Bellicum Reports Safety Results and Promising Activity of Its Controlled CAR-T Candidate BPX-601 in Patients with Advanced Pa...
December 14 2018 - 7:00AM
Rimiducid-activated GoCAR-T® resulted in significant
expansion and persistence of T cells
Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in
developing novel, controllable cellular immunotherapies for cancers
and orphan inherited blood disorders, today reported safety and
promising activity of BPX-601 in Part 1 of a Phase 1/2
dose-escalation study in patients with advanced, metastatic
pancreatic cancer expressing PSCA (prostate stem cell antigen).
BPX-601 is a novel GoCAR-T® cell candidate incorporating
Bellicum’s co-activation domain, iMC, designed to boost T cell
proliferation and persistence via administration of rimiducid. Data
were reviewed during an oral presentation at the European Society
for Medical Oncology Immuno-Oncology Congress (ESMO-IO) held in
Geneva, Switzerland from December 13-16.
“These initial results in advanced pancreatic cancer suggest
that having greater control over the expansion and persistence of
therapeutic cells may provide unique treatment benefits. We have
observed promising initial clinical activity with BPX-601 in
patients with one of the most challenging solid tumors, where there
is a critical need for better treatments,” commented Carlos R.
Becerra, M.D., lead study investigator and oncologist and medical
director of the Innovative Clinical Trials Center at Baylor
University Medical Center at Dallas. “I am looking forward to the
next phase of our study, which allows for a standard
lymphodepletion regimen and administration of multiple doses of
rimiducid to further increase the expansion and persistence of
BPX-601 cells and the potential for greater impact against
pancreatic and other tumor types.”
Study OverviewA total of 12 patients with
advanced metastatic pancreatic cancer expressing PSCA were treated
with escalating doses of BPX-601 cells in a 3+3 design. Nine of 12
patients received a single dose of rimiducid following BPX-601
treatment to evaluate its effect on cell expansion and persistence.
Patients in the study received a reduced conditioning regimen
consisting of cyclophosphamide only.
Interim Results:
- The administration of BPX-601 without rimiducid resulted in
limited expansion of cells, but the cells did not persist;
- A single dose of rimiducid 7 days following BPX-601
administration resulted in significant expansion of cells
(three-fold to 20-fold) in four patients in spite of a reduced
conditioning regimen;
- BPX-601 cells persisted longer than three weeks in three
patients after a single dose of rimiducid;
- Increases in key cytokine levels were observed in patients
receiving higher doses of BPX-601 cells and rimiducid;
- 4 of 6 efficacy-evaluable patients treated with BPX-601 and a
single dose of rimiducid had stable disease, with two patients
demonstrating tumor shrinkage greater than 20 percent;
- No cytokine release syndrome or neurotoxicity of any grade was
reported;
- The most frequently observed AEs were consistent with those
experienced by advanced cancer patients undergoing cytotoxic
chemotherapy or other cancer immunotherapies;
- Patients continue to be evaluated in the study.
“These results provide the first clinical evidence suggesting
that our GoCAR-T technology drives expansion and persistence of
therapeutic T cells in patients,” said Rick Fair, President &
CEO of Bellicum Pharmaceuticals. “We are excited about BPX-601
and the broader application of our technology intended to improve
the safety and efficacy of cell therapies. With these promising
results, we’re preparing to begin Part 2 of the BPX-601 study,
adding patients with prostate and gastric cancers, allowing
multiple doses of rimiducid and a more complete conditioning
regimen. We’re looking forward to reporting updated results in
2019.”
About BPX-601BPX-601, the Company’s first
GoCAR-T® product candidate, incorporates iMC, Bellicum’s
inducible co-activation domain. iMC (inducible MyD88/CD40) is
designed to provide a powerful boost to T cell proliferation and
persistence, and enable the CAR-T to override key immune inhibitory
mechanisms, including PD-1 and TGF-beta. BPX-601 is being evaluated
as a treatment for solid tumors expressing prostate stem cell
antigen (PSCA), including pancreatic, prostate and gastric cancers.
About Bellicum Pharmaceuticals Bellicum is a
clinical stage biopharmaceutical company striving to deliver cures
through controllable cell therapies. The Company’s next-generation
product candidates are differentiated by powerful cell signaling
technologies designed to produce more effective CAR-T, TCR and
allogeneic T cell therapies. Its lead product candidate, rivo-cel™,
is an allogeneic polyclonal T cell therapy that has shown promising
clinical trial results in reducing leukemia relapse after a stem
cell transplant. Bellicum’s lead GoCAR-T® candidate, BPX-601, is
designed to be a more efficacious CAR-T cell product capable of
overriding key immune inhibitory mechanisms. More information can
be found at www.bellicum.com.
Forward-Looking StatementThis press release
contains forward-looking statements for purposes of the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
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-601 and other GoCART
candidates, rimiducid and other iMC activating agents, and
rivo-cel™; the presentation of our preclinical and clinical data at
medical or scientific meetings; and our cash uses and cash runway.
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 quarterly report on Form 10-Q for the three months
ended September 30, 2018 and our annual report on Form
10-K for the year ended December 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.
Source: Bellicum Pharmaceuticals
Investors:
Chad Rubin
646-378-2947
crubin@soleburytrout.com
Media:
Brad Miles
917-570-7340
bmiles@soleburytrout.com
-or-
Amy Bonanno
914-450-0349
abonanno@soleburytrout.com
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