Adicet Bio Receives FDA Fast Track Designation for Lead Candidate ADI-001
19 Aprile 2022 - 1:00PM
Business Wire
Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology
company discovering and developing first-in-class allogeneic gamma
delta chimeric antigen receptor (CAR) T cell therapies for cancer,
today announced the U.S. Food and Drug Administration (FDA) has
granted Fast Track Designation to its lead program ADI-001, an
investigational therapy targeting CD20 for the potential treatment
of relapsed or refractory B-cell Non-Hodgkin’s lymphoma (NHL).
ADI-001 is currently being evaluated in an ongoing dose
escalation Phase 1 study evaluating the safety and tolerability of
ADI-001 for the potential treatment of NHL. The Fast Track
Designation was granted based on ADI-001’s potential to address an
unmet need within the adult NHL patient population.
“Fast Track Designation represents an important milestone in the
clinical development of ADI-001,” said Chen Schor, President and
Chief Executive Officer of Adicet Bio. “We believe ADI-001 is
unique in that it is designed to target malignant B cells by
leveraging the innate and adaptive receptors found naturally on
gamma delta T cells with the added benefit of an engineered anti
CD20 CAR. We remain optimistic about the potential of our program
and look forward to reporting additional data from the Phase 1
trial of ADI-001 in the first half of 2022.”
Fast Track Designation is a process designed to facilitate the
development and expedite the review of drugs intended to treat
serious conditions and fill an unmet medical need.
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 CAR and T cell receptor-like
targeting moieties 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.
These forward-looking statements include, but are not limited to,
express or implied statements regarding Adicet’s beliefs and
expectations regarding: the expected potential therapeutic effects,
safety and tolerability profile, design, implementation, timing,
and success of ADI-001; and the significance and expected benefits
of FDA’s Fast Track Designation for ADI-001.
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 Adicet’s
business and financial results, including with respect to
disruptions to Adicet’s 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 Adicet’s 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 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220419005427/en/
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
Grafico Azioni Adicet Bio (NASDAQ:ACET)
Storico
Da Giu 2024 a Lug 2024
Grafico Azioni Adicet Bio (NASDAQ:ACET)
Storico
Da Lug 2023 a Lug 2024