Bellicum Announces Data Presentation Demonstrating Improved Immune Recovery Following Haploidentical Stem Cell Transplant wit...
December 09 2017 - 2:00PM
Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in
developing novel, controllable cellular immunotherapies for cancers
and orphan inherited blood disorders, today announced results from
a leading European transplant center participating in the BP-004
trial in children with blood cancers and nonmalignant disorders.
Patients were treated with BPX-501 following an alpha/beta T cell
and CD19+ B cell depleted haploidentical hematopoietic stem cell
transplant (haplo-HSCT). Results demonstrated that donor BPX-501
cells infused after transplant expanded in vivo and persisted over
time, contributing to improved immune recovery for patients in the
study as compared to historical controls from the same transplant
center. The data were reviewed in an oral presentation today during
the 59th Annual Meeting of the American Society of
Hematology (ASH).
According to study author and presenter Pietro Merli of
Ospedale Pediatrico Bambino Gesù in Rome, “These data show
that administering BPX-501 cells following a haplo-HSCT may result
in improved immune recovery and infection control, addressing
significant risks in children undergoing a stem cell transplant who
do not have access to a matched donor. Adding BPX-501 to a
haplo-HSCT has the potential to improve outcomes and to make the
curative benefits of transplants available to more children with
cancers and genetic blood diseases.”
Study Design and Highlights (Abstract #211)
Investigators evaluated immune recovery and outcomes of 112
pediatric patients who underwent a haplo-HSCT followed by treatment
with BPX-501. Children in the study had acute leukemia (n=53),
Primary Immune Deficiencies (n=26), erythroid disorders (n=17),
Fanconi anemia (n=7), and other diseases (n=9). All patients were
transplanted after depletion of donor alpha/beta T cells and CD19 B
cells to prevent graft-versus-host disease (GvHD) and
post-transplant lymphoproliferative disorders (PTLD). BPX-501 cells
were scheduled to be infused approximately two weeks
post-transplant.
Results showed:
- BPX-501 cells infused after haplo-HSCT expand and persist in
patients, potentially contributing to improved recovery of adaptive
immunity.
- Peak expansion of BPX-501 cells is reached at nine months after
infusion, and BPX-501 cells are consistently detected after two
years.
- CMV infection is a main driver of BPX-501 cell expansion,
suggesting that BPX-501 cells cooperate in clearing the viral
infection.
- The overall pattern of immune recovery in 112 children studied
may be improved when compared to patients who received a similar
haplo-HSCT without BPX-501.
“Improved immune recovery and control over infections, as
demonstrated in this study, may have a direct impact on
treatment-related morbidity and mortality,” commented Rick Fair,
Bellicum’s President & Chief Executive Officer. “We look
forward to reporting on these and other outcomes from our ongoing
BP-004 trial in 2018.”
A copy of the ASH presentation will be made available in the
“Investors & Media” section of the Company’s website.
About BPX-501 BPX-501 is an adjunct T cell
therapy administered after allogeneic HSCT, comprising genetically
modified donor T cells incorporating Bellicum’s
CaspaCIDe® safety switch. It is designed to provide a safety
net to eliminate alloreactive BPX-501 T cells (via administration
of activator agent rimiducid) should uncontrollable GvHD occur.
This enables physicians to more safely perform stem cell
transplants by administering BPX-501 engineered T cells to speed
immune reconstitution, provide control over viral infections and
enhance Graft-versus-leukemic effect without unacceptable GvHD
risk. The ongoing BP-004 clinical study of BPX-501 is being
conducted at transplant centers in the U.S. and Europe.
About Bellicum Pharmaceuticals Bellicum is
a clinical stage biopharmaceutical company focused on discovering
and developing cellular immunotherapies for cancers and orphan
inherited blood disorders. Bellicum is using its proprietary
Chemical Induction of Dimerization (CID) technology platform to
engineer and control components of the immune system. Bellicum is
developing next-generation product candidates in some of the most
important areas of cellular immunotherapy, including hematopoietic
stem cell transplantation (HSCT), and CAR-T and TCR cell therapies.
More information can be found at www.bellicum.com.
Forward-Looking Statement
This press release contains forward-looking statements for
purposes of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. Bellicum may, in some cases, use
terms such as “predicts,” “believes,” “potential,” “proposed,”
“continue,” “designed,” “estimates,” “anticipates,” “expects,”
“plans,” “intends,” “may,” “could,” “might,” “will,” “should” or
other words that convey uncertainty of future events or outcomes to
identify these forward-looking statements. Forward-looking
statements include statements regarding our intentions, beliefs,
projections, outlook, analyses or current expectations concerning,
among other things: our research and development activities
relating to BPX-501, BPX-601, BPX-701, rimiducid, CaspaCIDe, iMC,
dual switch, CAR-T and TCR programs; the effectiveness of BPX-501,
BPX-601 and BPX-701, their possible ranges of application and
potential curative effects and safety in the treatment of diseases,
including as compared to other treatment options and competitive
therapies; the timing and success of our clinical trials, including
our BP-004 study and observational trials; the rate and progress of
enrollment in our clinical trials for BPX-501, BPX-601 and BPX-701,
including our planned registration trials for BPX-501 and
rimiducid; the timing of regulatory filings for BPX-501 and
rimiducid; our research and development activities relating to our
GoCAR-T and GoTCR technologies, and our collaborations with
academic institutions. Various factors may cause differences
between Bellicum’s expectations and actual results as discussed in
greater detail under the heading “Risk Factors” in Bellicum’s
filings with the Securities and Exchange Commission, including
without limitation our annual report on Form 10-K for the year
ended December 31, 2016 and our report on Form 10-Q for the quarter
ended March 31, 2017. Any forward-looking statements that Bellicum
makes in this press release speak only as of the date of this press
release. Bellicum assumes no obligation to update our
forward-looking statements whether as a result of new information,
future events or otherwise, after the date of this press
release.
Investors:
Bellicum Pharmaceuticals, Inc.
Alan Musso, CFO
832-384-1116
amusso@bellicum.com
Media:
BMC Communications
Brad Miles
917-570-7340
bmiles@bmccommunications.com
or
BMC Communications
Amy Bonanno
914-450-0349
abonanno@bmccommunications.com
Source: Bellicum Pharmaceuticals
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