2seventy bio Announces Clinical Study Pause of PLAT-08 Trial of SC-DARIC33 in Acute Myeloid Leukemia
14 Junio 2023 - 6:00AM
Business Wire
2seventy bio, Inc. (Nasdaq: TSVT), a leading immuno-oncology
cell therapy company, today announced that the Phase 1 trial of the
PLAT-08 study of SC-DARIC33 in Acute Myeloid Leukemia (AML) has
been paused by Seattle Children’s, the Company’s partner and the
regulatory sponsor of the study. The pause was instituted as part
of the clinical study protocol stopping rules in response to a
recent Grade 5 (fatal) serious adverse event (SAE) and was followed
by the required notification to the U.S. Food & Drug
Administration (FDA). The root cause of this SAE and its potential
relationship to the study drug is currently under
investigation.
PLAT-08 is the Phase 1 study of SC-DARIC33 in
relapsed/refractory pediatric AML, conducted by Seattle Children’s,
and couples 2seventy bio’s DARIC T cell platform with Seattle
Children’s expertise in oncology cell therapies. This study is a
first-in-human investigation of the DARIC T cell platform. The SAE
occurred in the first patient treated at the second dose level in
the Phase 1 trial.
“Importantly, I’d like to offer that our thoughts are with the
family during this time. The safety of every patient who
participates in our studies or is treated with our therapies is the
utmost priority for us, and we are in communication with FDA while
we assess the data surrounding this SAE, and the potential next
steps for the study,” said Steve Bernstein, M.D., chief medical
officer, 2seventy bio.
About 2seventy bio Our name,
2seventy bio, reflects why we do what we do - TIME. Cancer rips
time away, and our goal is to work at the maximum speed of
translating human thought into action – 270 miles per hour – to
give the people we serve more time. We are building the leading
immuno-oncology cell therapy company, focused on discovering and
developing new therapies that truly disrupt the cancer treatment
landscape.
With a deep understanding of the human body’s immune response to
tumor cells and how to translate cell therapies into practice,
we’re applying this knowledge to deliver next generation cellular
therapies that focus on a broad range of hematologic malignancies,
including the first FDA-approved CAR T cell therapy for multiple
myeloma, as well as solid tumors. Our research and development is
focused on delivering therapies that are designed with the goal to
“think” smarter and faster than the disease. Importantly, we remain
focused on accomplishing these goals by staying genuine and
authentic to our “why” and keeping our people and culture top of
mind every day.
For more information, visit www.2seventybio.com.
Follow 2seventy bio on social media: Twitter and LinkedIn.
2seventy bio is a trademark of 2seventy bio, Inc.
Cautionary Note Regarding Forward-Looking Statements This
release contains “forward-looking statements” within the meaning of
the Private Securities Litigation Reform Act of 1995. These
statements include, but are not limited to: statements about the
Grade 5 SAE in the PLAT-08 study, the root cause of this toxicity
and its relationship to the study drug, and the implication of this
SAE on our other clinical programs. Any forward-looking statements
in this press release are based on management's current
expectations and beliefs and are subject to a number of risks,
uncertainties and important factors that may cause actual events or
results to differ materially from those expressed or implied by any
forward-looking statements contained in this press release. For a
discussion of other risks and uncertainties, and other important
factors, any of which could cause our actual results to differ from
those contained in the forward-looking statements, see the section
entitled “Risk Factors” in our annual report on Form 10-K for the
year ended December 31, 2022, as supplemented and/or modified by
our most recent Quarterly Report on Form 10-Q and any other filings
that we have made or will make with the Securities and Exchange
Commission in the future. All information in this press release is
as of the date of the release, and 2seventy bio undertakes no duty
to update this information unless required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20230614964229/en/
Investors: Jenn Snyder, 617-448-0281
Jenn.snyder@2seventybio.com
Media: Minyan Weiss, 516-458-0842
Minyan.weiss@gcihealth.com
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