ADI-001 demonstrated 75% overall response rate
(ORR) and 69% complete response (CR) across all dose levels with
favorable safety and tolerability profile in patients with
relapsed/refractory high-grade aggressive NHL, as of December 5,
2022 data-cut date
100% ORR and CR rate in 5/5 anti-CD19
autologous chimeric antigen receptor T cells (CAR-T) relapsed large
B-cell lymphoma (LBCL) patients
86% CR rate in LBCL patients across dose level
three (DL3) and above (75% CR rate in LBCL patients across all dose
levels)
Both dose level 2 (DL2) and DL3 demonstrated a
six-month CR rate of 33%; Patient follow up continues in dose level
4 (DL4) to assess six-month durability
Circulating ADI-001 cells visible through day
28 in peripheral blood at DL4
Company expects to initiate a potentially
pivotal study in post-CAR T LBCL patients in the second quarter of
2023; Evaluating potential second pivotal study in earlier-line
LBCL patients
Company to host investor webcast Sunday,
December 11 at 9:00 am 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 B-cell NHL. The
Company believes these data continue to support the potential of
Adicet’s investigational gamma delta CAR T cell therapy to provide
significant benefit both in terms of anti-tumor activity and
safety. Based on the study findings as of a December 5, 2022
data-cut date, Adicet plans to transition ADI-001 into a
potentially pivotal program in the second quarter of 2023.
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Figure 1: ADI-001: Preliminary Efficacy
Data (Graphic: Adicet Bio)
“It is very encouraging to see durability of response at six
months and beyond along with a continued favorable safety profile
in patients with aggressive lymphomas,” said Francesco Galimi,
M.D., Ph.D., Senior Vice President and Chief Medical Officer of
Adicet Bio. “Notably, a 100% complete response rate with ADI-001 in
post-autologous CAR T-relapsed LBCL patients may offer a potential
treatment option to those patients, who do not currently have
effective therapies.”
“These data are exciting and support our belief that ADI-001 has
the potential to generate meaningful clinical responses for
patients,” said Chen Schor, President and Chief Executive Officer
of Adicet Bio. “Based on the positive data reported today, we plan
to transition ADI-001 into a potential pivotal program with a
potentially best-in-class ORR, CR and durability profile in the
second quarter of 2023.”
“As these data mature, it is impressive to see continued
complete responses across all dose levels including six-month
durable responses and a 100% ORR and CR rate in LBCL patients
previously treated with autologous CAR T therapy,” said Sattva
Neelapu, M.D., Professor in the Department of Lymphoma/Myeloma at
The University of Texas MD Anderson Cancer Center. “Achieving these
results in such high-risk patients with aggressive disease suggests
that an allogeneic gamma delta CAR T cell therapy like ADI-001
could provide a significant advance for NHL patients.”
Data highlights as of the December 5, 2022 data-cut date were as
follows:
- Of the 16 evaluable patients, three received ADI-001 at dose
level 1 (DL1) (30 million CAR+ cells), three received ADI-001 at
DL2 (100 million CAR+ cells), three received ADI-001 at DL3 (300
million CAR+ cells), one received two infusions of ADI-001 at DL3
(2X 300 million CAR+ cells on day one and seven following a single
lymphodepletion), and six received ADI-001 at DL4 (1 billion CAR+
cells).
- On an exploratory basis, primarily to understand safety and
pharmacokinetics of a second ADI-001 dose, the first and second
patient in DL3 while testing negative for minimal residual disease
(MRD) and in CR, received a second DL3 dose, three and two months
after the first infusion, respectively.
- Patients were heavily pretreated with a median number of prior
therapies of four (range two-six) and had a poor prognostic outlook
based on their median International Prognostic Index (IPI)
score.
- ADI-001 treatment demonstrated a 75% ORR and 69% CR rate in the
study across all dose levels.
- In five LBCL patients that previously relapsed after prior
autologous anti-CD19 CAR T therapy, treatment with ADI-001
demonstrated 100% ORR and CR rate (5/5). These patients included a
triple-hit high-grade B-cell lymphoma patient, three diffuse large
B-cell lymphoma (DLBCL) patients, and a double-hit high-grade
B-cell lymphoma patient. ADI-001 resulted in CR in patients who
previously showed a partial response (PR) to autologous CAR T
(2/2).
- An 86% CR rate (6/7) was observed in LBCL patients across DL3
and above. 75% CR rate (9/12) in LBCL across all dose levels.
- Both DL2 and DL3 demonstrated a six-month CR rate of 33%;
Patient follow up continues in DL4 to assess six-month
durability.
- Circulating ADI-001 cells were visible through day 28 in
peripheral blood at DL4.
- ADI-001 was generally 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.
Table 2: Summary of Phase 1 ADI-001 Preliminary Safety Data in
Efficacy-Evaluable Patients as of the December 5, 2022 data-cut
date:+
DL1 (3E7) N=3
DL2 (1E8) N=3
DL3 (3E8) N=3
DL3 (2X 3E8) Day 1&7 N=1
DL4 (1E9) N=6
Total N=16
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 (%)
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%)
1 (100%)
0
3 (50%)
0 (0%)
6(38%)
0 (0)
ICANS
0 (0%)
0 (0%)
1 (33%)
0 (0%)
0 (0%)
0 (0%)
0
0
1(17%)
0 (0%)
2(13%)
0 (0)
GvHD
0 (0%)
0 (0%)
0 (0%)
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%)
0 (0%)
0 (0)
0 (0)
Infection
1 (33%)
0 (0%)
0 (0%)
0 (0%)
1 (33%)
1 (33%)
0
0
0 (0%)
0 (0%)
2 (13%)
1 (6%)
SAE - TEAE
1
(33%)
1
(33%)
2 (67%)
2 (67%)
2
(67%)
2 (67%)
0
0
1
(17%)
0
(0%)
6
(38%)
5
(31%)
+Safety assessment was performed using the Common Terminology
Criteria for Adverse Events (v5) and the American Society for
Transplantation and Cellular Therapy criteria.
Enrollment in the Phase 1 clinical study of ADI-001 is currently
ongoing to provide additional durability data and further support
the recommended Phase 2 dose.
The Company expects to discuss with the U.S. Food and Drug
Administration (FDA) and the European Medicines Agency (EMA) a
potential path to support a Biologics License Application (BLA) and
Marketing Authorization Application (MAA) for ADI-001, including
potential pivotal studies in post-CAR-T LBCL patients and in
earlier line LBCL patients, respectively.
Webcast / Conference Call information
Adicet will host a webcast presentation on Sunday, December 11,
2022 at 9:00 a.m. EST 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 event will feature Sattva Neelapu, M.D., Professor
in the Department of Lymphoma-Myeloma, Division of Cancer Medicine
at The University of Texas MD Anderson Cancer Center, alongside
members of the Adicet management team.
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 1-833-548-0276
(domestic) or 1-646-876-9923 (international) and referencing the
conference ID 98173615816.
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
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.
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 ongoing patient enrollment and the
identification of a recommended Phase 2 dose; initiation of a
potentially pivotal study in the second quarter of 2023 and
the potential for a second pivotal study in earlier line LBCL
patients; and the Company’s plans to discuss with the EMA and FDA
regarding the path to support a BLA and MAA 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 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 interim 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, 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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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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