Enrollment underway for lupus nephritis (LN)
patients
Preliminary clinical data in LN anticipated in
1H25
Initiation of patient enrollment in systemic
lupus erythematosus (SLE), systemic sclerosis (SSc), idiopathic
inflammatory myopathy (IIM) and stiff person syndrome (SPS)
expected in 1Q25; patient enrollment in anti-neutrophil cytoplasmic
autoantibody (ANCA) associated vasculitis (AAV) expected in
2H25
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 first LN patient has been dosed in the Phase 1 clinical trial
evaluating ADI-001 in autoimmune diseases.
“Dosing the first lupus nephritis patient in our Phase 1 trial
of ADI-001 marks an important step forward in our mission of
improving the lives of patients affected by autoimmune diseases,
particularly lupus nephritis,” said Francesco Galimi, M.D., Ph.D.,
Senior Vice President and Chief Medical Officer of Adicet Bio.
“With clinical biomarker data from our study in non-Hodgkin’s
lymphoma demonstrating robust tissue trafficking and complete CD19+
B cell depletion in peripheral blood and secondary lymphoid tissue,
ADI-001 has the potential to be a transformative off-the-shelf
treatment option for several autoimmune diseases. Additionally, the
FDA’s Fast Track Designation to ADI-001 in relapsed/refractory
class III or class IV LN and the clearance of our investigational
IND amendment application of ADI-001 for the treatment of SPS and
IIM further serves to emphasize the broad and urgent unmet need for
approved therapies to address autoimmune diseases.”
Dr. Galimi continued, “With clinical sites open for enrollment
and additional sites that are expected to open in the near future,
we anticipate sharing preliminary clinical data from the trial in
the first half of 2025. In addition, we look forward to initiating
enrollment for SLE, SSc, IIM, and SPS patients in the first quarter
of 2025 and for AAV patients in the second half of 2025."
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.
About the Phase 1 Trial
The Phase 1 study has four separate arms, enrolling LN and SLE
patients into one arm, SSc patients into a second arm, IIM and SPS
patients in a third arm and AAV patients into a fourth 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.
For more information about becoming a study site, please email
clinicaltrials@adicetbio.com or visit
https://www.adicetbio.com/hcp/autoimmune/.
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;
ADI-001’s potential to be a transformational off-the-shelf
treatment option for several autoimmune diseases; timing and
success of the Phase 1 clinical study of ADI-001 in LN, SLE, SSc,
AAV, IIM and SPS, including timing and expectations for site
activation, enrollment, future data releases and Adicet’s ability
to demonstrate proof-of-concept; and the potential benefits of fast
track designation for ADI-001 for the treatment of LN.
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20241118011893/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
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