-Abstract will be shared at Presidential
Symposium and featured in this year’s “Live with Best Abstracts”
session-
Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy
company committed to cures for blood cancers and serious
hematologic diseases, today announced the results of a Phase 3
clinical study of omidubicel presented in an oral session at the
Presidential Symposium of the 47th Annual Meeting of the European
Society for Blood and Marrow Transplantation (EBMT 2021). In
addition to the Presidential Symposium, the session will be
featured in a live panel discussion, “EBMT Talks: Live with the
Best Abstracts.”
“There is an acute need in stem cell transplantation to treat
patients who do not have access to a matched donor, and the results
of this global Phase 3 study demonstrate that omidubicel has the
potential to address this critical gap,” said Professor Guillermo
F. Sanz, M.D., Ph.D., Head, Hematology Department, Hospital
Universitario y Politécnico La Fe in Valencia, Spain. “In the
study, treatment with omidubicel showed faster hematopoietic
recovery, fewer bacterial and viral infections and fewer days in
hospital. These pivotal data create a compelling case that
omidubicel could transform outcomes for patients.”
This clinical data set, which was also recently presented at the
Transplantation & Cellular Therapy Meetings of the American
Society of Transplantation and Cellular Therapy (ASTCT) and Center
for International Blood & Marrow Transplant Research (CIBMTR),
or the TCT Meetings, was from the international, multi-center,
randomized Phase 3 study of omidubicel designed to evaluate the
safety and efficacy of omidubicel in patients with high-risk
hematologic malignancies undergoing a bone marrow transplant
compared to patients who received a standard umbilical cord blood
transplant.
“The inclusion of the omidubicel Phase 3 results in these
prominent sessions at EBMT 2021 and other recent prestigious
peer-reviewed settings reinforce the strength of these data and the
potential of omidubicel to make a meaningful impact in the
hematopoietic bone marrow transplant treatment landscape,” said
Julian Adams, Ph.D., chief executive officer of Gamida Cell. “As
always, we thank the patients and investigators in this global
clinical trial for their contributions as we work to bring this
potentially curative cell therapy to those whose future depends on
stem cell transplantation but who do not have a matched donor.”
The full presentation shared at the Presidential Symposium is
available on the Gamida Cell website.
Details of Phase 3 Efficacy and Safety Results Shared at
EBMT Patient demographics including racial and ethnic diversity
and baseline characteristics were well-balanced across the two
study groups. The study’s intent-to-treat analysis included 125
patients aged 13–65 years with a median age of 41. Diseases
included acute lymphoblastic leukemia, acute myelogenous leukemia,
chronic myelogenous leukemia, myelodysplastic syndrome or lymphoma.
Patients were enrolled at more than 30 clinical centers in the
United States, Europe, Asia, and Latin America.
Gamida Cell previously reported in May 2020 that the study
achieved its primary endpoint, showing that
omidubicel demonstrated a statistically significant reduction in
time to neutrophil engraftment, a measure of how quickly the stem
cells a patient receives in a transplant are established and begin
to make healthy new cells, and a key milestone in a patient’s
recovery from a bone marrow transplant. 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).
All three secondary endpoints demonstrated a statistically
significant improvement among patients who were randomized to
omidubicel in relation to patients randomized to the comparator
group (intent-to-treat). Platelet engraftment was significantly
accelerated with omidubicel, with 55 percent of patients randomized
to omidubicel achieving platelet engraftment at day 42, compared to
35 percent for the comparator (p = 0.028). The rate of infection
was significantly reduced for patients randomized to omidubicel,
with the cumulative incidence of first grade 2 or grade 3 bacterial
or invasive fungal infection for patients randomized to omidubicel
of 37 percent, compared to 57 percent for the comparator (p =
0.027). Hospitalization in the first 100 days after transplant was
also reduced in patients randomized to omidubicel, with a median
number of days alive and out of hospital for patients randomized to
omidubicel of 60.5 days, compared to 48.0 days for the comparator
(p = 0.005). The details of these data were first reported
in December 2020.
Data from the study relating to exploratory endpoints also
support the clinical benefit demonstrated by the study’s primary
and secondary endpoints. There was no statistically significant
difference between the two patient groups related to grade III/IV
acute GvHD (14 percent for omidubicel, 21 percent for the
comparator) or all grades chronic GvHD at one year (35 percent for
omidubicel, 29 percent for the comparator). Transplants with
umbilical cord blood, the comparator, have been historically shown
to result in low incidence of GvHD in relation to other graft
sources, and in this study, omidubicel demonstrated a similar GvHD
profile. Non-relapse mortality was shown to be 11 percent for
patients randomized to omidubicel and 24 percent for patients
randomized to the comparator (p = 0.09).
These clinical data results will form the basis of a Biologics
License Application (BLA) that Gamida Cell expects to submit to the
U.S. Food and Drug Administration (FDA) in the fourth quarter of
2021.
About Omidubicel
Omidubicel 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), for which it has been granted
Breakthrough Status by the US Food and Drug Administration. In both
Phase 1/2 and Phase 3 clinical studies (NCT01816230, NCT02730299),
omidubicel demonstrated rapid and durable time to engraftment and
was generally well tolerated.1,2 Based on the recently reported
Phase 3 clinical study, in which omidubicel achieved statistically
significant and clinical meaningful results in the prespecified
primary and secondary endpoints, Gamida Cell plans to submit the
full Biologics License Application (BLA) to the FDA in the fourth
quarter of 2021. 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.
Omidubicel is an investigational therapy, and its safety and
efficacy have not been established by the FDA or any other health
authority.
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 the anticipated submission of a BLA for
omidubicel, which statements are subject to a number of risks,
uncertainties and assumptions, including, but not limited to Gamida
Cell’s ability to prepare regulatory filings and the review process
therefor; complications in Gamida Cell’s plans to manufacture its
products for commercial distribution; 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 March 9, 2021, 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 Gamida Cell press release, “Gamida Cell Announces Positive
Topline Data from Phase 3 Clinical Study of Omidubicel in Patients
with High-Risk Hematologic Malignancies,” issued May 12, 2020. Last
accessed August 31, 2020. 2 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210315005204/en/
For investors: Stephanie Ascher Stern Investor Relations,
Inc. stephanie.ascher@sternir.com 1-212-362-1200
For media: Rhiannon Jeselonis Ten Bridge Communications
rhiannon@tenbridgecommunications.com 1-978-417-1946
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