Gamida Cell to Present Corporate Highlights at the H.C. Wainwright Global Life Sciences Conference
May 17 2022 - 04:30PM
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
company management will present at the upcoming H.C. Wainwright
Global Life Sciences Conference. A pre-recorded presentation will
become available to registered conference attendees on May 24, 2022
at 7:00 a.m. ET. Management will discuss 2022 catalysts and
potential milestones including the U.S. launch opportunity for
omidubicel upon potential U.S. Food and Drug Administration
approval, 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 presentation 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 under
development as a potential life-saving allogeneic hematopoietic
stem cell (bone marrow) transplant for patients with blood cancers.
Omidubicel is the first stem cell transplant donor source to
receive Breakthrough Therapy Designation from the U.S. FDA and has
also received Orphan Drug Designation in the U.S. and EU. Gamida
Cell has completed an international, multi-center, randomized Phase
3 study (NCT0273029) evaluating the safety and efficacy of
omidubicel in patients with hematologic malignancies undergoing
allogeneic bone marrow transplant compared to a comparator group of
patients who received a standard umbilical cord blood transplant.
That study achieved its primary endpoint, demonstrating a highly
statistically significant reduction in time to neutrophil
engraftment, a key milestone in a patient’s recovery from a stem
cell transplant. The Phase 3 study also achieved its secondary
endpoints of reduced time to platelet engraftment, reduced
infections and fewer days of hospitalization. Gamida Cell initiated
a rolling BLA submission for omidubicel in the first quarter of
2022 with full BLA submission on track for the second quarter of
2022. In 2019, approximately 8,000 patients who were 12 years old
and up with hematologic malignancies underwent an allogeneic stem
cell transplant. Unfortunately it is estimated that another 1,200
patients were eligible for transplant but could not find a donor
source. Omidubicel has the opportunity, upon FDA approval to
improve outcomes for patients based on transplanter feedback and
increase access for patients to get to transplant. Omidubicel has
the potential to treat approximately 2000 – 2500 patients each year
in the U.S. For more information about omidubicel, please visit
https://www.gamida-cell.com.
Omidubicel is an investigational therapy, and its safety and
efficacy have not been established by the FDA or any other health
authority.
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 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 trial
results. GDA-201 addresses key limitations of NK cells by
increasing the cytotoxicity and in vivo retention and proliferation
in the bone marrow and lymphoid organs. Furthermore, GDA-201
improves antibody-dependent cellular cytotoxicity (ADCC) and tumor
targeting of NK cells. There are approximately 40,000 patients with
relapsed/refractory lymphoma in the E.U.5 and U.S. which is the
patient population that will be studied in the 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 therapy, and its safety and
efficacy have not been established by the FDA or any other health
authority.
About NAM Technology
Our NAM-enabling technology, supported by positive Phase 3 data,
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 therapies 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 therapies 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 GDA-201), anticipated regulatory
filings (including the timing of submission of the BLA for
omidubicel to the FDA), commercialization planning efforts, and the
potentially life-saving or curative therapeutic and commercial
potential of Gamida Cell’s product candidates (including GDA-201
and 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 Annual Report on Form 10-K, filed with the Securities and
Exchange Commission (SEC) on March 24, 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/20220517005996/en/
For investors: Courtney Turiano Stern Investor Relations, Inc.
Courtney.Turiano@sternir.com 1-212-362-1200
For media: Rhiannon Jeselonis Ten Bridge Communications
rhiannon@tenbridgecommunications.com 1-978-417-1946
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