Core Insights - Actuate Therapeutics, Inc. reported significant clinical benefits of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) for patients with first-line metastatic pancreatic adenocarcinoma, showing a near doubling of 1-year overall survival (OS) and a 43% reduction in risk of death compared to GnP alone [1][2][7] Company Overview - Actuate Therapeutics is a clinical-stage biopharmaceutical company focused on developing therapies for difficult-to-treat cancers, with elraglusib as its lead investigational drug targeting GSK-3β to inhibit tumor growth and enhance anti-tumor immunity [9] Clinical Trial Results - In the Phase 2 trial (Actuate-1801 Part 3B), patients receiving elraglusib plus GnP achieved a median overall survival (mOS) of 12.5 months compared to 8.5 months in the control group, with a disease control rate (DCR) of 53.4% versus 44.8% and an overall response rate (ORR) of 37.9% versus 29.3% [2][5] - Patients with liver metastases experienced a 2.5-fold increase in 1-year OS and a 38% reduction in risk of death, with a survival probability of 13.6% at 18 months for those treated with elraglusib [5][7] Efficacy Metrics - Additional efficacy metrics for patients with liver metastases included a DCR of 36.8% versus 27.9%, an ORR of 29.8% versus 19.7%, and a median progression-free survival (PFS) of 4.9 months compared to 3.9 months in the control group [5][7]

Core Insights - Actuate Therapeutics, Inc. is hosting a key opinion leader event at the 2025 ASCO annual meeting to discuss topline clinical data from the randomized Phase 2 study of elraglusib [1][3][7] - The event will feature a discussion moderated by the CEO of Actuate and include four distinguished KOLs from leading medical institutions [2][3] - The focus will be on the clinical relevance and potential impact of the study's findings on treatment paradigms for metastatic pancreatic ductal adenocarcinoma (mPDAC) [3][7] Event Details - The event is scheduled for May 31, 2025, at 6:30 PM CDT, and will be available both in-person and via live webcast [4][7] - Registration details and a replay of the event will be accessible on the Actuate website [4] Featured Speakers - The event will include notable speakers such as Dr. Tanios Bekaii-Saab, Dr. Devalingam Mahalingam, Dr. Rachna Shroff, and Dr. Colin Weekes, all of whom have significant expertise in gastrointestinal cancers [5][6][8][9] ASCO Presentation Details - Actuate will present preliminary results from the randomized Phase 2 study of elraglusib in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel alone for previously untreated mPDAC patients [10][11] - The study enrolled 286 patients, randomized in a 2:1 ratio to receive elraglusib or the control treatment [13] - The primary endpoint is the 1-year survival rate, with secondary endpoints including disease control rate, overall response rate, progression-free survival, and adverse events [13] Mechanism of Action - Elraglusib, a GSK-3β inhibitor, may enhance chemotherapy activity, activate anti-tumor immunity, and regulate gene expression, potentially improving survival outcomes [14][15]

CHICAGO and FORT WORTH, Texas, May 06, 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 that elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) met the primary endpoints and achieved statistical significance in topline results from ...

Core Insights - Actuate Therapeutics, Inc. announced that topline clinical data from its Phase 2 study of elraglusib in combination with gemcitabine/nab-paclitaxel for treating metastatic pancreatic ductal adenocarcinoma has been selected for oral presentation at the 2025 ASCO Annual Meeting [1][2] Company Overview - Actuate Therapeutics is a clinical-stage biopharmaceutical company focused on developing therapies for high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β) [1][3] - The lead investigational drug, elraglusib, targets molecular pathways involved in tumor growth and resistance to conventional cancer drugs, potentially mediating anti-tumor immunity [3] Presentation Details - The oral presentation will include preliminary results from the randomized Phase 2 study comparing elraglusib in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel alone in previously untreated patients with metastatic pancreatic ductal adenocarcinoma [2] - The session is scheduled for May 31, 2025, from 3:00 PM to 6:00 PM CDT, under the title "Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary" [3]