BOSTON–(BUSINESS WIRE)–$GMDA–Gamida Cell Ltd. (Nasdaq: GMDA), a leading cellular and immune
therapeutics company, today announced the appointment of Tracey Lodie,
Ph.D., as chief scientific officer. Dr. Lodie will be responsible for
setting the scientific strategy, synthetic biology and priorities for
Gamida Cell, as well as overseeing translational research for our
clinical pipeline. She succeeds Tony Peled, who will transition to the
newly created role of chief technology officer, where she will be
responsible for leveraging the transformative potential of Gamida Cell’s
proprietary, nicotinamide-based, or NAM-based, technology, into a
multi-product pipeline.
“We are delighted to welcome Tracey to Gamida Cell. Her deep experience
in autoimmunity and immuno-oncology research will be critical as we
continue to develop GDA-201 an investigational, natural killer
cell-based immunotherapy in Phase 1 development with the potential to
treat hematologic malignancies and solid tumors,” said Julian Adams,
Ph.D., chief executive officer of Gamida Cell. “In addition, we look
forward to Tony’s contributions in her new role as chief technology
officer. As a co-founder of the company and a lead researcher behind our
NAM-based technology, she is uniquely qualified to help us realize its
vast potential to address the limitations of currently available cell
therapies, given its broad application to other cell types.”
Dr. Lodie is an immunologist with over 16 years of drug discovery
experience in the areas of autoimmunity, transplant biology and
immuno-oncology. Prior to joining Gamida Cell, Dr. Lodie served as
senior vice president, translational immunology at BlueRock
Therapeutics, where she helped to advance their universal pluripotent
stem cell platform into central nervous system, cardiovascular, and
autoimmune therapeutic areas. She also served as vice president of
immunology at Syros Pharmaceuticals, where she developed new
autoimmunity and immuno-oncology research programs. Prior to Syros
Pharmaceuticals, Dr. Lodie spent over 14 years at Sanofi-Genzyme, where
she held roles of increasing responsibility. At Sanofi-Genzyme, Dr.
Lodie was instrumental in advancing several development programs through
regulatory approval in the area of transplant and autoimmunity. Dr.
Lodie has experience as an academic instructor and has served in various
industry related and non-profit leadership roles, including scientific
advisory boards. Dr. Lodie holds a Ph.D. in immunology and pathology
from Boston University School of Medicine and a B.S. in biology from
Fairfield University.
“I am honored to join Gamida Cell’s impressive leadership team at this
exciting time in the company’s growth. Gamida Cell has established its
technology platform through developing omidubicel, an investigational
advanced cell therapy in Phase 3 clinical development designed to
enhance the life-saving benefits of bone marrow transplant,” said Dr.
Lodie. “With natural killer cells emerging as a potentially
revolutionary approach in cell therapy, I look forward to helping to
advance GDA-201 and also strengthening our research capabilities,
particularly in the area of immunology, to further expand our pipeline.”
About Omidubicel
Omidubicel (formerly known as NiCord®),
the company’s lead clinical program, is an advanced cell therapy under
development as a potential life-saving allogeneic hematopoietic stem
cell (bone marrow) transplant solution for patients with hematologic
malignancies (blood cancers). Omidubicel is the first bone marrow
transplant product to receive Breakthrough Therapy Designation from the
U.S. Food and Drug Administration and has also received Orphan Drug
Designation in the U.S. and EU. In a Phase 1/2 clinical study,
omidubicel demonstrated rapid and durable time to engraftment and was
generally well-tolerated.1 A Phase 3 study evaluating
omidubicel in patients with leukemia and lymphoma is ongoing in the
U.S., Europe and Asia.2 Omidubicel 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 omidubicel. For more
information on clinical trials of omidubicel, please visit www.clinicaltrials.gov.
About GDA-201
Gamida Cell applied the capabilities of its
NAM-based cell expansion technology to develop GDA-201 (formerly known
as NAM-NK), 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.4
Omidubicel and GDA-201 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 committed to developing advanced cell
therapies with the potential to cure blood cancers and rare, serious
hematologic diseases. We are leveraging our proprietary
nicotinamide-based, or NAM-based, cell expansion technology to develop
product candidates designed to address the limitations of cell
therapies. For additional information, please visit www.gamida-cell.com.
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 progress of the clinical trials of Gamida
Cell’s product candidates, 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
variability, 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 of Gamida Cell’s public filing on
Form 20-F, filed with the SEC on February 25, 2019, 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 Horwitz M.E., Wease S., Blackwell B., Valcarcel D. et al.
Phase I/II study of stem-cell transplantation using a single cord blood
unit expanded ex vivo with nicotinamide. J Clin Oncol. 2019 Feb
10;37(5):367-374.
2 ClinicalTrials.gov identifier
NCT02730299.
3 ClinicalTrials.gov identifier NCT03173937.
4
ClinicalTrials.gov identifier NCT03019666.
Contacts
Jaren Irene Madden
jaren@gamida-cell.com
1-617-286-6264
Krystle
Gibbs (media)
krystle@tenbridgecommunications.com
508-479-6358