Pancreatic cancer continues to pose a significant challenge in oncology, with treatment options remaining scarce. Actuate Therapeutics has emerged as a beacon of hope with its investigational drug, elraglusib, which has shown promising results against metastatic pancreatic cancer. This type of cancer accounts for approximately 80–85% of all pancreatic cancer cases, and the market for treatments is projected to grow from $2.92 billion last year to $5.84 billion by 2030, according to Grand View Research.
The prognosis for patients diagnosed with pancreatic cancer remains dire, with a five-year survival rate of only 13% for all stages and a mere 3% for those with metastatic disease, as reported by the American Cancer Society. The cost of treatment per patient exceeds $100,000, presenting a daunting financial burden on individuals and healthcare systems alike.
Positive Clinical Data from Actuate-1801 Trial
Actuate’s recent presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting highlighted the positive outcomes from the Phase II Actuate-1801 Part 3β trial (NCT03678883). This trial evaluated the efficacy of elraglusib in combination with the chemotherapy regimen of gemcitabine/nab-paclitaxel (GnP) for patients with first-line metastatic pancreatic ductal adenocarcinoma (mPDAC).
The data revealed a significant increase in median overall survival to 10.1 months among 155 patients using the elraglusib combination, compared to 7.2 months for those receiving GnP alone. Among 29 patients deemed efficacy evaluable, the median overall survival reached 15.3 months, with two patients achieving a complete response and nine others demonstrating partial responses. This outcome is noteworthy when compared to historical data, including the 8.5 months median overall survival from the 2013 MPACT trial and the 11.1 months from the 2020-21 NAPOLI 3 trial.
Daniel M. Schmitt, Actuate’s Co-founder, President, and CEO, emphasized the trial’s success, 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.” With no significant advances in pancreatic cancer treatments over the past 13 years, elraglusib presents a potential breakthrough.
Regulatory Path and Future Trials
Actuate plans to submit an amended investigational new drug (IND) application to support regulatory submissions to the FDA and the European Medicines Agency (EMA) by the end of this year, continuing into early 2026. The company is also pursuing Breakthrough Therapy designation from the FDA, which would expedite the development and review process, contingent on demonstrating substantial improvement over existing therapies.
The Actuate-1801 trial included 286 patients with mPDAC who had not received prior systemic treatment, randomized in a 2:1 ratio to receive the elraglusib/GnP combination or GnP alone. The trial is ongoing, with recent reports indicating that 22 patients in the elraglusib arm are either in active treatment or in follow-up, with durations on study ranging from 20 to 42 months.
Beyond the Actuate-1801 trial, researchers at Harvard Medical School and Massachusetts General Hospital are leading a Phase II trial evaluating elraglusib in combination with Folfirinox and losartan for metastatic pancreatic cancer. Additionally, Actuate is collaborating with UPMC Hillman Cancer Center and Incyte on the Phase I RiLEY trial, which is studying elraglusib alongside a modified version of Folfirinox and the PD-1-blocking antibody Zynyz® (retifanlimab-dlwr).
Elraglusib targets glycogen synthase kinase-3 beta (GSK-3β), an enzyme implicated in tumor progression and resistance to chemotherapy. By inhibiting this pathway, elraglusib aims to enhance the effectiveness of traditional cancer treatments, offering new hope in the battle against pancreatic and other forms of cancer.
Actuate has reported a net loss of $5.407 million for the third quarter, an improvement from $5.971 million in the same period last year. The company has also secured funding through various capital-raising events, positioning itself for future growth. However, it has acknowledged that its existing cash reserves will not satisfy operational needs beyond the second quarter of 2026 without additional capital.
Schmitt noted two potential paths for Actuate’s future: organic growth and engaging in merger-and-acquisition deals. The company’s workforce currently comprises around 12 core members, with additional consultants brought in as needed. The direction of Actuate’s growth will depend significantly on FDA feedback regarding elraglusib.
The advancements made by Actuate Therapeutics offer a glimmer of hope in the challenging landscape of pancreatic cancer treatment. With ongoing trials and a focus on innovative therapies, the company is poised to make meaningful contributions to the field of oncology.
