No Events of Cancer Relapse
Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical-stage
biopharmaceutical company dedicated to the development of
programmed cellular immunotherapies for cancer and immune
disorders, announced today additional clinical data from the Phase
1 stage of its PROTECT clinical trial of ProTmune™, the Company’s
next-generation hematopoietic cell graft. The data is being
featured in a poster presentation at the 44th Annual Meeting of the
European Society for Blood and Marrow Transplantation being held in
Lisbon, Portugal, March 18-21, 2018.
“The primary objective of hematopoietic cell transplantation for
cancer patients is disease-free survival. We are very encouraged
that no events of cancer relapse have occurred with ProTmune in the
Phase 1 stage of PROTECT,” said Chris Storgard, M.D., Chief Medical
Officer of Fate Therapeutics. “Our clinical findings underscore the
compelling safety profile of ProTmune and suggest that ProTmune has
the unique potential to attenuate early, life-threatening events of
acute GvHD and promote the curative potential of allogeneic
transplant. We continue to follow Phase 1 subjects and look forward
to assessing key one-year outcomes with ProTmune, including
incidence and severity of chronic GvHD, cancer relapse and
disease-free survival.”
Seven adult subjects with hematologic malignancies undergoing
matched unrelated donor hematopoietic cell transplantation (HCT)
received ProTmune as the hematopoietic cell graft in the Phase 1
stage of PROTECT. As of a February 26, 2018 data cut-off, there
have been no events of cancer relapse with a median time on study
of 228 days. Additionally, no serious adverse events related to
ProTmune have been reported by investigators. The randomized,
controlled and double-blinded Phase 2 stage of PROTECT is currently
enrolling up to 60 subjects at 14 U.S. centers.
Fate Therapeutics is developing ProTmune as a preventative
therapy to reduce the incidence and severity of acute
graft-versus-host disease (GvHD) by Day 100 following HCT. Acute
GvHD is the leading cause of early morbidity and mortality
following allogeneic HCT. Extended use of immunosuppressive agents
to treat acute GvHD compromises the anti-leukemia activity of the
transplant procedure and significantly increases the risk of cancer
relapse and mortality. Additionally, treatment of acute GvHD is
ineffective in about half of patients, and these refractory
patients have a dismal prognosis with mortality rates in excess of
70%. There are currently no therapies for the prevention of acute
GvHD approved by the U.S. Food and Drug Administration.
Day 100 clinical data from the Phase 1 stage of PROTECT were
previously presented at the 59th American Society of Hematology
Annual Meeting and Exposition in December 2017. All seven subjects
receiving ProTmune remained alive and relapse-free during the first
100 days following HCT. Three of the seven subjects experienced
acute GvHD during the first 100 days following HCT, all of whom
responded to standard-of-care steroid treatment. The median time to
resolution of the maximum GvHD grade was seven days [range: 5-8
days].
Three subjects with acute lymphoblastic leukemia (ALL), three
subjects with acute myeloid leukemia (AML) and one subject with
myelodysplastic syndrome (MDS) received ProTmune as the
hematopoietic cell graft in the Phase 1 stage. All subjects are
being followed for a period of up to two years post-HCT.
Non-relapse mortality deemed not attributable to ProTmune occurred
in two subjects (Subject 1 on Day 228 from pulmonary edema; Subject
3 on Day 151 from atrial fibrillation). The remaining five of seven
Phase 1 subjects are alive and relapse-free.
PROTECT Clinical Data – Time on Study
* |
Subject |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
Age / Gender |
66 / F |
56 / F |
66 / F |
34 / F |
48 / M |
56 / M |
69 / F |
Hematologic Malignancy |
MDS |
AML |
AML |
ALL |
ALL |
ALL |
AML |
CD34+ cell dose (x106/kg) |
10.3 |
4.6 |
10.9 |
4.8 |
3.2 |
3.0 |
9.4 |
CD3+ cell dose (x108/kg) |
3.1 |
1.8 |
2.6 |
2.8 |
2.0 |
1.2 |
2.8 |
Time on Study (Days) |
228 |
343 |
151 |
251 |
243 |
208 |
195 |
ProTmune-related SAEs |
None |
None |
None |
None |
None |
None |
None |
Cancer Relapse-free |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Survival |
No |
Yes |
No |
Yes |
Yes |
Yes |
Yes |
* Data is based on a February 26, 2018 data cut-off.
The database is not locked, and final data are subject to
change. |
PROTECT Phase 2 Clinical TrialThe ongoing Phase 2 stage of
PROTECT is a randomized, controlled and double-blinded clinical
trial assessing the safety and efficacy of ProTmune in up to 60
adult subjects with hematologic malignancies undergoing matched
unrelated donor HCT following myeloablative conditioning. Subjects
are being randomized, in a 1:1 ratio, to receive either ProTmune as
the hematopoietic cell graft or a conventional matched unrelated
donor mobilized peripheral blood cell graft. The primary efficacy
endpoint of PROTECT is cumulative incidence of Grades 2-4 acute
GvHD by Day 100 following HCT, where prospective clinical studies
have shown that 40% to 80% of patients undergoing matched unrelated
donor HCT experience Grades 2-4 acute GvHD. Additional key
endpoints, including rates of chronic GvHD, cancer relapse, and
disease-free and overall survival, are also being assessed.
About ProTmune™ProTmune™ is an investigational
next-generation hematopoietic cell graft for the prevention of
acute GvHD in patients undergoing allogeneic HCT. ProTmune is
manufactured by pharmacologically modulating an allogeneic
donor-sourced, mobilized peripheral blood graft ex vivo with two
small molecules (FT1050 and FT4145) to decrease the incidence and
severity of acute GvHD while maintaining the anti-leukemia activity
of the graft. ProTmune has been granted Orphan Drug and Fast Track
Designations by the U.S. Food and Drug Administration, and Orphan
Medicinal Product Designation by the European Commission.
