Orca Bio to Present New Clinical Data on Orca-T at the 63rd American Society of Hematology Annual Meeting

Press release

Menlo Park, CA

November 4, 2021

Orca Bio to Present New Clinical Data on Orca-T at the 63rd American Society of Hematology Annual Meeting

Oral and poster presentations will include one-year follow-up data from an expanded group of patients and an analysis of treatment outcomes in patients with myelofibrosis

MENLO PARK, CA, November 4, 2021 – Orca Bio, a clinical-stage biotechnology company developing purified, high-precision cell therapies for cancer, autoimmune and genetic blood disorders, today announced that new data will be presented from a single-center Phase 2 trial and a multi-center Phase 1b trial at the American Society of Hematology (ASH) Annual Meeting. Specifically, pooled data from patients treated with Orca-T, an investigational high-precision cell therapy product being studied in patients with hematologic malignancies, will be shared in an oral presentation. Additionally, results of Orca-T in a subset of patients with myelofibrosis from those same trials will be shared in a poster presentation.

“Our clinical experience with Orca-T has grown significantly over the past year and we are pleased to present data on an expanded group of patients who now have one year of follow-up with Orca-T,” said Ivan Dimov, Ph.D., cofounder and chief executive officer of Orca Bio. “We look forward to presenting these important findings at ASH as we continue to work to deliver on our promise of maximizing patient survival while minimizing the compromise of toxicities to enable better outcomes.”

The ASH abstracts are now available at www.hematology.org.

Details of the Orca Bio presentations follow:

Orca-T Results in High GVHD-Free and Relapse-Free Survival Following Myeloablative Conditioning for Hematological Malignancies: Results of a Single Center Phase 2 and a Multicenter Phase 1b Study

Abstract Number: 98

Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution: Prevention of graft vs. host disease after allogeneic hematopoietic cell transplantation

Presentation Date: Saturday, December 11, 2021, at 9:45 AM EST

Location: Georgia World Congress Center, B302-B303

Poster Presentation: Outcomes for Myelofibrosis Patients Following Myeloablative Allogeneic Stem Cell Transplantation Using the Orca-T Graft from HLA-Matched Related and Unrelated Donors

Abstract Number: 1819

Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution: Poster I

Presentation Date: Saturday, December 11, 2021, at 5:30 PM – 7:30 PM EST

Location: Georgia World Congress Center, Hall B5

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


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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


Visit our newsroom
Orca Bio to Present at the 39th Annual J.P. Morgan Healthcare Conference

MENLO PARK, CA, January 6, 2021 – Orca Bio, a clinical-stage biotechnology company developing high-precision cell therapies for patients with blood diseases, today announced that Ivan Dimov, PhD, Chief Executive Officer, will present a company overview at the 39th Annual J.P. Morgan Healthcare Conference. The presentation will be held virtually on Monday, January 11, 2021, at 1:55 PM PT (4:55 PM ET), immediately followed by a Q&A session.

Management will be available for meetings during the week of the conference.

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 Announces Oral Presentation of Orca-T Clinical Data at the 62nd American Society of Hematology (ASH) Annual Meeting

Data provide insights into manufacturing efficiency, logistics, and early clinical outcomes of Orca-T for patients with blood cancers

MENLO PARK, CA, November 4, 2020 – Orca Bio, a clinical-stage biotechnology company, today announced that preliminary data from the phase I/II clinical trials of Orca-T (NCT04013685 and NCT01660607) will be presented at the 62nd American Society of Hematology (ASH) Annual Meeting, to be held virtually from December 5-8, 2020. Data will be presented on manufacturing, logistics, and early clinical outcomes. Patients in the Orca-T trial are compared with a retrospective contemporaneous control group from Stanford University. Everett Meyer, MD, PhD, Medical and Scientific Director of the Cellular Therapy Facility, Stanford Health Care and Assistant Professor of Medicine, Blood and Marrow Transplantation, Stanford University, will present the data.

Orca-T is a high-precision allogeneic cell therapy under investigation to replace a conventional mobilized blood product in hematopoietic stem cell transplant (HSCT). The therapy is designed with the goal of preventing graft-versus-host disease and other transplant related complications. Orca-T is manufactured via a proprietary GMP platform in a central lab. Patients with both related donors and unrelated donors are eligible and fresh, viable products are distributed to clinical sites around the continental United States. Data supporting reliability of manufacturing and transport will also be presented.

The US Food and Drug Administration has granted Orca-T regenerative medicine advanced therapy (RMAT) and orphan drug designation to treat patients eligible for a hematopoietic stem cell transplant. The RMAT designation provides Orca Bio the avenue to receive early guidance from the FDA to steer manufacturing and clinical development.

