Adicet Bio Receives FDA Fast Track Designation for ADI-001 in Lupus Nephritis
June 05 2024 - 6:00AM
Business Wire
Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology
company discovering and developing allogeneic gamma delta T cell
therapies for autoimmune diseases and cancer, today announced the
U.S. Food and Drug Administration (FDA) has granted Fast Track
Designation to ADI-001 for the potential treatment of
relapsed/refractory class III or class IV lupus nephritis.
“The FDA’s decision to grant ADI-001 Fast Track Designation for
lupus nephritis underscores the urgent need for new therapies for
this chronic disease,” said Chen Schor, President and Chief
Executive Officer of Adicet Bio. “We plan to initiate our Phase 1
clinical study in lupus nephritis later this month. With clinical
data for ADI-001 in non-Hodgkin’s lymphoma demonstrating CD19+
B-cell depletion that mirrors data by autologous alpha-beta CAR T
in academic clinical studies in several autoimmune diseases, we
believe we are well positioned to expand our autoimmune program to
address additional indications beyond lupus nephritis. We look
forward to providing a comprehensive update on our autoimmune
program to investors in the near term.”
Fast Track Designation is a process designed to facilitate the
development and expedite the review of drugs intended to treat
serious conditions and fill an unmet medical need.
About Adicet Bio, Inc.
Adicet Bio, Inc. is a clinical stage biotechnology company
discovering and developing allogeneic gamma delta T cell therapies
for autoimmune diseases and cancer. Adicet is advancing a pipeline
of “off-the-shelf” gamma delta T cells, engineered with chimeric
antigen receptors (CARs), to facilitate durable activity in
patients. For more information, please visit our website at
https://www.adicetbio.com.
Forward-Looking Statements
This press release contains “forward-looking statements” of
Adicet within the meaning of the Private Securities Litigation
Reform Act of 1995 relating to the business and operations of
Adicet. The words “anticipate,” “believe,” “continue,” “could,”
“estimate,” “expect,” “intend,” “may,” “plan,” “potential,”
“predict,” “project,” “should,” “target,” “would” and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. These forward-looking statements include, but
are not limited to, express or implied statements regarding:
clinical development of Adicet’s product candidates, including
future plans or expectations for ADI-001; the expected progress,
timing and success of the Phase 1 clinical study of ADI-001 in
lupus nephritis; and the Company’s expectations regarding ADI-001’s
potential to be effective in other indications
Any forward-looking statements in this press release are based
on management’s current expectations and beliefs of future events,
and are subject to a number of risks and uncertainties that could
cause actual results to differ materially and adversely from those
set forth in or implied by such forward-looking statements,
including without limitation, the effect of global economic
conditions and public health emergencies on Adicet’s business and
financial results, including with respect to disruptions to our
preclinical and clinical studies, business operations, employee
hiring and retention, and ability to raise additional capital;
Adicet’s ability to execute on its strategy including obtaining the
requisite regulatory approvals on the expected timeline, if at all;
that positive results, including interim results, from a
preclinical or clinical study may not necessarily be predictive of
the results of future or ongoing studies; clinical studies may fail
to demonstrate adequate safety and efficacy of Adicet’s product
candidates, which would prevent, delay, or limit the scope of
regulatory approval and commercialization; and regulatory approval
processes of the U.S. Food and Drug Administration and comparable
foreign regulatory authorities are lengthy, time-consuming, and
inherently unpredictable; and Adicet’s ability to meet production
and product release expectations. For a discussion of these and
other risks and uncertainties, and other important factors, any of
which could cause Adicet’s actual results to differ from those
contained in the forward-looking statements, see the section
entitled “Risk Factors” in Adicet’s most recent annual report on
Form 10-K and our periodic reports on Form 10-Q and Form 8-K filed
with the U.S. Securities and Exchange Commission (SEC), as well as
discussions of potential risks, uncertainties, and other important
factors in Adicet’s other filings with the SEC. All information in
this press release is as of the date of the release, and Adicet
undertakes no duty to update this information unless required by
law.
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Adicet Bio, Inc. Investor and Media Contacts
Anne Bowdidge abowdidge@adicetbio.com
Janhavi Mohite Precision AQ 212-362-1200
Adicet Bio (NASDAQ:ACET)
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