Expanding clinical development of ADI-001 into
autoimmune diseases following clearance of Investigational New Drug
Application (IND); plan to initiate Phase 1 clinical study in 2Q
2024
Focusing enrollment on mantle cell lymphoma
(MCL) in ongoing ADI-001 Phase 1 clinical trial given favorable
complete response (CR) rate, durability, and safety
ADI-001 clinical update expected 2H 2024
ADI-270 IND submission in renal cell carcinoma
expected in 2Q 2024
Updated cash runway into 2H 2025
Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology
company discovering and developing allogeneic gamma delta T cell
therapies for cancer and autoimmune diseases, today provided
corporate updates and highlighted upcoming priorities for its
pipeline programs in 2024.
“In 2024, we aim to make significant strides across our pipeline
of differentiated gamma delta T cell therapies through our
strategic and disciplined approach,” said Chen Schor, President and
Chief Executive Officer at Adicet Bio. “The U.S. FDA’s IND
clearance of ADI-001 in lupus nephritis marks an important
milestone in maximizing the ADI-001 opportunity in the autoimmune
therapeutic category that we believe it is ideally suited to
address. Clinical data for ADI-001 have demonstrated B-cell
depletion that mirrors the B cell depletion by autologous
alpha-beta CAR T in academic clinical studies in systemic lupus
erythematosus, systemic sclerosis, and idiopathic inflammatory
myopathy patients. Given that gamma delta 1 T cells preferentially
traffic to organs and tissues, ADI-001 is designed to target and
deplete B cells in the periphery, secondary lymphoid organs,
kidneys, and other organs, which is highly desirable in autoimmune
diseases. ADI-001’s off-the-shelf availability and the favorable
safety profile provide the potential for outpatient
administration.”
Mr. Schor continued: “Our internal research and development
efforts are focused in areas where we believe we have a high
probability of success and opportunity for significant
differentiation. In our ongoing Phase 1 clinical trial of ADI-001
in relapsed or refractory NHL, we have decided to focus our current
patient enrollment on the MCL population, which demonstrated the
greatest clinical benefit in our June 2023 clinical update. With
projected cash runway into the second half of 2025, multiple
upcoming milestones, and a disciplined approach, we believe we are
well-positioned to advance our pipeline of allogeneic T cell
therapy candidates to address substantial unmet needs in oncology
and autoimmune diseases.”
Program Updates and Expected Milestones for 2024
ADI-001 is an investigational allogeneic gamma delta CAR T cell
therapy targeting CD20 for the potential treatment of relapsed or
refractory B-cell non-Hodgkin’s Lymphoma (NHL) and autoimmune
diseases.
Autoimmune diseases
- IND cleared for lupus nephritis. In December 2023, the FDA
cleared Adicet’s IND application for ADI-001 in lupus
nephritis.
- Initiate Phase 1 clinical trial of ADI-001 for the treatment of
lupus nephritis in the second quarter of 2024. The Company plans to
initiate a Phase 1 clinical trial to assess the safety and efficacy
of ADI-001 in lupus nephritis and may provide a clinical update
from the trial in the second half of 2024. Adicet expects to expand
into additional autoimmune indications in the near future.
Hematologic malignancies
- Focus enrollment on MCL patients in ongoing Phase 1 GLEAN
study. Adicet will focus on the MCL patient population in
the ongoing Phase 1 GLEAN study (at dose level 4), which
experienced the greatest clinical benefit in the June 2023 update.
While these were early data, an 80% CR rate and 60% 6-month CR rate
in late line MCL patients were reported in the June 2023 clinical
update, Cmax and exposure by area under the curve (AUC) exceeded
that of approved autologous CD19 CAR T therapies, and a favorable
safety profile was observed with no significant risk of cytokine
release syndrome, immune effector cell associated neurotoxicity
syndrome or T-cell malignancies. These initial clinical results,
coupled with the potential to dose off-the-shelf in a community
setting, support ADI-001 as a potentially attractive therapy for
MCL patients. The Company is evaluating the option of advancing
ADI-001 to a potentially pivotal study in MCL patients under an
accelerated approval pathway.
- The Company remains on track to provide an ADI-001 clinical
update in the second half of 2024.
ADI-270 is an investigational allogeneic gamma delta CAR T cell
therapy targeting CD70 via the CD27-ligand for the treatment of
renal cell carcinoma with potential in other solid tumor
indications. ADI-270 is designed to home to solid tumors, with a
highly specific targeting moiety for CD70 and an armoring
technology of TGF beta dominant- negative receptor to address
immunosuppressive factors in the tumor microenvironment. Building
on gamma delta 1 tissue tropism to solid tumors and three
mechanisms of anti-tumor activity (CAR, innate and adaptive), CAR
gamma delta 1 T cells may be well positioned to address solid
tumors.
Renal cell carcinoma
- Plan to file IND for ADI-270 in 2Q 2024. Following positive
feedback from a pre-IND meeting with the FDA, the Company remains
on track to file an IND application for ADI-270 in the second
quarter of 2024.
Financial Outlook
- The Company expects cash and cash equivalents on hand as of
December 31, 2023, to enable funding for current and planned
operations into the second half of 2025.
Webcast/ Conference Call Information
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 888-788-0099
(domestic) or 312-626-6799 (international) and referencing the
conference ID 918 2940 8885. 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 Adicet Bio, Inc.
Adicet Bio, Inc. is a clinical stage biotechnology company
discovering and developing allogeneic gamma delta T cell therapies
for cancer and autoimmune diseases. Adicet is advancing a pipeline
of “off-the-shelf” gamma delta T cells, engineered with chimeric
antigen receptors (CARs), to enhance selective tumor targeting and
facilitate innate and adaptive immune response for durable activity
in patients. For more information, please visit our website at
https://www.adicetbio.com.
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 the 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:
preclinical and clinical development of Adicet’s product
candidates, including future plans or expectations for ADI-001 and
ADI-270 and the potential safety, durability, tolerability and
efficacy of these product candidates; the expected progress, timing
and success of the Phase 1 clinical trial of ADI-001, including
continued enrollment and expectations around a clinical update in
the second half of 2024; the Company’s plan to initiate a Phase 1
clinical trial of ADI-001 in lupus nephritis and expand into other
autoimmune indications in the future; the Company’s expectations
regarding the submission of an IND for ADI-270 in renal cell
carcinoma in the second quarter of 2024; and expectations regarding
its uses of capital, expenses and financial results, including the
expected cash runway. 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 global economic conditions and public health emergencies
on Adicet’s business and financial results, including with respect
to disruptions to our preclinical and clinical studies, business
operations, employee hiring and retention, 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; and Adicet’s ability
to meet production and product release expectations. 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 and our periodic reports on Form 10-Q
and Form 8-K filed with the SEC, as well as discussions of
potential risks, uncertainties, and other important factors in
Adicet’s other 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/20240104790871/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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