—GDA-201 was well-tolerated and no
dose-limiting toxicities were observed—
—GDA-201 demonstrated significant clinical
activity in patients with non-Hodgkin lymphoma, with multiple
complete responses observed—
—Phase 2 clinical trial of GDA-201 in
non-Hodgkin lymphoma planned; IND submission anticipated in
2021—
Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy
company committed to cures for blood cancers and serious
hematologic diseases, today announced in an oral presentation the
updated and expanded results from a Phase 1 clinical study of
GDA-201, an investigational, natural killer (NK) cell-based cancer
immunotherapy for the treatment of patients with non-Hodgkin
lymphoma (NHL) and multiple myeloma (MM), at the 62nd American
Society of Hematology (ASH) Annual Meeting & Exposition, which
is being held virtually December 5–8.
GDA-201 was well-tolerated and no dose-limiting toxicities were
observed in 35 patients (19 with NHL and 16 with MM). The data show
that therapy using GDA-201 with monoclonal antibodies demonstrated
significant clinical activity in heavily pretreated patients with
advanced NHL. Of the 19 patients with NHL, 13 complete responses
and one partial response were observed, with an overall response
rate of 74 percent and a complete response rate of 68 percent. The
maximum tolerated dose was not achieved, as no dose limiting
toxicities were observed in patients who received the maximum
target dose (2 x 108 cells/kg).
“Data from an expanded group of patients in this Phase 1
clinical study for GDA-201 show that NK cell therapies continue to
exhibit impressive therapeutic potential to treat relapsed and
refractory patients with lymphomas, while maintaining a favorable
safety profile,” said Veronika Bachanova, M.D., Ph.D., Professor of
Medicine in the Division of Hematology, Oncology and
Transplantation at the University of Minnesota and principal
investigator of the study. “Despite recent advancements in
therapies for patients with hematologic malignancies, too many
patients progress to develop refractory or resistant disease. I
look forward to the continued clinical development of this novel
investigational therapy.”
NK cell immunotherapies are thought to offer tremendous
potential for transforming the care of hematologic malignancies.
With GDA-201, Gamida Cell is pioneering a novel approach that
harnesses the power of its cell expansion technology to improve
antibody-dependent cellular cytotoxicity (ADCC) and tumor targeting
of NK cells.
“These additional results again show that GDA-201 has striking
signs of efficacy and safety in patients with heavily pre-treated
NHL,” said Julian Adams, Ph.D., chief executive officer of Gamida
Cell. “With these results in hand, we plan to initiate a Phase 2
clinical study, with the goal of submitting an IND in 2021.”
GDA-201 Phase 1 Clinical Data
The presentation, “Results of a Phase 1 Trial of GDA-201,
Nicotinamide-Expanded Allogeneic Natural Killer (NK) Cells in
Patients with Refractory Non-Hodgkin Lymphoma (NHL) and Multiple
Myeloma,” described results from the Phase 1 clinical study of
GDA-201 in heavily pre-treated patients with advanced NHL and MM.
Preliminary results from this study were presented at the 2019 ASH
Annual Meeting.
In the study, cell therapy using GDA-201 with monoclonal
antibodies was shown to be safe; there were no dose-limiting
toxicities, neurotoxic events, confirmed cytokine release syndrome,
graft versus host disease or marrow aplasia. Overall survival and
progression-free survival at one year in the NHL cohort suggest
durable disease control, with a median follow-up of ten months
(range 1–28 months). The most common adverse events were decreased
neutrophil count, febrile neutropenia, anemia and low platelet
counts.
In the NHL cohort, durable complete responses were observed in
patients with both follicular and diffuse large B cell lymphoma,
with an overall response rate of 74 percent. Future development of
GDA-201 may include cryopreservation and the exploration of
multiple treatment cycles in a multi-center Phase 2 trial in
patients with NHL.
About GDA-201
Gamida Cell applied the capabilities of its NAM-based cell
expansion technology to develop GDA-201, an innate natural killer
(NK) cell immunotherapy for the treatment of hematologic and solid
tumors in combination with standard of care antibody therapies.
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 of NK cells expanded in culture. GDA-201
is in Phase 1 development through an investigator-sponsored study
in patients with refractory non-Hodgkin lymphoma and multiple
myeloma.1 For more information on the clinical study 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 U.S. Food and Drug
Administration or any other health authority.
About the NAM Therapeutic Platform
Gamida Cell’s proprietary NAM-based cell expansion platform is
designed to enhance the number and functionality of donor cells in
culture, enabling the creation of potentially transformative
therapies that move beyond what is possible with existing
approaches. The NAM therapeutic platform leverages the unique
properties of nicotinamide to enable the expansion of multiple cell
types — including stem cells and natural killer (NK) cells — with
appropriate growth factors to maintain the cells' original
phenotype and potency. This can enable the administration of a
therapeutic dose of cells with the potential to improve patient
outcomes.
About Gamida Cell
Gamida Cell is an advanced cell therapy company committed to
cures for patients with blood cancers and serious blood diseases.
We harness our cell expansion platform to create therapies with the
potential to redefine standards of care in areas of serious medical
need. For additional information, please visit www.gamida-cell.com
or follow Gamida Cell on LinkedIn or Twitter 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, anticipated regulatory filings,
commercialization efforts and Gamida Cell’s expectations regarding
its projected ongoing operating activities, which statements are
subject to a number of risks, uncertainties and assumptions,
including, but not limited to the scope, progress and expansion of
Gamida Cell’s clinical trials and ramifications for the cost
thereof; and clinical, scientific, regulatory and technical
developments. 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
20-F, filed with the Securities and Exchange Commission (SEC) on
February 26, 2020, its Reports on Form 6-K filed with the SEC on
May 18, 2020, August 11, 2020 and November 10, 2020, 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. Any
forward-looking statements speak only as of the date of this press
release and are based on information available to Gamida Cell as of
the date of this release.
1 Clinicaltrials.gov identifier NCT03019666
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