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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media@orcabio.com

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Joshua Murray

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Orca Bio Expands Manufacturing Capabilities to Develop and Commercialize its Precision Cell Therapies

Press release

Menlo Park, CA

September 8, 2022

Orca Bio Expands Manufacturing Capabilities to Develop and Commercialize its Precision Cell Therapies

New state-of-the art manufacturing facility is designed to enable the reliable production of Orca Bio's investigational cell therapies from late-stage clinical development through potential commercialization

The 100,000-square-foot facility is located in Metro Air Park, Sacramento

MENLO PARK, CA, September 8, 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 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.

“The new state-of-the-art facility represents critical infrastructure to enable the advancement of our pipeline and the future commercial availability of our potentially life-saving products,” said Jeroen Bekaert, Ph.D., co-founder and chief operating officer of Orca Bio. “With the capacity to manufacture approximately 3,000 cell therapy products per year, the facility will allow us to scale to meet future demand. Investing in our manufacturing capabilities is essential to our mission of delivering a cure without compromise while ensuring timely access to the patients who need it, when they need it.” 

The new facility is strategically located in Sacramento's newly developed Metro Air Park next to the Sacramento International Airport, enabling direct shipping access to transplant centers across the U.S. It is also in close proximity to Orca Bio's existing clinical manufacturing building. The facility is uniquely tailored to manufacture precision cell therapies designed to replace cancerous blood and immune systems with healthy ones. It touts modular production suites, which are adjustable for future growth, quality control laboratories, warehouse space and offices. The construction began in August of 2021 and is scheduled to be completed later this year. The facility is expected to be fully validated and operational in the first half of 2023. 

“Throughout the clinical development of our products, we have demonstrated the ability to reliably manufacture and deliver high-precision cell therapies with rapid turnaround times, regardless of donor and patient location,” said Ivan Dimov, Ph.D., co-founder and chief executive officer of Orca Bio. “This new facility will further enhance our capabilities to deliver our therapies urgently and seamlessly to patients at scale, while meeting the highest quality and regulatory standards.”

Orca Bio’s unique approach uses precision cell selection technology to identify the less than 1% of the 100 billion donor cells that potentially contain therapeutic benefits for patients. These cells are then manufactured into potentially curative cell therapies designed to maximize efficacy of treatment and significantly limit treatment-related risks. Orca Bio recently announced Precision-T, its pivotal Phase 3 study evaluating Orca-T for the treatment of acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and high-risk myelodysplastic syndromes (MDS), is open for enrollment at leading transplant centers across the U.S.

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 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. 

Contact:

Corporate Communications

Kelsey Grossman

media@orcabio.com

Investor Relations

Joshua Murray

ir@orcabio.com


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Orca Bio Announces the Precision-T Phase 3 Study is Open and Enrolling Patients at Transplant Centers Across the U.S.

– The pivotal Precision-T Study is evaluating the safety and efficacy of Orca Bio’s investigational Orca-T compared to standard of care allogeneic hematopoietic stem cell transplant –

– Precision-T is expected to enroll approximately 174 patients across more than 20 clinical trial sites –

MENLO PARK, CA, August 2, 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 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.

Precision-T (NCT05316701) is a randomized, open-label multi-center study that is evaluating the safety and efficacy of Orca Bio’s lead investigational high-precision cell therapy, Orca-T, compared to standard of care allogeneic hematopoietic stem cell transplant (standard allo-HSCT). Orca Bio received guidance from the Food and Drug Administration on the design of Precision-T, which will evaluate Orca-T in patients with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and high-risk myelodysplastic syndromes (MDS).

“By precision engineering the donor graft, we aim to create a cell therapy that retains the benefits of transplant without serious complications like graft versus host disease and disease relapse,” said Robert Negrin, M.D., professor of medicine at the Stanford School of Medicine. “This has been demonstrated by the recent results of the Phase 1b/2 single-arm trials with Orca-T, and we are pleased to be evaluating this novel cell therapy in a randomized Phase 3 clinical trial.”

The primary endpoint of the Precision-T study is the rate of moderate-to-severe chronic GvHD-free survival. The secondary endpoints are graft-versus-host-disease and relapse-free survival (GRFS), moderate-to-severe chronic GvHD and relapse-free survival. The randomized Phase 3 trial is being conducted concurrently with Orca Bio’s ongoing single-arm Phase 1b trial of Orca-T.

“The Precision-T study is an important step forward for patients battling deadly blood cancers like AML and ALL, which are often aggressive and for which standard allo-HSCT treatment carries significant risks,” said Ivan Dimov, Ph.D., co-founder and chief executive officer of Orca Bio. “We are pleased to collaborate with these clinical trial centers and the broader blood cancer community to advance this study with the ultimate goal of delivering a safe and effective therapy to the patients who need it.”

