ADI-270 is the first gamma delta 1 CAR T
candidate to enter clinical development for solid tumors
Phase 1 clinical study to evaluate safety and
anti-tumor activity of ADI-270 in relapsed/refractory RCC
patients
Phase 1 clinical study to be initiated in 2H
2024; preliminary clinical data expected in 1H 2025
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 that
the U.S. Food and Drug Administration (FDA) has cleared the
Company’s Investigational New Drug (IND) application to evaluate
ADI-270, an armored allogeneic “off-the-shelf” gamma delta chimeric
antigen receptor (CAR) T cell therapy candidate targeting CD70+
cancers, for the treatment of relapsed/refractory renal cell
carcinoma (RCC). The Company plans to initiate a Phase 1 clinical
trial to assess the safety and anti-tumor activity of ADI-270 in
RCC patients in the second half of 2024.
“ADI-270 is the first ever gamma delta 1 CAR T cell therapy
candidate to enter clinical trials for the treatment of solid
tumors,” said Chen Schor, President and Chief Executive Officer of
Adicet Bio. “The FDA’s clearance of our IND application to evaluate
ADI-270 in patients with RCC underscores a significant achievement
for Adicet. ADI-270 is a third-generation CAR T designed to target
CD70+ tumors with high specificity, increased exposure, persistence
and tumor infiltration, while addressing immunosuppressive factors
in the tumor microenvironment. RCC is the most common type of
kidney cancer and has a high unmet need with limited viable
treatment options available. With its highly differentiated
profile, we believe that ADI-270 has the potential to become an
important therapeutic option for patients with RCC and other CD70+
tumors.”
The Phase 1 multicenter, open-label clinical trial is designed
to investigate ADI-270 as monotherapy in adults with relapsed or
refractory clear cell RCC. Following lymphodepletion, patients will
be eligible to receive a single dose of ADI-270 with a starting
dose level of 3E8 CAR+ cells. Subject to meeting protocol defined
criteria, patients enrolled in the study may be eligible to receive
a second dose of ADI-270.
The dose escalation and dose expansion portions of the trial
will evaluate safety, tolerability, and pharmacokinetics as well as
anti-tumor activity as assessed by overall response rate, duration
of response and disease control rate.
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 design 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) designed 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 Renal Cell Carcinoma
Renal cell carcinoma (RCC) is the most common tumor of the
kidney, constituting 80% to 85% of primary renal neoplasms. Clear
cell RCCs (ccRCC) are the most common subtype, accounting for 80%
of all RCCs. ccRCC is an aggressive subtype arising from renal stem
cells commonly arising in the proximal nephron and tubular
epithelium, and often metastasizes to the lungs, liver, and bones.
Approximately 20% of newly diagnosed cases of RCC are locally
advanced or metastatic and up to 30% of patients will develop
metastatic disease following nephrectomy. While the 5-year survival
rate for localized RCC is 93%, the 5-year survival rate for
advanced disease is 15%.
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 the Company’s 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 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: preclinical and 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; the potential of ADI-270 to
become an important therapeutic option for RCC patients and other
patients with CD70+ tumors; and the expected progress, enrollment,
timing and success of the Phase 1 study of ADI-270 in relapsed or
refractory RCC patients, including expectations around Phase 1
trial initiation in the second half of 2024 and availability of
preliminary clinical data in the first half of 2025.
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, economic conditions and public health emergencies on
Adicet’s business and financial results, including with respect to
disruptions to the Company’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. 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 reports on Form 10-Q and Form 8-K
filed with the 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
janhavi.mohite@precisionaq.com
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