Adicet Bio Receives FDA Fast Track Designation for ADI-270 in Metastatic/Advanced Clear Cell Renal Cell Carcinoma
2024年7月8日 - 8:00PM
ビジネスワイヤ(英語)
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-270 for the potential treatment of patients with
metastatic/advanced clear cell renal cell carcinoma (ccRCC) who
have been treated with an immune checkpoint inhibitor and a
vascular endothelial growth factor inhibitor.
“We are pleased that ADI-270, our first ever gamma delta 1 CAR T
cell therapy candidate to enter clinical trials for solid tumors,
has been granted Fast Track Designation by the FDA,” said Chen
Schor, President and Chief Executive Officer of Adicet Bio. “ccRCC
is the most common type of kidney cancer, and this significant
milestone underscores our commitment to advancing innovative
treatments to these patients as quickly as possible.”
Fast Track Designation is a process designed to facilitate
development and expedite the review of drugs intended to treat
serious conditions and fill an unmet medical need.
About ADI-270
ADI-270 is an armored allogeneic “off-the-shelf” gamma delta CAR
T cell therapy candidate targeting CD70-positive cancers. CD70 is a
compelling target due to its high expression in both solid and
hematological malignancies. ADI-270 is engineered with a
third-generation CAR designed to target CD70 using its natural
receptor, CD27, as the binding moiety and is further armored with a
dominant negative form of the transforming growth factor-β receptor
II (dnTGFβRII) to provide functional resilience to the
immunosuppressive tumor microenvironment. ADI-270 is also designed
to increase exposure and persistence by reducing susceptibility to
host vs. graft elimination. These properties of ADI-270 combined
with the potent tumor infiltration demonstrated with gamma delta 1
T cells aim to improve clinical responses of RCC patients and other
patients with CD70+ tumors.
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-270; the potential safety,
durability, tolerability and activity of ADI-270; and the potential
of ADI-270 to become a treatment for patients with
metastatic/advanced ccRCC.
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 geopolitical
conflicts and economic conditions on Adicet’s business and
financial results, including with respect to disruptions to
Adicet’s 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 FDA 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 periodic and
current 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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