Orca Bio to Present Positive Clinical Outcomes with Orca-T in Patients with AML at 2024 ASCO Annual Meeting
May 23 2024 - 5:00PM
Business Wire
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.
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 includes infusions containing
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.
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Corporate Communications Kelsey Grossman media@orcabio.com
Investor Relations Joshua Murray ir@orcabio.com