Adicet Bio Highlights ADI-001 Expansion, Persistence and Pharmacodynamic Profile from Ongoing Phase 1 Study at the 65th American Society of Hematology (ASH) Annual Meeting
10 Diciembre 2023 - 11:00AM
Business Wire
ADI-001 showed robust dose-dependent expansion
and persistence in patients with relapsed/refractory aggressive
B-cell non-Hodgkin’s lymphoma (NHL)
Strong exposure and persistence profile further
supports Adicet’s allogeneic chimeric antigen receptor (CAR) T
platform potential as best-in-class
Pharmacodynamic (PD) and pharmacokinetic (PK)
analyses will be presented during poster presentation at ASH Annual
Meeting on Sunday, December 10, 2023, from 6:00 - 8.00 p.m. PST
Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology
company discovering and developing allogeneic gamma delta T cell
therapies for cancer, today announced that an abstract outlining PK
and PD profiling data from the Company’s ongoing Phase 1 study of
ADI-001 for the potential treatment of relapsed or refractory
aggressive B-cell NHL was made available as part of the 65th ASH
Annual Meeting, being held December 9-12, 2023 in San Diego,
California. The data will be provided during a poster presentation
at the ASH Annual Meeting on Sunday, December 10, 2023.
“We are pleased to share encouraging observations from the
pharmacokinetic and pharmacodynamic analyses of ADI-001 at ASH,
further characterizing its potential as a best-in-class allogeneic
CAR T platform. The data presented today showed dose-dependent
expansion and persistence that met or exceeded that in prescribing
information of approved autologous CD19 CAR T therapies, supporting
ADI-001’s potential as an effective therapeutic option for patients
with advanced cancers,” said Francesco Galimi, M.D., Ph.D., Chief
Medical Officer. “Historically, expansion and persistence of cell
therapy products and release of functional cytokines have
correlated with patient outcomes. We remain on track to provide a
clinical update from the Phase 1 study in NHL patients in the
second half of 2024."
Data highlights included in the ASH presentation were as
follows:
- Robust dose-dependent expansion and persistence of ADI-001 were
observed using three different methodologies for measuring
exposure.
- ADI-001 displayed a strong exposure profile and was positively
associated with both PD correlates and clinical response, as
supported by the following:
- At DL3 and DL4, ADI-001 Cmax and Tmax that met or exceeded that
in prescribing information of approved autologous CD19 CAR T
therapies.
- Increasing dose levels showed higher Cmax and AUC and were
associated with patient clinical responses.
- ADI-001 stimulation and proliferation were associated with peak
levels of CAR+ cells and higher production of polyfunctional
cytokines, particularly in patients whose best overall response was
complete response or partial response.
- Elevating levels of endogenous cytokines, comprising stem cell
factor and IL-15, may potentially contribute to increased ADI-001
expansion and clinical response.
- ADI-001 exposure or clinical response showed no correlation
with the degree of shared HLA alleles between patient and
ADI-001.
Details of the poster presentation are as follows:
- Title: Expansion, Persistence and Pharmacodynamic Profile of
ADI-001, a First-in-Class Allogeneic CD20-Targeted CAR Gamma Delta
T Cell Therapy, in Patients with Relapsed/Refractory Aggressive
B-Cell Non-Hodgkin’s Lymphoma
- Poster Number: 3478
- Session Name: 704. Cellular Immunotherapies: Early Phase and
Investigational Therapies: Poster II
- Presenting Author: Monica Moreno, Ph.D.
- Date/Time: Sunday, December 10, 2023, from 6:00 - 8:00 p.m.
PST
About ADI-001
ADI-001 is an investigational allogeneic gamma delta CAR T cell
therapy being developed as a potential treatment for relapsed or
refractory B-cell NHL. ADI-001 targets malignant B-cells via an
anti-CD20 CAR and via the gamma delta innate and T cell endogenous
cytotoxicity receptors. Gamma delta T cells engineered with an
anti-CD20 CAR have demonstrated potent antitumor activity in
preclinical models, leading to long-term control of tumor growth.
ADI-001 was granted Fast Track Designation by the U.S. Food and
Drug Administration (FDA) for the potential treatment of relapsed
or refractory B-cell NHL.
About the GLEAN Study
The Phase 1 study is an open-label, multi-center study of
ADI-001 enrolling adults diagnosed with B-cell malignancies who
have either relapsed, or are refractory to, at least two prior
regimens. The primary objectives of the study are to evaluate the
safety, tolerability, pharmacokinetics and pharmacodynamics of
ADI-001, and to determine optimal dosing as a monotherapy. For more
information about the clinical study design, please visit
www.clinicaltrials.gov (NCT04735471).
About Adicet Bio, Inc.
Adicet Bio, Inc. is a clinical stage biotechnology company
discovering and developing allogeneic gamma delta T cell therapies
for cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma
delta T cells, engineered with chimeric antigen receptors (CARs) to
enhance selective tumor targeting and facilitate innate and
adaptive anti-tumor immune response for 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 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-001, the potential safety, durability,
tolerability and efficacy of ADI-001; the potential of Adicet’s
allogenic CAR T cell platform to be best-in-class; and the expected
progress, timing and success of the Phase 1 study of ADI-001 in
relapsed/refractory B-cell NHL patients, including expectations
around a clinical update in the second half of 2024. 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 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 our 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 Stern Investor Relations, Inc. 212-362-1200
janhavi.mohite@sternir.com
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