• Elraglusib oral tablet formulation to drive next-phase clinical development and broader clinical use
  • FDA cleared IND for Phase 1/2 study of oral elraglusib in advanced cancer patients, with focus on metastatic melanoma, NSCLC, colorectal, and pancreatic cancers with initiation planned for 2H 2026
  • Elraglusib plus RAS inhibitor preclinical results expected in mid-2026
  • Industry veteran Martin Huber, MD, joins Board of Directors

CHICAGO and FORT WORTH, Texas, May 11, 2026 (GLOBE NEWSWIRE) -- Actuate Therapeutics, Inc. (NASDAQ:ACTU) ("Actuate" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers, today announced key initiatives to advance and expand the potential of the elraglusib development program.

Actuate is prioritizing the development of the elraglusib oral tablet formulation, which is intended to enhance patient convenience, broaden potential clinical utility, and improve the pharmacokinetic exposure of elraglusib across multiple oncology indications. This strategy is supported by an analysis of patient data from the recently completed Phase 2 study in metastatic pancreatic ductal adenocarcinoma (mPDAC), which identified a positive correlation between drug exposure and clinical outcomes, including meaningful improvement in overall survival.

To support this initiative, the Company recently received Investigational New Drug (IND) clearance from FDA to conduct a Phase 1/2 study designed to demonstrate that a higher overall exposure to elraglusib can be achieved with the oral formulation compared to the IV formulation. The study will evaluate the safety and potential efficacy of the oral formulation as a monotherapy in solid tumor patients, including those with metastatic melanoma, NSCLC, colorectal, and pancreatic cancers, based on evidence of efficacy of the IV formulation in prior clinical studies and machine learning therapeutic target analyses.

The Company has worked with the European Medicines Agency (EMA) to obtain specific guidance regarding elements of a trial design for a potential single registration study for IV treatment of mPDAC. As demonstrated by the positive Phase 2 results published in Nature Medicine, elraglusib combined with gemcitabine plus nab-paclitaxel (GnP) showed statistically significant improvement in overall survival in patients that received the IV formulation of elraglusib once weekly. Going forward, the Company will work with the EMA and FDA on specific guidance regarding elements of the trial design for a potential single registration study with the oral tablet formulation of elraglusib.