Core Insights - Actuate Therapeutics, Inc. announced promising results from a Phase II study of elraglusib, showing a median overall survival of 18.6 months and 40% of patients alive at 2 years [1][5][6] 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 [8] Study Details - The Phase II study evaluated elraglusib in combination with platinum chemotherapy in patients with advanced, metastatic salivary gland cancers, including adenoid cystic carcinoma [3][7] - The study enrolled 32 patients, with a median progression-free survival of 6.4 months and 27% of patients progression-free at 1 year [5][11] Key Findings - Nuclear GSK-3β expression was significantly higher in responders (50%) compared to non-responders (2%), suggesting its potential as a biomarker for treatment response [3][11] - Among non-ACC patients receiving immune priming followed by cisplatin plus elraglusib, the response rate was 18%, with all responders showing elevated nuclear GSK-3β expression [4][6] Treatment Efficacy - The median overall survival for non-ACC patients was notably higher at 27.8 months, indicating a potential benefit of elraglusib in this subgroup [5] - The combination treatment was well tolerated, with no treatment-related deaths and a low discontinuation rate due to toxicity [11]

Core Insights - Actuate Therapeutics, Inc. is advancing its investigational drug elraglusib for the treatment of metastatic pancreatic cancer, with a recent public offering raising $17.25 million to support its regulatory path and clinical initiatives [1][5] Regulatory Path and Clinical Trials - The company has amended its IND application with updated clinical data from the Actuate-1801 Part 3B trial, which demonstrated a statistically significant improvement in median overall survival for patients receiving elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) compared to GnP alone [2][5] - The ongoing Phase 2 study has enrolled 286 patients, with 22 patients currently in the elraglusib plus GnP arm showing survival follow-up ranging from 20 to 42 months [3][6] - The trial met its primary endpoint, showing a 37% reduction in the risk of death and a doubling of the 12-month survival rate for the elraglusib combination arm [7] Mechanism of Action and Clinical Collaborations - Elraglusib is a GSK-3β inhibitor that may enhance chemotherapy efficacy and regulate anti-tumor immunity, potentially serving as a backbone therapy in pancreatic cancer treatment [8][10] - The company is collaborating with Incyte and UPMC Hillman Cancer Center to explore elraglusib in combination with modified FOLFIRINOX and retifanlimab for advanced pancreatic cancer [4][8] Financial Position and Future Outlook - The recent financing is expected to provide sufficient capital to support corporate initiatives through the second half of 2026, including anticipated interactions with the FDA and EMA regarding elraglusib's regulatory path [5][8] - The company is optimistic about the survival benefits observed with elraglusib and its potential to be combined with various treatment regimens, addressing the limited options available for pancreatic cancer patients [5][8]

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]

Core Insights - Actuate Therapeutics announced that elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) met primary endpoints and achieved statistical significance in the ongoing Phase 2 trial for metastatic pancreatic ductal adenocarcinoma (mPDAC) [1][7] - The topline results indicate a substantial improvement in median overall survival compared to previous data, with details to be presented at the ASCO Annual Meeting on May 31, 2025 [2][7] Company Overview - Actuate Therapeutics is a clinical-stage biopharmaceutical company focused on developing therapies for high-impact, difficult-to-treat cancers, specifically targeting GSK-3β to inhibit tumor growth [1][8] - The lead investigational drug, elraglusib, aims to enhance chemotherapy activity and activate anti-tumor immunity through various mechanisms [6][8] Clinical Trial Details - The Actuate-1801 Part 3B study is a randomized, controlled Phase 2 trial involving 286 mPDAC patients, comparing elraglusib with GnP versus GnP alone [5] - The primary endpoint of the study is median overall survival, with secondary endpoints including disease control rate (DCR), overall response rate (ORR), progression-free survival (PFS), and adverse events (AE) [5] Presentation Information - The topline data will be presented in an oral session at the ASCO Annual Meeting, with the abstract titled "Preliminary results from the randomized phase 2 study (1801 part 3B) of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) versus GnP alone" [4][7]

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]