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Orca Bio Presents Positive Data Reinforcing Clinical Profile of Orca-T and Orca-Q at 2023 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR

– Three oral presentations showcase clinical evidence for Orca Bio’s promising pipeline of early- and late-stage high-precision cell therapies –

– Orca-T demonstrated high relapse-free survival in recipients with fully matched donors and early potential in patients with mismatched donors –

– Orca-Q showed improved graft-versus-host disease-free, relapse-free survival in patients with haploidentical donors –

MENLO PARK, CA, February 16, 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 data from the company’s investigational high-precision cell therapy programs, Orca-T and Orca-Q, were presented in three oral presentations at the 2023 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR.

Positive data on Orca-T was presented from the single-center Phase 2 and multi-center Phase 1b trials of patients with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndromes (MDS) and other hematological malignancies. Outcomes with Orca-T appeared to be further enhanced in patients who received a conditioning regimen of busulfan, fludarabine and thiotepa (BFT). At 12 months, the 71 patients in the Orca-T BFT subgroup reported no non-relapse mortality (0%), and high rates of relapse-free survival (87%), graft-versus-host disease-free, relapse-free survival (GRFS) (81%) and overall survival (94%). These data were previously presented at the 64th American Society of Hematology (ASH) Annual Meeting in December 2022.

In a second oral presentation, new data highlighted how expanding the donor pool may help address disparities in access to transplant. Today, approximately 70% of blood cancer patients do not have access to a fully matched related donor, and the likelihood of a patient finding a matched unrelated donor in the U.S. is as low as 29% for some ethnic backgrounds. While the use of human leukocyte antigen (HLA) mismatched donors has increased access to treatment for these patients undergoing allogeneic hematopoietic stem cell transplant (alloHSCT), clinical outcomes have also been associated with significantly worse overall survival, disease-free survival, treatment-related mortality and acute graft versus host disease (aGvHD). In a small cohort (n=8), Orca-T demonstrated promising results in patients with HLA mismatched (7/8) donors, including no cases of severe GvHD or non-relapse mortality and 100% overall survival to date. While this early data is encouraging, more studies of Orca-T in this patient population are ongoing and will provide additional clinical data in this setting.

"As we continue to enroll patients in our pivotal Phase 3 trial of Orca-T, we are extremely encouraged by its continued potential to improve relapse-free and overall survival rates,” said Ivan Dimov, Ph.D., co-founder and chief executive officer of Orca Bio. “Beyond its promise to enhance outcomes and reduce deadly, transplant-related risks, this early evidence that Orca-T may improve clinical outcomes in patients who can’t find a fully matched donor is an important step toward our ultimate goal of offering a safe and effective treatment to all patients who may benefit.”

Orca Bio also presented findings from a Phase 1 multi-center trial of its second investigational cell therapy, Orca-Q, showing that patients with haploidentical – or half-matched – allogeneic hematopoietic stem cell donors, experienced no moderate-to-severe chronic GvHD (0%) and an improved GRFS rate (75%). Orca-Q is a proprietary composition of enriched CD34+ stem cells combined with specific T cell subsets derived from haploidentical donors. Unlike standard of care haploidentical alloHSCT, Orca-Q does not require post-transplant cyclophosphamide (PTCy). These data were also previously presented at the ASH Annual Meeting.

“A haploidentical stem cell transplant is currently the only curative treatment option available for the majority of blood cancer patients who lack a matched donor, but providers often find themselves balancing the risk of relapse and the risk of debilitating side effects like GvHD, infections and other toxicities,” said Samer Srour, M.D., Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center. “These interim findings show patients treated with Orca-Q experienced improved outcomes with significantly fewer transplant-related toxicities, suggesting this novel cell therapy could help to address this critical unmet medical need.”

Links to the abstracts follow:

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

Oral Presentation Title: Orca-T, a High-Precision Cell Therapy, for the Treatment of Hematologic Malignancies in Patients with 7/8 Mismatch Donors

Oral Presentation Title: Orca-Q Demonstrates Favorable GvHD-and-Relapse-Free Survival with Haploidentical Donors without Post-Transplant Cyclophosphamide

Poster Presentation Title: Estimating the Current and Future Costs and Health Outcomes of Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HCT)

About Orca-T

Orca-T is an investigational high-precision allogeneic cell 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 hematological malignancies.

