Salarius Pharmaceuticals Issued U.S. Patent for Next-Generation Targeted Protein Degraders

Rhea-AI Summary

Salarius Pharmaceuticals, Inc. (SLRX) has expanded its IP portfolio with composition-of-matter protection until 2039 for novel molecular glues, adding to its existing 17 issued patents across six patent families. This expansion covers the composition of matter for novel molecular glue degraders and extends the protection of Salarius’ targeted protein degradation (TPD) pipeline. The company is also exploring strategic options to advance the development of the TPD portfolio with third parties.

Biotechnology Patent Analyst

The issuance of U.S. Patent No. 11,773,080 to Salarius Pharmaceuticals significantly bolsters the company's intellectual property (IP) portfolio, specifically in the burgeoning field of targeted protein degradation (TPD). TPD is a cutting-edge therapeutic approach that leverages the body's cellular machinery to eliminate pathogenic proteins. The patent's extended protection into 2039 provides Salarius with a substantial competitive advantage, as it secures exclusive rights to their novel molecular glue degraders for an extended period.

From a biotechnology patent perspective, the strength and breadth of a company's IP portfolio are critical factors in its ability to attract partnerships, funding and to defend its market position against competitors. The fact that this is the 17th patent issued across six patent families indicates a robust and diverse research and development effort, which is essential for sustaining innovation and maintaining a pipeline of potential new therapies.

Moreover, the utilization of deuterium-enabled chiral switching (DECS) technology in their TPD platform is a noteworthy innovation. DECS technology involves the strategic replacement of hydrogen atoms with deuterium, potentially leading to drugs with improved pharmacokinetic properties, such as increased metabolic stability and reduced toxicity. Such technological advancements could play a vital role in the future success of Salarius' TPD pipeline.

Pharmaceutical Market Analyst

The strategic review initiated by Salarius Pharmaceuticals, with Canaccord Genuity LLC at the helm, is indicative of a pivotal moment for the company as it seeks to maximize shareholder value. The review could lead to a range of outcomes, including partnerships, mergers, or even a sale of the company. Investors often view such reviews as a signal that the company is open to significant corporate changes that could enhance its value or improve its operational strategy.

For stakeholders, the extended patent protection and the initiation of a Phase 1 clinical trial for SP-3164, a molecular glue degrader, are promising developments. The entry into clinical trials marks a transition from preclinical research to human testing, which is a critical milestone in drug development and can have a substantial impact on a company's valuation. Positive trial results can lead to an increase in stock price and investor confidence, while negative results can have the opposite effect.

It is important to note that while TPD is a promising field, it is also highly complex and competitive. The ability of Salarius to successfully navigate clinical trials and eventually bring products to market will depend on various factors, including the efficacy and safety of their compounds, regulatory hurdles and the competitive landscape. The long-term potential of Salarius' TPD portfolio will be contingent upon these factors, along with the company's strategic decisions following the review of alternatives.

Clinical Trials Expert

The approval by the FDA to begin a Phase 1 clinical trial for Salarius' SP-3164 is a momentous step for the company. Phase 1 trials are primarily concerned with assessing the safety, tolerability, pharmacokinetics and pharmacodynamics of a drug. The successful completion of this phase is crucial as it sets the stage for subsequent trials that will evaluate efficacy and further safety in larger populations.

Given the innovative nature of molecular glue degraders within TPD, the focus will be on demonstrating a favorable safety profile and determining the optimal dosage for future studies. The unique mechanism of action of these degraders, which involves the selective elimination of disease-causing proteins, represents a significant departure from traditional small molecule inhibitors. As a result, there will be a particular emphasis on monitoring for any unforeseen effects stemming from the novel therapeutic approach.

It is also worth noting that the FDA's clearance for Phase 1 trials suggests a preliminary validation of the underlying science and the potential therapeutic benefits. However, the path from Phase 1 to FDA approval is long and fraught with challenges, including demonstrating clear clinical benefits and navigating complex regulatory requirements. The outcome of these early trials will be closely watched by investors and industry peers alike, as they will influence the perceived potential and value of Salarius' entire TPD pipeline.

