Thought leaders Dr. Steven Devine and Dr.
Usama Gergis to share perspectives on unmet needs and the clinical
landscape in stem cell transplant
Update on the progress of the commercial
launch for Omisirge® to be provided
Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working
to turn cells into powerful therapeutics, will host an Investor Day
on Thursday, June 29, 2023 beginning at 8 a.m. EDT in New York
City, and will also be available via a live webcast.
The Investor Day will feature presentations by two thought
leaders in stem cell transplant: Steven M. Devine, M.D., Chief
Medical Officer at the National Marrow Donor Program® (NMDP)/Be The
Match®, who will discuss the unmet needs in stem cell transplant,
and Usama Gergis, M.D., M.B.A., Director of Stem Cell Transplant
and Immune Cellular Therapy, Department of Medical Oncology, Sidney
Kimmel Cancer Center, Thomas Jefferson University in Philadelphia,
who will discuss the clinical landscape for patients in need of
stem cell transplant.
Additionally, the program will feature presentations by the
Gamida Cell executive team regarding Omisirge® (omidubicel-onlv),
which was approved April 17, 2023 by the U.S. Food and Drug
Administration for patients with hematologic malignancies who are
planned for allogeneic hematopoietic stem cell transplantation.
Please see full Prescribing Information, including the Boxed
Warning.
The program will take place at the offices of Cooley LLP,
entrance at 55 Hudson Yards, New York, NY 10001. For those unable
to attend in person, there will be a simultaneous live webcast.
This event is intended for institutional investors, sell-side
research analysts and business development professionals only.
Please RSVP in advance if you plan to attend, as space is limited.
To reserve a seat, please click here to register.
To access the webcast, please register here.
A copy of the presentation materials and webcast links may be
accessed on the Events and Presentations page under the Investors
section of the Gamida Cell website.
Omisirge Indication
Omisirge is a nicotinamide modified allogeneic hematopoietic
progenitor cell therapy derived from cord blood indicated for use
in adults and pediatric patients 12 years and older with
hematologic malignancies who are planned for umbilical cord blood
transplantation following myeloablative conditioning to reduce the
time to neutrophil recovery and the incidence of infection.
Important Safety Information for Omisirge
BOXED WARNING: INFUSION REACTIONS, GRAFT VERSUS HOST DISEASE,
ENGRAFTMENT SYNDROME, AND GRAFT FAILURE
- Infusion reactions may be fatal. Monitor patients during
infusion and discontinue for severe reactions. Use is
contraindicated in patients with known allergy to dimethyl
sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin or
bovine material.
- Graft-versus-Host Disease may be fatal. Administration of
immunosuppressive therapy may decrease the risk of GvHD.
- Engraftment syndrome may be fatal. Treat engraftment
syndrome promptly with corticosteroids.
- Graft failure may be fatal. Monitor patients for laboratory
evidence of hematopoietic recovery.
Contraindications
OMISIRGE is contraindicated in patients with known
hypersensitivity to dimethyl sulfoxide (DMSO), Dextran 40,
gentamicin, human serum albumin, or bovine products.
Warnings and Precautions
Hypersensitivity Reactions
Allergic reactions may occur with the infusion of OMISIRGE.
Reactions include bronchospasm, wheezing, angioedema, pruritis and
hives. Serious hypersensitivity reactions, including anaphylaxis,
may be due to DMSO, residual gentamicin, Dextran 40, human serum
albumin (HSA) and bovine material in OMISIRGE. OMISIRGE may contain
residual antibiotics if the cord blood donor was exposed to
antibiotics in utero. Patients with a history of allergic reactions
to antibiotics should be monitored for allergic reactions following
OMISIRGE administration.
Infusion Reactions
Infusion reactions occurred following OMISIRGE infusion,
including hypertension, mucosal inflammation, dysphagia, dyspnea,
vomiting, and gastrointestinal toxicity. Premedication with
antipyretics, histamine antagonists, and corticosteroids may reduce
the incidence and intensity of infusion reactions. In patients
transplanted with OMISIRGE in clinical trials, 47% (55/117)
patients had an infusion reaction of any severity. Grade 3-4
infusion reactions were reported in 15% (18/117) patients. Infusion
reactions may begin within minutes of the start of infusion of
OMISIRGE, although symptoms may continue to intensify and not peak
for several hours after the completion of the infusion. Monitor
patients for signs and symptoms of infusion reactions during and
after OMISIRGE administration. When a reaction occurs, pause the
infusion and institute supportive care as needed.