“This therapy was originally pioneered by Dr. Everett Meyer and Dr. Robert Negrin in a single-center trial at Stanford University, and Orca Bio has further developed the Orca-T drug in a multicenter trial. Leveraging the Orca Bio manufacturing platform, we aim to provide access to this potentially curative cell therapy to patients worldwide,” said Nate Fernhoff, PhD, Chief Scientific Officer and Cofounder of Orca Bio.

Details of the presentation

Orca Bio Receives Regenerative Medicine Advanced Therapy (RMAT) Designation for Orca-T

FDA grants RMAT and Orphan Drug Designations (ODD) to Orca-T for treating patients eligible for allogeneic hematopoietic stem cell transplant

MENLO PARK, CA, October 14, 2020 – Orca Bio, a clinical-stage biotechnology company, today announced that the US Food and Drug Administration (FDA) has granted RMAT designation to Orca-T (NCT04013685). Orca-T is an investigational allogeneic, high-precision cell therapy for patients with blood cancers who are eligible for a hematopoietic (blood) stem cell transplant. In addition, Orca-T has received ODD from the FDA for enhancing cell engraftment in patients who qualify for a hematopoietic stem cell transplant.

RMAT is a dedicated program designed to expedite the development of new regenerative therapies, including cell therapies that have the potential to treat life-threatening medical conditions. Cell therapies granted the RMAT designation also receive the benefits of fast track and breakthrough therapy designations. These advantages include early guidance from the FDA to steer manufacturing and clinical development, such as determination of intermediate endpoints to potentially support accelerated approval. ODD status is granted for therapies that address rare diseases affecting fewer than 200,000 people in the US. If a therapy with ODD receives the first FDA approval for the designated condition, it is eligible for 7-year market exclusivity.

For many patients with blood cancers, blood stem cell transplants from donors are the only hope for a cure. However, conventional transplants are often associated with cancer relapse and complications such as graft-versus-host disease (GvHD)—a condition in which immune cells from the donor attack the patient’s healthy cells, leading to organ failure and even death. Orca-T is a precisely controlled formulation of hematopoietic stem cells and T cells that aims to improve outcomes for these patients.

“The RMAT and ODD for Orca-T is uplifting news for patients with various blood cancers, including acute myeloid leukemia, acute lymphoid leukemia, myelodysplastic syndrome, and myelofibrosis,” said Ivan Dimov, PhD, Chief Executive Officer and Cofounder of Orca Bio. “We now have the opportunity to work closely with the FDA to open potential ways to support accelerated approval.” Clinical data from the ongoing Orca-T trial will be presented at the 62nd American Society of Hematology Annual Meeting later this year.

Orca Bio and Lyell Immunopharma Announce Research Partnership

The partnership promotes complementary scientific technologies to develop next-generation cell-based therapies for patients with solid cancers

MENLO PARK, CA, and SOUTH SAN FRANCISCO, CA, September 2, 2020 – Orca Bio and Lyell Immunopharma today announced a research partnership to jointly identify next-generation T cell therapies that will combine the high-precision purification T cell technologies from Orca Bio with the scientific expertise in T cell biology from Lyell to generate potentially synergistic therapeutic solutions for solid tumors.

Lyell Immunopharma has brought together an unrivaled scientific team focused on advancing the science of therapeutic T cells, including the role of T cell differentiation. Orca Bio has developed T cell therapies for patients with blood diseases while also streamlining the commercial manufacture of high-precision cell therapies using OrcaSort™, an ultra-fast, clinically compatible cell sorter.

The ability to produce optimal starting-cell populations is one of many continuing challenges in the development of curative T cell therapies. Evidence from current generation cell therapies suggest that the proportion of cell types and their stages of differentiation may impact the safety and efficacy of T cell therapies. Together, the companies aim to mitigate this challenge by utilizing their proprietary technologies to effectively treat solid tumor cancers.

“Lyell Immunopharma is focused on developing curative T cell therapies for solid tumor cancers by defining starting-cell preparations and modulating T cells, so they are functional in the immunosuppressive tumor microenvironment,” said Nick Restifo, MD, Executive Vice President of Research for Lyell Immunopharma. “This collaboration with Orca Bio provides the potential to more efficiently define starting-cell preparations, which I believe could lead to more effective T cell therapies.”

“Orca Bio has developed extremely pure doses of stem and immune cells that can be precisely formulated to treat cancers,” said Ivan Dimov, PhD, cofounder and CEO of Orca Bio. “By combining our scientific expertise with that of Lyell Immunopharma, and by applying our specialized manufacturing platform, we aim to create the scalable production of adoptive T cell therapies that can reach patients with unprecedented speed.”

