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, today announces promising preclinical
results for its investigational candidate, certepetide (formerly
LSTA1). The data, presented in a poster by Dr. Dan G. Duda of
Massachusetts General Hospital at the 2024 Cholangiocarcinoma
Foundation Annual Conference, showed that certepetide combined with
standard-of-care chemotherapy and immunotherapy improved survival
in mice with intrahepatic cholangiocarcinoma. These findings
suggest potential benefits for human patients with this aggressive
cancer and support advancing clinical development efforts for
certepetide in intrahepatic cholangiocarcinoma.
“Previous preclinical and early clinical results for certepetide
show promise, and Lisata is optimistic about its potential to
benefit patients with advanced solid tumors, including
cholangiocarcinoma,” stated Kristen K. Buck, M.D., Executive Vice
President of Research and Development and Chief Medical Officer at
Lisata. “We are currently conducting a Phase 2a clinical trial,
known as the BOLSTER trial, to evaluate certepetide in combination
with standard-of-care chemotherapy as first-line treatment for
cholangiocarcinoma. Additionally, based on the recommendations of
the investigators involved in BOLSTER and the serious unmet medical
need for treatments in a second line, we will soon be adding
another arm to BOLSTER to test certepetide in combination with
standard-of-care chemoimmunotherapy in intrahepatic
cholangiocarcinoma patients. We look forward to sharing updates on
this trial throughout the year, with results anticipated for both
arms during 2025.”
Dr. Duda's research, titled "Enhancing the Efficacy of Standard
Therapy in Intrahepatic Cholangiocarcinoma Using LSTA1
(certepetide), a Novel Tumor Targeting and Penetration Agent,”
evaluated the efficacy of certepetide alongside standard anti-PD-1
immunotherapy and gemcitabine/cisplatin chemotherapy in an
aggressive intrahepatic cholangiocarcinoma mouse model. The study
demonstrated that certepetide, in combination with standard
chemotherapy plus immunotherapy, significantly prolonged survival,
reduced disease morbidity (ascites and pleural effusions), and lung
metastasis, and decreased the risk of death by 76%. Treatment was
well tolerated in mice, with no overt additional toxicities.
Initial data suggest that certepetide promoted immune cell
infiltration into the tumor tissues by opening the collapsed tumor
vessels and enhancing immune cell infiltration.
“These preclinical data on certepetide are very encouraging,”
stated Prof. Dan G. Duda. “Intrahepatic cholangiocarcinoma is a
devastating disease with a poor prognosis, and there remains a
critical need for new and improved treatment options. These
findings, while based on an animal model, support the continued
development of certepetide as a potential breakthrough treatment in
patients living with intrahepatic cholangiocarcinoma.”
About Intrahepatic Cholangiocarcinoma
Intrahepatic cholangiocarcinoma, also known as intrahepatic bile
duct cancer, is a rare, aggressive cancer that starts in the bile
ducts within the liver. It is the second most common liver
malignancy, making up about 10% of all cholangiocarcinoma.
Intrahepatic cholangiocarcinoma has an overall poor prognosis, and
symptoms are usually nonspecific, contributing to an advanced tumor
stage at diagnosis.
About Certepetide
Certepetide (formerly 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. Certepetide 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. Certepetide has also been shown to
modify the tumor microenvironment, diminishing its
immunosuppressive nature and inhibiting the metastatic cascade. We
and our collaborators have amassed significant non-clinical data
demonstrating enhanced delivery of various emerging anti-cancer
therapies, including immunotherapies and RNA-based therapeutics. To
date, certepetide 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. Lisata is exploring the potential of certepetide to enable
a variety of treatment modalities to treat a range of solid tumors
more effectively. Certepetide has been awarded Fast Track
designation (U.S.) and Orphan Drug Designation for pancreatic
cancer (U.S. and E.U.) as well as Orphan Drug Designation for
glioma (U.S.) and osteosarcoma (U.S.). Additionally, certepetide
has received Rare Pediatric Disease Designation for osteosarcoma
(U.S.).
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 product candidate, certepetide
(formerly LSTA1), is an investigational drug designed to activate a
novel uptake pathway that allows co-administered or tethered
anti-cancer drugs to selectively target and penetrate solid tumors
more effectively. Lisata has already established noteworthy
commercial and R&D partnerships based on its CendR Platform®
technology. The Company expects to announce numerous milestones
over the next two years and believes that its projected capital
will fund operations into early 2026, encompassing anticipated data
milestones from its ongoing and planned clinical trials. 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 the Company’s
clinical development programs 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, the potential efficacy of
certepetide as a treatment for patients with metastatic pancreatic
ductal adenocarcinoma and other solid tumors; statements relating
to 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: results observed from a
single patient case study are not necessarily indicative of final
results and one or more of the clinical outcomes may materially
change following more comprehensive reviews of the data and as more
patient data becomes available, including the risk that unconfirmed
responses may not ultimately result in confirmed responses to
treatment after follow-up evaluations; the risk that product
candidates that appeared promising in early research and clinical
trials do not demonstrate safety and/or efficacy in larger-scale or
later clinical trials; 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; 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 February 29, 2024, 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:
Investors:
Lisata Therapeutics, Inc.John MendittoVice President, Investor
Relations and Corporate
CommunicationsPhone: 908-842-0084Email: jmenditto@lisata.com
Media:
ICR WestwickeElizabeth ColemanSenior AssociatePhone:
203-682-4783Email: elizabeth.coleman@westwicke.com
Lisata Therapeutics (NASDAQ:LSTA)
Historical Stock Chart
From Aug 2024 to Sep 2024
Lisata Therapeutics (NASDAQ:LSTA)
Historical Stock Chart
From Sep 2023 to Sep 2024