MENLO PARK, Calif. and
BOSTON, Mass., March 10, 2021 /PRNewswire/ -- Adicet Bio,
Inc. (Nasdaq: ACET), a biotechnology company discovering and
developing allogeneic gamma delta T cell therapies for cancer and
other diseases, today announced that it has initiated its
First-in-Human Phase I clinical trial evaluating ADI-001 for the
treatment of B cell non-Hodgkin's lymphoma (NHL). ADI-001 is an
investigational first-in-class allogeneic gamma delta T cell
therapy expressing a chimeric antigen receptor (CAR) targeting
CD20, engineered to potentially enhance selective tumor targeting,
facilitate innate and adaptive anti-tumor immune response, and
improve persistence for durable activity in patients.
"Initiating the Phase 1 trial represents an important milestone
in the development of our lead product candidate, ADI-001, for
patients with NHL, and for Adicet's emerging pipeline of
"off-the-shelf" gamma delta T cell product candidates. Based on
ADI-001's encouraging preclinical data, we believe our novel CAR
gamma delta T cell therapy has the potential to provide an
attractive treatment option for NHL patients," said Francesco Galimi, M.D., Ph.D., Senior Vice
President and Chief Medical Officer of Adicet. "We are excited to
bring ADI-001 into clinical development and look forward to
advancing our product pipeline to address additional solid and
hematologic tumors."
Adicet's Phase I trial 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 trial are to evaluate the
safety, tolerability, pharmacokinetics and pharmacodynamics of
ADI-001, and to determine optimal dosing as a monotherapy. A
combination of ADI-001 and interleukin 2 may also be evaluated in
this trial. The trial is expected to enroll approximately 75
patients, with preliminary safety and tolerability data expected by
the end of 2021, subject to the impact of COVID-19. For more
information about the clinical trial design, please visit:
www.clinicaltrials.gov (NCT04735471).
About non-Hodgkin's lymphoma
NHL is the most common cancer of the lymphatic system, and
develops in white blood cells called lymphocytes. Approximately 90%
of NHL patients in western countries are diagnosed with B cell
lymphomas of various types. Diffuse Large B cell lymphoma, or
DLBCL, is the most common type of NHL, accounting for 30% of NHL
diagnoses. Most types of NHL are incurable with available
therapies, and more than 70,000 new cases of NHL are diagnosed each
year in the United States.
About ADI-001
ADI-001 is an investigational allogeneic gamma delta T cell
therapy being developed as a treatment for B-cell non-Hodgkin's
lymphoma (NHL). ADI-001 targets malignant B-cells via an anti-CD20
CAR and via the gamma delta 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
About Adicet Bio, Inc.
Adicet Bio, Inc. is a biotechnology company discovering and
developing allogeneic gamma delta T cell therapies for cancer and
other diseases. Adicet is advancing a pipeline of "off-the-shelf"
gamma delta T cells, engineered with chimeric antigen receptors and
T cell receptor-like antibodies to enhance selective tumor
targeting, facilitate innate and adaptive anti-tumor immune
response, and improve persistence for durable activity in patients.
For more information, please visit our website at
http://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
including, but not limited to the initiation of Adicet's Phase 1
trial of ADI-001 for the treatment of B cell non-Hodgkin's
lymphoma, including future plans or expectations as well as the
expected potential therapeutic effects, the timing and outcome of
discussions with FDA and other regulatory agencies, expectations
regarding the design, implementation, timing, and success of future
clinical studies of ADI-001, including whether they are pivotal or
would support registration, and expectations regarding its other
CAR gamma delta T cell therapy development activities.
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 COVID-19 on our
business and financial results, including with respect to
disruptions to our clinical trials, business operations, and
ability to raise additional capital; Adicet's ability to execute on
its strategy; that positive results from a clinical study may not
necessarily be predictive of the results of future or ongoing
clinical studies; future clinical studies may fail to demonstrate
adequate safety and efficacy of our product candidates, which would
prevent, delay, or limit the scope of regulatory approval and
commercialization; regulatory approval processes of the FDA and
comparable foreign regulatory authorities are lengthy,
time–consuming, and inherently unpredictable; regulatory
developments in the United States
and foreign countries; and the company's estimates regarding
expenses, future revenue, and capital requirements. 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.
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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SOURCE Adicet Bio, Inc.