Caribou Biosciences Provides Regulatory Update on CB-010 Pivotal Plan with Phase 3 Trial Initiation Expected by YE 2024
13 12월 2023 - 6:02AM
Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage
CRISPR genome-editing biopharmaceutical company, today provided an
update based on feedback from the U.S. Food and Drug Administration
(FDA) following recent communications and a Type B clinical meeting
regarding the CB-010 development program. The company has received
the FDA’s feedback on a Phase 3 randomized controlled trial for
CB-010, an allogeneic anti-CD19 CAR-T cell therapy in development
for patients with second-line relapsed or refractory large B cell
lymphoma (r/r LBCL). The FDA stated that Caribou’s proposed
comparator arm of platinum-based immunochemotherapy followed by
high dose chemotherapy (HDCT) and autologous stem cell
transplantation (ASCT) is acceptable.
“FDA feedback on our CB-010 pivotal development plan represents
an important step in advancing our lead therapy to enable broader
access of CAR-T cell therapies for patients living with large B
cell lymphoma,” said Rachel Haurwitz, PhD, Caribou’s president and
chief executive officer. “As our ongoing ANTLER trial progresses,
we look forward to engaging again with the FDA ahead of initiating
our planned Phase 3 pivotal trial. Our goal is to establish a new
second-line standard of care by delivering an off-the-shelf CAR-T
cell therapy to patients as expeditiously as possible.”
In the ongoing ANTLER Phase 1 trial, Caribou is enrolling
second-line LBCL patients in the dose expansion portion based on
promising data from the dose escalation portion of the trial.
Currently, 22 sites are active in the U.S. and the first
international site is active in Australia, with additional site
activation underway in the U.S. and globally. To Caribou’s
knowledge, CB-010 is the first anti-CD19 allogeneic CAR-T cell
therapy to be evaluated in the second-line LBCL setting and it has
been granted Regenerative Medicine Advanced Therapy (RMAT), Fast
Track, and Orphan Drug designations by the FDA. In Q2 2024, the
company plans to report initial dose expansion data from the ANTLER
trial and share the recommended Phase 2 dose (RP2D) for CB-010.
Caribou plans to initiate a Phase 3 pivotal trial with this RP2D by
year-end 2024.
About CB-010CB-010 is the lead product
candidate from Caribou’s allogeneic CAR-T cell therapy platform and
is being evaluated in patients with relapsed or refractory B cell
non-Hodgkin lymphoma (r/r B-NHL). In the ongoing ANTLER Phase 1
trial, Caribou is enrolling second-line patients with large B cell
lymphoma (LBCL) comprised of different subtypes of aggressive r/r
B-NHL (DLBCL NOS, PMBCL, HGBL, tFL, and tMZL). CB-010 is an
allogeneic anti-CD19 CAR-T cell therapy engineered using Cas9
CRISPR hybrid RNA-DNA (chRDNA) genome-editing technology. To
Caribou’s knowledge, CB-010 is the first allogeneic CAR-T cell
therapy in the clinic with a PD-1 knockout, a genome-editing
strategy designed to improve antitumor activity by limiting
premature CAR-T cell exhaustion. Also, to Caribou’s knowledge,
CB-010 is the first anti-CD19 allogeneic CAR-T cell therapy to be
evaluated in the second-line LBCL setting and it has been granted
Regenerative Medicine Advanced Therapy (RMAT), Fast Track, and
Orphan Drug designations by the FDA. Additional information on the
ANTLER trial (NCT04637763) can be found at clinicaltrials.gov.
About Caribou’s novel next-generation CRISPR
platform CRISPR 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 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.
Forward-looking statements This 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, objectives, and expectations
regarding its clinical and preclinical development programs,
including its expectations relating to the timing of initiating
patient enrollment in the Phase 3 pivotal trial by year-end 2024,
reporting of initial dose expansion data from the ongoing ANTLER 1
Phase 1 trial and sharing the recommended Phase 2 dose for CB-010
in Q2 2024, and the timing of updates from its ANTLER Phase 1
clinical trial for CB-010. 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, preliminary, 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 patient enrollment continues and as more patient data becomes
available; the risk that preclinical study results observed will
not be borne out in human patients or different conclusions or
considerations are reached once additional data have been received
and fully evaluated; the ability to obtain key regulatory input and
approvals 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
Caribou Biosciences (NASDAQ:CRBU)
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부터 4월(4) 2024 으로 5월(5) 2024
Caribou Biosciences (NASDAQ:CRBU)
과거 데이터 주식 차트
부터 5월(5) 2023 으로 5월(5) 2024