Caribou Biosciences Announces FDA Granted Fast Track Designation to CB-011, an Allogeneic CAR-T Cell Therapy for Relapsed or Refractory Multiple Myeloma
April 04 2023 - 8:00AM
Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage
CRISPR genome-editing biopharmaceutical company, today announced
that the U.S. Food and Drug Administration (FDA) has granted Fast
Track designation to CB-011, which is being developed for relapsed
or refractory multiple myeloma (r/r MM). CB-011 is being evaluated
in the company’s ongoing CaMMouflage Phase 1 clinical trial in
patients with r/r MM.
“Fast Track designation for CB-011 allows us instrumental
interactions with the FDA as we progress our clinical development
and regulatory plans for CB-011. This designation could not be more
timely as we recently dosed our first patient in the CaMMouflage
Phase 1 trial,” said Syed Rizvi, MD, Caribou’s chief medical
officer. “Our goal is to develop CB-011 as a readily available
off-the-shelf treatment option for patients with relapsed or
refractory multiple myeloma to overcome the need for apheresis or
bridging therapy, variable quality and long manufacturing
timelines, manufacturing failures, or the inability to bear the
burden of treatments that require frequent dosing over several
months.”
Fast Track designation is designed to expedite the development
and review processes for promising therapeutic candidates that may
fill an unmet medical need. Clinical programs with Fast Track
designation may benefit from early and frequent communication with
the FDA throughout the regulatory review process and may also be
eligible for Accelerated Approval and Priority Review if relevant
criteria are met.
About CB-011CB-011 is the second product
candidate from Caribou’s allogeneic CAR-T cell therapy platform and
is being evaluated in patients with relapsed or refractory multiple
myeloma (r/r MM) in the CaMMouflage Phase 1 trial. CB-011 is an
allogeneic anti-BCMA CAR-T cell therapy engineered using Cas12a
chRDNA technology. CB-011 is the first allogeneic CAR-T cell
therapy in the clinic, to Caribou’s knowledge, that is engineered
to improve antitumor activity through an immune cloaking strategy
with a B2M knockout and insertion of a B2M–HLA-E fusion protein to
blunt immune-mediated rejection. Additional information on the
CaMMouflage trial (NCT05722418) can be found at
clinicaltrials.gov.
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
have exhibited editing at 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, as well as the timing of regulatory review and approval.
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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