Dr. Santiesteban will lead the development of SP-3164 and other targeted protein degradation assets
HOUSTON, Feb. 03, 2022 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company developing potential new medicines for patients with sarcomas, pediatric cancers, and other cancers, today announced that Daniela Santiesteban, Ph.D., has been named Director of the Company’s new targeted protein degradation program. In this newly created position, Dr. Santiesteban will assume responsibility for overseeing the development of SP-3164, the program’s lead drug candidate, and advancing it into clinical trials. Her appointment immediately follows Salarius’ recent strategic expansion into the targeted protein degradation field through its acquisition of SP-3164 and other assets from DeuteRx LLC.
“Our expansion into the targeted protein degradation field marks a seminal moment for Salarius, and I can think of no one better to lead those efforts than Daniela,” stated David Arthur, CEO of Salarius Pharmaceuticals. “Daniela is an accomplished leader with considerable scientific acumen who has helped advance our clinical-stage drug candidate, seclidemstat, and recently spearheaded the acquisition of SP-3164 and other targeted protein degradation assets. I am confident Daniela’s expertise will prove invaluable as we progress SP-3164 into the clinic and advance a development pipeline built around two exciting approaches to cancer-drug research – targeted protein degradation and protein inhibition.”
Following the transaction with DeuteRx, announced January 13, 2022, and in addition to seclidemstat, Salarius now owns a collection of targeted protein degradation assets that include SP-3164, the related patent family, including issued composition of matter patents, and the opportunity to develop additional undisclosed cancer-fighting assets in the targeted protein degradation space. Salarius plans to develop SP-3164 for hematologic and solid tumors.
“Targeted protein degradation has the potential to transform how we treat cancer,” stated Dr. Santiesteban. “I could not be more excited to lead the development of Salarius’s targeted protein degradation program and help achieve our goal of bringing novel treatments to patients who need them the most.”
Dr. Santiesteban will lead the Salarius team working with DeuteRx scientists to complete studies that will be included in Investigational New Drug (IND) applications for SP-3164 and other targeted protein degradation assets emerging from the purchased intellectual property portfolio. Salarius expects to file an IND for SP-3164 with the U.S. Food and Drug Administration (FDA) in the first half of 2023.
Dr. Santiesteban earned a doctorate in Biomedical Engineering from the Georgia Institute of Technology and Emory University where she focused on the development of novel cancer diagnostic and therapeutic agents. She joined Salarius in 2018 and has served in several key roles including leading business development activities, pursuing academic and business partnerships, and supporting the company’s product development strategy.
About Targeted Protein Degradation and SP-3164
Targeted protein degradation is a fast-growing field of drug research that takes advantage of the body’s own degradation system to promote the selective elimination of disease-causing proteins. SP-3164 is the next-generation, deuterium-stabilized (S)-enantiomer of avadomide, an existing compound also known as CC-122 previously under development by Celgene. Avadomide is one of the most extensively studied molecular glues, a class of targeted protein degraders. It has been studied in more than 400 subjects across 10 clinical trials for patients with hematological cancers and solid tumors and has demonstrated efficacy when used as a single agent and when used in combination therapy. SP-3164 is a patent-protected new molecular entity with the potential for increased efficacy and improved safety compared to avadomide.
Avadomide is a 1:1 mixture of two mirror-image compounds ((R)- and (S)-enantiomers) that interconvert in vitro and in vivo. Using deuterium, DeuteRx stabilized each enantiomer and characterized their dramatically different pharmacological properties. In in vitro studies, SP-3164, the deuterium-stabilized (S)-enantiomer, has been shown to be the active enantiomer as it is primarily responsible for the cereblon-binding and the anti-inflammatory activity of avadomide1. As a result, in a preclinical efficacy model, SP3164 exhibited the anti-tumorigenic activity while the (R)-enantiomer appears to promote tumor growth2. Based upon preclinical results to date, SP-3164 has the potential to exhibit a better therapeutic profile than avadomide and will be the first stabilized, single enantiomer cereblon-binding targeted protein degradation agent to enter the clinic.
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 targeted 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 “developing,” “expect,” “potential,” “plan,” “potential,” “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 the filing of an IND and the initiation of clinical trials for SP-3164; the advantages of protein degraders including the value of SP-3164 as a cancer treatment; the company’s plan to develop SP-3164 for hematologic and solid tumors; 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.
1. Jacques, et al., Proc Natl Acad Sci. 2015, 112(12), E1471-9.
2. DeWitt, et al., Poster presented at Hematologic Malignancies, FASEB Science Research Conference (SRC); 2017 Jul 23-28; Saxtons River, VT
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