Gamida Cell Provides Update on Pre-BLA Meeting With FDA for Omidubicel
November 11 2021 - 7:00AM
Business Wire
- Gamida Cell conducted pre-BLA meeting for omidubicel with
FDA
- FDA requested revised analysis of manufacturing data generated
at Gamida Cell’s commercial manufacturing facility
- BLA submission expected in the first half of 2022
Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy
company committed to cures for cancer and other serious diseases,
completed a Type B Pre-Biologics License Application (BLA) meeting
with the U.S. Food and Drug Administration (FDA) for omidubicel, a
potentially life-saving treatment for patients with blood cancers
in need of stem cell transplant. The FDA requested that Gamida Cell
provide revised analysis of the manufacturing data generated at
Gamida Cell’s wholly-owned commercial manufacturing facility to
demonstrate the comparability to the omidubicel that was produced
at the clinical manufacturing sites for the Phase 3 study. The FDA
did not request additional clinical data to initiate the BLA
submission once analytical comparability is demonstrated. The
company will continue to work collaboratively with the FDA and
anticipates submitting the BLA in the first half of 2022 in lieu of
the company’s previous plan to submit the BLA by the end of
2021.
“Despite the delay in timing to bring omidubicel to patients
after a potential FDA approval, we are encouraged by the FDA’s
reaction to our Phase 3 data as the pivotal trial of omidubicel. We
have gained further clarity with the FDA on the requirements for
demonstrating comparability for our commercial manufacturing
facility,” said Julian Adams, Ph.D., Chief Executive Officer of
Gamida Cell. “With the FDA’s feedback in hand, we believe that we
are one step closer for omidubicel to be made available to patients
in need.”
Omidubicel, an investigational advanced cell therapy for
allogeneic bone marrow transplant
Omidubicel is the foundational product based on Gamida Cell’s
proprietary NAM-enabled cell expansion technology. It is the first
cell therapy for bone marrow transplant to receive Breakthrough
Therapy Designation from the FDA. The BLA submission will be based
on the results of an international, randomized Phase 3 study of
omidubicel that was designed to evaluate the safety and efficacy of
omidubicel in patients with hematologic malignancies undergoing a
bone marrow transplant compared to patients who received a standard
umbilical cord blood transplant. The study achieved its primary
endpoint, a statistically significant reduction in time to
neutrophil engraftment, as well as all key secondary endpoints. A
key milestone in a patient’s recovery, neutrophil engraftment is a
measure of how quickly the stem cells a patient receives in a bone
marrow transplant are established and begin to make healthy new
cells. In the Phase 3 study, the median time to neutrophil
engraftment was 12 days for patients randomized to omidubicel
compared to 22 days for the comparator group (p < 0.001).
Additionally, the study met key secondary endpoints related to the
speed of platelet engraftment, decrease in infections and reduction
in hospitalizations, all significant clinical measures in bone
marrow transplant.
About Gamida Cell
Gamida Cell is pioneering a diverse immunotherapy pipeline of
potentially curative cell therapies 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 therapies 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.
About Omidubicel
Omidubicel is an advanced cell therapy under development as a
potential life-saving allogeneic hematopoietic stem cell (bone
marrow) transplant for patients with hematologic malignancies
(blood cancers), for which it has been granted Breakthrough Status
by the FDA. Omidubicel is also being evaluated in a Phase 1/2
clinical study in patients with severe aplastic anemia
(NCT03173937). 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.
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 (including the
timing of submission of the BLA for omidubicel to the FDA),
commercialization planning efforts and the potentially life-saving
or curative therapeutic and commercial potential of omidubicel. 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 the impact that the
COVID-19 pandemic could have on our business, and including the
scope, progress and expansion of Gamida Cell’s clinical trials and
ramifications for the cost thereof; 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, and in 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 Annual Report on Form 20-F, filed
with the Securities and Exchange Commission (SEC) on March 9, 2021,
as amended, 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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version on businesswire.com: https://www.businesswire.com/news/home/20211111005505/en/
For investors: Courtney Turiano Stern Investor Relations, Inc.
Courtney.Turiano@sternir.com 1-212-362-1200
For media: Rhiannon Jeselonis Ten Bridge Communications
rhiannon@tenbridgecommunications.com 1-978-417-1946
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