Salarius Pharmaceuticals Completes SP-3164 Pre-Investigational New Drug Meeting Process with the U.S. Food and Drug Administration
May 11 2022 - 4:05PM
Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage
biopharmaceutical company developing potential new medicines for
patients with sarcomas, pediatric cancers, hematologic cancers and
other cancers, today announced the successful completion of its
pre-IND (Investigational New Drug) meeting process with the U.S.
Food and Drug Administration (FDA) for SP-3164. SP-3164 is a
next-generation targeted protein degrader that induces selective
elimination of cancer-causing proteins. Salarius is developing
SP-3164 as a potential treatment for hematological cancers and
solid tumors.
Through the pre-IND meeting process, Salarius
obtained valuable FDA input that provided clarity on preclinical,
clinical, and other regulatory matters for preparing and submitting
an IND. Salarius is planning to submit an IND in 2023 and, upon
receiving IND activation from the FDA, initiate the first clinical
trial that same year.
“SP-3164 is a unique opportunity for Salarius to
enter the fast-growing field of targeted protein degradation, which
offers potential to develop medicines targeting cancer-promoting
proteins that have historically been considered undruggable,” said
David Arthur, CEO of Salarius Pharmaceuticals. “The successful
completion of the pre-IND meeting process supports our plan to
initiate the first clinical trial with SP-3164 in 2023. We look
forward to having multiple clinical programs across two important
drug classes: protein degradation with SP-3164 and protein
inhibition with seclidemstat.”
About SP-3164
SP-3164 is a next-generation,
deuterium-stabilized (S)-enantiomer of avadomide (CC-122).
Avadomide is one of the most extensively studied molecular glues, a
class of targeted protein degraders, and data from various clinical
trials in hematological cancers and solid tumors has shown
potential efficacy and tolerability. SP-3164 is a patent-protected
new molecular entity derived from avadomide with the potential for
increased efficacy and improved safety, based upon preclinical
results to date.
About Salarius
Pharmaceuticals
Salarius Pharmaceuticals, Inc. is a
clinical-stage biopharmaceutical company developing cancer
therapies for patients in need of new treatment options. Salarius’
product portfolio includes seclidemstat, the company’s lead
candidate, which is being studied as a potential treatment for
pediatric cancers, sarcomas, and other cancers with limited
treatment options, and SP-3164, an oral small molecule protein
degrader. Seclidemstat is currently in a Phase 1/2 clinical trial
for relapsed/refractory Ewing sarcoma and select additional
sarcomas that share a similar biology to Ewing sarcoma, also
referred to as Ewing-related or FET-rearranged sarcomas.
Seclidemstat has received Fast Track Designation, Orphan Drug
Designation, and Rare Pediatric Disease Designation for Ewing
sarcoma from the U.S. Food and Drug Administration. Salarius is
also exploring seclidemstat’s potential in several cancers with
high unmet medical need, with a second Phase 1/2 clinical study in
hematologic cancers, initiated by MD Anderson Cancer Center.
Salarius has received financial support from the National Pediatric
Cancer Foundation to advance the Ewing sarcoma clinical program and
was also a recipient of a Product Development Award from the Cancer
Prevention and Research Institute of Texas (CPRIT). For more
information, please visit salariuspharma.com or follow Salarius on
Twitter and LinkedIn.
Forward-Looking
Statements
This press release contains
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995. All statements, other
than statements of historical facts, included in this press release
are forward-looking statements. These forward-looking statements
may be identified by terms such as “aim,” “believe,” “can,”
“continue,” “developing,” “estimate,” “expect,” “look forward to,”
“opportunity,” “potential,” “progress,” “could prove,” “plan,”
“position,” “potential,” “suggest,” “will,” and similar
terms or expressions or the negative thereof. Examples of such
statements include, but are not limited to, statements relating to
the following: the company’s growth strategy; the timing of IND
submission and initiation of clinical trials for SP-3164; the
advantages of protein degraders including the value of SP-3164 as a
cancer treatment; whether the company will develop additional
undisclosed cancer-fighting assets in the targeted protein
degradation space; collaborations between the company and its
DeuteRx colleagues to complete SP-3164 development activities and
development of future products; the value
of seclidemstat as a treatment for Ewing sarcoma,
Ewing-related sarcomas, and other cancers; expanding the scope of
the Company’s research and focus to high unmet need patient
populations; milestones of the company’s current and
future clinical trials, including the timing of data readouts;
and the expectation that Salarius’ cash runway extending through
2022. Salarius may not actually achieve the plans, carry out the
intentions or meet the expectations or objectives disclosed in the
forward-looking statements. You should not place undue reliance on
these forward-looking statements. These statements are subject to
risks and uncertainties which could cause actual results and
performance to differ materially from those discussed in the
forward-looking statements. These risks and uncertainties include,
but are not limited to, the following: the sufficiency of the
company’s capital resources; the ability of, and need for, the
company to raise additional capital to meet the company’s business
operational needs and to achieve its business objectives and
strategy; the company’s ability to project future capital needs and
cash utilization and timing and accuracy thereof; the ability of
the company to access the remaining funding available under the
CPRIT grant; future clinical trial results and impact of results on
the company; that the results of studies and clinical trials may
not be predictive of future clinical trial results; the sufficiency
of Salarius’ intellectual property protection; risks related to the
drug development and the regulatory approval process; the
competitive landscape and other industry-related risks; market
conditions and regulatory or contractual restrictions which may
impact the ability of Salarius to raise additional capital; the
possibility of unexpected expenses or other uses of Salarius’ cash
resources; risks related to the COVID-19 outbreak; and other risks
described in Salarius’ filings with the Securities and Exchange
Commission, including those discussed in the company’s quarterly
report on Form 10-Q for the quarter ended June 30, 2021
and in the company’s annual report on Form 10-K for the year ended
December 31, 2020. The forward-looking statements contained in this
press release speak only as of the date of this press release and
are based on management’s assumptions and estimates as of such
date. Salarius disclaims any intent or obligation to update these
forward-looking statements to reflect events or circumstances that
exist after the date on which they were made.
ContactTiberend Strategic Advisors, Inc. Jason
Rando/Daniel Kontoh-Boateng (Investors)jrando@tiberend.com
dboateng@tiberend.com
Bill Borden (Media)bborden@tiberend.com
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