Caribou Biosciences Announces Dosing of First Patient in the CaMMouflage Phase 1 Trial of CB-011, an Allogeneic Anti-BCMA CAR-T Cell Therapy for the Treatment of Relapsed or Refractory Multiple Myeloma
March 29 2023 - 8:00AM
Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage
CRISPR genome-editing biopharmaceutical company, today announced
the first patient has been dosed with CB-011 at dose level 1
(50x106 CAR-T cells) in the CaMMouflage Phase 1 trial for adults
with relapsed or refractory multiple myeloma (r/r MM). CB-011 is an
allogeneic anti-BCMA CAR-T cell therapy designed to improve
antitumor activity by reducing T and natural killer (NK)
cell-mediated rejection.
“We are excited to announce the first patient has been treated
with CB-011 in the CaMMouflage Phase 1 trial for relapsed or
refractory multiple myeloma,” said Rachel Haurwitz, PhD, Caribou’s
president and chief executive officer. “Initiation of the
CaMMouflage trial is the first step in evaluating the safety of
CB-011 and assessing how our immune cloaking approach for CB-011
may improve the antitumor activity. We continue to be humbled by
the patients, their families, and the physicians who are partnering
with Caribou as we develop off-the-shelf CAR-T cell therapies that
have the potential to address the needs of broad patient
populations.”
CB-011 is the first allogeneic CAR-T cell therapy, to Caribou’s
knowledge, with an immune cloaking approach that includes both
removal of the endogenous beta-2 microglobulin (B2M) protein and
insertion of a B2M–human-leukocyte-antigen-E–peptide (B2M–HLA-E)
transgene. This strategy has the potential to improve the antitumor
activity by blunting CAR-T cell rejection mediated by both the
patient’s T cells and NK cells.
“Approved therapies have demonstrated efficacy in patients with
relapsed or refractory multiple myeloma, but challenges remain with
patient access, tolerability, and treatment burden,” said Sundar
Jagannath, MD, professor of medicine and Mount Sinai endowed chair
for multiple myeloma at Mount Sinai School of Medicine and director
of the Multiple Myeloma Center of Excellence at Tisch Cancer
Institute, Mount Sinai Hospital, New York. “There is a significant
unmet need for an off-the-shelf CAR-T cell therapy as a readily
available treatment option that does not require multiple rounds of
treatment.”
Caribou plans to continue to enroll additional patients at dose
level 1 in the CaMMouflage trial and provide an update on the
clearance of dose levels as appropriate.
About the CaMMouflage TrialThe CaMMouflage
Phase 1 trial (NCT05722418) is an open-label, multicenter clinical
trial designed to evaluate CB-011 in adults with relapsed or
refractory multiple myeloma (r/r MM). Part A, a 3+3 dose escalation
design, will evaluate the safety and tolerability of CB-011 at
multiple dose levels and will be utilized to determine the maximum
tolerated dose and/or the recommended Phase 2 dose. Part B is the
dose expansion portion with the primary objective of determining
tumor response after a single dose of CB-011. CaMMouflage will
include patients who have had 3 or more prior lines of therapy and
will exclude patients who have received a BCMA-targeted therapy
within the last 3 months and/or any prior CAR-T cell therapy. For
more information about the CaMMouflage trial (NCT05722418), please
visit clinicaltrials.gov.
About Multiple MyelomaAs of 2022, multiple
myeloma (MM) made up 18% of hematologic malignancies in the United
States and 1.8% of all cancers. In 2022, there were an estimated
34,470 new cases in the United States and an estimated 12,640
deaths. Median age of diagnosis for MM is 69 years and the
five-year survival in these patients is approximately
58%.About Caribou’s Novel Next-Generation CRISPR
PlatformCRISPR genome editing uses easily designed,
modular biological tools to make DNA changes in living cells. There
are two basic components of Class 2 CRISPR systems: the nuclease
protein that cuts DNA and the RNA molecule(s) that guide the
nuclease to generate a site-specific, double-stranded break,
leading to an edit at the targeted genomic site. CRISPR systems are
capable of editing unintended genomic sites, known as off-target
editing, which may lead to harmful effects on cellular function and
phenotype. In response to this challenge, Caribou has developed
CRISPR hybrid RNA-DNA guides (chRDNAs; pronounced “chardonnays”)
that direct substantially more precise genome editing compared to
all-RNA guides. Caribou is deploying the power of its Cas12a chRDNA
technology to carry out high efficiency multiple edits, including
multiplex gene insertions, to develop CRISPR-edited therapies.
About Caribou Biosciences, Inc.Caribou
Biosciences is a clinical-stage CRISPR genome-editing
biopharmaceutical company dedicated to developing transformative
therapies for patients with devastating diseases. The company’s
genome-editing platform, including its proprietary Cas12a chRDNA
technology, enables superior precision to develop cell therapies
that are armored to potentially improve antitumor activity. Caribou
is advancing a pipeline of off-the-shelf cell therapies from its
CAR-T and CAR-NK platforms as readily available treatments for
patients with hematologic malignancies and solid tumors.
Follow us @CaribouBio and visit www.cariboubio.com.
“Caribou Biosciences” and the Caribou logo are registered
trademarks of Caribou Biosciences, Inc.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. These
forward-looking statements include, without limitation, statements
related to Caribou’s strategy, plans, and objectives, and
expectations regarding its clinical and preclinical development
programs, including its expectations relating to the enrollment,
status, and updates from its CaMMouflage Phase 1 clinical trial for
CB-011. Management believes that these forward-looking statements
are reasonable as and when made. However, such forward-looking
statements are subject to risks and uncertainties, and actual
results may differ materially from any future results expressed or
implied by the forward-looking statements. Risks and uncertainties
include, without limitation, risks inherent in the development of
cell therapy products; uncertainties related to the initiation,
cost, timing, progress, and results of Caribou’s current and future
research and development programs, preclinical studies, and
clinical trials; and the risk that initial or interim clinical
trial data will not ultimately be predictive of the safety and
efficacy of Caribou’s product candidates or that clinical outcomes
may differ as more patient data becomes available; the risk that
preclinical study results we observed will not be borne out in
human patients; as well as other risk factors described from time
to time in Caribou’s filings with the Securities and Exchange
Commission, including its Annual Report on Form 10-K for the year
ended December 31, 2022 and subsequent filings. In light of the
significant uncertainties in these forward-looking statements, you
should not rely upon forward-looking statements as predictions of
future events. Except as required by law, Caribou undertakes no
obligation to update publicly any forward-looking statements for
any reason.
Caribou Biosciences, Inc. Contacts:
Investors:Amy Figueroa,
CFAinvestor.relations@cariboubio.com
Media:Peggy Vorwald,
PhDmedia@cariboubio.com
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