- Patients treated with omidubicel reported higher
health-related quality of life scores during first-year
post-transplant as compared to transplantation with umbilical cord
blood (UCB)
- If approved, Omidubicel is projected to have meaningful
improvement in patient outcomes among racial and ethnic minorities
by potentially extending access to allogeneic hematopoietic cell
transplant (allo-HCT) and reducing time to transplant
- Data highlights robust and diverse T cell reconstitution, with
significantly higher recent thymic emigrant (RTE) T cells at 1
year, no loss of TCR repertoire diversity, providing mechanistic
rationale for lower viral and overall infection rates observed in
patients transplanted with omidubicel
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 data supporting the potential of omidubicel for the
treatment of patients with blood cancers in need of an allogeneic
hematopoietic stem cell transplant at the 2022 Cord Blood Connect
Meeting, being held in South Beach, Florida. “We continue to be
encouraged by the growing body of evidence supporting the improved
outcomes and lower infection rates seen in patients treated with
omidubicel as well as the superior health-related quality of life
scores compared to transplantation with UCB. We also demonstrated
the potential role for omidubicel to address the unmet need for
patients who are currently eligible for transplant, but cannot find
a match,” said Julian Adams, chief executive officer of Gamida
Cell. “Our omidubicel BLA was accepted by the FDA and granted
priority review with a PDUFA date of January 30, 2023, which we
believe further underscores the unmet need for patients with blood
cancers in need of a stem cell transplant.”
Gamida Cell presented a poster titled “Health-Related Quality of
Life (HRQL) Following Transplantation with Omidubicel Versus
Umbilical Cord Blood (UCB) in Patients with Hematological
Malignancies: Results from a Phase III Randomized, Multicenter
Study,” which included an analysis of 75 patients to evaluate
changes in HRQL measures between the two study arms. Outcomes
evaluated included Functional Assessment of Cancer Therapy General
(FACT-G) domain scores for physical, social/family, functional and
emotional well-being, and EQ-5D-3L index scores at days 42, 100,
180 and 365 post-transplant. During the first-year post-transplant,
patients receiving omidubicel had numerically superior average
FACT-G domain and EQ-5D-3L index scores compared to UCB, with mean
differences across time points ranging from 1.4-3.1 for physical
well-being, 0-1.3 for social/family well-being, 0.5-1.4 for
emotional well-being, 1.6-3.2 for functional well-being, and
0.03-0.09 for the EQ-5D-3L index score. The data suggest
meaningfully greater preservation or improvement of important HRQL
domains in patients treated with omidubicel compared to UCB. Learn
more
Gamida Cell also presented a poster titled “Projected Impact of
Omidubicel on Racial and Ethnic Disparities in Allogeneic
Hematopoietic Cell Transplant Access and Outcomes for Patients with
Hematologic Malignancies in the US,” which featured an analysis of
projected impact of allogeneic hematopoietic cell transplant
(allo-HCT) access and clinical outcomes in a hypothetical
population of 10,000 allo-HCT-eligible patients with hematologic
malignancies lacking an HLA-matched related donor. Assuming 20%
omidubicel use, the proportion of patients receiving allo-HCT
increased by 71% in Black, 43% in Asian, 30% in Hispanic, and 5% in
white patients. The model suggests that access to omidubicel, upon
approval, is projected to decrease time to allo-HCT and improve
patient outcomes, with the greatest improvements among the racial
and ethnic groups underserved by the current standard of care.
Learn more
In a poster titled “Hematopoietic Stem Cell Transplantation
(HSCT) with Omidubicel Leads to Robust Recovery and Diversity of T
cells” patients treated with omidubicel were found to have robust
and diverse T cell constitution. In an analysis of the T-cell
development of 37 patients, patients transplanted with omidubicel
demonstrated higher numbers of Recent Thymic Emigrants (RTEs) in
peripheral blood at one year post transplant compared to
transplantation with UCB, which suggest faster thymopoiesis and
provide mechanistic rational for the lower infection rates and
improved outcomes in these patients. Learn more
All three posters were made available beginning Saturday,
September 10, 2022, 6:15-7:45 p.m. ET, during the 2022 Cord Blood
Connect Meeting.
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 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 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 August
15, 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/20220912005342/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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