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Gamida
Cell To Host Investor Day
2023-06-14
·
BioSpace
细胞疗法
上市批准
临床结果
临床研究
免疫疗法
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 BOSTON--(BUSINESS WIRE)--
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
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 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 ), 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: Contacts Investor and Media Contact: Dan Boyle Orangefiery media@orangefiery.com 1-818-209-1692 Source:
Gamida Cell Ltd.
View this news release online at:
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机构
Gamida SA
Gamida Cell Ltd.
Kimmel Cancer Center
[+4]
适应症
多器官功能衰竭
脊髓小脑性共济失调
癌症
[+31]
靶点
Hemoglobins
药物
Omidubicel (Gamida Cell)
硫酸庆大霉素
二甲亚砜
[+3]
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