Salarius Pharmaceuticals Presents Compelling Data in Two SP-3164 Targeted Protein Degrader Posters at the American Association for Cancer Research Annual Meeting
April 20 2023 - 7:30AM
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, today announced the presentation of
two posters related to the company’s novel molecular glue, SP-3164,
at the American Association for Cancer Research (AACR) Annual
Meeting. Both abstracts highlight preclinical findings with
SP-3164, with one focused on non-Hodgkin lymphoma (NHL) and the
other on multiple myeloma (MM).
“These two studies presented at the prestigious
AACR Annual Meeting are adding to the growing body of SP-3164
preclinical data demonstrating anticancer activity alone and in
combination with standard-of-care treatments,” said David Arthur,
president and chief executive officer of Salarius. “In addition, we
were excited at the level of interest – at both poster
presentations – by representatives from large pharmaceutical
companies, biotech companies, and cancer researchers.”
Research presented at AACR by Daniela
Santiesteban, Ph.D., director of protein degradation development at
Salarius, in a poster titled “SP-3164, a novel Ikaros and Aiolos
molecular glue degrader with preclinical activity in non-Hodgkin
lymphomas,” demonstrated:
- The robust protein degradation
effects of SP-3164 and validated it as the active anticancer
species of avadomide; and
- SP-3164’s compelling antitumor
activity of SP-3164 in animal models of follicular lymphoma, a type
of NHL, as a single agent and in combination with approved agents,
venetoclax (Venclexta®) or tazemetostat (Tazverik®).
The other poster was presented by Aundrietta
Duncan, Ph.D., director of non-clinical development at Salarius,
and was titled “SP-3164, a novel molecular glue degrader with
activity in preclinical models of multiple myeloma.” These studies
demonstrated the protein degradation and antitumor activity of
SP-3164 in both cell line and animal models of multiple myeloma. In
addition, the data showed SP-3164 induced apoptosis in multiple
myeloma cell lines. In animal models, SP-3164 demonstrated superior
single-agent activity compared to both lenalidomide (Revlimid®) and
pomalidomide (Pomalyst®). Also in MM animal models, the combination
treatment of SP-3164 and the approved therapy bortezomib (Velcade®)
was superior to the combination of pomalidomide and bortezomib.
Both posters are available on Salarius’ website
at www.salariuspharma.com.
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 also currently on a partial clinical hold 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 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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