Activated clinical sites for Phase 1 trial of
ADI-001 in autoimmune diseases, including lupus nephritis (LN),
systemic lupus erythematosus (SLE), systemic sclerosis (SSc) and
anti-neutrophil cytoplasmic autoantibody (ANCA) associated
vasculitis (AAV)
Enrollment open for patients with LN;
enrollment in SLE, SSC, and AAV expected to open in the fourth
quarter of 2024
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
opening of enrollment for the Phase 1 clinical trial evaluating
ADI-001 in autoimmune diseases.
“The favorable safety profile, cellular kinetics and B cell
depletion in peripheral blood and secondary lymphoid tissue
demonstrated with ADI-001 clinical experience to date, positions
ADI-001 to potentially bring a paradigm shift in the treatment of
autoimmune diseases,” said Francesco Galimi, M.D., Ph.D., Senior
Vice President and Chief Medical Officer of Adicet Bio. “We expect
to have several additional sites open for enrollment by the end of
the fourth quarter of 2024, and further increase the number of
active sites during the first quarter of 2025. At this time, our
sites are open to enroll patients with LN, and we plan to initiate
enrollment of patients with SLE, SSc, and AAV in the fourth quarter
of this year. We look forward to reporting preliminary clinical
data from this trial of ADI-001 in LN as well as SLE, SSc, and AAV
in the first half of 2025.”
This announcement follows the U.S. Food and Drug
Administration’s (FDA) decision to grant Fast Track Designation to
ADI-001 for the treatment of relapsed/refractory class III or class
IV LN and clearance from the FDA to develop ADI-001 in four
autoimmune indications, including LN, SLE, SSc, and AAV.
The Phase 1 study has three separate arms, enrolling LN and SLE
patients into one arm, SSc patients into a second arm and AAV
patients into a third arm. Enrolled patients will receive a single
dose of ADI-001. The dose-limiting toxicity window is 28 days with
response and safety assessments conducted on Day 28 and during the
follow up period on months 3, 6, 9, 12, 18 and 24. The primary
objectives of the study are to evaluate the safety and tolerability
of ADI-001. Secondary objectives include measuring cellular
kinetics, pharmacodynamics, changes in autoantibody titers, and
appropriate disease activity scores in each indication.
About ADI-001
ADI-001 is an investigational allogeneic gamma delta CAR T cell
therapy targeting B-cells via an anti-CD20 CAR. ADI-001 was granted
Fast Track Designation by the FDA for the potential treatment of
relapsed/refractory class III or class IV lupus nephritis and
relapsed or refractory B-cell NHL.
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 and the potential safety,
tolerability and efficacy for the treatment of autoimmune diseases;
expectations for ADI-0001 to bring a paradigm shift in treatment of
autoimmune diseases; and the expected progress, timing and success
of the Phase 1 clinical study of ADI-001 in LN, SLE, SSc, and AAV,
including timing and expectations for site activation, enrollment,
future data releases and Adicet’s ability to demonstrate
proof-of-concept.
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-Q and subsequent filings 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240930628469/en/
Adicet Bio, Inc. Investor and Media Contacts
Investors: Anne Bowdidge abowdidge@adicetbio.com
Janhavi Mohite Precision AQ 212-362-1200
janhavi.mohite@precisionaq.com
Media: Kerry Beth Daly kbdaly@adicetbio.com
Adicet Bio (NASDAQ:ACET)
過去 株価チャート
から 1 2025 まで 2 2025
Adicet Bio (NASDAQ:ACET)
過去 株価チャート
から 2 2024 まで 2 2025
