Long-Term Data from Omidubicel Phase 3 Trial Demonstrates Overall Survival and Sustainable Durable Outcomes for Patients with Blood Cancers at the Society of Hematologic Oncology Meeting
September 29 2022 - 7:00AM
Business Wire
At three years, new data showed overall
survival and disease-free survival of 63% and 56% respectively
At ten years, follow-up data demonstrated
sustained long-term bone marrow recovery
Omidubicel patients reported clinically
meaningful health-related quality of life scores compared to
umbilical cord blood
Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development
of NAM-enabled cell therapies for patients with hematologic and
solid cancers and other serious diseases, today announced the
presentation of new long term follow-up data and health-related
quality of life scores of patients treated with omidubicel at the
Tenth Annual Meeting of the Society of Hematologic Oncology (SOHO),
being held in Houston, Texas.
“These data reinforce our commitment to advance transformational
cell therapy research and underscore the potential of our NAM
technology platform. Our lead stem cell therapy candidate,
omidubicel, addresses the unmet need for patients with hematologic
malignancies, demonstrated by the robust and growing body of
encouraging clinical evidence, including the long-term follow up
data and quality of life improvement,” said Ronit Simantov, M.D.,
Chief Medical Officer of Gamida Cell. “As we approach the PDUFA
date of January 30, 2023, and upon potential FDA approval, we are
prepared to execute our plan that ensures access to those patients
who can benefit from omidubicel as quickly as possible.”
The long-term, durable clinical benefit of omidubicel was
observed at three years across a patient population that typically
has a poor prognosis. A study titled, “Multicenter Long-Term Follow
Up of Allogeneic Hematopoietic Stem Cell Transplantation with
Omidubicel: A Pooled Analysis of Five Prospective Clinical Trials,”
highlighted long-term follow-up of 105 patients transplanted with
omidubicel between 2006-2020 (median follow-up of 22 months). The
data demonstrated an overall survival and disease-free survival of
63% (95% CI, 53%-73%) and 56% (95% CI, 47%-67%) at three years,
respectively, as well as durable long-term hematopoiesis and immune
competence. Learn More
Overall well-being health-related quality of life scores for
patients treated with omidubicel demonstrated clinical benefit
compared to standard of care. A study titled, “Health-Related
Quality of Life Following Allogeneic Hematopoietic Stem Cell
Transplantation with Omidubicel Versus Standard Umbilical Cord
Blood” featured an analysis of 108 patients that completed
validated health-related quality of life (HRQL) surveys on
screening and days 42, 100, 180, and 365 post-transplant. Measures
of physical and functional well-being and other HRQL scores were
more favorable with omidubicel. These data suggest clinically
meaningful and sustained improvements in physical, functional, and
overall well-being compared to umbilical cord blood
transplantation. Learn More
About NAM Technology
Our NAM-enabling technology is designed to enhance the number
and functionality of targeted cells, enabling us to pursue a
curative approach that moves beyond what is possible with existing
therapies. Leveraging the unique properties of NAM (nicotinamide),
we can expand and metabolically modulate multiple cell types —
including stem cells and natural killer cells — with appropriate
growth factors to maintain the cells’ active phenotype and enhance
potency. Additionally, our NAM technology improves the metabolic
fitness of cells, allowing for continued activity throughout the
expansion process.
About Omidubicel
Omidubicel is an advanced cell therapy candidate developed as a
potential life-saving allogeneic hematopoietic stem cell (bone
marrow) transplant for patients with blood cancers. Omidubicel
demonstrated a statistically significant reduction in time to
neutrophil engraftment in comparison to standard umbilical cord
blood in an international, multi-center, randomized Phase 3 study
(NCT0273029) in patients with hematologic malignancies undergoing
allogeneic bone marrow transplant. The Phase 3 study also showed
reduced time to platelet engraftment, reduced infections and fewer
days of hospitalization. One-year post-transplant data showed
sustained clinical benefits with omidubicel as demonstrated by
significant reduction in infectious complications as well as
reduced non-relapse mortality and no significant increase in
relapse rates nor increases in graft-versus-host-disease (GvHD)
rates. Omidubicel is the first stem cell transplant donor source to
receive Breakthrough Therapy Designation from the FDA and has also
received Orphan Drug Designation in the US and EU.
Omidubicel is an investigational stem cell therapy candidate,
and its safety and efficacy have not been established by the FDA or
any other health authority. For more information about omidubicel,
please visit https://www.gamida-cell.com.
About Gamida Cell
Gamida Cell is pioneering a diverse immunotherapy pipeline of
potentially curative cell therapy candidates for patients with
solid tumor and blood cancers and other serious blood diseases. We
apply a proprietary expansion platform leveraging the properties of
NAM to allogeneic cell sources including umbilical cord
blood-derived cells and NK cells to create therapy candidates with
potential to redefine standards of care. These include omidubicel,
an investigational product with potential as a life-saving
alternative for patients in need of bone marrow transplant, and a
line of modified and unmodified NAM-enabled NK cells targeted at
solid tumor and hematological malignancies. For additional
information, please visit www.gamida-cell.com or follow Gamida Cell
on LinkedIn, Twitter, Facebook or Instagram at @GamidaCellTx.
Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements as that
term is defined in the Private Securities Litigation Reform Act of
1995, including with respect to timing of initiation and progress
of, and data reported from, the clinical trials of Gamida Cell’s
product candidates (including omidubicel), regulatory filings
submitted to the FDA (including the potential timing of the FDA’s
review of the BLA for omidubicel), commercialization planning
efforts, and the potentially life-saving or curative therapeutic
and commercial potential of Gamida Cell’s product candidates
(including omidubicel), and Gamida Cell’s expectations for the
expected clinical development milestones set forth herein. Any
statement describing Gamida Cell’s goals, expectations, financial
or other projections, intentions or beliefs is a forward-looking
statement and should be considered an at-risk statement. Such
statements are subject to a number of risks, uncertainties and
assumptions, including those related to the impact that the
COVID-19 pandemic could have on our business, and including the
scope, progress and expansion of Gamida Cell’s clinical trials and
ramifications for the cost thereof; clinical, scientific,
regulatory and technical developments; and those inherent in the
process of developing and commercializing product candidates that
are safe and effective for use as human therapeutics, and in the
endeavor of building a business around such product candidates. In
light of these risks and uncertainties, and other risks and
uncertainties that are described in the Risk Factors section and
other sections of Gamida Cell’s Quarterly Report on Form 10-Q,
filed with the Securities and Exchange Commission (SEC) on May 12,
2022, as amended, and other filings that Gamida Cell makes with the
SEC from time to time (which are available at http://www.sec.gov),
the events and circumstances discussed in such forward-looking
statements may not occur, and Gamida Cell’s actual results could
differ materially and adversely from those anticipated or implied
thereby. Although Gamida Cell’s forward-looking statements reflect
the good faith judgment of its management, these statements are
based only on facts and factors currently known by Gamida Cell. As
a result, you are cautioned not to rely on these forward-looking
statements.
1CIBMTR 2019 – allogeneic transplants in patients 12+ years with
hematological malignancies. 2Gamida Cell market research
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version on businesswire.com: https://www.businesswire.com/news/home/20220929005316/en/
For investors: Courtney Turiano Stern Investor Relations,
Inc. Courtney.Turiano@sternir.com 1-212-362-1200
For media: Heather DiVecchia Director, Investor Relations
and Corporate Communications Heather@gamida-cell.com
1-617-892-9083
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