Adicet Announces FDA Clearance of IND Application for First-in-Class Allogeneic CAR Gamma-Delta T Cell Therapy
October 22 2020 - 7:00AM
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 the U.S. Food
and Drug Administration (FDA) has cleared the Company’s
Investigational New Drug (IND) application for ADI-001, an
allogeneic gamma delta (γδ) T cell therapy expressing a chimeric
antigen receptor (CAR) targeting CD20 for treatment of
non-Hodgkin’s lymphoma (NHL). The active IND enables the Company to
initiate the first-in-human clinical trial to assess safety and
efficacy of ADI-001 in NHL patients.
“The clearance of the IND for ADI-001 by the FDA is a
significant milestone in the development of CAR γδ T cell therapies
by Adicet, and marks the beginning of clinical development of a
deep pipeline of “off-the-shelf” γδ T cell products,” said Chen
Schor, President and Chief Executive Officer of Adicet. “We are
particularly excited to advance on our goal to exploit the
therapeutic potential of our first in class engineered CAR γδ T
cell therapy in NHL patients. We believe that ADI-001 offers the
opportunity for on demand treatment, selective tumor targeting,
innate and adaptive anti-tumor immune response, and durable
activity in patients. We look forward to advancing our product
pipeline to address additional solid and hematologic tumors.”
The Phase 1 study for ADI-001 will enroll up to 80 late-stage
non-Hodgkin’s lymphoma patients at a number of cancer centers
across the U.S. The study includes a dose finding portion followed
by dose expansion cohorts to explore the activity of ADI-001 in
multiple subtypes of NHL. Site initiation activities are underway
and interim clinical data from this study are expected in 2021.
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 highly potent antitumor activity in preclinical
models, leading to effective long-term control of tumor growth.
About Adicet
Adicet 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 preclinical and clinical development
of Adicet’s product candidates, including future plans or
expectations for ADI-001 and potential therapeutic effects of
ADI-001, the timing and outcome of discussions with FDA and other
regulatory agencies, expectations regarding the design,
implementation, timing, and success of its future clinical studies
of ADI-001, including whether they are pivotal or would support
registration, and expectations regarding its other CAR γδ 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;
the company’s estimates regarding expenses, future revenue, and
capital requirements; as well as those risks and uncertainties set
forth in the company’s most recent annual report on Form 10-K and
subsequent filings with the Securities and Exchange
Commission. 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 ContactsAnne
Bowdidgeabowdidge@adicetbio.com
Janhavi MohiteStern Investor Relations,
Inc.212-362-1200janhavi.mohite@sternir.com
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