About Orca-Q

Orca-Q is Orca Bio’s second investigational high-precision allogeneic cell 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 donors that are purified through Orca Bio’s high-precision platform. Orca-Q is a 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 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:

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Kelsey Grossman

media@orcabio.com

Investor Relations

Joshua Murray

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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.

Orca Bio Presents Encouraging Interim Clinical Data on Orca-Q in Haploidentical Allogeneic Hematopoietic Stem Cell Transplants at 64th ASH Annual 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 64^th 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 purposes^1,2,3,4.

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.

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.

Orca Bio Presents Data Demonstrating its Lead Investigational High-Precision Cell Therapy Orca-T Significantly Improved Relapse-Free Survival at 64th Annual Meeting

Orca Bio Presents Data Demonstrating its Lead Investigational High-Precision Cell Therapy Orca-T Significantly Improved Relapse-Free Survival at 64th ASH Annual Meeting

Updated data from Phase 1b/2 trials include 151 patients with acute myeloid leukemia, acute lymphocytic leukemia, myelodysplastic syndromes and other hematologic malignancies

Relapse-free survival was 87% at one year in a group of 71 patients who received the preferred conditioning regimen being used in the Precision-T Phase 3 Study of Orca-T

Data also showed improved graft-versus-host disease-free, relapse-free survival rates and overall survival rates at one year with Orca-T compared to standard of care

Precision-T is ongoing and enrolling patients at transplant centers across the U.S.

MENLO PARK, CA, Dec. 10, 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 presented updated positive clinical data on its lead investigational cell therapy, Orca-T, during an oral presentation at the 64th American Society of Hematology (ASH) Annual Meeting.

The data demonstrated a significant improvement in relapse-free survival (RFS) at one year with 87% in 71 patients who received Orca-T and busulfan, fludarabine, and thiotepa (BFT) conditioning. BFT is the preferred conditioning regimen used in Precision-T, the ongoing Phase 3 pivotal study of Orca-T. Additionally, across all 151 patients, there was an increase in graft-versus-host disease, relapse-free survival (GRFS) rates and overall survival rates at one year with Orca-T compared to an independent cohort.

“Today, providers must balance treatment decisions with the goal of fighting cancer while minimizing toxicities. With a standard allogeneic transplant, highly myeloablative conditioning regimens can lead to reduced rates of patient relapse, but can also increase rates of non-relapse mortality,” said Everett Meyer, M.D., Ph.D., primary investigator. “It is encouraging to see that the use of Orca-T across multiple hematological malignancies resulted in a remarkable improvement in relapse-free and overall survival while lowering the rate of serious toxicities compared to standard of care allogeneic hematopoietic stem cell transplants.”

The results of the patient subgroup conditioned with BFT were presented today along with pooled results from the single-center Phase 2 and multi-center Phase 1b trials from 151 patients treated with Orca-T with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndromes (MDS) and other hematological malignancies. For comparison purposes, an independent Center for International Blood and Marrow Transplant Research (CIBMTR)-based cohort was identified consisting of patients with AML, ALL or MDS who received a standard of care allogeneic hematopoietic stem cell transplant.

Results demonstrated that patients conditioned with BFT and treated with Orca-T experienced:

87% RFS at one year among all groups, including minimal residual disease positive acute leukemia patients.
81% GRFS at one year.
0% non-relapse mortality and only 5% moderate-to-severe chronic GvHD at one year.
94% overall survival (OS) at one year.

In pooled results from all patients treated with Orca-T, patients experienced:

70% GRFS at one year compared to 21% in the CIBMTR-based cohort.
4% non-relapse mortality at one year compared to 10% in the CIBMTR-based cohort.

88% OS at one year compared to 68% in the CIBMTR-based cohort.

Importantly, Orca-T was manufactured reliably and delivered with vein-to-vein times of 72 hours or less across the U.S.

“These relapse-free and overall survival rates from more than 150 patients treated with Orca-T are very encouraging, and we are extremely pleased to see the strong results of patients who were given the preferred conditioning regimen used in our pivotal Phase 3 trial,” said Ivan Dimov, Ph.D., co-founder and chief executive officer of Orca Bio. “These new data continue to reinforce the potential of this high-precision cell therapy to become a better treatment option for patients and transplant physicians. We remain laser-focused on advancing Orca-T through Precision-T and ultimately on delivering the therapy to more patients in need.”

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