Gamida Cell Announces Omidubicel Data To Be Presented as an Oral Presentation at 64th ASH Annual Meeting
November 03 2022 - 9:07AM
Business Wire
Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development
of NAM-enabled cell therapy candidates for patients with
hematological and solid cancers and other serious diseases, today
announced an oral presentation of a real-world analysis comparing
the effectiveness of omidubicel to other allo-HCT donor sources
from the Center for International Blood and Marrow Transplant
Research (CIBMTR) database. These data are being presented at the
64th American Society of Hematology (ASH) Annual Meeting, which is
being held in New Orleans from December 10-13, 2022.
“Data from our phase 3 study compared the safety and efficacy of
omidubicel to standard cord blood. We are delighted to have the
opportunity, in a podium presentation at ASH, to share the work we
have done with CIBMTR, exploring their expansive real-world
database and performing the first comparative efficacy analyses
between omidubicel and other donor sources for patients undergoing
allogeneic stem cell transplant,” said Ronit Simantov, M.D., Chief
Medical and Scientific Officer of Gamida Cell. “These data
reinforce the clinical relevance of the rapid time to neutrophil
engraftment observed in patients transplanted with omidubicel, and
support the potential use of omidubicel in patients with
hematologic malignancies requiring transplant. We are diligently
preparing to bring this important therapy to patients upon
potential FDA approval.”
Details about the ASH presentation are as follows:
Title: Clinical Outcomes Following Allogeneic
Hematopoietic Cell Transplantation with Omidubicel or Other Donor
Sources in Patients with Hematologic Malignancies: Comparison of
Clinical Trial Results to Center for International Blood and Marrow
Transplant Research Database Controls Session Title: 732.
Allogeneic Transplantation: Disease Response and Comparative
Treatment Studies: Clinical Outcome: Real World Studies Based on
Database Analyses Lead Author: Smitha Sivaraman, PhD.
Time: Saturday, December 10, 2022, 2:00 p.m. – 3:30 p.m. EST
(session time) and 2:30 p.m. EST (presentation time)
Location: Ernest N. Morial Convention Center, 391 – 392
A prospective cohort analysis study to compare the effectiveness
of omidubicel versus other allo-HCT donor sources (MUD, MMUD and
haploidentical) used in clinical practice is being presented. The
study compared data from the omidubicel (n=52) and control arms
(n=56) of the phase 3 study with a cohort of similar patients
derived from the CIBMTR database (n = 807) who had undergone
transplant with matched unrelated donors, mismatched unrelated
donors, or haploidentical donors. The analysis showed that
omidubicel was associated with more rapid neutrophil recovery
(median: 10 days) compared to all other donor sources (median 15-20
days; p<0.001). While platelet recovery took longer in the
omidubicel cohort, rates of severe acute and chronic graft versus
host disease (GVHD) were comparable. Importantly, analyses of
non-relapse mortality, disease-free survival, and overall survival
showed similar results among all donor sources. While the phase 3
study compared omidubicel to standard cord blood, these real-world
data reinforce the clinical utility of omidubicel as a graft source
in patients in need of an allogeneic stem cell transplant.
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.
The BLA for omidubicel has been assigned a Prescription Drug
User Fee Act (PDUFA) target action date of January 30, 2023. If
approved, omidubicel will be the first allogeneic advanced stem
cell therapy donor source for patients with blood cancers in need
of a stem cell transplant.
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/20221102006193/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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