As of the February 14, 2022 ASCO abstract
data-cut date, ADI-001 demonstrated a 67% complete response rate
with positive preliminary durability data and a favorable safety
and tolerability profile
Updated data from a May 31, 2022 data-cut date
will be presented during oral presentation at ASCO Annual Meeting
on June 6, 2022, at 6:00am PT / 9:00am ET
Company to host webcast on June 6, 2022, at
1:30pm PT / 4:30pm ET
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 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 2022 American
Society of Clinical Oncology (ASCO) Annual Meeting, to be held June
3-7, 2022. The abstract provides a summary of clinical data as of a
February 14, 2022, data-cut date.
“We are very pleased to see the continued positive data
resulting from our ongoing Phase 1 clinical trial evaluating
ADI-001 in relapsed/refractory NHL. We believe that our allogeneic
gamma delta CAR T cell therapy approach may improve complete
response rate and durability by the complementary innate, adaptive
and CAR-mediated anti-tumor response,” said Chen Schor, President
and Chief Executive Officer of Adicet. “We look forward to
presenting updated data on safety, efficacy, pharmacokinetics and
longer follow up, including available data from patients enrolled
in dose level 3, at the upcoming 2022 ASCO Annual Meeting with a
coinciding press release as well as a company webcast later that
afternoon.”
Data highlights as of the February 14, 2022 data-cut date
included in the ASCO abstract were as follows:
- Six evaluable patients were enrolled in dose level 1 (DL1; 30
million CAR+ cells) and dose level 2 (DL2; 100 million CAR+ cells),
33% (2/6) were female and the median age was 62 years (range
45-75). There were five patients with large B-cell lymphoma and one
with mantle cell lymphoma. Indolent lymphomas, such as follicular
lymphoma, are currently not enrolled in the study.
- Overall, the patients were heavily pretreated with a median
number of prior therapies of 3.5 (range 2-5) and had a poor
prognostic outlook as indicated by the median International
Prognostic Index (IPI) score of 3.5 (range 2-4). One patient
previously progressed following two prior treatments with
autologous anti-CD19 CAR T cell therapy (lisocabtagene maraleucel)
prior to receiving ADI-001.
- At Day 28, the overall response rate (ORR) and the complete
response (CR) rate based upon independent central reading by PET/CT
were 67% (4/6 patients).
- As of the February 14, 2022 data-cut date, of the four patients
who achieved CR after treatment with ADI-001:
- Two patients remained in CR with ≥ three months post-treatment
follow-up, including a triple-hit large B-cell lymphoma patient who
had previously progressed following two administrations of
autologous anti-CD19 CAR-T and a total of five lines of prior
therapy.
- As previously disclosed, one patient, a 66-year-old female who
had responded to ADI-001, developed COVID-19 related pneumonia
approximately two and a half months after ADI-001 administration
and later died of complications from it, unrelated to ADI-001. This
patient was previously reported as a partial response (PR) by local
radiological assessment and has been assessed as a CR by
independent central reading.
- One patient with a CR had not reached the three-month
assessment date as of the data-cut date for the ASCO abstract
submission.
- Safety data from the trial at the February 14, 2022 data-cut
date were consistent with the previously reported well tolerated
profile, with no occurrence of Grade ≥ 3 Cytokine Release Syndrome
(CRS), Immune Effector Cell-Associated Neurotoxicity Syndrome
(ICANS) or Graft vs Host Disease. No dose-limiting toxicities were
documented.
- All response data have been determined per protocol by
independent central reading of PET/CT per Lugano (2014)
criteria.
The full abstract is available online on the ASCO website.
Updated data from a May 31, 2022 data-cut date will be presented
during an oral presentation by Sattva Neelapu, M.D. Professor in
the Department of Lymphoma/Myeloma at The University of Texas MD
Anderson Cancer Center, at the ASCO Annual Meeting on June 6, 2022.
Adicet will summarize the data from the May 31, 2022 data-cut date
in a press release and provide additional information in a company
webcast on June 6, 2022.
Details of the oral presentation are as follows:
Abstract Number: 7509 Abstract Title: A Phase 1
Study of ADI-001: Anti-CD20 CAR-engineered Allogeneic Gamma Delta
(γδ) T cells in Adults with B-cell malignancies Presenting
Author: Sattva Neelapu, M.D., The University of Texas MD
Anderson Cancer Center Session Type/Title: Clinical Science
Symposium/ Beating Bad Blood: The Power of Immunotherapy in
Hematologic Malignancies Date: Monday, June 6, 2022
Time: 8:00 AM-9:30 AM CDT
Adicet Investor Webcast/ Conference Call Information
The Company will host a conference call and webcast on June 6,
2022, at 4:30 p.m. ET to discuss the results. The live webcast of
the presentation can be accessed under “Presentations & Events”
in the investors section of the Company’s website at
www.adicetbio.com or by dialing (877) 800-3802 (domestic) or +1
(615) 622-8057 (international) and reference the conference ID
5466375. The archived webcast will be available on the Company's
website beginning approximately two hours after the event.
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 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 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 and the
expectations around the upcoming release of interim clinical data
from Adicet’s Phase 1 trial of ADI-001 in NHL patients at the ASCO
Annual Meeting.
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 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 titled "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 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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version on businesswire.com: https://www.businesswire.com/news/home/20220526005630/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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