Actuate’s Elraglusib Offers Hope in Battle Against Pancreatic Cancer

Actuate Therapeutics has announced promising results for its drug, elraglusib, in the fight against metastatic pancreatic cancer. This update follows the bleak statistics surrounding the disease, which affects approximately 80-85% of pancreatic cancer patients. Despite limited treatment options, Actuate’s research indicates a potential breakthrough, particularly for patients with metastatic pancreatic ductal adenocarcinoma (mPDAC).

Promising Clinical Data from Actuate-1801 Trial

At the recent American Society of Clinical Oncology (ASCO) Annual Meeting, Actuate unveiled positive topline data from the Phase II Actuate-1801 Part 3β trial (NCT03678883). The trial assessed elraglusib in combination with the chemotherapy regimen of gemcitabine/nab-paclitaxel (GnP) for mPDAC. Results showed a significant increase in median overall survival (mOS) of 10.1 months for patients receiving the combination treatment, compared to just 7.2 months for those receiving GnP alone.

Among the 29 efficacy-evaluable patients, the mOS for those treated with elraglusib reached 15.3 months, which included two patients achieving complete response (CR) and nine experiencing partial response. This performance is particularly noteworthy when compared to previous trials, such as the 2013 MPACT trial, which reported an mOS of 8.5 months, and the 2020-21 NAPOLI 3 trial with an mOS of 11.1 months.

Regulatory Path and Future Prospects

Actuate’s president and CEO, Daniel M. Schmitt, highlighted the significance of these findings, stating, “Everything points at this drug [elraglusib] being highly active and meeting the endpoint the FDA is most interested in, which is an increase in overall survival.” The company plans to submit an amended investigational new drug (IND) application to the FDA and the European Medicines Agency (EMA) by the end of 2025.

The Actuate-1801 trial enrolled 286 patients with mPDAC who had not undergone prior systemic treatment. Patients were randomized in a 2:1 ratio to receive either the elraglusib/GnP combination or GnP alone. Preliminary results indicate that elraglusib may become a new backbone therapy in treating this aggressive cancer.

In September, Actuate reported that 22 patients in the elraglusib plus GnP arm are still in active treatment or follow-up, with times on study ranging from 20 to 42 months. This contrasts sharply with only three patients in the GnP arm, whose duration on study was between 21 to 23 months.

Additionally, Actuate is advancing its research with multiple ongoing trials. Collaborating with institutions like Harvard Medical School and Massachusetts General Hospital, Actuate is exploring elraglusib’s efficacy in combination with other treatments for metastatic pancreatic cancer.

Financial Considerations and Future Challenges

Despite the promising clinical results, Actuate faces financial challenges. The company reported a net loss of $5.407 million for the third quarter of 2025, a slight improvement from the previous year. Actuate has successfully raised capital through various methods, including a total of $15.574 million from a public offering in September.

Looking ahead, Actuate acknowledges that its current cash reserves will not sustain operations beyond the second quarter of 2026 without additional funding. “If events or circumstances occur such that the Company does not obtain additional funding, it may be necessary to significantly reduce our scope of operations,” the company noted in its quarterly report.

Schmitt indicated that Actuate is considering two pathways for growth: organic expansion or potential merger and acquisition (M&A) opportunities. He emphasized the importance of FDA feedback regarding elraglusib, which will significantly influence the company’s staffing and operational strategies moving forward.

As Actuate Therapeutics navigates the complexities of clinical trials and regulatory pathways, it remains focused on delivering innovative treatments for pancreatic cancer, a disease that continues to challenge both patients and the medical community.