Orca-T is a first-in-class high-precision cell therapy that combines purified cells from a matched donor. It is designed to replace a patient’s diseased blood and immune system with a healthy one while lowering the risk of developing GvHD and other life-threatening transplant-related side effects. Almost 200 patients have been treated to date with Orca-T in single-arm trials with extremely encouraging results, which were recently presented at the European Hematology Association (EHA) 2022 Congress, the 2022 Transplantation & Cellular Therapy ASTCT and CIBMTR Tandem Meetings 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. 

Orca Bio to Present New Clinical Data on Orca-T at the European Hematology Association 2022 Congress

Press release

Menlo Park, CA

May 12, 2022

Orca Bio to Present New Clinical Data on Orca-T at the European Hematology Association 2022 Congress

MENLO PARK, CA, May 12, 2022 – 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.

Oral Session: Clinical Studies in Transplantation

Title: Orca-T, an Engineered Allograft, Results in High GVHD-Free and Relapse-Free Survival Following Myeloablative Conditioning for Hematological Malignancies

Abstract Number: S237

Date and Time: Sunday, June 12, at 11:30–12:45 CEST / 5:30AM–6:45AM EDT

Location: Hall Stolz 1-2

The presentation will highlight results from the single-center Phase 2 and multi-center Phase 1b trials of Orca-T in patients with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and myelodysplastic syndromes (MDS). Data included in the abstract will be updated at the time of presentation.

The oral session will take place in Vienna and will be livestreamed on the EHA Congress platform.

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


Visit our newsroom
Orca Bio Presents Positive Data Reinforcing Clinical Profile and Manufacturing Reliability of Orca-T at 2022 Transplantation & Cellular Therapy ASTCT and CIBMTR Tandem Meetings

– Pooled data from 137 patients show Orca-T high-precision cell therapy improved overall survival and reduced chronic graft versus host disease compared to standard of care –

– Orca-T was well-tolerated and resulted in engraftment with regression of marrow fibrosis in patients with myelofibrosis –

– Manufacturing reliability analysis found vein-to-vein times for all grafts were under 72 hours regardless of donor collection site and transplant center locations –

– The Precision-T Phase 3 randomized registrational study of Orca-T versus standard of care is now open –

MENLO PARK, CA, Apr. 25, 2022 – 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.

The new data on Orca Bio’s lead investigational high-precision cell therapy, Orca-T, include updated results from 137 patients with hematologic malignancies, which continued to show an increase in overall survival rates and a reduction of acute and chronic graft versus host disease (GvHD) compared to standard of care; positive outcomes in a subset of patients with myelofibrosis who received Orca-T; and new analyses demonstrating Orca Bio’s manufacturing platform is reliable, robust and scalable.

“These data from an expanded group of patients are very encouraging and demonstrate that Orca-T appears to improve survival while reducing GvHD. This could be a compelling option for patients battling serious hematological malignancies who currently face devastating transplant-related risks,” said Everett Meyer, M.D., Ph.D., primary investigator. “These results, combined with the reliable and centralized Orca-T manufacturing, could potentially transform treatment options for patients and physicians.’

Orca Bio presented pooled data from 137 patients in the single-center Phase 2 and multi-center Phase 1b trials of Orca-T with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and myelodysplastic syndromes (MDS), with at least 100 days of follow-up and a median of 341 days. For comparison purposes, an independent CIBMTR-based control arm was identified, consisting of similar patients with hematologic malignancies who received a standard of care allogeneic hematopoietic stem cell transplant (“alloHSCT”) over a similar timeframe. Results demonstrated that:

Additionally, Orca Bio presented findings from a manufacturing reliability analysis of 100 Orca-T products in the Phase 1b trial. All investigational cell therapies were manufactured at Orca Bio’s cGMP facility in Sacramento, CA, and transplant centers and donor sites were located across the U.S. All products were successfully delivered and infused to patients within 72 hours or less.

“We produce a unique batch of drug for each patient who receives an Orca-T product, and this drug is made up of fresh, living cells that need to be infused on an extremely rapid timeline,” said Nate Fernhoff, Ph.D., co-founder and chief scientific officer at Orca Bio. “Reliable and scalable manufacturing have been integral to the development of our therapies since day one. These results not only show that Orca-T continues to reduce GvHD and improve survival rates over time, but that we have maintained the ability to reliably manufacture, deliver and infuse all patients in a timely manner regardless of donor and patient location. This is an important indication of our ability to potentially deliver this therapy urgently and seamlessly to patients in need.”

In a separate poster, Orca Bio presented updated data on the treatment impact of Orca-T in 12 patients with myelofibrosis compared to nine patients who received a standard of care alloHSCT. Orca-T recipients had lower incidence of acute and chronic GvHD (33% with Orca-T versus 100% with alloHSCT) and the data suggest Orca-T was well-tolerated. Treatment with Orca-T resulted in engraftment with regression of marrow fibrosis, indicating potential efficacy for the treatment of myelofibrosis.

Based on the favorable results of the Phase 1b and 2 clinical trials, a randomized registrational Phase 3 trial evaluating Orca-T against standard of care alloHSCT, named Precision-T, is now open. More details will be announced in the coming weeks.

