Salarius Pharmaceuticals Presents SP-3164 Targeted Protein Degrader Preclinical Data at the European Hematology Association 2023 Hybrid Congress
June 12 2023 - 8:00AM
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 presentation of a
poster related to the company’s novel molecular glue, SP-3164, at
the European Hematology Association 2023 Hybrid Conference, which
was held in Frankfurt, Germany and virtually June 8-11, 2023.
Research presented on June 9, 2023 by Aundrietta
Duncan, Ph.D., director of non-clinical development at Salarius, in
a poster titled “A Novel Cereblon-Binding Molecular Glue, Sp-3164,
Shows Preclinical Activity In Non-Hodgkin Lymphomas” and available
here, demonstrated:
- Potent degradation of Ikaros and
Aiolos (I/A) in peripheral blood mononuclear cells (PBMC) within 2
hours of dosing, which increased in a dose- and time-dependent
manner over 24 hours.
- SP-3164 does not negatively impact
PBMC at clinically relevant concentrations up to 96 hours
post-treatment.
- In addition to having direct
antitumor effects, SP-3164 also induces an anticancer
immunomodulatory effect as demonstrated through the induction of
cytokine secretion in human T cells following treatment.
In addition, new quantitative proteomic data
revealed that in Jeko-1 (lymphoma) cells, SP-3164 induces twice the
degradation of target proteins I/A at 1/10th the dose of
lenalidomide, providing further support for the development of
SP-3164 in relapsed refractory non-Hodgkin lymphoma.
“We continue to advance our body of knowledge
for SP-3164, with data generated to date demonstrating potent
antitumor activity that supports our plans to file an
Investigational New Drug application with the U.S. Food and Drug
Administration in the coming weeks. We plan to begin a Phase 1
study in the second half of the year,” said David Arthur, president
and chief executive officer of Salarius. “Our first therapeutic
target is blood cancer, and we are excited to embark on a potential
new treatment option for these patients.”
About Salarius
Pharmaceuticals
Salarius 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 that is being
developed as a treatment for non-Hodgkin lymphoma.
Seclidemstat has received fast track, orphan
drug and rare pediatric disease designations for Ewing sarcoma from
the U.S. Food and Drug Administration and is currently in a Phase
1/2 clinical trial for relapsed/refractory Ewing sarcoma. 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.
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 is anticipated to enter the clinic in
2023.
Forward-Looking StatementsThis
press release and the referenced presentations contain
“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
and the referenced presentations are forward-looking statements.
These forward-looking statements may be identified by terms such as
“will,” “believe,” “developing,” “expect,” “excited,” “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); the advantages of protein degraders including
the value of SP-3164 as a cancer treatment; the timing of clinical
trials for SP-3164 and expected therapeutic options for SP-3164 and
related effects and projected efficacy; the 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: Salarius’ ability to
continue as a going concern; it may take considerable time and
expense to resolve the partial clinical hold that has been placed
on Salarius’ Phase 1/2 trial of seclidemstat as a treatment for
Ewing sarcoma and FET-rearranged sarcomas by the FDA, and no
assurance can be given that the FDA will remove the partial
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
and the referenced presentations speak only as of the date of this
press release and the referenced presentations 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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