Allogene Therapeutics to Present New Data Demonstrating the Potential of ALLO-316 in Heavily Pretreated Adult Patients with CD70 Positive Advanced Renal Cell Carcinoma (RCC) at the International Kidney Cancer Symposium (IKCS) and Society for Immunotherapy
November 05 2024 - 9:10AM
Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage
biotechnology company pioneering the development of allogeneic CAR
T (AlloCAR T™) products for cancer and autoimmune disease, today
announced that it will present new data from the ongoing Phase 1
TRAVERSE trial at the 2024 International Kidney Cancer Symposium
(IKCS) and the Society for Immunotherapy of Cancer's (SITC) annual
meeting. The trial evaluates ALLO-316, the Company’s first AlloCAR
T product candidate for the potential treatment of solid tumors.
These presentations will highlight data from 26 heavily pretreated
patients with CD70 positive renal cell carcinoma (RCC) and will
include details on the diagnostic and treatment algorithm used to
mitigate treatment-associated hyperinflammatory response seen in
some patients. The ongoing Phase 1 data supported the U.S. Food and
Drug Administration’s (FDA) October 2024 decision to grant
Regenerative Medicine Advanced Therapy (RMAT) designation for
ALLO-316 based on clinical data from the TRAVERSE trial indicating
its to address the unmet need for adult patients with advanced or
metastatic CD70 positive RCC who have failed multiple standard RCC
therapies, including an immune checkpoint inhibitor and a
VEGF-targeting therapy.
“We are looking forward to presenting the most recent Phase 1
data from our ongoing TRAVERSE trial at both SITC and IKCS,” said
Zachary Roberts, M.D., Ph.D., EVP of Research & Development and
Chief Medical Officer. “There is significant unmet need for these
heavily pretreated patients with advanced RCC. In treating their
disease, these patients rarely get any form of treatment break as
their disease quickly progresses. This data highlights the
potential of ALLO-316 to elicit a response from a single infusion,
suggesting a breakthrough in allogeneic CAR T therapy for solid
tumors. As the Phase 1 data matures, we plan to seek FDA’s input
for the next stage of clinical development.”
2024 International Kidney Cancer Symposium
(IKCS)Title: TRAVERSE: Updated safety and
efficacy of ALLO-316 in advanced/metastatic clear cell renal cell
carcinoma (ccRCC)Presenter: Ritesh Kotecha, M.D.,
Memorial Sloan Kettering Cancer Center Session Date and
Time: Friday, November 8, 11:50 a.m. ET
The Society for Immunotherapy of Cancer's (SITC) Annual
Meeting Title: ALLO-316 in patients with
advanced or metastatic clear cell renal cell carcinoma (ccRCC):
Updated safety and efficacy from the phase 1 TRAVERSE multicenter
studyPresenter: Samer Srour, M.D., The University
of Texas MD Anderson Cancer CenterAbstract Number:
322Date and Time: Saturday, November 9, 12:15-1:45
p.m. CT, 7:00-8:30 p.m. CT
The ongoing Phase 1 TRAVERSE trial is designed to evaluate the
safety, tolerability, and activity of ALLO-316 in patients with
advanced or metastatic RCC. The development of ALLO-316 continues
to advance the scientific understanding and applicability of the
Dagger technology as the next-generation allogeneic platform with
the ability to maximize the potential of a one-time infusion. In
April 2024, the Company announced a $15 million award from the
California Institute for Regenerative Medicine (CIRM) to support
the ongoing TRAVERSE trial with ALLO-316 in RCC.
About ALLO-316 (TRAVERSE)ALLO-316, an AlloCAR
T™ investigational product, targets CD70 which is highly expressed
in renal cell carcinoma (RCC). CD70 is also selectively expressed
in several cancers, creating the potential for ALLO-316 to be
developed across a variety of both hematologic malignancies and
solid tumors. ALLO-316 utilizes the Dagger® technology to
optimize CAR T cell expansion and persistence to maximize the
potential efficacy in solid tumors with a one-time infusion. The
ongoing Phase 1 TRAVERSE trial is designed to evaluate the safety,
tolerability, and activity of ALLO-316 in patients with advanced or
metastatic clear cell RCC. In March 2022, the U.S. Food
and Drug Administration (FDA) granted Fast Track Designation
(FTD) to ALLO-316, and in October 2024 the FDA granted
Regenerative Medicine Advanced Therapy (RMAT) designation to
ALLO-316 based on its potential to address the unmet need for adult
patients with CD70 positive advanced or metastatic RCC who have
failed standard RCC therapies.
