Actuate Therapeutics Advances Elraglusib As Potential Backbone Therapy For Pancreatic Cancer With Phase 2 Data Supporting Upcoming FDA And EMA Submissions

• Elraglusib represents a potential back bone therapy in pancreatic cancer with three ongoing trials in combination with current standards of care and novel immunotherapies
• Recent financing provides extended runway through key anticipated regulatory inflection points
• Additional nonclinical studies are ongoing combining elraglusib with RAS inhibitors based on potential synergies and complimentary mechanisms of action
  
   

CHICAGO and FORT WORTH, Texas, Sept. 22, 2025 (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 through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), today announced a corporate update on the regulatory path for elraglusib in pancreatic cancer and anticipated milestones enabled by the recent $17.25 million public offering.

Actuate has amended its investigational new drug (IND) application with updated clinical data from its international randomized Phase 2 trial in first-line treatment of metastatic pancreatic cancer (Actuate-1801 Part 3B), which showed a statistically significant improvement in median overall survival with the combination arm of elraglusib plus gemcitabine/nab-paclitaxel (GnP) versus GnP alone. These data are intended to support planned regulatory submissions with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) beginning later this year and continuing into early 2026.

The 1801-3B Phase 2 study is currently ongoing, with 22 patients in the elraglusib plus GnP arm either in active treatment or survival follow-up, ranging from 20 to 42 months in time on study, while only 3 patients remain in survival follow-up in the GnP arm, with time on study ranging from 21 to 23 months.

These compelling results of elraglusib in combination with GnP, combined with early data demonstrating significant and durable long term responses in patients with highly metastatic disease treated with the combination of elraglusib/FOLFIRINOX/losartan in the ongoing clinical trial in patients with mPDAC led by Havard/MGH, plus the new clinical collaboration with Incyte and UPMC Hillman Cancer Center in patients with advanced pancreatic cancer using the combination of modified FOLFIRINOX and Incyte's anti-PD-1 retifanlimab, further strengthen the case for elraglusib as a back-bone therapy that can be combined with different regimens used to treat this highly aggressive and deadly disease.