Data To Be Presented on Gamida Cell Natural Killer (NK) Cell Therapy Candidate GDA-201 at the International Society for Cell & Gene Therapy 2023 Annual Meeting
May 31 2023 - 7:00AM
Business Wire
New data for batch-to-batch variability and
cytotoxicity of GDA-201 show long term stability and unique
phenotype of allogeneic NAM-NK cell therapy
GDA-201 is in an ongoing Phase 1/2 clinical
trial for non-Hodgkin lymphoma
Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working
to turn cells into powerful therapeutics, today announced that an
oral presentation highlighting Gamida Cell’s investigational
natural killer (NK) cell therapy candidate GDA-201 will be shared
at the International Society for Cell and Gene Therapy (ISCT) 2023
Annual Meeting. The meeting takes place May 31-June 3 in Paris,
France.
Additionally, a poster will be presented with data from Gamida
Cell’s pre-clinical NK cell therapy candidate GDA-501, an
engineered intrinsic NK cell with a CAR modification targeting the
HER2 protein.
“The data being presented at ISCT add to the body of evidence
demonstrating the power of our nicotinamide (NAM) technology to
enhance and expand cells,” said Ronit Simantov, M.D., Chief Medical
and Scientific Officer of Gamida Cell. “The unique, active
phenotype of NAM-NK cells and the high levels of potency and
cytotoxicity observed support the strong potential of GDA-201 as a
cell therapy for cancer.”
Additional details about the presentations are as follows:
Title: GDA-201: Phenotypic and Functional
Characterization of Cryopreserved Nicotinamide-Expanded Allogeneic
Natural Killer Cells Demonstrate an Activated and Non-exhausted
Phenotype Abstract Number: 36 Presentation Date: June
2, 9:15-10:15 am CET Presenting Author: Yona Geffen, Ph.D.;
Vice President of R&D at Gamida Cell
- Highlights: This study investigated the phenotype and
function of GDA-201, NK cells expanded using Gamida Cell’s
proprietary NAM technology. NAM-NK demonstrated increased
expression of lymphoid homing marker CD62L and decreased levels of
lineage exhaustion markers CD57 and CD161 compared with NK cells
expanded in the absence of NAM. Batch-to-batch variability of 18
batches of cryopreserved formulation of GDA-201 from 18 donors
demonstrated an overall variability of ≤25% in critical parameters
including viability, phenotyping and cytotoxicity.
Title: GDA-501 HER2 Chimeric Antigen Receptor Natural
Killer Cells: Dual Cytotoxicity in Solid Tumors Mediated via HER2
and TRAIL Abstract Number: 1225 Presentation Date:
June 1, 6-7:30 pm CET Presenting Author: Julia Rifman,
Ph.D.; Senior Project Manager at Gamida Cell
- Highlights: GDA-501, an expanded, enhanced and
engineered NAM HER2-CAR NK cell, showed high levels of TNF-related
apoptosis-inducing ligand (TRAIL) expression, suggesting possible
meditation of target cell apoptosis. Compared with non-engineered
NK cells cultured with NAM, GDA-501 cells displayed increased
cytotoxicity against HER2+ tumor cells. When TRAIL was neutralized
on GDA-501, a decrease in cytotoxicity was observed. These data
suggest that the cytotoxic effect of GDA-501 may be mediated by
dual mechanisms: HER2 binding by the HER2-CAR and apoptosis
mediated by TRAIL.
- Note: Gamida Cell announced it would discontinue the
development of GDA-501 in March 2023.
About GDA-201
GDA-201 is an intrinsic NK cell therapy candidate being
investigated for the treatment of hematologic malignancies.
Preclinical studies have shown that GDA-201 may address key
limitations of cultured NK cells by increasing cytotoxicity and in
vivo retention as well as 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. A multicenter Phase 1/2 study of GDA-201 for
the treatment of non-Hodgkin lymphoma is ongoing (NCT05296525).
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 a cell therapy pioneer working to turn cells into
powerful therapeutics. The company’s proprietary nicotinamide (NAM)
technology leverages the properties of NAM to enhance and expand
cells, creating allogeneic cell therapy products and candidates
that are potentially curative for patients with hematologic
malignancies. These include Omisirge®, an FDA-approved nicotinamide
modified allogeneic hematopoietic progenitor cell therapy, and
GDA-201, an intrinsic NK cell therapy candidate being investigated
for the treatment of hematologic malignancies. For additional
information, please visit www.gamida-cell.com or follow Gamida Cell
on LinkedIn, Facebook, Twitter and Instagram.
Omisirge® is a registered trademark of Gamida Cell Inc. © 2023
Gamida Cell Inc. All Rights Reserved.
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 potentially life-saving or
curative therapeutic and commercial potential of GDA-201. 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 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 SEC
on May 15, 2023, the accompanying prospectus and other filings that
Gamida Cell makes with the SEC from time to time (which are
available at 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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