Gamida Cell Announces Data from NAM-NK and NiCord® Programs to Be Presented at 2019 TCT Annual Meeting
During the meeting, new data will be presented from the ongoing Phase 1 study of NAM-NK, an investigational, cell-based cancer immunotherapy, in patients with non-Hodgkin lymphoma and multiple myeloma.
Gamida
Cell Ltd. (Nasdaq: GMDA), a leading cellular and immune therapeutics
company, today announced that new data from its clinical programs will
be presented at the 2019 Transplantation & Cellular Therapy (TCT)
Meetings of American Society for Blood and Marrow Transplantation
(ASBMT) and Center for International Blood and Marrow Transplant
Research (CIBMTR) taking place in Houston, Texas, February 20 - 24.
During the meeting, new data will be presented from the ongoing Phase 1
study of NAM-NK, an investigational, cell-based cancer immunotherapy, in
patients with non-Hodgkin lymphoma and multiple myeloma. Additionally,
there will be two presentations on NiCord®, an
investigational universal bone marrow donor source, including an oral
presentation describing translational data from the completed Phase 1/2
study of NiCord in patients with high-risk hematologic malignancies, or
blood cancers. Initial data from a Phase 1/2 study of NiCord in patients
with severe aplastic anemia will also be presented.
“We are pleased with our continued progress with NiCord, our late-stage
development program in bone marrow transplantation, and we are
encouraged by the clinical profile of NAM-NK that is emerging from this
first Phase 1 clinical study,” stated Ronit Simantov, M.D., chief
medical officer at Gamida Cell. “Collectively, the data that will be
presented next month reinforce our belief that our proprietary
nicotinamide, or NAM, cell expansion technology has the potential to
deliver transformative treatments to patients.”
Details about the presentations are as follows:
Time: Wednesday, February 20, 2019, 9:00 a.m. – 5:00 p.m. CT
(poster displayed) and 6:45 p.m. – 7:45 p.m. CT (presentation)
Title:
First-in-Human Phase I Study of Nicotinamide-Expanded Related Donor
Natural Killer Cells for the Treatment of Relapsed/Refractory
Non-Hodgkin Lymphoma and Multiple Myeloma
Poster Number: 242
Lead
Author: Veronika Bachanova, M.D., Ph.D., associate professor of
medicine, division of hematology, oncology and transplantation,
University of Minnesota
Location: George R. Brown Convention
Center, Level 3, Hall B
Time: Wednesday, February 20, 2019, 9:00 a.m. – 5:00 p.m. CT
(poster displayed) and 6:45 p.m. – 7:45 p.m. CT (presentation)
Title:
Ex Vivo Nicotinamide-Expanded (NAM-Expanded) Unrelated Cord Blood
Transplantation (UCB) for Refractory Severe Aplastic Anemia Results in
Rapid Engraftment and Expedites Immune Recovery
Poster Number: 295
Lead
Author: Joseph Clara, M.D., Hematology Branch, National
Heart, Lung, and Blood Institute
Location: George R. Brown
Convention Center, Level 3, Hall B
Time: Saturday, February 23, 2019, 4:45 p.m. – 5:00 p.m. CT (oral
presentation)
Title: Rapid and Robust CD4+ and CD8+ T-, NK-,
B-Cell, Dendritic Cell, and Monocyte Reconstitution after
Nicotinamide-Expanded Cord Blood Transplantation
Abstract
Number: 69
Lead Author: Jaap-Jan Boelens, M.D., Ph.D.,
Chief, Pediatric Stem Cell Transplantation and Cellular Therapies
Service, Memorial Sloan Kettering Cancer Center
Location: Hilton
Americas Houston, Grand Ballroom G
Abstracts are available on the 2019
TCT Meetings of ASBMT and CIBMTR website.
About NAM-NK
Gamida Cell applied the capabilities of its
NAM-based cell expansion technology to highly functional NK cells to
develop NAM-NK, an innate immunotherapy for the treatment of hematologic
and solid tumors in combination with standard of care antibody
therapies. NAM-NK 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. NAM-NK
is in Phase 1 development through an investigator-sponsored study in
patients with refractory non-Hodgkin lymphoma and multiple myeloma.1
About NiCord
NiCord, the company’s lead clinical program, is
under development as a universal bone marrow transplant solution for
patients with high-risk hematologic malignancies. NiCord has been
granted Breakthrough Therapy designation by the U.S. Food and Drug
Administration, making it the first bone marrow transplant alternative
to receive this designation. It has also received U.S. and EU orphan
drug designation. A Phase 3 clinical study evaluating NiCord in patients
with leukemia and lymphoma is ongoing in the United States, Europe and
Asia.2 NiCord is also being evaluated in a Phase 1/2 clinical
study in patients with severe aplastic anemia.3 The aplastic
anemia investigational new drug application is currently filed with the
FDA under the brand name CordIn®, which is the same
investigational development candidate as NiCord. For more information on
clinical trials of NiCord, please visit www.clinicaltrials.gov.
NAM-NK and NiCord are investigational therapies, and their safety and
efficacy have not been evaluated by the U.S. Food and Drug
Administration or any other health authority.
About Gamida Cell
Gamida Cell is a clinical stage
biopharmaceutical company leveraging its proprietary technology to
develop cell therapies that are designed to cure cancer and rare,
serious hematologic diseases. The company is leveraging its
nicotinamide-, or NAM-, based cell expansion technology to develop a
pipeline of products designed to address the limitations of cell
therapies.
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 the presentation of data related
to the Phase 1 study of NAM-NK, the Phase 1/2 study of NiCord for the
treatment of hematologic malignancies, and the Phase 1/2 study of NiCord
for the treatment of severe aplastic anemia, 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
studies. In light of these risks and uncertainties, and other risks and
uncertainties that are described in the Risk Factors section of our
Registration Statement on Form F-1 filed with the SEC on September 28,
2018, 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.
1ClinicalTrials.gov identifier NCT03019666.
2ClinicalTrials.gov
identifier NCT02730299.
3ClinicalTrials.gov identifier
NCT03173937.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190124005215/en/