt Cancer Center. “These new findings suggest Orca-T has the potential to offer a cure with low rates of treatment-related mortality, and could provide an important option for patients with AML. With its goal of alleviating the tradeoff between the risk of relapse and the risk of toxicities observed with standard of care stem cell transplant, this novel approach has the potential to expand curative treatment to many more patients.”

A new subanalysis from the ongoing multi-center Phase 1b single-arm trial evaluated outcomes with Orca-T among a subgroup of 37 patients with AML who had a median age of 51 years and median follow-up of 14 months. All patients received myeloablative conditioning (MAC) with busulfan, fludarabine and thiotepa (BFT), followed by Orca-T and single-agent graft versus host disease (GvHD) prophylaxis with tacrolimus. At 12 months, results found relapse-free survival was 82.5% (95% CI: 65.0, 91.7) and non-relapse mortality was 0%. Overall survival was 100% (95% CI: 100, 100) at 12 months. The safety profile of Orca-T in this subgroup was consistent with the larger Phase 1b population with no new safety signals identified. Across all patients, Orca-T was manufactured reliably and delivered with vein-to-vein times of 72 hours or less across the U.S.

“We’re pleased to present at ASCO for the first time and share the latest findings that support the potential for Orca-T to offer a curative solution and fulfill a significant unmet need for patients with AML,” said Scott McClellan, M.D., Ph.D., chief medical officer at Orca Bio. “These data continue to advance our mission of expanding potentially life-saving treatment to patients and their providers who face limited viable options today.”

Details of the Orca Bio presentation follow:

Title: Treatment of Acute Myeloid Leukemia with Orca-T

Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Abstract Number: 6552

Poster Code: 111

Date and Time: June 3, 2024, from 9AM - 12PM CDT

Location: Oncology Professionals Hall

The ASCO abstracts are available at https://conferences.asco.org/am/abstracts. 

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

Press release

Menlo Park, CA

June 5, 2024

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


Visit our newsroom
Orca Bio to Present at the 41st Annual J.P. Morgan Healthcare Conference

Press release

Menlo Park, CA

January 06, 2023

Orca Bio to Present at the 41st Annual J.P. Morgan Healthcare Conference

MENLO PARK, CA, Jan. 6, 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 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.

The company presentation will take place on Monday, January 9, 2023, at 7:30 AM 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 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.

Contact:

Corporate Communications

media@orcabio.com

Investor Relations

Joshua Murray

ir@orcabio.com

Visit our newsroom