Expands IP portfolio with composition-of-matter protection into 2039 for novel molecular glues

Protein degrader portfolio now includes 17 issued patents across six patent families

HOUSTON, Jan. 16, 2024 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (NASDAQ: SLRX), announces that the U.S. Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,773,080, titled “Deuterium-enriched isoindolinonyl-azepanediones and related compounds and methods of treating medical disorders using same.” This patent covers the composition of matter for novel molecular glue degraders and expires in mid-2039.

As reported on August 8, 2023, Salarius retained Canaccord Genuity, LLC to lead a comprehensive review of strategic alternatives focusing on maximizing shareholder value. While these efforts are ongoing, the company continues to support its current programs, as appropriate.

Targeted protein degradation (TPD) utilizes the body’s own degradation system to promote the selective elimination of disease-causing proteins. This newly issued patent expands and extends protection of Salarius’ TPD pipeline, which is led by SP-3164, a molecular glue that is cleared by the U.S. Food and Drug Administration to begin a Phase 1 clinical trial.

David Arthur, President and CEO of Salarius, said, “We are delighted to continue building our TPD portfolio using our deuterium-enabled chiral switching (DECS) platform to identify and develop new therapeutics. The granting of this patent, the 17^th issued to Salarius in TPDs across six patent families, demonstrates the ability of the DECS platform to develop novel protein degraders.”

Salarius is currently evaluating strategic options to advance the development of the TPD portfolio with third parties.  

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, a potential treatment for pediatric cancers, sarcomas and hematologic or blood cancers, and SP-3164, an oral small molecule protein degrader for the treatment of non-Hodgkin’s lymphoma. Salarius has received financial support from the National Pediatric Cancer Foundation to advance the Ewing sarcoma program and was 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 “will,” “believe,” “developing,” “expect,” “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: Salarius’ expectations regarding the exploration of strategic alternatives, opportunities to extend Salarius’ resources, the future of the Company’s operations and product candidates; the future of the Company’s preclinical studies and clinical trials and development activities; the advantages of protein degraders including the value of SP-3164 as a cancer treatment; 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. Salarius may not actually achieve the plans, carry out the intentions or meet the expectations or objectives disclosed in these 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 risk that exploration of strategic alternatives may not result in any definitive transaction or enhance stockholder value and may create a distraction or uncertainty that may adversely affect our operating results, business, or investor perceptions; expectations regarding future costs and expenses; our product candidates being in early stages of development; the uncertainty about the paths of our programs and our ability to evaluate and identify a path forward for those programs, particularly given the constraints we have as a small company with limited financial, personnel and other operating resources (including with respect to the allocation of our limited capital and the sufficiency of our capital in the near term for any path we do select); Salarius’ ability to continue as a going concern; the sufficiency of Salarius’ capital resources; availability of suitable third parties with which to conduct contemplated strategic transactions; whether the Company will be able to pursue a strategic transaction, or whether any transaction, if pursued, will be completed successfully and on attractive terms or at all; whether our cash resources will be sufficient to fund the Company’s foreseeable and unforeseeable operating expenses and capital requirements; changes in the Company’s operating plans that may impact its cash expenditures; the uncertainties inherent in research and development, future clinical data and analysis; the risks associated with reductions in workforce, including reduced morale and attrition of additional employees necessary for the strategic reprioritization; 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; 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 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.

Contact:

LHA Investor Relations
Kim Sutton Golodetz
kgolodetz@lhai.com
212-838-3777

What is the new U.S. Patent No. 11,773,080 about?

The new U.S. Patent No. 11,773,080 covers the composition of matter for novel molecular glue degraders and expires in mid-2039.

How many patents does Salarius currently have in its TPD portfolio?

Salarius currently has 17 issued patents across six patent families in its TPD portfolio.

What is SP-3164 and its current status?

SP-3164 is a molecular glue that is cleared by the U.S. Food and Drug Administration to begin a Phase 1 clinical trial.

Who is leading the review of strategic alternatives for Salarius?

Canaccord Genuity, LLC is leading the comprehensive review of strategic alternatives for Salarius.

What is the company's plan for its current programs during the review of strategic alternatives?

The company continues to support its current programs, as appropriate, while the review of strategic alternatives is ongoing.