Gamida Cell Provides Regulatory Update on Omidubicel
November 21 2022 - 4:52PM
Business Wire
Recent company submission in response to FDA
request extends PDUFA date by three months
Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development
of NAM-enabled cell therapies for patients with hematological and
solid cancers and other serious diseases, today provided an update
on recent interactions with the U.S. Food and Drug Administration
(FDA) relating to the company’s Biologics License Application (BLA)
for omidubicel, the company’s advanced cell therapy candidate for
allogeneic hematopoietic stem cell transplant.
As part of its ongoing BLA review, FDA issued an information
request and viewed the data in the response as a major amendment,
resulting in an extension of the omidubicel Prescription Drug User
Fee Act (PDUFA) date from January 30, 2023 to May 1, 2023. The
agency also rescheduled Gamida Cell’s late-cycle meeting to the
first quarter of 2023.
The data FDA requested were laboratory results for intermediate
time points for patients enrolled in the Phase 3 study. These
additional data provided by Gamida Cell to FDA are consistent with
prior data submissions.
“We appreciate the FDA’s collaboration as they conduct their
review of omidubicel,” said Abigail “Abbey” Jenkins, Gamida Cell’s
President and Chief Executive Officer. “If approved, omidubicel
will be the first and only advanced cell therapy for patients with
blood cancer in need of an allogeneic stem cell transplant. We are
committed to bringing this potentially transformative therapy
forward as quickly as possible.”
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 the FDA’s review of the
BLA for omidubicel, and the potentially life-saving or curative
therapeutic and commercial potential of Gamida Cell’s product
candidates. 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;
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. 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 November 14, 2022, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20221121005927/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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