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Salarius Pharmaceuticals Completes SP-3164 Pre-Investigational New Drug Meeting Process with the U.S. Food and Drug Administration

Salarius planning for SP-3164 IND Application Submission in 2023

HOUSTON, May 11, 2022 (GLOBE NEWSWIRE) -- 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. 

Tiberend Strategic Advisors, Inc.
Jason Rando/Daniel Kontoh-Boateng (Investors)

Bill Borden (Media)

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Source: Salarius Pharmaceuticals, Inc.