Gamida Cell Announces Dosing of First Patient in Company-Sponsored Phase 1/2 Study of NK Cell Therapy Candidate GDA-201
August 10 2022 - 7:00AM
Business Wire
-The company-sponsored Phase 1/2 study is
evaluating a cryopreserved, readily available formulation of
GDA-201 for the treatment of follicular and diffuse large B cell
lymphomas -
Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development
of NAM-enabled cell therapy candidates for patients with
hematologic and solid cancers and other serious diseases, announces
dosing of the first patient in a company-sponsored Phase 1/2 study
evaluating a cryopreserved, readily available formulation of
GDA-201 for the treatment of follicular and diffuse large B cell
lymphomas (NCT05296525).
“We are excited to further advance the development of GDA-201, a
NAM-enabled natural killer (NK) cell therapy candidate which we
believe has the potential to be a new readily available,
cryopreserved treatment option for cancer patients with
relapsed/refractory lymphoma,” said Ronit Simantov, M.D., chief
medical and scientific officer of Gamida Cell. “Our NK cells
elicited an adaptive immune response in patients in the previous
investigator-sponsored study with the fresh formulation of GDA-201,
potentially leading to durable remissions. We are truly grateful
for the contribution of all the participants and clinical
collaborators who will allow us to continue studying GDA-201 in
this multi-center open label trial.”
The Phase 1 portion of the study is a dose escalation phase,
designed to evaluate the safety of GDA-201, and will include
patients with follicular lymphoma (FL), diffuse large B-cell
lymphoma (DLBCL)/high grade B-cell lymphoma, marginal zone lymphoma
or mantle cell lymphoma. The Phase 2 expansion phase is designed to
evaluate the safety and efficacy of GDA-201 in 63 patients
comprised of two cohorts of patients with either FL or DLBCL. The
study will include patients who have relapsed or refractory
lymphoma after at least two prior treatments, which may include
CAR-T or stem cell transplant.
“Interest in NK cell therapies has increased in recent years as
a potential alternative to current cell therapies, as NK cells have
the potential to be effective in hematological and solid tumors
while avoiding common safety issues,” said Veronika Bachanova,
M.D., Ph.D., University of Minnesota. “We are particularly excited
about Gamida’s cryopreserved formulation of GDA-201, which has
potential as a new treatment option for patients.”
GDA-201 leverages Gamida Cell’s proprietary NAM (nicotinamide)
technology platform to expand the number and functionality of NK
cells to direct tumor cell killing properties and
antibody-dependent cellular cytotoxicity (ADCC). In an
investigator-sponsored Phase 1/2 study in patients with relapsed or
refractory lymphoma, treatment with the fresh formulation of
GDA-201 with rituximab demonstrated significant clinical activity.
Of the 19 patients with non-Hodgkin lymphoma (NHL), 13 complete
responses and one partial response were observed, with an overall
response rate of 74% and a complete response rate of 68%. Two-year
data on outcomes and cytokine biomarkers associated with survival
data demonstrated a median duration of response of 16 months (range
5-36 months) and an overall survival at two years of 78% (95% CI,
51%–91%). In this study, GDA-201 was well-tolerated and no
dose-limiting toxicities were observed in 19 patients with NHL and
16 patients with multiple myeloma. The most common Grade 3/4
adverse events were thrombocytopenia, hypertension, neutropenia,
febrile neutropenia, and anemia. There were no incidents of
cytokine release syndrome, neurotoxic events, graft versus host
disease or marrow aplasia.
About NAM Technology
Our NAM-enabled technology, supported by positive Phase 3 data
for omidubicel, 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, we can expand and metabolically
modulate multiple cell types — including stem cells and NK 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 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 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 therapy, 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: the timing of initiation of the
expansion portion of the currently ongoing Phase 1/2 clinical trial
of GDA-201, as well as the progress of, and data reported from,
this clinical trial; the potentially life-saving or curative
therapeutic and commercial potential of Gamida Cell’s product
candidates (including omidubicel and GDA-201); and Gamida Cell’s
expectations for the expected clinical development milestones set
forth herein. Any statement describing Gamida Cell’s goals,
expectations, 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 statements related to: the
impact that the COVID-19 pandemic could have on our business; the
scope, progress and expansion of Gamida Cell’s clinical trials and
ramifications for the cost thereof; clinical, scientific,
regulatory and technical developments; the process of developing
and commercializing product candidates that are safe and effective
for use as human therapeutics; and 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 May 12, 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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Courtney Turiano Stern Investor Relations, Inc.
Courtney.Turiano@sternir.com 1-212-362-1200
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