As of the July 15, 2022 ASH abstract data-cut
date, ADI-001 demonstrated a 78% overall and complete response rate
and sustained durability in patients, including those previously
exposed to CAR T therapy
100% ORR and CR rate in four anti-CD19 CAR T
relapsed patients
ADI-001 continued to demonstrate a favorable
safety and tolerability profile
Clinical data will be presented during poster
presentation at ASH Annual Meeting on Saturday, December 10, 2022,
from 5:30 – 7:30 p.m. CT
Adicet to host ADI-001 webcast to discuss more
recent data-cut date from Phase 1 study on Sunday, December 11,
2022, at 8:00 a.m. CT / 9:00 a.m. ET
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 detailing
updated safety and efficacy data from the Company’s Phase 1 study
of ADI-001 for the potential treatment of relapsed or refractory
B-cell Non-Hodgkin’s lymphoma (NHL) was made available as part of
the 64th American Society of Hematology (ASH) Annual Meeting, which
is being held December 10-13, 2022 in New Orleans, Louisiana. The
abstract outlines a summary of clinical data as of a July 15, 2022
data-cut date. Clinical data will be provided during a poster
presentation by Sattva Neelapu, M.D., from the MD Anderson Cancer
Center at the ASH Annual Meeting on Saturday, December 10,
2022.
“The latest data-cut from our ongoing study of ADI-001 is
extremely encouraging, as we continue to see complete responses and
preliminary durability coupled with a benign safety profile in
heavily pre-treated patients with aggressive NHL. We look forward
to providing additional clinical data from a later data-cut date
during the ASH Annual Meeting,” said Francesco Galimi, M.D., Ph.D.,
Chief Medical Officer of Adicet Bio. “With the data generated to
date coupled with the pace of enrollment in dose level 4, we remain
on track to initiate a potentially pivotal program for ADI-001 in
the first half of 2023.”
Data highlights as of the July 15, 2022 data-cut date included
in the ASH abstract were as follows:
- Of the nine evaluable patients, three patients were treated at
each of the three dose levels: dose level 1 (DL1; 30 million CAR+
cells), dose level 2 (DL2; 100 million CAR+ cells), and dose level
3 (DL3; 300 million CAR+ cells). Two patients at DL3 were re-dosed
with a second course of ADI-001, per protocol. Six of nine were
male (67%) and the median age was 62 years (range 45-75). There
were eight patients with large B-cell lymphoma (LBCL) and one with
mantle cell lymphoma. Of the eight patients with LBCL, five had
diffuse-large B-cell lymphoma (DLBCL), two had high-grade B-cell
lymphoma (HGBCL) with double/triple hit, and one had HGBCL not
otherwise specified. Indolent lymphomas, such as follicular
lymphoma, are currently excluded from the study.
- Overall, the patients were heavily pretreated with a median
number of prior therapies of four (range 2-5), and had a poor
prognostic outlook as indicated by the median International
Prognostic Index (IPI) score of four (range 2-4); the median tumor
burden was 2,974 (150-7,919) mm2, and 89% (8/9) had stage III/IV
disease.
- The best overall response rate (ORR) and complete response rate
(CR) was 78% (7/9). For the four patients who had prior autologous
CD19 CAR T therapies, the ORR and CR rate was 100% (4/4). As of the
data-cut date, of the seven patients who had achieved CR, two
patients progressed, one died of unrelated causes while in complete
remission and four were still in CR and in active follow up, with a
range of follow-up time between 1.2 and 8.8 months.
- CAR+ gamma delta T cell kinetics in the peripheral blood
increased in a dose-dependent manner with peak cell expansion
occurring between Days seven and 10 at DL3 based on flow
cytometry.
- Of the nine patients, there were no ≥ Grade 3 Cytokine Release
Syndrome (CRS) or Immune Effector Cell-Associated Neurotoxicity
Syndrome (ICANS) events. Two patients developed CRS: one Grade 1
and one Grade 2. At the time of the ASH abstract submission, there
were three reported related serious adverse events: Grade 2 CRS,
Grade 1 ICANS and Grade 3 adenoviraemia. There was no reported
graft versus host disease or protocol-defined dose-limiting
toxicity events.
- Response data were evaluated per Lugano 2014 criteria by
independent radiographic review.
The full abstract is available online on the ASH website.
Clinical data will be presented during a poster presentation by
Sattva Neelapu, M.D. at the ASH Annual Meeting on Saturday,
December 10, 2022 from 5:30 - 7:30 p.m. CT. Adicet will provide
data from a more recent data-cut date from the Phase 1 study in a
press release and company webcast on Sunday, December 11, 2022 at
8:00 a.m. CT/ 9:00 a.m. ET.
Details of the poster presentation are as follows:
Session Title: 704. Cellular Immunotherapies: Early Phase
and Investigational Therapies: Poster I Title: A Phase 1
Study of ADI-001: Anti-CD20 CAR-Engineered Allogeneic Gamma Delta1
(γδ) T Cells in Adults with B-Cell Malignancies Presenting
Author: Sattva Neelapu, M.D., MD Anderson Cancer Center
Date/Time: Saturday, December 10, 2022 from 5:30 - 7:30 p.m.
CT.
Adicet ADI-001 Webcast Information
The Company will host a webcast event on Sunday, December 11,
2022, at 8:00 a.m. CT/ 9:00 a.m. ET to discuss recent data from its
ongoing Phase 1 clinical study of ADI-001 in relapsed or refractory
aggressive B-cell NHL.
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.
In April 2022, 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
This 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. The
study is expected to enroll approximately 75 patients. 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)
and adaptors (CAds), 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.
Available Information
Adicet announces material information to the public about the
Company, its product candidates and clinical trials, and other
matters through a variety of means, including filings with the U.S.
Securities and Exchange Commission (SEC), press releases, public
conference calls, webcasts, the investor relations section of the
Company website at investor.adicetbio.com and the Company’s Twitter
account (@AdicetBio), in order to achieve broad, non-exclusionary
distribution of information to the public and for complying with
its disclosure obligations under Regulation FD.
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 the potential safety,
durability, tolerability and therapeutic effects of ADI-001; plans
and timing for the release of additional clinical data from
Adicet’s Phase 1 trial of ADI-001 in NHL patients; future progress
of the Phase 1 trial, including ongoing patient enrollment in the
dose level 4 cohort; and expectations around the initiation of a
potentially pivotal program in the first half of 2023.
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, including obtaining the requisite regulatory
approvals on the expected timeline, if at all; that positive
results including interim results from a clinical study may not
necessarily be predictive of the results of future or ongoing
clinical 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. 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 for the year ended December 31, 2021 and
subsequent filings with the Securities and Exchange Commission. 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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version on businesswire.com: https://www.businesswire.com/news/home/20221103005397/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
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