ADI-001 demonstrated 75% CR and ORR rate across
all dose levels with favorable safety and tolerability profile in
patients with relapsed/refractory high grade aggressive
Non-Hodgkin’s Lymphoma (NHL), as of May 31, 2022 data-cut date
80% ORR and CR rate at dose levels 2 and 3
combined
100% ORR and CR rate in three anti-CD19 CAR-T
relapsed patients
50% of evaluable patients with at least six
months follow-up remain cancer free
Dose-related increase of ADI-001 exposure
observed in blood
Company expects to identify recommended Phase 2
dose in second half of 2022 and initiate at least one potentially
pivotal study in first half of 2023
Company to host webcast today 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 emerging positive 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) in an
oral presentation at the 2022 American Society of Clinical Oncology
(ASCO) Annual Meeting on June 6, 2022. The presentation outlines a
summary of clinical data as of a May 31, 2022, data-cut date.
“Adicet is a pioneer in the field of gamma delta CAR T cell
therapies and it is gratifying to see the highly encouraging
clinical data for ADI-001 unfold as a potential best-in-class
therapy for NHL,” said Chen Schor, President and Chief Executive
Officer of Adicet Bio. “Notably, with a favorable safety and
tolerability profile, treatment to date with ADI-001 demonstrated
an impressive CR rate, including 100% in CAR-T relapsed patients,
and very encouraging durability of response. We look forward to
discussing the data in more detail and outlining next steps in our
webcast this afternoon.”
“It is impressive to see 50 percent of six-month evaluable
patients cancer free beyond seven months. One of these patients had
previously relapsed after two treatments with autologous anti-CD19
CAR T and now remains cancer free seven and a half months following
administration of ADI-001, suggesting the patient has had major
clinical benefit from ADI-001. This is particularly notable because
patients who relapse after autologous anti-CD19 CAR T have dismal
outcomes with a median survival of approximately six months,” said
Sattva Neelapu, M.D., Professor in the Department of
Lymphoma/Myeloma at The University of Texas MD Anderson Cancer
Center. “When we look at the totality of these early data, we have
an indicator that allogeneic gamma-delta CAR T cell therapy like
ADI-001 could be a significant advance.”
“NHL remains a disease that is very difficult to treat,
especially in high-risk patients with aggressive disease. Our study
is enrolling patients with aggressive B-cell lymphoma, including
patients with double-hit and triple-hit high-grade B cell lymphoma
and patients who had a prior relapse to autologous anti-CD19 CAR T
therapy,” said Francesco Galimi, M.D., Ph.D., Senior Vice President
and Chief Medical Officer of Adicet Bio. “We are encouraged by the
CRs observed to date in the Phase 1 study and are committed to
rapidly advancing ADI-001 into a potential pivotal program.”
Data highlights as of the May 31, 2022 data-cut date included in
the ASCO presentation are as follows:
- Of the eight evaluable patients, three received ADI-001 at dose
level 1 (30 million CAR+ cells), three received ADI-001 at dose
level 2 (100 million CAR+ cells) and two received ADI-001 at dose
level 3 (300 million CAR+ cells). There are currently no patients
with indolent lymphoma, such as follicular lymphoma, enrolled in
the study.
- Patients were heavily pretreated with a median number of prior
therapies of 4 (range 2-5) and had a poor prognostic outlook as
indicated by the median International Prognostic Index (IPI) score
of 4 (range 2-5).
- ADI-001 treatment demonstrated a 75% overall response rate
(ORR) and complete response (CR) in the study across all dose
levels. In dose levels 2 and 3 combined, ADI-001 demonstrated an
80% ORR and CR rate.
- In three patients that previously relapsed after prior
autologous anti-CD19 CAR T therapy, treatment with ADI-001
demonstrated 100% ORR and CR rate. These patients included a
triple-hit high grade B-cell lymphoma patient with prior exposure
to Liso-cel, as well as a DLBCL patient and a double-hit high grade
B-cell lymphoma patient who had previously achieved a PR to
Axi-cel.
- Early data indicate encouraging durable anti-tumor responses
with potential for dose related increase in durability. 50% (2 of
4) of evaluable patients with at least six months follow up remain
cancer free.
- Detection of circulating ADI-001 in the blood by flow cytometry
indicated in vivo expansion and dose-related increase of ADI-001
exposure in patients.
- ADI-001 was well tolerated in the study to date. There were no
occurrences of dose-limiting toxicities, graft vs host disease
(GvHD), or Grade 3 or higher Cytokine Release Syndrome (CRS) or
immune effector cell-associated neurotoxicity syndrome (ICANS)
reported. There were no infections associated with enhanced
lymphodepletion (eLD).
Table 1: Summary of ADI-001 interim data from three dosing
cohorts: *
Dose Level
Age/Sex
B-cell lymphoma
subtypes
# prior lines of
therapies
Time since ADI-001 initial
dosing (months)
Prior CAR T?
BOR by Lugano Criteria
2014
DL 1
30 million CAR+ cells
62/F
Transformed DLBCL
(from chronic lymphocytic
leukemia)
5 prior lines
>6
No
PD
66/F
Transformed high grade
B-cell lymphoma (from follicular
lymphoma)
4 prior lines
>6
No
CR
75/M
Triple-hit high grade B-cell
lymphoma
5 prior lines
>6
Yes
CR
DL 2
100 million CAR+ cells
62/M
Mantle cell lymphoma
5 prior lines
>6
No
CR
45/M
Diffuse large B-cell lymphoma
3 prior lines
3-6
No
PD
61/M
Diffuse large B-cell lymphoma
2 prior lines
3-6
No
CR
DL 3
300 million CAR+ cells
62/M
Double-hit high grade B-cell
lymphoma
4 prior lines
3-6
Yes
CR
64/F
Diffuse large B-cell lymphoma
4 prior lines
1-3
Yes
CR
*Efficacy-evaluable patients as of the May 31, 2022 data-cut
date. Data are subject to further review and verification. BOR=
best overall response. PD=progressive disease.
