ADI-001 demonstrated 71% overall response rate
(ORR) and 63% complete response (CR) rate across all dose levels in
patients with median 4 prior lines of therapy; 50% of patients
enrolled had previously progressed on anti-CD19 chimeric antigen
receptor T cell (CAR T) therapy
83% ORR and 67% CR rate observed in heavily
pre-treated patients who had progressed on prior CAR T
Six-month CR rate consistent with autologous
CAR T cell therapy
Favorable safety with no significant incidence
of CRS (cytokine release syndrome) or ICANS (immune effector cell
associated neurotoxicity syndrome)
Robust pharmacokinetic profile in dose level 4
(DL4) with Cmax and Day 28 persistence exceeding approved CD19
autologous CAR T therapy
Plan to transition ADI-001 program into
potentially pivotal Phase 2 study in post-CAR T large B-cell
lymphoma (LBCL) patients in first half of 2024
Clinical update from additional post-CAR T LBCL
patients expected in second half of 2024
Company to host investor webcast on Monday,
June 26 at 4:30pm ET
Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology
company discovering and developing allogeneic gamma delta T cell
therapies for cancer, today announced positive safety and efficacy
data from the Company’s ongoing Phase 1 study of ADI-001 for the
potential treatment of relapsed or refractory aggressive B-cell
non-Hodgkin's lymphoma (NHL).
“These data are exciting and beyond what one might expect to see
given that patients enrolled in the study were heavily
pre-treated,” said Francesco Galimi, M.D., Ph.D., Senior Vice
President and Chief Medical Officer of Adicet Bio. “Autologous CD19
CAR T therapies were studied on CAR T naïve patients with a median
of 3 prior lines of therapy. In contrast, the ADI-001 Phase 1 trial
enrolled patients with a median of 4 lines of prior therapy and,
importantly, 50% had previously progressed on autologous CAR T
therapy. Despite the advanced nature of the patients at baseline in
the ADI-001 Phase 1 study, at our recommended Phase 2 dose (DL4)
ADI-001 demonstrated an overall CR rate of 63%, a 6-month CR rate
of 25%, and in patients that had progressed following autologous
CD19 CAR T therapy, the CR rate of ADI-001 was 67% with a 6-month
CR rate of 33%.”
Added Galimi, “We plan to transition the ADI-001 program into a
potential pivotal Phase 2 study in post-CAR T LBCL in the first
half of 2024. In addition, we expect to provide a clinical update
which will include efficacy, 6-month CR rate, and safety data, from
additional post-CAR T LBCL patients in the second half of
2024.”
“The autologous CD19 CAR T market is estimated to have an annual
run rate in excess of $2.2 billion and is growing given recent
approvals in the second line setting. Unfortunately, approximately
60-70% of these patients progress, which represents a significant
unmet medical need,” said Chen Schor, President and Chief Executive
Officer of Adicet Bio. “In May we met with the FDA and discussed
the design of our first potentially pivotal Phase 2 study with an
accelerated approval pathway. We are very encouraged by these data
and look forward to advancing ADI-001 into the next stage of
clinical development and progressing our pipeline of novel gamma
delta T cell product candidates in both hematologic malignancies
and solid tumors.”
Data highlights as of the May 4, 2023 data-cut date were as
follows:
- Of the 24 efficacy-evaluable patients, 3 received ADI-001 at
dose level 1 (DL1) (30 million CAR+ cells), 3 received ADI-001 at
dose level 2 (DL2) (100 million CAR+ cells), 6 received ADI-001 at
dose level 3 (DL3) (300 million CAR+ cells), 4 received two
infusions of ADI-001 at DL3 (two doses of 300 million CAR+ cells,
one on day 1 and the second dose on day 7 following a single
lymphodepletion), and 8 received ADI-001 at dose level 4 (DL4) (1
billion CAR+ cells).
- Patients were heavily pretreated with a median of 4 prior lines
of therapy (range 2-9), had relatively high tumor burden, and had a
poor prognostic outlook based on their median International
Prognostic Index (IPI) score. 50% of patients enrolled in the study
had progressed on prior CAR T.
- ADI-001 treatment demonstrated a 71% ORR and 63% CR rate in the
study across all dose levels.
- ADI-001 demonstrated an 83% ORR and 67% CR rate in heavily
pre-treated patients (4 median prior lines of therapy) who had
progressed on prior CAR T.
- ADI-001 demonstrated a 6-month CR rate consistent with
autologous CAR T when factoring number of prior lines of therapy
and percent of patients enrolled in the study who progressed on
prior CAR T.
- Adicet selected the recommended Phase 2 dose (RP2D) as 1
billion CAR positive cells (DL4).
- At the RP2D (DL4) (with 4 median prior lines of therapy, 38%
post-CAR T) the 6-month CR rate was 25%. At this dose level, in
patients who had progressed on prior CAR T, the CR rate was 67% and
the 6-month CR rate was 33%.
- The expansion and persistence of ADI-001 at the RP2D exceed
values reported for approved autologous CD19 CAR T cell therapy.
DL4 demonstrated a mean Cmax of 483 cells/ul with a mean
time-to-peak at approximately day 9 and demonstrated persistence
through day 28 with a mean concentration of 21 cells/ul.
