Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage
CRISPR genome-editing biopharmaceutical company, today announced
the presentation of additional initial clinical data from its
ANTLER Phase 1 trial for CB-010 in patients with relapsed or
refractory B cell non-Hodgkin lymphoma (r/r B-NHL). Following a
single dose at the initial dose level of CB-010, a 100% complete
response (CR) rate (6 of 6 patients) was observed as best response.
At 6 months following the single dose of CB-010, 40% of patients
remained in CR (2 of 5 patients) as of the May 13, 2022 data cutoff
date. The data are being presented at the European Hematology
Association (EHA) 2022 Hybrid Congress, being held in Vienna,
Austria, June 9-17, 2022.
“The preliminary safety and efficacy results are promising. All
six patients treated with CB-010 at the initial dose level of 40
million CAR-T cells achieved a complete response, and we are now
enrolling dose level 2 and look forward to seeing this study
mature,” said Loretta J. Nastoupil, M.D., associate professor,
Department of Lymphoma/Myeloma in the Division of Cancer Medicine
at The University of Texas MD Anderson Cancer Center and the
presenting investigator on the ANTLER trial. “CB-010 was generally
well-tolerated and the adverse events observed are consistent with
autologous or allogeneic CAR-T cell therapies.”
Additional data, which was received after the cutoff date of May
13, 2022 and was not included in the EHA poster, showed the first
patient treated in the ANTLER trial remained in CR at their
12-month evaluation.
“We believe the 100% complete response achieved in the ANTLER
CB-010 trial is unparalleled for a single, starting dose of cell
therapy and represents an important step toward showing the
potential of our chRDNA genome-editing platform and pipeline of
allogeneic cell therapies,” said Rachel Haurwitz, Ph.D., Caribou’s
president and chief executive officer. “As the first allogeneic
anti-CD19 CAR-T cell therapy in the clinic with a PD-1 knockout,
CB-010 is designed to have sustained antitumor activity by limiting
premature CAR-T cell exhaustion in patients with r/r B-NHL. As we
enroll patients in cohort 2 at dose level 2 of the ANTLER trial, we
are grateful for the patients, caregivers, and investigators who
have participated in this clinical trial. We continue to advance
CB-010, as our goal is to develop an allogeneic cell therapy that
may meaningfully rival autologous cell therapies and extend the
potential reach of off-the-shelf treatments for patients.”
Image available at: Patient response rates following
treatment with CB-010, single dose at dose level 1, in the ANTLER
Phase 1 trial
The EHA poster presentation includes safety, tolerability, and
initial antitumor activity data for CB-010 administered at dose
level 1 (40x106 CAR-T cells) to 6 patients with r/r B-NHL who had
relapsed after previous treatment with a median of 3 prior
therapies (range 2-8).
Following treatment with CB-010, there were no cases of graft
versus host disease in the six patients. Grade 3 or 4 treatment
emergent adverse events (TEAEs) developed in 5 of 6 patients, see
details in accompanying table. Two patients experienced Grade 1 CRS
(33%) and one patient experienced Grade 3 ICANS (17%), which was
characterized as a dose limiting toxicity (DLT), for which the
patient received tocilizumab and steroids and recovered within 39
hours. This patient went on to achieve a CR.
Image available at: Treatment emergent adverse events in the
ANTLER Phase 1 trial
Based on promising initial safety and efficacy data from cohort
1 at dose level 1 (40x106 CAR-T cells), the ANTLER trial is now
enrolling patients in cohort 2 at dose level 2 (80x106 CAR-T
cells). Additional data are expected by year end.
Details of the poster presentation at EHA are as
follows:Title: First-in-human trial of CB-010, a
CRISPR-edited allogeneic anti-CD19 CAR-T cell therapy with a PD-1
knock out, in patients with relapsed or refractory B cell
non-Hodgkin lymphoma (ANTLER study) Abstract:
3103Presenter: Loretta J. Nastoupil, M.D., section
chief, new drug development; associate professor, Department of
Lymphoma/Myeloma, The University of Texas MD Anderson Cancer
CenterDate and Time: Friday, June 10, 2022, 16:30
– 17:45 CEST (10:30 – 11:45 am ET)Session Title:
Gene therapy, cellular immunotherapy and vaccination -
ClinicalLocation: Messe Wien Exhibition &
Congress Center, Vienna, Austria
The poster is available on the Presentations page of the
Investors section of Caribou’s website.
Webcast Conference Call Today at 8:00 am
ETCaribou will host a webcast conference call today to
discuss the data presented at EHA on the initial ANTLER data for
CB-010.
The live webcast and conference call at 8:00 am ET, with an
accompanying presentation, will be accessible under Events in the
Investors section of the company’s website. To participate in the
conference call, dial 1-844-862-9351 (domestic) or 1-929-517-0932
(international) and reference conference ID #4657536. The archived
audio webcast will be available on Caribou’s website following the
call and will be available for 30 days.
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. CB-010 is an allogeneic anti-CD19 CAR-T cell therapy
engineered using Cas9 CRISPR hybrid RNA-DNA (chRDNA) technology to
insert a CD19-specific CAR into the TRAC gene and knock out PD-1 to
boost the persistence of antitumor activity. CB-010 is the first
allogeneic CAR-T cell therapy in the clinic with a PD-1 knock out.
Additional information on the ANTLER trial can be found at
https://clinicaltrials.gov using identifier NCT04637763.
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 proprietary
Cas12a chRDNA technology, enables superior precision to develop
cell therapies that are specifically engineered for enhanced
persistence. Caribou is advancing a pipeline of off-the-shelf CAR-T
and CAR-NK cell therapies for the treatment of 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 timing of the
release of initial and additional patient data 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 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; 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, 2021, 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:
InvestorsAmy Figueroa,
CFAafigueroa@cariboubio.com
MediaPeggy Vorwald,
Ph.D.pvorwald@cariboubio.com
Investors and
Media: Elizabeth Wolffe, Ph.D., and Sylvia
WheelerWheelhouse
LSA lwolffe@wheelhouselsa.comswheeler@wheelhouselsa.com
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