Orca Bio and Lyell Immunopharma will each continue to pursue programs independently and through their other partnerships.

Orca Bio Emerges With Nearly $300 Million to Transform Allogeneic Cell Therapy

Company aims to safely and effectively regenerate a healthy blood and immune system for patients with hematological malignancies, genetic diseases and autoimmune disorders

High-precision cell therapies manufactured by Orca Bio have the potential to replace conventional bone marrow transplants and expand the eligible patient population

$192 million Series D financing strengthens the company with resources to propel lead product candidate to completion of clinical development

MENLO PARK, CA, June 17, 2020 – Orca Bio, a clinical-stage biotechnology company developing high-precision allogeneic cell therapies, today announced a Series D financing that brings its total capital raised since its 2016 launch to nearly $300 million. The company creates precisely controlled cell therapies by building each dose cell-by-cell from another person’s blood. Each therapy is constructed by formulating a proprietary mixture of cells that aims to cure the patient’s disease and eliminate dangerous side effects.

Orca Bio’s $192 million Series D financing was co-led by Lightspeed Venture Partners and an undisclosed investor. Other new and existing blue-chip investors also participated in the latest round, including 8VC, DCVC Bio, ND Capital, Mubadala Investment Company, Kaiser Foundation Hospitals, Kaiser Permanente Group Trust and IMRF.

The financing will support the continued advancement of Orca Bio’s cell therapy pipeline and its novel manufacturing platform, which sorts blood with single-cell precision and a high level of purity and speed to create optimal therapeutic mixtures of immune and stem cells. These proprietary mixtures have the potential to revolutionize allogeneic cell therapy for hematological and other cancers, as well as many other diseases and disorders.

A conventional bone marrow transplant relies on naturally occurring T cells. However, the uncontrolled cellular composition often results in life-threatening complications. The company’s most advanced program, TRGFT-201, is evaluating a highly controlled formulation of T cells that includes subsets of regulatory T cells, in a phase I/II clinical study in patients with certain blood cancers. The company’s second program, OGFT-001, is evaluating a fully controlled cell product candidate that contains a next-generation formulation of T cells, in a phase I study, also in patients with blood cancers. Orca Bio’s 2 ongoing clinical studies are among the largest phase I cell therapy trials ever conducted. Each product candidate has the potential to deliver curative outcomes for the initial indications Orca Bio is pursuing, as well as the promise to significantly expand the eligible patient population by substantially reducing the severe toxicities associated with conventional bone marrow transplants.

“The capital we have raised has formed the launchpad for a world-class, fully integrated allogeneic cell therapy company differentiated from all others,” said Ivan Dimov, PhD, Cofounder and Chief Executive Officer of Orca Bio. “Replacing bone marrow transplants is a logical first step in next-generation allogeneic cell therapy. While a conventional bone marrow transplant administers an uncontrolled cell product, Orca Bio has been the first to deliver a high-precision cell therapy. We are initially focused on two clinical programs in patients with blood cancers and have successfully treated the largest-ever number of patients with a high-precision cell therapy. We believe our approach has the potential to transform allogeneic cell therapy, and thus the treatment of not only blood cancer, but also many other diseases with significant unmet need, such as a variety of genetic diseases and autoimmune disorders.”

“With precise reconstitution using highly defined cell preps and a swift reboot of the patient’s immune system, Orca Bio’s product candidates have the potential to eliminate fatal side effects, such as graft-versus-host disease, and infections commonly associated with bone marrow transplants while maintaining or enhancing antitumor efficacy,” said Rick Klausner, MD, an investor and member of Orca Bio’s advisory board. “The possibility of improving cure rates and minimizing toxicity holds the promise of expanding the eligible patient population for successful bone marrow transplantation in cancer.”

“Orca Bio’s visionary leadership team, seasoned advisors, solid financial foundation, and novel technology make the company uniquely suited to develop truly differentiated, scalable allogeneic cell therapies,” said Jonathan MacQuitty, PhD, Venture Partner at Lightspeed Venture Partners. “I look forward to the Orca Bio team’s continued development and commercialization of revolutionary allogeneic cell therapies.”

Internationally Recognized Experts and Leaders

Orca Bio’s leadership, Ivan Dimov, PhD, Chief Executive Officer, Nate Fernhoff, PhD, Chief Scientific Officer, and Jeroen Bekaert, PhD, Chief Operating Officer, met at Stanford University and launched the company in 2016. Orca Bio’s board of directors and advisory board are comprised of renowned scientific leaders and seasoned biotech executives with extensive experience in drug discovery and cell-based therapeutics, including: