Actuate’s Elraglusib Shows Promise Against Pancreatic Cancer

Actuate Therapeutics has reported promising results from its investigational drug, elraglusib, in the fight against pancreatic cancer. The company presented positive clinical data at the recent American Society of Clinical Oncology (ASCO) Annual Meeting, showcasing potential benefits in patients suffering from metastatic pancreatic ductal adenocarcinoma (mPDAC). This development comes nearly five years after television personality Alex Trebek publicly revealed his battle with stage IV metastatic pancreatic cancer.

Pancreatic cancer remains one of the deadliest forms of cancer, with approximately 80–85% of diagnoses classified as metastatic. The treatment market for this disease is projected to grow at a compound annual growth rate of 12.3%, climbing from $2.92 billion in 2024 to an estimated $5.84 billion by 2030, according to Grand View Research. Alarmingly, the five-year survival rate for all stages of the disease is just 13%, and a mere 3% for those with distant metastatic forms.

In the Phase II Actuate-1801 Part 3β trial, Actuate assessed elraglusib in combination with the chemotherapy regimen of gemcitabine/nab-paclitaxel (GnP). The trial, which involved 155 patients, revealed a significant increase in median overall survival, reporting an improvement of 10.1 months compared to the GnP regimen alone, which had a median survival of 7.2 months for 78 patients. Among the 29 efficacy evaluable patients, elraglusib demonstrated a median overall survival of 15.3 months, which included confirmed complete responses (CR) in two patients and partial responses in nine.

Actuate’s findings are particularly noteworthy when compared to previous trials. The median overall survival in the 2013 MPACT trial was 8.5 months, while the 2020-21 NAPOLI 3 trial reported an overall survival of 11.1 months. Daniel M. Schmitt, Actuate’s president and CEO, emphasized the significance of these results, stating, “Everything points at this drug [elraglusib] being highly active and meeting the endpoint the FDA is most interested in, which is increase in overall survival.”

The Actuate-1801 trial enrolled a total of 286 patients, all with mPDAC and no prior systemic treatment. The primary endpoint focused on median overall survival. Actuate plans to submit its findings to regulatory authorities, including the FDA and the European Medicines Agency (EMA), by the end of 2026. The company is also pursuing Breakthrough Therapy designation from the FDA, which would require elraglusib to demonstrate substantial improvement over existing treatments.

Schmitt noted that the safety profile of elraglusib is “exceptional,” and the drug has already been tested in over 500 patients across various chemotherapeutic combinations. He foresees elraglusib potentially becoming a new “backbone” therapy for pancreatic cancer, a disease that has seen no significant advancements in treatment in over a decade.

Research efforts continue as Actuate collaborates with institutions such as Harvard Medical School and Massachusetts General Hospital. These partnerships are exploring elraglusib in different chemotherapy combinations, including a Phase II trial evaluating elraglusib combined with Folfirinox and losartan, and a Phase I trial assessing elraglusib with a modified version of Folfirinox and Incyte’s PD-1-blocking antibody, Zynyz®.

As the landscape for pancreatic cancer therapies evolves, Actuate has also identified potential applications of elraglusib in treating other cancers, including colorectal cancer and melanoma. The company is planning a Phase I trial for Actuate-2401, an oral tablet formulation of elraglusib.

Financially, Actuate reported a net loss of $5.407 million for the third quarter of 2025, improving from $5.971 million the previous year. The company ended that quarter with cash and cash equivalents of $16.925 million, nearly double the amount reported at the end of 2024. This financial stability has been bolstered by several capital raising events in 2025, including a public offering that generated net proceeds of $15.574 million.

Looking ahead, Actuate anticipates that its cash reserves may not sufficiently cover operational and capital needs beyond the second quarter of 2026 without additional funding. Schmitt indicated that to sustain growth, the company is exploring both organic expansion and potential merger-and-acquisition opportunities.

In a landscape marked by limited treatment options, Actuate’s advancements with elraglusib could offer new hope to pancreatic cancer patients and their families. The ongoing trials and regulatory engagements reflect a significant step forward in addressing this formidable disease.