Salarius Pharmaceuticals Reports No Adverse Safety Signals from Two Good Laboratory Practice Toxicology Studies with its Targeted Protein Degrader SP-3164
01 May 2023 - 10:30PM
Salarius Pharmaceuticals, Inc. (NASDAQ: SLRX), a
clinical-stage biopharmaceutical company using protein inhibition
and protein degradation to develop cancer therapies for patients in
need of new treatment options, announces the completion of two Good
Laboratory Practice (GLP) toxicology studies with its targeted
protein degrader SP-3164, with no unexpected safety findings during
the course of either study. These GLP toxicology reports will be
included in the Investigational New Drug (IND) application the
company plans to submit to the U.S. Food and Drug Administration
(FDA) in the second quarter of 2023.
“We are encouraged by the successful completion
of these GLP toxicology studies, which represents another
significant milestone in the development of SP-3164. Based on
preclinical research completed to date, we believe SP-3164 has
potential to address several types of lymphomas and other cancers
both as monotherapy and in combination with approved standard of
care therapies,” said David Arthur, president and chief executive
officer of Salarius. “These results reinforce our belief that
SP-3164 holds significant promise to improve the treatment paradigm
for blood cancers.”
Salarius held a pre-IND meeting with the FDA in
May 2022 and is in the process of completing activities that will
allow it to commence a Phase 1 study in the second half of this
year.
About SP-3164SP-3164 is an
oral, next-generation molecular glue that uses Salarius’
deuterium-enabled chiral switching platform to stabilize the
preferred (S)-enantiomer of avadomide, an extensively studied
clinical compound that has demonstrated encouraging single-agent
and combination-therapy clinical efficacy in non-Hodgkin Lymphomas
(NHL) and other hematologic malignancies. The addition of deuterium
at the chiral center of the molecule prevents conversion to the
unwanted (R)-enantiomer, allowing for isolation and development of
the preferred (S)-enantiomer into a potential new cancer
treatment.
As such, SP-3164 is a new chemical entity and
has been issued a U.S. composition-of-matter patent. Data presented
in December 2022 at the American Society for Hematology Annual
Meeting showed compelling SP-3164 activity in lymphoma models and
supports SP-3164’s potential for the Phase 1 clinical trial in NHL
planned to initiate in 2023. Additional supporting data were
presented in April 2023 at the American Association for Cancer
Research Annual Meeting showing SP-3164 demonstrates compelling
antitumor activity in animal models of follicular lymphoma and
multiple myeloma.
About Salarius
PharmaceuticalsSalarius Pharmaceuticals, Inc. is a
clinical-stage biopharmaceutical company developing therapies for
patients with cancer in need of new treatment options. Salarius’
product portfolio includes seclidemstat, Salarius’ 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. This trial is currently on a partial clinical hold
and is not enrolling new patients. Seclidemstat has received fast
track, orphan drug and rare pediatric disease designations 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 an investigator-initiated Phase 1/2
clinical study in hematologic cancers at MD Anderson Cancer Center.
This trial is currently on a voluntary pause and is not enrolling
new patients. Salarius has received financial support from the
National Pediatric Cancer Foundation to advance the Ewing program
and was a recipient of a Product Development Award from the Cancer
Prevention and Research Institute of Texas (CPRIT). SP-3164 is
currently in IND-enabling studies and anticipated to enter the
clinic in 2023. 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
“will,” “believe,” “developing,” “expect,” “may,” “progress,”
“potential,” “could,” “look forward,” “encouraging,” “might,”
“should,” 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 future of the company’s
Phase 1/2 trial of seclidemstat as a treatment for Ewing sarcoma
and FET-rearranged sarcomas following the recently announced
suspected unexpected severe adverse reaction (SUSAR) event and
resulting partial clinical hold by the U.S. Food and Drug
Administration (FDA); impact that the addition of new clinical
sites will have on the development of Salarius’ product candidates;
the timing of Salarius’ IND submissions to the FDA and subsequent
timing for initiating clinical trials; interim data related to
Salarius’ clinical trials, including the timing of when such data
is available and made public; Salarius’ growth strategy; the value
of seclidemstat as a treatment for Ewing sarcoma, Ewing-related
sarcomas, and other cancers and its ability to improve the life of
patients; expanding the scope of Salarius’ research and focus to
high unmet need patient populations; milestones of Salarius’
current and future clinical trials, including the timing of data
readouts. 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 FDA may impose
additional restrictions on the company’s Phase 1/2 trial of
seclidemstat as a treatment for Ewing sarcoma and FET-rearranged
sarcomas following the SUSAR, including a partial or full clinical
hold; Salarius’ ability to resume enrollment in the clinical trial
following its review of the available data surrounding the SUSAR;
the sufficiency of Salarius’ capital resources; the ability of, and
need for, Salarius to raise additional capital to meet Salarius’
business operational needs and to achieve its business objectives
and strategy; future clinical trial results and the impact of such
results on Salarius; that the results of studies and clinical
trials may not be predictive of future clinical trial results;
risks related to the drug development and the regulatory approval
process; the competitive landscape and other industry-related
risks; and other risks described in Salarius’ filings with
the Securities and Exchange Commission, including its Annual Report
on Form 10-K for the fiscal year ended December 31, 2022, as
revised or supplemented by its Quarterly Reports on Form 10-Q and
other documents filed with the SEC. 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.
CONTACT:
LHA Investor RelationsKim Sutton Golodetz
kgolodetz@lhai.com212-838-3777
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