Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the
“Company”), a clinical-stage pharmaceutical company developing
innovative therapies for the treatment of advanced solid tumors and
other serious diseases, and WARPNINE Incorporated (“WARPNINE”),
Western Australia’s first not-for-profit clinical research
organization for pancreatic, gastro-intestinal and rare cancers,
today announced the treatment of the first patient in the iLSTA
Trial of Lisata’s LSTA1 in combination with standard-of-care
chemotherapy and immunotherapy as a first-line treatment in locally
advanced non-resectable pancreatic ductal adenocarcinoma (“PDAC”).
The iLSTA Trial is a 30-patient, randomized, single-blind,
single-center, safety and pharmacodynamic phase 1b/2a study
evaluating LSTA1 in combination with the checkpoint inhibitor,
durvalumab, plus standard-of-care chemotherapy, nab-paclitaxel and
gemcitabine, versus standard-of-care alone in patients with locally
advanced non-resectable PDAC. As the study sponsor, WARPNINE will
provide all funding and manage all recruitment activities for the
study while Lisata will provide the study drug, LSTA1, as well as
regulatory support. WARPNINE and Lisata will share use of the data
with the goal of advancing development of LSTA1 toward registration
to the benefit of patients in need.
“The iLSTA Trial is potentially the first major opportunity that
we have to enable immunotherapy to fully engage against pancreatic
cancer as, to date, pancreatic cancer has been resistant to the
effects of immunotherapy due to both the hostile tumour
microenvironment and the protective layer of tissue surrounding the
tumour (called the stroma). The use of LSTA1 in combination with
standard-of-care chemotherapy and immunotherapy is intended to both
augment chemotherapy delivery into the tumour and facilitate the
effects of tumour infiltrating lymphocytes and immunotherapy
compounds to optimize therapy against cancer of the pancreas,”
stated Dr. Andrew Dean, MBChB, MRCP (UK), FRACP, Medical
Oncologist, Principal Investigator.
“WARPNINE exists to fund research into pancreatic,
gastro-intestinal and rare cancers. We are committed to transform
these cancers into curable diseases and addressing the inequity in
outcomes for patients and families impacted by these devastating
malignancies. The extraordinary support of the WARPNINE community
has enabled us to sponsor this innovative and potentially
game-changing trial. Community is power and together we are
charging at “warp speed” to find the cancer treatments of the
future, today,” said Meg Croucher, Chief Executive Officer of
WARPNINE, iLSTA Trial sponsor.
“Dosing the first patient in our iLSTA Trial of LSTA1 in
patients with pancreatic cancer in Australia is an important step
in our mission to create new hope for patients by providing
meaningful treatments to those with few remaining alternatives. We
believe that LSTA1 represents a new treatment option for these
patients who haven’t been fully served by standard-of-care alone,”
stated Kristen K. Buck, M.D., Executive Vice President of R&D
and Chief Medical Officer of Lisata. “We are thrilled by the
progress being made to help advance LSTA1 through the clinical
trial process and are grateful to WARPNINE for their financial and
operational support.”
About LSTA1
LSTA1 is an investigational drug designed to activate a novel
uptake pathway that allows co-administered or tethered anti-cancer
drugs to penetrate solid tumors more effectively. LSTA1 actuates
this active transport system in a tumor-specific manner, resulting
in systemically co-administered anti-cancer drugs more efficiently
penetrating and accumulating in the tumor. LSTA1 also has the
potential to modify the tumor microenvironment, with the objective
of making tumors more susceptible to immunotherapies. We and our
collaborators have amassed significant non-clinical data
demonstrating enhanced delivery of a range of emerging anti-cancer
therapies, including immunotherapies and RNA-based therapeutics. To
date, LSTA1 has also demonstrated favorable safety, tolerability
and clinical activity in completed and ongoing clinical trials
designed to test its ability to enhance the effectiveness of
standard-of-care chemotherapy for pancreatic cancer.
About WARPNINE Incorporated
WARPNINE is Western Australia’s research into pancreatic,
gastro-intestinal, and rare cancers. Established by a group of
leading cancer specialists, WARPNINE seeks to address the inequity
in cancer outcomes for what are essentially underfunded and
under-researched malignancies. We are committed to providing real
and meaningful benefit to patients, while building on Western
Australia’s best-in-the-world outcomes for these cancers. For more
information on WARPNINE, please visit
www.warpnine.org.au.