About Allogeneic HCTThere are approximately
30,000 allogeneic HCT procedures performed globally each year
according to the Center for International Blood and Marrow
Transplant Research. The procedure is performed with curative
intent most often for patients with acute leukemias and
myelodysplastic syndromes. However, patients face a multitude of
life-threatening complications during the initial weeks and months
following allogeneic HCT, and only about 50% of patients remain
alive and are relapse-free at one year following HCT. The two
leading causes of morbidity and mortality are cancer relapse, which
occurs in 25% to 30% of patients, and GvHD.
About Acute GvHDAcute GvHD is a severe
immunological disease that commonly arises in patients during the
first weeks following allogeneic HCT when newly-transplanted donor
immune cells attack the patient’s tissues and organs, resulting in
a potentially fatal immune system reaction. Prospective clinical
studies have shown that 40% to 80% of patients undergoing matched
unrelated donor HCT experience Grades 2-4 acute GvHD, with most
incidents occurring by Day 60 following HCT despite the use of
standard prophylaxis regimens. Mortality directly attributable to
acute GvHD or its treatment occurs in 10% to 20% of patients.
About Fate Therapeutics, Inc. Fate Therapeutics
is a clinical-stage biopharmaceutical company dedicated to the
development of first-in-class cellular immunotherapies for cancer
and immune disorders. The Company is pioneering the development of
off-the-shelf cell therapies using its proprietary induced
pluripotent stem cell (iPSC) product platform. This platform
uniquely enables the single-cell selection of a precisely
engineered iPSC clone and the subsequent creation and maintenance
of a clonal master iPSC line. Analogous to master cell lines used
to manufacture biopharmaceutical drug products such as monoclonal
antibodies, clonal master iPSC lines are a renewable source for
consistently and repeatedly manufacturing homogeneous cell products
in quantities that support the treatment of many thousands of
patients in an off-the-shelf manner. The Company’s immuno-oncology
pipeline is comprised of FATE-NK100, a donor-derived natural killer
(NK) cell cancer immunotherapy that is currently being evaluated in
three Phase 1 clinical trials, as well as iPSC-derived NK cell and
T-cell immunotherapies, with a focus on developing augmented cell
products intended to synergize with checkpoint inhibitor and
monoclonal antibody therapies and to target tumor-specific
antigens. The Company’s immuno-regulatory pipeline includes
ProTmune™, a next-generation donor cell graft that is currently
being evaluated in a Phase 2 clinical trial for the prevention of
graft-versus-host disease, and a myeloid-derived suppressor cell
immunotherapy for promoting immune tolerance in patients with
immune disorders. Fate Therapeutics is headquartered in San Diego,
CA. For more information, please visit
www.fatetherapeutics.com.
Forward-Looking StatementsThis release contains
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995 including statements
regarding the therapeutic and market potential of ProTmune™, the
Company’s advancement of and plans for its clinical investigation
of ProTmune, including the Company’s ability to assess key one-year
outcomes from the Phase 1 stage of PROTECT and continue the ongoing
Phase 2 stage of PROTECT, the ability of ProTmune to prevent, or
reduce the occurrence of, graft-versus-host disease, disease
relapse or mortality, the potential safety of ProTmune in the
treatment of diseases, the timing for receipt of clinical data and
success of the Company’s PROTECT clinical trial, and the Company’s
development and product registration strategy for ProTmune,
including its ability to pursue accelerated registration. These and
any other forward-looking statements in this release are based on
management's current expectations of future events and are subject
to a number of risks and uncertainties that could cause actual
results to differ materially and adversely from those set forth in
or implied by such forward-looking statements. These risks and
uncertainties include, but are not limited to, the risk of
cessation or delay of planned development and clinical activities
for a variety of reasons (including any difficulties or delay in
enrolling subjects in clinical trials or in manufacturing or
supplying ProTmune for clinical testing, the occurrence of any
adverse events or other results that may be observed during
development, or any requirements that may be imposed by regulatory
authorities on the manufacture or conduct of clinical trials of
ProTmune including those necessary to support product
registration), the risk that results observed in prior preclinical
studies and early-stage clinical trials of ProTmune may not be
observed in ongoing or future studies or clinical trials, the risk
that ProTmune may not produce therapeutic benefits or may cause
other unanticipated adverse effects, the risk that the Company’s
expenditures may exceed current expectations for a variety of
reasons, and the risk that the Company may allocate its financial
and other resources to programs or product candidates that
ultimately have less therapeutic or commercial potential than other
product opportunities. For a discussion of other risks and
uncertainties, and other important factors, any of which could
cause the Company’s actual results to differ from those contained
in the forward-looking statements, see the risks and uncertainties
detailed in the Company’s periodic filings with the Securities and
Exchange Commission, including but not limited to the Company’s
most recently filed periodic report, and from time to time in the
Company’s press releases and other investor
communications. Fate Therapeutics is providing the information
in this release as of this date and does not undertake any
obligation to update any forward-looking statements contained in
this release as a result of new information, future events or
otherwise.
Contact: Christina Tartaglia Stern Investor
Relations, Inc. 212.362.1200 christina@sternir.com
Fate Therapeutics (NASDAQ:FATE)
Historical Stock Chart
From Feb 2024 to Mar 2024
Fate Therapeutics (NASDAQ:FATE)
Historical Stock Chart
From Mar 2023 to Mar 2024