Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage
CRISPR genome-editing biopharmaceutical company, today announced
initial results demonstrating a 100% overall response rate (ORR)
and 80% complete response rate (CR) in cohort 1 (n=5 evaluable)
from its ANTLER Phase 1 trial for CB-010 in patients with relapsed
or refractory B cell non-Hodgkin lymphoma (r/r B-NHL). These
initial data are scheduled to be shared at the European Hematology
Association (EHA) 2022 Hybrid Congress, being held in Vienna,
Austria, June 9-17, 2022.
“Our initial CB-010 data are exciting, and we believe these
results show the potential to set a new therapeutic bar in treating
patients with aggressive r/r B-NHL. These excellent initial
outcomes represent important steps toward validating our chRDNA
genome-editing platform as well as our plans for future development
of CB-010 and our broader pipeline,” said Rachel Haurwitz, Ph.D.,
Caribou’s president and chief executive officer. “CB-010 is the
first allogeneic anti-CD19 CAR-T cell therapy in the clinic with a
PD-1 knock-out, a genome-editing strategy designed to limit
premature CAR-T cell exhaustion, potentially leading to better
tumor debulking and an improved therapeutic index through sustained
antitumor activity. We are slated to present additional ANTLER
interim data at EHA next month and expect more data by year end as
we continue to advance our lead program. Our overarching goal is to
develop CB-010 such that it will meaningfully rival autologous cell
therapies to reach broader groups of patients globally who are in
need of off-the-shelf treatments.”
“We are excited to see a 100% overall response rate with CB-010
at dose level 1 for these patients who have limited treatment
options,” said Syed Rizvi, M.D., Caribou’s chief medical officer.
“We believe this initial level of activity is unparalleled for a
single, starting dose of cell therapy. CB-010 was generally
well-tolerated with adverse events routinely observed in autologous
or allogeneic anti-CD19 CAR-T cell therapies. At EHA next month, we
are scheduled to share longer follow up data from the patients in
Cohort 1 who received a single administration of CB-010 at the
first dose level. We look forward to continuing the development of
our pipeline of allogeneic CAR-T cell therapies for patients with
hematologic malignancies.”
The EHA abstract includes safety, tolerability, and initial
antitumor activity of 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).
Prior to a single dose of CB-010, patients received a
lymphodepletion regimen consisting of cyclophosphamide at 60
mg/kg/d for 2 days followed by fludarabine at 25 mg/m2/d for 5
days.
As of the February 23, 2022 data cutoff date, 6 patients had
been treated with CB-010 and 5 had completed the 28-day
dose-limiting toxicity (DLT) evaluation period. 100% (n=5) achieved
a response; 80% (n=4) achieved a CR, and 20% (n=1) achieved a
partial response (PR). All 4 patients who achieved a CR at 28 days
had an ongoing CR at 3 months. The longest measured CR as of the
data cutoff date was 6 months.
A photo accompanying this announcement is available
at: https://www.globenewswire.com/NewsRoom/AttachmentNg/84334b1d-6bd0-4170-b931-fe5ca329bc98
Following treatment with CB-010, there were no cases of graft
versus host disease. 3 of 6 patients developed Grade 3 or 4 adverse
events (AEs) within the first 28 days: neutropenia (50%),
thrombocytopenia (33%), anemia (17%), and hypogammaglobulinemia
(17%). One patient experienced Grade 1 CRS (17%) and Grade 3 ICANS
(17%), which was characterized as a DLT, for which the patient
received tocilizumab and steroids and recovered from the DLT within
39 hours. This patient went on to achieve a CR.
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:
P1455Presenter: 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
Presentations and posters will be available for registered
attendees of EHA for on-demand viewing on the EHA website on June
10, 2022 at 9:00 am CEST (3:00 am ET). Caribou plans to issue a
press release on the data at 9:00 am CEST (3:00 am ET) on Friday
June 10, 2022 and the poster will be available on the Presentations
page of the Investors section of Caribou’s website.
Webcast Conference Call Today at 10:15 am
ETCaribou will host a webcast conference call today to
discuss the initial ANTLER data for CB-010 in the accepted EHA
abstract. The webcast presenters will include:
- Rachel Haurwitz, Ph.D., president and chief executive officer
of Caribou
- Syed Rizvi, M.D., chief medical officer of Caribou
- Steven Kanner, Ph.D., chief scientific officer of Caribou
- Jason O’Byrne, chief financial officer of Caribou
The live webcast and conference call, 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 844-862-9351 (domestic) or 929-517-0932 (international)
and reference conference ID #7589468. 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 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: |
Amy Figueroa, CFA |
Investor Relations and Corporate
Communications |
afigueroa@cariboubio.com |
|
Investors and
Media: |
Elizabeth Wolffe, Ph.D., and
Sylvia Wheeler |
Wheelhouse LSA |
lwolffe@wheelhouselsa.com |
swheeler@wheelhouselsa.com |
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