Bellicum Reports Clinical Results of BPX-501 in Pediatric Leukemias at the 22nd Congress of the European Hematology Associati...
June 23 2017 - 7:00AM
Bellicum Pharmaceuticals, Inc. (Nasdaq:BLCM), a leader in
developing novel, controllable cellular immunotherapies for cancers
and orphan inherited blood disorders, today announced data from its
ongoing multicenter BP-004 trial of BPX-501 and rimiducid in a
cohort of pediatric patients with acute leukemias who lack a
matched donor. Results from 47 patients demonstrated that
administering BPX-501 following an alpha/beta T-cell depleted
haploidentical hematopoietic stem cell transplant (alpha/beta
T-cell depleted haplo-HSCT) produced rapid immune reconstitution,
low incidence of acute and chronic Graft versus Host Disease
(GvHD), and a low rate of disease relapse. The data will be
reviewed in an oral presentation at the 22nd Congress of the
European Hematology Association (EHA) at 5 p.m. CEST on June 24 in
Madrid, Spain.
“These data demonstrate that BPX-501-modified T cells can
provide rapid hematological reconstitution and a potentially
stronger anti-leukemic effect in children with high-risk disease
than traditional T-cell depleted transplants,” said Franco
Locatelli, MD, PhD, Director of the Department of Hematology and
Oncology at Ospedale Pediatrico Bambino Gesù in Rome, Italy. “The
incidence of GvHD was low, and managed by standard treatments or
the administration of rimiducid. Patients who received rimiducid
experienced a recovery of the beneficial, non-reactive BPX-501 T
cells. These are very encouraging early outcome results for
children who need a stem cell transplant and lack a matched
donor.”
Summary of Results (Abstract S495)
Investigators evaluated the safety and efficacy of an infusion
of BPX-501 in children with high-risk acute lymphoblastic
leukemia (ALL) (n=28) and acute myeloid leukemia (AML)
(n=19) following an alpha/beta T-cell depleted haplo-HSCT. Patients
had a median follow-up of approximately eight months (11 months in
surviving patients). Results from the three European trial sites
showed:
- Disease relapse rate of 14.72% in BPX-501 treated patients
- Median neutrophil recovery = 16 days (9-24); median platelet
engraftment = 11 days (8-19); median time to hospital discharge =
21.5 days (14-103)
- Acute GvHD Grade 2-4 was 11.83%; acute GvHD Grade 3-4 was
4.70%
- Chronic GvHD Grade Moderate-Severe was 3.23%
- Non-relapse mortality (NRM) of 3.23% in BPX-501 patients
- Re-expansion of infection-fighting BPX-501 cells after a sharp
decrease following infusion of rimiducid, with no reoccurrence of
GvHD
- Results compare favorably to historic controls1
Commented Rick Fair, President and CEO of Bellicum
Pharmaceuticals, “We are pleased by the profile observed with
BPX-501 in pediatric patients receiving a haploidentical
transplant, and by its potential to reduce disease relapse. These
results provide important insights into the potential long-term
benefits of BPX-501, and support our plans to begin a mid-stage
study this year in adults with hematologic cancers, for whom lack
of a matched donor and disease relapse are significant treatment
challenges.”
The presentation slides (abstract S495) will be made available
in the Events and Presentations section of the Bellicum
website shortly after the time of the presentation.
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 PharmaceuticalsBellicum 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.
1 Locatelli F. et al, Blood 2017 in press
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 our BPX-501,
CaspaCIDe, CID, CAR T and TCR programs; the effectiveness of
BPX-501 and of rimiducid; their possible range of application and
potential curative effects and safety in the treatment of diseases;
and, the timing and success of our clinical trials. 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
646-513-3125
bmiles@bmccommunications.com
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