-Data demonstrate characteristics essential for
treatment of autoimmune diseases, including robust tissue homing
and complete CD19+ B cell depletion in secondary lymphoid
tissue
-Results highlight the potential benefits
unique to gamma delta 1 CAR T cell therapy and ADI-001's potential
as a best-in-class off-the-shelf cell therapy for autoimmune
diseases
-The company is pursuing ADI-001 in a basket
study across six indications including lupus nephritis (LN),
systemic lupus erythematosus (SLE), systemic sclerosis (SSc),
idiopathic inflammatory myopathy (IIM), stiff person syndrome (SPS)
and anti-neutrophil cytoplasmic autoantibody (ANCA)-associated
vasculitis (AAV)
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
clinical biomarker data from the ADI-001 Phase 1 GLEAN trial which
demonstrates robust tissue homing, significant CAR T cell
activation, and complete CD19+ B cell depletion in secondary
lymphoid tissue will be featured in an oral session at ACR
Convergence 2024 in Washington, D.C., November 14-19.
“We believe the key to advancing care for autoimmune patients is
to develop a therapeutic candidate that demonstrates robust tissue
homing, complete CD19+ B cell depletion in tissue, and superior
drug exposure in secondary lymphoid tissue with a positive safety
profile. We are proud to share data and analyses, including
clinical biomarker data, at ACR that support the potential of
ADI-001 in autoimmune diseases,” said Francesco Galimi, M.D.,
Ph.D., Chief Medical Officer. “After activating clinical trial
sites for LN and receiving investigational new drug application
(IND) clearances to pursue additional autoimmune indications, we
are committed to advancing ADI-001 in a basket study across six
autoimmune indications. This strategy highlights our focus on
addressing the significant unmet medical needs of patients who
urgently require innovative and effective new treatment
options.”
A summary of the results is reported below:
- ADI-001 demonstrated significant levels of CAR T cell
activation and tissue exposure in lymph node biopsies in the GLEAN
trial, representing a range of 27-64% of total cellular material
detected by ddPCR in evaluable biopsies at the 1E9 dose, and
exceeding levels previously reported for patients who received
autologous alpha-beta CAR T therapies. CAR T cells detected in
tissues also demonstrated a robust activation profile, based on in
situ levels of granzyme B.
- Recently published studies have demonstrated depletion of CD19+
plasmablasts, memory B cells and naïve B cells in peripheral blood
using anti-CD20 targeted antibodies, however, these CD20-targeted
antibody modalities failed to fully deplete B cells within
secondary lymphoid tissue.
- Concurrent with ADI-001 tissue trafficking and activation,
complete depletion of CD19+ B cells within analyzed lymph node
tissue was also observed. These results support ADI-001’s potential
for achieving complete B-cell depletion in peripheral blood and
within tissues.
Details of the oral presentation
Title: ADI-001: An Allogeneic CD20-targeted γδ CAR T Cell
Therapy with Potential for Improved Tissue Homing in Autoimmune
Indications Session Name: Abstracts: Miscellaneous Rheumatic
& Inflammatory Diseases II Abstract Number: 1866169
Presenting Author: Monica Moreno, Ph.D. Date and
Time: November 19, 2024; 12:00 p.m. – 12:15 p.m. ET
About ADI-001 in Autoimmune Diseases
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 (LN).
Adicet is exploring the potential of ADI-001 in a basket study
across six indications including lupus nephritis (LN), systemic
lupus erythematosus (SLE), systemic sclerosis (SSc), idiopathic
inflammatory myopathy (IIM), stiff person syndrome (SPS) and
anti-neutrophil cytoplasmic autoantibody (ANCA)-associated
vasculitis (AAV).
For more information about becoming a study site, please email
clinicaltrials@adicetbio.com or visit
https://www.adicetbio.com/hcp/autoimmune/.
About the Phase 1 Clinical 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.
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: the
potential safety, tolerability and efficacy of ADI- 001 in multiple
autoimmune indications; the potential for ADI-001 to be
best-in-class allogenic cell therapy for autoimmune diseases; and
the clinical development of ADI-001 in LN, SLE, SSc, IIM, SPS and
AAV.
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/20241116291819/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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