Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage
CRISPR genome-editing biopharmaceutical company, today announced
that Pfizer Inc. (NYSE: PFE) has made a $25 million equity
investment in the company. Pfizer purchased 4,690,431 of Caribou
common shares at a price of $5.33 per share, pursuant to the terms
of a Securities Purchase Agreement dated June 29, 2023. The
purchase by Pfizer closed on June 30, 2023. In conjunction with the
investment, Sriram Krishnaswami, PhD, has joined
Caribou’s Scientific Advisory Board.
“We believe Pfizer’s investment in Caribou highlights the
potential of our clinical programs and we are excited to establish
this partnership with one of the world’s premier biopharmaceutical
companies,” said Rachel Haurwitz, PhD, Caribou’s president and
chief executive officer. “We are actively advancing our allogeneic
CAR-T cell therapy pipeline and look forward to providing updates
from all of our programs over the next six months, including
6-month dose escalation data from our ANTLER Phase 1 clinical trial
for CB-010, dose escalation updates on our CaMMouflage Phase 1
clinical trial for CB-011, and submission of an investigational new
drug application for CB-012.”
“We are encouraged by Caribou’s chRDNA genome-editing technology
and the potential of allogeneic cell therapies as a promising
off-the-shelf approach to cancer treatment,” said Dr. Krishnaswami.
“Pfizer has a long history of supporting early, innovative science
in the biotech ecosystem, and we look forward to supporting Caribou
as they continue to advance their ANTLER Phase 1 trial for CB-010,
as well as their clinical program for CB-011, an allogeneic
anti-BCMA cell therapy for multiple myeloma.”
Caribou will use the proceeds of this investment to advance
CB-011, an immune cloaked allogeneic CAR-T cell therapy currently
being evaluated in the CaMMouflage Phase 1 clinical trial in
patients with relapsed or refractory multiple myeloma (r/r MM).
Caribou will maintain full ownership and control of its pipeline of
allogeneic CAR-T and CAR-NK cell therapies.
The securities sold in this financing were made in a transaction
not involving a public offering and have not been registered under
the Securities Act of 1933, as amended, and may not be offered or
sold in the United States except pursuant to an effective
registration statement or an applicable exemption from the
registration requirements. This press release shall not constitute
an offer to sell or the solicitation of an offer to buy the common
shares, nor shall there be any sale of the common shares in any
state or other jurisdiction in which such offer, solicitation, or
sale would be unlawful prior to the registration or qualification
under the securities laws of any such state or other
jurisdiction.
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) comprising four different subtypes of aggressive
r/r B-NHL (DLBCL NOS, PMBCL, HGBL, and tFL). CB-010 is an
allogeneic anti-CD19 CAR-T cell therapy engineered using Cas9
CRISPR hybrid RNA-DNA (chRDNA) technology. CB-010 is the first
allogeneic CAR-T cell therapy in the clinic, to Caribou’s
knowledge, with a PD-1 knockout, a genome-editing strategy designed
to improve antitumor activity by limiting premature CAR-T cell
exhaustion. To Caribou’s knowledge, CB-010 is also the first
anti-CD19 allogeneic CAR-T cell therapy to be evaluated in the
second-line setting and 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 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. To Caribou’s knowledge, CB-011 is the first
allogeneic CAR-T cell therapy in the clinic 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. CB-011 has been granted Fast Track
designation by the FDA. Additional information on the CaMMouflage
trial (NCT05722418) can be found at clinicaltrials.gov.
About CB-012CB-012 is the third product
candidate from Caribou’s allogeneic CAR-T cell therapy platform and
is being evaluated in investigational new drug (IND)-enabling
studies. To Caribou’s knowledge, CB-012 is the first allogeneic
CAR-T cell therapy with both checkpoint disruption, through a PD-1
knockout, and immune cloaking, through a B2M knockout and B2M–HLA-E
fusion protein insertion; both armoring strategies are designed to
improve antitumor activity. CB-012 is engineered with five genome
edits, enabled by Caribou’s patented next-generation CRISPR
technology platform, which uses Cas12a chRDNA genome editing to
significantly improve the specificity of genome edits.
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 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
updates from its ANTLER Phase 1 clinical trial for CB-010 as well
as the status and updates from its CaMMouflage Phase 1 clinical
trial for CB-011, expectations about product developments in 2023,
and expectations regarding the submission of an IND application for
CB-012. 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 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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