Full Press Release Details
Oral tablet form expected to allow Company to optimize patient plasma exposure levels with convenient daily dosing of drug
Sustained plasma levels of elraglusib expected to have multiple effects on immune cell dynamics with potential to enhance anti-tumor immune response
Patent allowance advances protection for Elraglusib Oral Tablet ahead of planned Phase 1/2 clinical trial in Q1 2027
CHICAGO and FORT WORTH, Texas, Nov. 02, 2026 (GLOBE NEWSWIRE) -- Actuate Therapeutics, Inc. (NASDAQ: ACTU) (“Actuate” or the “Company”), a clinical-stage biopharmaceutical company focused on developing novel therapies for difficult-to-treat cancers, today announced 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.
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.
About Actuate Therapeutics, Inc.
Actuate is a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers. Actuate’s lead investigational drug, elraglusib (a novel GSK-3β inhibitor), targets molecular pathways in cancer that are involved in activation of anti-tumor immunity through the regulation of multiple immune checkpoints and immune cell function in addition to targeting those promoting tumor growth and resistance to conventional chemotherapy.
For additional information, please visit the Company’s website at www.actuatetherapeutics.com or follow us on LinkedIn, X, and Facebook.
Forward-Looking Statements
This press release contains forward-looking statements under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including statements regarding the expected issuance of a patent from U.S. Patent Application No. 19/669,218, the scope of protection it may provide, the anticipated timing and design of a Phase 1/2 clinical trial of the Elraglusib Oral Tablet, and the potential benefits of oral elraglusib, including its potential to enhance antitumor activity, improve patient convenience and expand therapeutic applications. Forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially, including (i) the risk that we may not be able to commence or complete our expected Phase 1/2 trial of Elraglusib Oral Tablet or, if we can, that the Phase 1/2 trial may not produce positive results, (ii) success in early phases of clinicals trials do not ensure later clinical trials will be successful; (iii) the risk that the Company may not be able to obtain additional working capital with which to complete the Phase 1/2 clinical trial, or advance to the initiation of registration-enabling studies, for Elraglusib Oral Tablet as and when needed and (iv) those other risks disclosed under the caption “Risk Factors” in Actuate’s Annual Report of Form 10-K filed with the Securities and Exchange Commission on March 26, 2026 and in Actuate’s subsequent filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. Actuate does not undertake and specifically disclaims any obligation to update or revise such statements to reflect new circumstances or unanticipated events as they occur, except as required by law.