On November 2, 2026 Actuate Therapeutics, Inc. (NASDAQ: ACTU) ("Actuate" or the "Company"), a clinical-stage biopharmaceutical company focused on developing novel therapies for difficult-to-treat cancers, reported that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application No. 19/669,218, titled "Oral Dosage Forms of Elraglusib." The allowed claims cover the composition of oral tablet forms of elraglusib, an inhibitor of GSK-3β, the Company’s lead clinical investigational candidate, including the optimized Elraglusib Oral Tablet developed for upcoming use in clinical trials.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Elraglusib Oral Tablet is being developed to enable convenient daily dosing with the potential to provide sustained GSK-3β inhibition, leading to enhanced antitumor activity. Pre-clinical and clinical exposure-effect analysis has identified threshold plasma levels of elraglusib associated with clinical benefit, inhibition of tumor growth and reduction in tumor size. Sustained exposure of elraglusib has been observed to elicit direct effects on tumor cells as well as a unique array of complementary effects on anti-tumor immune response that lead to increased CD8+ and NK cell recruitment, attenuation of immune suppressive features and altering the tumor immune microenvironment to prime the tumor for sustained anti-tumor immune response. To date, elraglusib has been administered intravenously (Elraglusib Injection) using weekly or twice weekly intermittent dosing in several clinical studies in refractory and resistant adult and pediatric cancers.
Elraglusib Oral Tablet is a key part of Actuate’s clinical development strategy, with potential utility as a monotherapy and in combination treatment and maintenance therapy approaches. Actuate plans to initiate a Phase 1/2 clinical trial of Elraglusib Oral Tablet in the first quarter of 2027 to evaluate its safety, tolerability, pharmacokinetics and screen for initial evidence of antitumor activity in patients with advanced cancer.
"The development of an optimized oral tablet dosage form marks an important advance in realizing elraglusib’s therapeutic potential," said Daniel Schmitt, President and Chief Executive Officer of Actuate Therapeutics. "Daily oral administration is expected to enable sustained plasma drug exposure and inhibition of GSK-3 in a tumor, potentially promoting sustained changes in immune cell dynamics that favor antitumor immune responses. This approach could also provide greater dosing flexibility and patient convenience and expand opportunities to investigate elraglusib as both a monotherapy and in combination with other cancer treatments."
"The allowance of this patent application represents an important milestone in strengthening our intellectual property portfolio around oral formulations of elraglusib including protection for the oral tablet dosage form," said Andrew Mazar, PhD, Chief Operating Officer at Actuate Therapeutics. "With our imminent Phase 1/2 clinical trial, we anticipate being able to more fully explore the clinical potential of elraglusib in the next stage of development as we bring a new oral treatment option with a unique immunomodulatory mechanism of action to cancer patients in need."
The patent, upon completion of customary USPTO procedures, is expected to further strengthen Actuate’s intellectual property portfolio, support continued stage appropriate development, leading to the future potential commercialization of oral elraglusib.
(Press release, Actuate Therapeutics, NOV 2, 2026, https://www.globenewswire.com/news-release/2026/11/02/3393067/0/en/actuate-therapeutics-receives-u-s-notice-of-allowance-for-patent-covering-elraglusib-oral-tablets.html [SID1234674067])