Gamida Cell to Present Corporate Highlights at the Jefferies London Healthcare Conference
November 10 2022 - 8:00AM
Business Wire
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 that
Abbey Jenkins, President and Chief Executive Officer, will present
its corporate highlights at the Jefferies London Healthcare
Conference, November 17, 2022 with a presentation at 9:10 a.m.
GMT.
Ms. Jenkins will discuss 2022 catalysts and potential milestones
including the U.S. market opportunity for omidubicel upon potential
U.S. Food and Drug Administration (FDA) approval. Additional topics
include, accelerating the development of its first-in-class
NAM-enabled natural killer (NK) cell therapy candidate, GDA-201, as
a potential new approach for patients with follicular and diffuse
large B-cell lymphomas, and expansion of its NAM-enabled cell
therapy pipeline with multiple next-generation,
genetically-engineered NK cells.
A webcast of the event will be available on the “Investors &
Media” section of Gamida Cell’s website at www.gamida-cell.com, and
will be available for at least 14 days following the event.
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 GDA-201
Gamida Cell applied the capabilities of its nicotinamide
(NAM)-enabled cell expansion technology to develop GDA-201, an
innate NK cell immunotherapy candidate for the potential treatment
of hematologic and solid tumors in combination with standard of
care antibody therapies. GDA-201, the lead candidate in the
NAM-enabled NK cell pipeline, has demonstrated promising initial
clinical study data. Preclinical studies have shown that GDA-201
may address key limitations of NK cells by increasing the
cytotoxicity and in vivo retention and proliferation in the bone
marrow and lymphoid organs. Furthermore, these data suggest GDA-201
may improve antibody-dependent cellular cytotoxicity (ADCC) and
tumor targeting of NK cells. There are approximately 40,000
patients with relapsed/refractory lymphoma in the US and EU, which
is the patient population that will be studied in the currently
ongoing GDA-201 Phase 1/2 clinical trial.
For more information about GDA-201, please visit
https://www.gamida-cell.com. For more information on the Phase 1/2
clinical trial of GDA-201, please visit www.clinicaltrials.gov.
GDA-201 is an investigational cell therapy candidate, and its
safety and efficacy have not been established by the FDA or any
other health authority.
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, the potentially life-saving or curative therapeutic and
commercial potential of Gamida Cell’s product candidates (including
omidubicel and GDA-201), Gamida Cell’s expectations for the
expected clinical development milestones set forth herein, and
Gamida Cell’s expectations regarding its projected cash to be used
for operating activities and cash runway. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20221110005457/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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