Table 2: ADI-001 Preliminary Efficacy Data: (Per protocol
analysis, independent radiographic assessment using Lugano
2014)
DL1 (3E7)
(N=3)
DL2 (1E8)
(N=3)
DL3 (3E8)
(N=2)
Total
(N=8)
Prior CD19 CAR-T
(N=3)
ORR / BOR
67% (2/3)
67% (2/3)
100% (2/2)
75% (6/8)
100% (3/3)
CR, % (N)
67% (2/3)
67% (2/3)
100% (2/2)
75% (6/8)
100% (3/3)
*Efficacy-evaluable patients as of the May 31, 2022, data-cut
date. Data are subject to further review and verification.
As of the May 31, 2022, data-cut date, of the six patients who
achieved CR:
Dose level 1:
As previously disclosed, one patient administered ADI-001 in
dose level 1, a 66-year-old female who had achieved a CR, 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 triple-hit high grade B-cell lymphoma in dose
level 1 who had relapsed following two prior treatments with
autologous anti-CD19 CAR T therapy, had a CR after treatment with
ADI-001. The patient developed a local skin relapse at four months,
and was administered local radiotherapy. The skin lesion resolved
with no systemic therapy provided to the patient. The patient
continues to be cancer free seven and a half months following
administration of ADI-001, as measured by a negative PET/CT
scan.
Dose level 2:
Both patients administered ADI-001 in dose level 2 have ongoing
CR. One patient has a CR beyond seven months and one patient has a
CR beyond four and a half months.
Dose level 3:
Both patients administered ADI-001 in dose level 3 have ongoing
CR with follow-up beyond three and one month, respectively.
In summary, 50% of evaluable patients with at least six months
follow up (2 of 4) remain cancer free.
Table 3: ADI-001 Preliminary Safety Data in Efficacy-Evaluable
Patients+
DL1 (3E7)
N=3
DL2 (1E8)
N=3
DL3 (3E8)
N=2
Total
N=8
Adverse Event Types
All
Grade
N (%)
Gr ≥3
N (%)
All
Grade
N (%)
Gr ≥3
N (%)
All
Grade
N (%)
Gr ≥3
N (%)
All
Grade
N (%)
Gr ≥3
N (%)
CRS
2 (67%)
0 (0%)
0 (0%)
0 (0%)
0 (0%)
0 (0%)
2 (25)
0 (0)
ICANS
0 (0%)
0 (0%)
1 (33%)
0 (0%)
0 (0%)
0 (0%)
1 (13)
0 (0)
GvHD
0 (0%)
0 (0%)
0 (0%)
0 (0%)
0 (0%)
0 (0%)
0 (0)
0 (0)
DLTs
0 (0%)
0 (0%)
0 (0%)
0 (0%)
0 (0%)
0 (0%)
0 (0)
0 (0)
Infection*
1(33%)
1(33%)
0 (0%)
0 (0%)
0 (0%)
0 (0%)
1 (13)
1 (13)
SAE - TEAE
1(33%)
1(33%)
1 (33%)
0 (0%)
0 (0%)
0 (0%)
2 (25)
1 (13)
+Safety assessment was performed using the Common Terminology
Criteria for Adverse Events (v5) and the American Society for
Transplantation and Cellular Therapy criteria. The two
ADI-001-related adverse events of special interest (AESI) were a
Grade 1 CRS at DL1 and a Grade 1 ICANS at DL2, which resolved
within 24 hours without medical intervention; No DLTs or GvHD; No
treatment discontinuations due to AEs; two patients administered
standard lymphodepletion (sLD) and six patients eLD; There were no
eLD-associated clinical infection.
*One patient in DL 1 who received sLD developed COVID-19
pneumonia later died of complications of it, unrelated to
ADI-001.
Given the safety profile to date, the protocol was amended to
include a new DL 4 (1E9 CAR+ cells) and a potential ADI-001
consolidation dosing at DL3 to finalize the recommended Phase 2
dose in the second half of 2022. The Company expects to provide at
least one additional clinical update for the ADI-001 Phase 1 study
in the second half of 2022. The Company will discuss with the U.S.
Food and Drug Administration (FDA) and the European Medicines
Agency (EMA) the design of two pivotal intent studies and a
potential path to support a Biologics License Application (BLA) and
Marketing Authorization Application (MAA) for ADI-001 and initiate
at least one potentially pivotal study in the first half of
2023.
Details of the ASCO Oral Presentation:
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
Webcast/ Conference Call information
The Company will host a conference call and webcast today, June
6, 2022, at 4:30pm 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 referencing 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 anti-tumor 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,
including the expected design, implementation, timing and success
of ADI-001, plans and timing for the release of additional clinical
data from Adicet’s Phase 1 trial of ADI-001 in relapsed/refractory
NHL patients. Future progress of the GLEAN study, including ongoing
patient enrollment; and timing of a dose selection for the Phase 2
trial in the second half of 2022 and 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 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220603005481/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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