Links to the abstracts follow:

Orca Bio to Present at the 40th Annual J.P. Morgan Healthcare Conference

MENLO PARK, CA, Jan. 6, 2022 – 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.

The company presentation will take place virtually on Tuesday, January 11, 2022, at 6:30 AM PST (9:30 AM EST).

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Positive clinical results on Orca-T presented at the 63rd ASH Annual Meeting.    |    Read more

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

Press release

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

Pooled study results showed significantly higher graft-versus-host disease-free, relapse-free survival rates and improved overall survival rates with Orca-T compared to standard of care
Data from Phase 1b/2 trials include 109 patients with acute myeloid leukemia, acute lymphocytic leukemia, myelodysplastic syndromes, myelofibrosis and other hematological malignancies
Data from eight patients with myelofibrosis who received Orca-T showed regression of marrow fibrosis
Orca-T was manufactured reliably and delivered with vein-to-vein times of 72 hours or less
Company plans to commence Phase 3 study in early 2022

MENLO PARK, CA, Apr. 25, 2022 – 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.

The new data on Orca Bio’s lead investigational high-precision cell therapy, Orca-T, include updated results from 137 patients with hematologic malignancies, which continued to show an increase in overall survival rates and a reduction of acute and chronic graft versus host disease (GvHD) compared to standard of care; positive outcomes in a subset of patients with myelofibrosis who received Orca-T; and new analyses demonstrating Orca Bio’s manufacturing platform is reliable, robust and scalable.

"These data from an expanded group of patients are very encouraging and demonstrate that Orca-T appears to improve survival while reducing GvHD. This could be a compelling option for patients battling serious hematological malignancies who currently face devastating transplant-related risks," said Everett Meyer, M.D., Ph.D., primary investigator. "These results, combined with the reliable and centralized Orca-T manufacturing, could potentially transform treatment options for patients and physicians."

Orca Bio presented pooled data from 137 patients in the single-center Phase 2 and multi-center Phase 1b trials of Orca-T with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and myelodysplastic syndromes (MDS), with at least 100 days of follow-up and a median of 341 days. For comparison purposes, an independent CIBMTR-based control arm was identified, consisting of similar patients with hematologic malignancies who received a standard of care allogeneic hematopoietic stem cell transplant (“alloHSCT”) over a similar timeframe. Results demonstrated that:

  • Rates of moderate-to-severe chronic GvHD were low among Orca-T recipients, occurring in only 5% of patients at one year compared to 38% who received a standard alloHSCT.
  • Orca-T showed the potential for lower rates of moderate-to-severe chronic graft versus host disease (GvHD) at 1 year post-transplant (3% vs. 43%; p<0.0005).
  • Overall survival rates with Orca-T (90% vs. 78%; p<0.03) and rates of chronic-GvHD-free survival (87% vs. 45%; p<0.0001) were improved.
  • Orca-T was manufactured reliably and delivered with vein-to-vein times of 72 hours or less across the continental U.S.


Additionally, Orca Bio presented findings from a manufacturing reliability analysis of 100 Orca-T products in the Phase 1b trial. All investigational cell therapies were manufactured at Orca Bio’s cGMP facility in Sacramento, CA, and transplant centers and donor sites were located across the U.S. All products were successfully delivered and infused to patients within 72 hours or less.

"We produce a unique batch of drug for each patient who receives an Orca-T product, and this drug is made up of fresh, living cells that need to be infused on an extremely rapid timeline," said Nate Fernhoff, Ph.D., co-founder and chief scientific officer at Orca Bio. "Reliable and scalable manufacturing have been integral to the development of our therapies since day one. These results not only show that Orca-T continues to reduce GvHD and improve survival rates over time, but that we have maintained the ability to reliably manufacture, deliver and infuse all patients in a timely manner regardless of donor and patient location. This is an important indication of our ability to potentially deliver this therapy urgently and seamlessly to patients in need."

In a separate poster, Orca Bio presented updated data on the treatment impact of Orca-T in 12 patients with myelofibrosis compared to nine patients who received a standard of care alloHSCT. Orca-T recipients had lower incidence of acute and chronic GvHD (33% with Orca-T versus 100% with alloHSCT) and the data suggest Orca-T was well-tolerated. Treatment with Orca-T resulted in engraftment with regression of marrow fibrosis, indicating potential efficacy for the treatment of myelofibrosis.

Based on the favorable results of the Phase 1b and 2 clinical trials, a randomized registrational Phase 3 trial evaluating Orca-T against standard of care alloHSCT, named Precision-T, is now open. More details will be announced in the coming weeks.

Links to the abstracts follow:

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

“The lower rates of graft versus host disease and improved relapse-free survival suggest Orca-T has the potential to become a safer and more effective treatment option for patients living with serious blood cancers.”

Ivan Dimov, Ph.D., cofounder and chief executive officer of 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

Visit our newsroom