- ADI-001 was generally well-tolerated in the study and there
were no occurrences of dose-limiting toxicities or graft vs host
disease (GvHD). Of the 24 patients evaluable for safety, there was
1 report of Grade 3 or higher CRS and 1 report of Grade 3 or higher
ICANS.
- In May, the Company completed a Type B meeting with the FDA and
expects to transition the ADI-001 program into a potentially
pivotal Phase 2 study in post- CAR T LBCL in the first half of
2024.
Table 1 – Summary of Phase 1 ADI-001 Preliminary Efficacy Data
as of the May 4, 2023 data-cut date:
Median No. of Prior
Lines
Post-CAR T Patients
ORR (%)
CR Rate (%)
3-month
CR Rate (%)
6-month
CR Rate (%)
DL4 (RP2D)
4
3/8 (37.5%)
6/8 (75.0%)
5/8 (62.5%)
4/8 (50.0%)
2/8 (25.0%)
DL4
(RP2D)
Post CAR T
4
3/3 (100.0%)
3/3 (100.0%)
2/3 (67.7%)
1/3 (33.3%)
1/3 (33.3%)
All Doses
4
12/24 (50%)
17/24 (70.8%)
15/24 (62.5%)
9/24 (37.5%)
4/24 (16.7%)
Post CAR T
All Doses
4
12/12 (100.0%)
10/12 (83.3%)
8/12 (66.7%)
4/12 (33.3%)
2/12 (16.7%)
Table 2 – Summary of Phase 1 ADI-001 Safety Data in Efficacy
Evaluable Patients as of the May 4, 2023 data-cut date*:
DL1(N=3)
DL2(N=3)
DL3(N=6)
DL3 X2(N=4)
DL4(N=8)
Total (N=24)
Any Grade
Gr>=3
Any Grade
Gr>=3
Any Grade
Gr>=3
Any Grade
Gr>=3
Any Grade
Gr>=3
Any Grade
Gr>=3
CRS
2 (66.7%)
0
0
0
1 (16.7%)
1 (16.7%)
4 (100.0%)
0
4 (50.0%)
0
11 (45.8%)
1 (4.2%)
ICANS
0
0
1 (33.3%)
0
0
0
1 (25.0%)
1 (25.0%)
1 (12.5%)
0
3 (12.5%)
1 (4.2%)
GvHD
0
0
0
0
0
0
0
0
0
0
0
0
DLT
0
0
0
0
0
0
0
0
0
0
0
0
Infection
1 (33.3%)
1 (33.3%)
2 (66.7%)
0
3 (50.0%)
2 (33.3%)
2 (50.0%)
1 (25.0%)
3 (37.5%)
2 (25.0%)
11 (45.8%)
6 (25.0%)
SAE-TEAE
1 (33.3%)
1 (33.3%)
2 (66.7%)
2 (66.7%)
4 (66.7%)
3 (50.0%)
2 (50.0%)
2 (50.0%)
3 (37.5%)
2 (25.0%)
12 (50.0%)
10 (41.7%)
Related SAE-TEAE
1 (33.3%)
0
1 (33.3%)
1 (33.3%)
3 (50.0%)
2 (33.3%)
2 (50.0%)
2 (50.0%)
3 (37.5%)
2 (25.0%)
10 (41.7%)
7 (29.2%)
*Safety assessment was performed using the Common Terminology
Criteria for Adverse Events (v5) and the American Society for
Transplantation and Cellular Therapy criteria.
Webcast/ Conference Call Information
Adicet will host a webcast presentation on Monday, June 26 at
4:30pm ET to discuss the most recent data-cut from its ongoing
Phase 1 study evaluating the safety and tolerability of ADI-001 for
the potential treatment of relapsed or refractory B-cell NHL.
The live webcast of the presentation can be accessed by
registering under “Presentations & Events” in the investors
section of the Company’s website at https://www.adicetbio.com. Upon
registration, all participants will receive a confirmation email
with a unique passcode to provide access to the webcast event. To
participate via telephone, please join by dialing 972-9349-2674
(domestic) or 1-646-876-9923 (international) and referencing the
conference ID 97293492674. An archived replay will be available for
30 days following the presentation. 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
FDA for the potential treatment of relapsed or refractory B-cell
NHL.
About the GLEAN Study
The 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. 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 chimeric antigen 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.
The words “anticipate,” “believe,” “continue,” “could,” “estimate,”
“expect,” “intend,” “may,” “plan,” “potential,” “predict,”
“project,” “should,” “target,” “would” and similar expressions are
intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. These
forward-looking statements include, but are not limited to, express
or implied statements regarding the potential safety, durability,
tolerability and efficacy of ADI-001; the expected progress, timing
and success of the Phase 1 study of ADI-001 in relapsed/refractory
NHL patients, including the identification of a recommended Phase 2
dose and the expected performance compared to approved CD19
autologous CAR T therapy; the plan to transition ADI-001 into a
potentially pivotal Phase 2 study in the first half of 2024; and
expected timing of additional data in post-CAR T LBCL patients in
the second half of 2024. 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 preclinical or
clinical studies, 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
results, from a preclinical or clinical study may not necessarily
be predictive of the results of future or ongoing 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, 2022 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/20230626163061/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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