Salarius Pharmaceuticals Announces Two Abstracts Accepted for Presentation at the American Association for Cancer Research Annual Meeting

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HOUSTON, March 15, 2023 (GLOBE NEWSWIRE) -- 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 that two abstracts related to the company’s novel molecular glue SP-3164 have been accepted for presentation at the American Association for Cancer Research (AACR) Annual Meeting, being held April 14-19 at the Orange County Convention Center in Orlando, Florida and also virtually. Both abstracts highlight preclinical activity with SP-3164, one focused on non-Hodgkin’s lymphoma (NHL) and the other on multiple myeloma (MM).

One abstract is titled “SP-3164, a novel Ikaros and Aiolos molecular glue degrader with preclinical activity in non-Hodgkin lymphomas,” and concludes that SP-3164 is a novel, orally available, cereblon-binding molecular glue with attractive therapeutic properties and significant anticancer activity in NHL cell line and animal models. Further assessment of SP-3164’s potential as a treatment for NHLs is warranted and a clinical trial is planned to start in 2023.

The other abstract, titled “SP-3164, a novel molecular glue degrader with activity in preclinical models of multiple myeloma,” concludes that SP-3164 is a potent cereblon-binding molecular glue with the ability to rapidly degrade cancer-promoting proteins and induce cell death in multiple myeloma cell lines. In multiple myeloma animal models, SP-3164 has superior single agent and combination treatment activity compared to approved molecular glues. These data support the continued development of SP-3164 as a novel therapy in MM.

The abstracts were published yesterday afternoon and are now available on the AACR website at https://www.aacr.org. Details of the presentations are as follows:

SP-3164 NHL Presentation

Title: “SP-3164, a novel Ikaros and Aiolos molecular glue degrader with preclinical activity in non-Hodgkin lymphomas”

Session Category: Experimental and Molecular Therapeutics

Session Title: Novel Antitumor Agents 2

Session Date and Time: Sunday Apr. 16, 2023, 1:30 PM - 5:00 PM

Location: Poster Section 18

Poster Board Number: 24

Published Abstract Number: 524

Presenter: Daniela Santiesteban, Ph.D., Director of Targeted Protein Degradation Development, Salarius

SP-3164 MM Presentation

Title: “SP-3164, a novel molecular glue degrader with activity in preclinical models of multiple myeloma”

Session Category: Experimental and Molecular Therapeutics

Session Title: DNA-reactive Agents, HDAC and Methyltransferase Inhibitors, and Tubulin Agents

Session Date and Time: Wednesday Apr. 19, 2023, 9:00 AM - 12:30 PM

Location: Poster Section 19

Poster Board Number: 23

Published Abstract Number: 6253

Presenter: Aundrietta D. Duncan, Ph.D., Director, Non-Clinical Development, Salarius

Following the presentations at AACR, both posters will be 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 and certain additional sarcomas that share a similar biology. 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 announcement 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 announcement and the referenced presentations are forward-looking statements. These forward-looking statements may be identified by terms such as “will,” “future,” “believe,” “developing,” “expect,” “may,” “progress,” “potential,” “could,” “look forward,” “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 advantages of seclidemstat (SP-2577) as a treatment for Ewing sarcoma, Ewing-related sarcomas, and other cancers and its ability to improve the life of patients; expected cohort readouts from the company’s clinical trials and expected therapeutic options for SP-2577 and related effects and projected efficacy, including SP-2577’s ability to inhibit LSD1; 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; impact that the addition of new clinical sites will have on the development of our product candidates; the timing of our IND submissions to the FDA and subsequent timing for initiating clinical trials; interim data related to our clinical trials, including the timing of when such data is available and made public; our growth strategy; whether the company will develop additional undisclosed cancer-fighting assets in the targeted protein degradation space; expanding the scope of our research and focus to high unmet need patient populations; and the commercial or market opportunity and expansion for each therapeutic option, including the availability and value of a pediatric priority review voucher for in-clinic treatments and potential for accelerated approval. We 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: Seclidemstat’s impact in Ewing sarcoma and as a potential new and less-toxic treatment; expected dose escalation and dose expansion; resolution of the FDA’s partial clinical hold on the company’s Phase 1/2 trial of seclidemstat as a treatment for Ewing sarcoma and FET-rearranged sarcomas following the SUSAR; our ability to resume enrollment in the clinical trial following its review of the available data surrounding the SUSAR; the adequacy of our capital to support our future operations and our ability to successfully initiate and complete clinical trials and regulatory submissions; the ability of, and need for, us to raise additional capital to meet our business operational needs and to achieve its business objectives and strategy; future clinical trial results and the impact of such results on us; 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 our filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2021, 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 announcement and the referenced presentations speak only as of the date of this announcement and the referenced presentations and are based on management’s assumptions and estimates as of such date. We disclaim 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 [email protected]212-838-3777