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]
Actuate Therapeutics Provides FDA with Updated Clinical Data Package to Support Planned Regulatory Interactions with FDA and EMA Over the Coming Months