Beam Therapeutics Announces FDA Has Lifted the Clinical Hold on the Investigational New Drug Application for BEAM-201
December 02 2022 - 6:30AM
Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company
developing precision genetic medicines through base editing, today
announced the U.S. Food and Drug Administration (FDA) has lifted
the clinical hold and cleared the Investigational New Drug (IND)
application for BEAM-201 for the treatment of relapsed/refractory
T-cell acute lymphoblastic leukemia (T-ALL)/T-cell lymphoblastic
lymphoma (T-LL). BEAM-201 is a potent and specific anti-CD7,
multiplex-edited, allogeneic chimeric antigen receptor T-cell
development candidate.
“The FDA’s clearance of our IND for BEAM-201 is an exciting
moment for Beam and for the field of gene editing, as it represents
the first IND clearance for a multiplex-base edited investigational
drug,” said John Evans, chief executive officer of Beam. “We
believe the future of cell therapy involves high levels of cell
engineering, enabled by multiplex base editing technology.
Combining four unique edits with high efficiency, BEAM-201 has the
potential to make a substantial impact for patients diagnosed with
these challenging T-cell cancers, who lack innovative, new
treatment options for their disease. We’re pleased that this
clearance allows us to bring this novel medicine into human
clinical trials, and we look forward to providing updates on next
steps for the program in 2023.”
About Beam TherapeuticsBeam Therapeutics
(Nasdaq: BEAM) is a biotechnology company committed to establishing
the leading, fully integrated platform for precision genetic
medicines. To achieve this vision, Beam has assembled a platform
that includes a suite of gene editing and delivery technologies and
is in the process of building internal manufacturing capabilities.
Beam’s suite of gene editing technologies is anchored by base
editing, a proprietary technology that is designed to enable
precise, predictable and efficient single base changes, at targeted
genomic sequences, without making double-stranded breaks in the
DNA. This has the potential to enable a wide range of potential
therapeutic editing strategies that Beam is using to advance a
diversified portfolio of base editing programs. Beam is a
values-driven organization committed to its people, cutting-edge
science, and a vision of providing life-long cures to patients
suffering from serious diseases.
Cautionary Note Regarding Forward-Looking
StatementsThis press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Investors are cautioned not to place undue
reliance on these forward-looking statements, including, but not
limited to, statements related to: the commencement of clinical
trials for BEAM-201; the therapeutic applications and potential of
our technology, including with respect to relapsed/refractory
T-ALL/T-LL; and our ability to develop life-long, curative,
precision genetic medicines for patients through base editing. Each
forward-looking statement is subject to important risks and
uncertainties that could cause actual results to differ materially
from those expressed or implied in such statement, including,
without limitation, risks and uncertainties related to: our ability
to develop, obtain regulatory approval for, and commercialize our
product candidates, which may take longer or cost more than
planned; our ability to raise additional funding, which may not be
available; our ability to obtain, maintain and enforce patent and
other intellectual property protection for our product candidates;
the potential impact of the COVID-19 pandemic, including its impact
on the global supply chain; the uncertainty that our product
candidates will receive regulatory approval necessary to initiate
human clinical studies; that preclinical testing of our product
candidates and preliminary or interim data from preclinical studies
and clinical trials may not be predictive of the results or success
of ongoing or later clinical trials; that enrollment and initiation
of our clinical trials may take longer than expected; that our
product candidates may experience manufacturing or supply
interruptions or failures; risks related to competitive products;
and the other risks and uncertainties identified under the headings
“Risk Factors Summary” and “Risk Factors” in our Annual Report on
Form 10-K for the year ended December 31, 2021, in our Quarterly
Report on Form 10-Q for the quarter ended September 30, 2022, and
in any subsequent filings with the Securities and Exchange
Commission. These forward-looking statements speak only as of the
date of this press release. Factors or events that could cause our
actual results to differ may emerge from time to time, and it is
not possible for us to predict all of them. We undertake no
obligation to update any forward-looking statement, whether as a
result of new information, future developments or otherwise, except
as may be required by applicable law.
This press release contains hyperlinks to information that is
not deemed to be incorporated by reference in this press
release.
Contacts:
Investors:Chelcie ListerTHRUST Strategic
Communicationschelcie@thrustsc.com
Media:Dan Budwick1ABdan@1abmedia.com
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