Fate Therapeutics Announces Day 100 Clinical Results from Phase 1 Stage of PROTECT Trial of ProTmune™ and Initiation of Pha...
December 11 2017 - 5:13PM
All Subjects Achieved Day 100 Relapse-free
Survival
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 Day 100 clinical data from the Phase 1
stage of its PROTECT clinical trial of ProTmune™, the Company’s
next-generation hematopoietic cell graft for patients with
hematologic malignancies. All seven subjects receiving ProTmune
remained alive and relapse-free during the first 100 days following
hematopoietic cell transplantation (HCT). Three of the seven
subjects experienced acute graft-versus-host disease (GvHD) during
the first 100 days following HCT. Each of these three subjects
responded to standard-of-care steroid treatment with a median time
to resolution of the maximum GvHD grade of 7 days [range: 5-8
days].
“The significant risk of GvHD limits broad application of
allogeneic transplant due to uncertainty of its short- and
long-term impact on the recipient. It occurs frequently with
variable intensity and can be a devastating disease when
unresponsive to treatment. The requisite extended use of
immunosuppressive agents to treat GvHD compromises the
anti-leukemia activity of the transplant procedure and can
significantly increase the risk of cancer relapse and mortality
while also placing patients at risk for opportunistic infection,”
said Richard Maziarz, M.D., Principal Investigator, Oregon Health
Sciences University. “The administration of a hematopoietic cell
graft that is optimized to attenuate T-cell alloreactivity and
maintain the graft’s anti-leukemia activity is a novel and
highly-attractive therapeutic approach to decrease the risk and
enhance the curative potential of allogeneic transplantation.”
PROTECT Phase 1 Day 100 Clinical Results
Clinical data from the Phase 1 stage of PROTECT were presented
today by Dr. Maziarz during a poster session at the 59th American
Society of Hematology Annual Meeting and Exposition. The Phase 1
stage included seven adult subjects with hematologic malignancies
undergoing matched unrelated donor HCT following myeloablative
conditioning. During the first 100 days following HCT, all seven
subjects receiving ProTmune remained alive and relapse-free. 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 7 days [range: 5-8 days]. There were no events of
graft failure, and there were no ProTmune-related serious adverse
events reported by investigators.
PROTECT Day 100 Clinical Data |
Subject |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
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 |
ProTmune-related SAEs |
None |
None |
None |
None |
None |
None |
None |
Day of Neutrophil Engraftment 1 |
Day 14 |
Day 18 |
Day 22 |
Day 15 |
Day 16 |
Day 18 |
Day 19 |
Acute GvHD / Grade (CIBMTR) |
None |
None |
Grade 2 |
None |
Grade 2 |
Grade 3 |
None |
Treatment Responsive |
--- |
--- |
Yes |
--- |
Yes |
Yes |
--- |
Time to Resolution of Maximum Grade |
--- |
--- |
7 days |
--- |
8 days |
5 days |
--- |
Cancer Relapse-free |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Survival |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
1 As
measured from the day following HCT |
|
“The Day 100 clinical results from our Phase 1 stage of PROTECT
support the unique therapeutic potential of ProTmune to reduce
graft-versus-host disease and promote relapse-free survival. We are
very encouraged by these initial clinical findings and the
potential of ProTmune to deliver transformative benefits to cancer
patients,” said Chris Storgard, M.D., Chief Medical Officer of Fate
Therapeutics. “The randomized, controlled and double-blinded Phase
2 stage of PROTECT is enrolling subjects at 14 U.S. centers of
excellence. Given the high rates of morbidity and mortality
underlying hematopoietic cell transplantation, we have also engaged
the FDA, under our Fast Track designation for ProTmune, to discuss
the necessary activities for product registration.”
All subjects receiving ProTmune in the PROTECT Phase 1 stage are
being followed for a period of two years following HCT. As of a
November 29, 2017 data cut-off, all subjects remained relapse-free,
and there were no events of graft failure and no serious adverse
events related to ProTmune reported by investigators. Non-relapse
mortality was reported in two subjects (Subject 1 on Day 228;
Subject 3 on Day 151). Five of seven subjects remained on study
with median time on study of 154 days [Day 106 – 254].
PROTECT Phase 2 DesignThe 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 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 transplant experience Grades 2-4
acute GvHD. Immunosuppressant treatments are effective in only
about half of affected HCT patients and are associated with a
marked increase in severe infections and cancer relapse. Additional
endpoints, such as rates of cancer relapse, chronic GvHD,
non-relapse mortality and overall survival, are also being
assessed. Fourteen U.S. centers are currently open for enrollment
in the Phase 2 stage of PROTECT.
About Acute GvHDAcute graft-versus-host disease
(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 transplant
experience Grades 2-4 acute GvHD, with most incidents occurring by
Day 60 following HCT despite the use of standard prophylaxis
regimens. The disease is the leading cause of early morbidity and
mortality in matched unrelated donor transplant, where death
directly attributable to acute GvHD or its treatment occurs in 10%
to 20% of patients. There are currently no FDA-approved preventive
therapies and very few treatment options for acute GvHD.
About ProTmune™ProTmune™ is an investigational
next-generation hematopoietic cell graft for the prevention of
acute graft-versus-host disease (GvHD) in patients undergoing
allogeneic hematopoietic cell transplantation. ProTmune is
manufactured by pharmacologically modulating a donor-sourced,
mobilized peripheral blood graft ex vivo with two small molecules
(FT1050 and FT4145) to decrease the morbidity and mortality 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 Fate Therapeutics, Inc. Fate Therapeutics
is a clinical-stage biopharmaceutical company dedicated to the
development of programmed cellular immunotherapies for cancer and
immune disorders. The Company's hematopoietic cell therapy pipeline
is comprised of NK- and T-cell immuno-oncology programs, including
off-the-shelf product candidates derived from engineered induced
pluripotent cell lines, and immuno-regulatory programs, including
product candidates to prevent life-threatening complications in
patients undergoing hematopoietic cell transplantation and to
promote immune tolerance in patients with autoimmune disease. Its
adoptive cell therapy programs are based on the Company's
novel ex vivo cell programming approach, which it applies
to modulate the therapeutic function and direct the fate of immune
cells. 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 progress and plans for its clinical investigation of
ProTmune, the ability of ProTmune to prevent, or reduce the
incidence or severity of, graft-versus-host disease, severe
infections, disease relapse or mortality, the potential safety of
ProTmune in the treatment of diseases, the timing and success of
the Company’s PROTECT clinical trial, and the Company’s 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 delay in enrolling patients in clinical trials, or
the occurrence of any adverse events or other results that may be
observed during development), the risk that results observed in
prior preclinical studies and early-stage clinical trials of
ProTmune may not be replicated in subsequent studies or clinical
trials, the risk that ProTmune may not produce therapeutic benefits
or may cause other unanticipated adverse effects, 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 other investor communications. The Company 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 Apr 2024 to May 2024
Fate Therapeutics (NASDAQ:FATE)
Historical Stock Chart
From May 2023 to May 2024