About Lisata Therapeutics
Lisata Therapeutics is a clinical-stage pharmaceutical company
dedicated to the discovery, development, and commercialization of
innovative therapies for the treatment of advanced solid tumors and
other major diseases. Lisata’s lead investigational product
candidate, LSTA1, is an investigational drug designed to activate a
novel uptake pathway that allows co-administered or tethered
anti-cancer drugs to penetrate solid tumors more effectively. LSTA1
actuates this active transport system in a tumor-specific manner,
resulting in systemically co-administered anti-cancer drugs more
efficiently penetrating and accumulating in the tumor, while normal
tissues are not affected. LSTA1 also has the potential to modify
the tumor microenvironment, with the objective of making tumors
more susceptible to immunotherapies. LSTA1 has demonstrated
favorable safety, tolerability, and activity in clinical trials to
enhance delivery of standard-of-care chemotherapy for pancreatic
cancer. Lisata and its collaborators have also amassed significant
non-clinical data demonstrating enhanced delivery of a range of
emerging anti-cancer therapies, including immunotherapies and
RNA-based therapeutics. Lisata is exploring the potential of LSTA1
to enable a variety of treatment modalities to treat a range of
solid tumors more effectively. For more information on the Company,
please visit www.lisata.com.
Forward-Looking Statements
This communication contains “forward-looking statements” that
involve substantial risks and uncertainties for purposes of the
safe harbor provided by the Private Securities Litigation Reform
Act of 1995. All statements, other than statements of historical
facts, included in this communication regarding strategy, future
operations, future financial position, future revenue, projected
expenses, prospects, plans and objectives of management are
forward-looking statements. In addition, when or if used in this
communication, the words “may,” “could,” “should,” “anticipate,”
“believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and
similar expressions and their variants, as they relate to Lisata or
its management, may identify forward-looking statements. Examples
of forward-looking statements include, but are not limited to,
statements relating to the long-term success of Lisata’s recently
completed merger (the “Merger”) with Cend Therapeutics, Inc.
(“Cend”), including the ongoing integration of Cend’s operations;
Lisata’s continued listing on the Nasdaq Capital Market;
expectations regarding the capitalization, resources and ownership
structure of Lisata; the approach Lisata is taking to discover and
develop novel therapeutics; the adequacy of Lisata’s capital to
support its future operations and its ability to successfully
initiate and complete clinical trials; and the difficulty in
predicting the time and cost of development of Lisata’s product
candidates. Actual results could differ materially from those
contained in any forward-looking statement as a result of various
factors, including, without limitation: the ongoing COVID-19
pandemic on Lisata’s business, the safety and efficacy of Lisata’s
product candidates, decisions of regulatory authorities and the
timing thereof, the duration and impact of regulatory delays in
Lisata’s clinical programs, Lisata’s ability to finance its
operations, the likelihood and timing of the receipt of future
milestone and licensing fees, the future success of Lisata’s
scientific studies, Lisata’s ability to successfully develop and
commercialize drug candidates, the timing for starting and
completing clinical trials, rapid technological change in Lisata’s
markets, the ability of Lisata to protect its intellectual property
rights; unexpected costs, charges or expenses resulting from the
Merger; potential adverse reactions or changes to business
relationships resulting from the completion of the Merger;
potential underperformance of Lisata’s business following the
Merger as compared to management’s initial expectations; and
legislative, regulatory, political and economic developments. The
foregoing review of important factors that could cause actual
events to differ from expectations should not be construed as
exhaustive and should be read in conjunction with statements that
are included herein and elsewhere, including the risk factors
included in Lisata’s Annual Report on Form 10-K filed with the SEC
on March 30, 2023 and in other documents filed by Lisata with the
Securities and Exchange Commission. Except as required by
applicable law, Lisata undertakes no obligation to revise or update
any forward-looking statement, or to make any other forward-looking
statements, whether as a result of new information, future events
or otherwise.
Contact:
WARPNINE Incorporated:
Meg CroucherChief Executive Officerm 0406 818
810e meg@warpnine.org.auwww.warpnine.org.au
Lisata Therapeutics Investors and Media:Lisata
Therapeutics, Inc.John MendittoVice President, Investor Relations
and Corporate
CommunicationsPhone: 908-842-0084Email: jmenditto@lisata.com
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