About Allogene TherapeuticsAllogene
Therapeutics, with headquarters in South San Francisco, is a
clinical-stage biotechnology company pioneering the
development of allogeneic chimeric antigen receptor T cell
(AlloCAR T™) products for cancer and autoimmune disease. Led by a
management team with significant experience in cell therapy,
Allogene is developing a pipeline of “off-the-shelf” CAR T cell
product candidates with the goal of delivering readily
available cell therapy on-demand, more reliably, and
at greater scale to more patients. For more information,
please visit www.allogene.com, and follow @AllogeneTx on X and
LinkedIn.
About the California Institute for Regenerative Medicine
(CIRM)At CIRM, we never forget that we were created by the
people of California to accelerate stem cell treatments to patients
with unmet medical needs, and act with a sense of urgency to
succeed in that mission. To meet this challenge, our team of highly
trained and experienced professionals actively partners with both
academia and industry in a hands-on, entrepreneurial environment to
fast-track the development of today’s most promising stem cell
technologies. CIRM is one of the world’s largest institutions
dedicated to helping people by bringing the future of regenerative
medicine closer to reality.
Cautionary Note on Forward-Looking Statements for
Allogene This press release contains forward-looking
statements for purposes of the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. The press release
may, in some cases, use terms such as “potential,” “continue,”
“plans,” “will,” “advance,” “goal,” or other words that convey
uncertainty of future events or outcomes to identify these
forward-looking statements. Forward-looking statements are
statements that are not historical facts, including statements
regarding intentions, beliefs, projections, outlook, analyses or
current expectations concerning, among other things: the future
development, timing, and success of clinical trials and product
candidates; statements regarding the potential of ALLO-316 as a
treatment for patients with advanced renal cell carcinoma (RCC);
the advancement of Allogene’s Dagger® technology as a
next-generation allogeneic platform; the anticipated benefits of a
one-time infusion therapy; Allogene’s plans to seek additional FDA
input for the clinical development of ALLO-316; and Allogene’s
ability to deliver cell therapy on-demand, faster, more reliably,
and at greater scale to more patients. Various factors may cause
material differences between Allogene’s expectations and actual
results, including, risks and uncertainties related to the ongoing
clinical trial for ALLO-316 and potential adverse effects;
uncertainties regarding regulatory interactions, including future
feedback from the U.S. Food and Drug Administration and
implications of the RMAT designation; risks relating to the
development of allogeneic cell therapy and CAR T products; the
impact of competitive and market conditions; uncertainties relating
to our novel technologies which makes it difficult to predict the
time and cost of product candidate development and obtaining
regulatory approval; difficulties we may encounter enrolling
patients in our clinical trials; and uncertainties regarding our
ability to obtain additional financing to develop our products and
implement our operating plans. These and other risks are discussed
in greater detail in Allogene’s filings with the SEC, including
without limitation under the “Risk Factors” heading in its Form
10-Q filed for the quarter ended June 30, 2024, filed with the SEC
on August 7, 2024. Any forward-looking statements that are made in
this press release speak only as of the date of this press release.
Allogene assumes no obligation to update the forward-looking
statements whether as a result of new information, future events or
otherwise, after the date of this press release.
AlloCAR T™ and Dagger® are trademarks of Allogene
Therapeutics, Inc.
Allogene’s investigational AlloCAR T™ oncology products utilize
Cellectis technologies. The anti-CD70 AlloCAR T™ program is
licensed exclusively from Cellectis by Allogene and Allogene holds
global development and commercial rights to this AlloCAR T™
program.
Allogene Media/Investor Contact:Christine
CassianoEVP, Chief Corporate Affairs & Brand Strategy
OfficerChristine.Cassiano@allogene.com
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