Graft-versus-Host Disease
Acute and chronic GvHD, including life-threatening and fatal
cases, occurred following treatment with OMISIRGE. In patients
transplanted with OMISIRGE Grade II-IV acute GvHD was reported in
58% (68/117). Grade III- IV acute GvHD was reported in 17%
(20/117). Chronic GvHD occurred in 35% (41/117) of patients. Acute
GvHD manifests as maculopapular rash, gastrointestinal symptoms,
and elevated bilirubin. Patients treated with OMISIRGE should
receive immunosuppressive drugs to decrease the risk of GvHD, be
monitored for signs and symptoms of GvHD, and treated if GvHD
develops.
Engraftment Syndrome
Engraftment syndrome may occur because OMISIRGE is derived from
umbilical cord blood. Monitor patients for unexplained fever, rash,
hypoxemia, weight gain, and pulmonary infiltrates in the
peri-engraftment period. Treat with corticosteroids as soon as
engraftment syndrome is recognized to ameliorate symptoms. If
untreated, engraftment syndrome may progress to multiorgan failure
and death.
Graft Failure
Primary graft failure occurred in 3% (4/117) of patients in
OMISIRGE clinical trials. Primary graft failure, which may be
fatal, is defined as failure to achieve an absolute neutrophil
count greater than 500 per microliter blood by Day 42 after
transplantation. Immunologic rejection is the primary cause of
graft failure. Monitor patients for laboratory evidence of
hematopoietic recovery.
Malignancies of Donor Origin
Two patients treated with OMISIRGE developed post-transplant
lymphoproliferative disorder (PTLD) in the second-year
post-transplant. PTLD manifests as a lymphoma-like disease favoring
non-nodal sites. PTLD is usually fatal if not treated. The etiology
is thought to be donor lymphoid cells transformed by Epstein-Barr
virus (EBV). Serial monitoring of blood for EBV DNA may be
warranted in patients with persistent cytopenias. One patient
treated with OMISIRGE developed a donor-cell derived
myelodysplastic syndrome (MDS) during the fourth-year
post-transplant. The natural history is presumed to be the same as
that for de novo MDS. Monitor life-long for secondary malignancies.
If a secondary malignancy occurs, contact Gamida Cell at (844)
477-7478.
Transmission of Serious Infections
Transmission of infectious disease may occur because OMISIRGE is
derived from umbilical cord blood. Disease may be caused by known
or unknown infectious agents. Donors are screened for increased
risk of infection, clinical evidence of sepsis, and communicable
disease risks associated with xenotransplantation. Maternal and
infant donor blood is tested for evidence of donor infection. See
full Prescribing Information, Warnings and Precautions,
Transmission of Serious Infections for list of testing performed.
OMISIRGE is tested for sterility, endotoxin, and mycoplasma. There
may be an effect on the reliability of the sterility test results
if the cord blood donor was exposed to antibiotics in utero.
Product manufacturing includes bovine-derived reagents. All
animal-derived reagents are tested for animal viruses, bacteria,
fungi, and mycoplasma before use. These measures do not eliminate
the risk of transmitting these or other transmissible infectious
diseases and disease agents. Test results may be found on the
container label and/or in accompanying records. If final
sterility results are not available at the time of use, Quality
Assurance will communicate any positive results from sterility
testing to the physician. Report the occurrence of transmitted
infection to Gamida Cell at (844) 477-7478.
Transmission of Rare Genetic Diseases
OMISIRGE may transmit rare genetic diseases involving the
hematopoietic system because it is derived from umbilical cord
blood. Cord blood donors have been screened to exclude donors with
sickle cell anemia, and anemias due to abnormalities in hemoglobins
C, D, and E. Because of the age of the donor at the time cord blood
collection takes place, the ability to exclude rare genetic
diseases is severely limited.
ADVERSE REACTIONS
The most common adverse reactions (incidence > 20%) are
infections, GvHD, and infusion reaction.
Please see full Prescribing Information,
including Boxed Warning.
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.
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 potentially life-saving or
curative therapeutic and commercial potential of Omisirge®
(omidubicel-onlv). 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 Securities and Exchange Commission (SEC)
on May 15, 2023, 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230613725727/en/
Investor and Media Contact: Dan Boyle Orangefiery
media@orangefiery.com 1-818-209-1692
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