Lisata Therapeutics Announces First Patient Treated in the BOLSTER Trial of LSTA1, a Novel Tumor-Targeting and Penetrating Peptide, in Patients with Advanced Solid Tumors
September 12 2023 - 8:00AM
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 announced treatment of the first
patient in the head and neck squamous cell carcinoma cohort of the
BOLSTER trial, by Dr. Alexander N. Starodub, a principal
investigator of the study, at The Christ Hospital in Cincinnati,
Ohio.
The BOLSTER trial is a Phase 2a, double-blind,
placebo-controlled, multi-center, randomized study evaluating LSTA1
when added to standard-of-care (“SOC”) versus SOC alone in patients
with either advanced second-line head and neck squamous cell
carcinoma, second-line esophageal squamous cell carcinoma, or
first-line cholangiocarcinoma. The BOLSTER trial is a basket trial
being conducted at approximately 40 sites in North America, Europe,
and Asia-Pacific. Total trial enrollment of 120 patients is
expected to be completed in the second half of 2024. A “basket”
trial is a trial in which a product (e.g., LSTA1) is tested in
multiple indications sharing a similar trait or challenge (e.g.,
dense stroma in solid tumors) in separate arms of the study. The
individual arms are enrolled and analyzed independently but share
operational synergies such that the study is more efficient to
execute than would be for conducting independent studies for each
indication. Each arm of BOLSTER will enroll 40 patients: 20
randomized to LSTA1 in combination with SOC, 20 randomized to
placebo in combination with SOC.
“We are excited to announce treatment of the first patient in
the second-line head and neck squamous cell carcinoma cohort of the
BOLSTER trial. Head and neck squamous cell carcinoma, which usually
begins in the mucosal surfaces of the mouth, throat or voice box,
is a rare and aggressive form of solid tumor cancer that is
diagnosed in roughly 67,000 patients a year in the U.S. Most head
and neck cancers eventually spread to the lymph nodes nearest to
the affected area and can become incurable or uncontrollable
resulting in advanced or terminal stage disease. The BOLSTER trial
gives us the opportunity to evaluate the potential of LSTA1 in a
variety of solid tumor settings in combination with corresponding
standards-of-care and will provide direction on potential next
steps in development,” stated Kristen K. Buck, M.D., Executive Vice
President of R&D and Chief Medical Officer of Lisata. “Now that
the first patient in BOLSTER has been treated, we expect an uptake
in enrollment in the coming quarters. We remain committed to
developing groundbreaking therapies that can transform the outcomes
of individuals facing these life-threatening conditions.”
For more information on the BOLSTER Trial, please visit
https://clinicaltrials.gov/study/NCT05712356.
About LSTA1
LSTA1 is an investigational drug designed to activate a novel
uptake pathway that allows co-administered or tethered (i.e.,
covalently bound) 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. Lisata and its collaborators have
amassed significant non-clinical data demonstrating enhanced
delivery of a range of existing and emerging anti-cancer therapies,
including chemotherapeutics, immunotherapies and RNA-based
therapeutics. Additionally, LSTA1 has demonstrated favorable
safety, tolerability and activity in clinical trials to enhance
delivery of SOC chemotherapy for pancreatic cancer. Lisata is
exploring the potential of LSTA1 to enable a variety of treatment
modalities to treat a range of solid tumors more effectively.
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, LSTA1, is an
investigational drug designed to activate a novel uptake pathway
that allows co-administered or tethered anti-cancer drugs to target
and penetrate solid tumors more effectively. Based on Lisata’s
CendR Platform® Technology, Lisata has already established
noteworthy commercial and R&D partnerships. The Company expects
to announce numerous clinical study and business milestones over
the next two years and has projected that its current business and
development plan is funded with available capital through these
milestones and into early 2026. 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 and capital, 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 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 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 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:
Investors and Media:Lisata Therapeutics, Inc.John MendittoVice
President, Investor Relations and Corporate
CommunicationsPhone: 908-842-0084Email: jmenditto@lisata.com
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