UPDATE: Actuate Therapeutics has announced promising results for its pancreatic cancer treatment, elraglusib, which showed a significant increase in patient survival rates during clinical trials. This development comes five years after television icon Alex Trebek revealed his battle with stage IV metastatic pancreatic cancer, a disease still facing a dire prognosis.
Metastatic pancreatic cancer accounts for approximately 80–85% of all diagnoses, and current therapies remain limited. The treatment market is projected to surge from $2.92 billion last year to $5.84 billion by 2030, according to Grand View Research. Disturbingly, the five-year survival rate sits at just 13% for all stages, and a mere 3% for advanced cases, emphasizing the urgent need for effective treatments.
At the American Society of Clinical Oncology (ASCO) Annual Meeting this past spring, Actuate presented encouraging topline data from its Phase II Actuate-1801 trial. The study focused on elraglusib combined with the chemotherapy regimen gemcitabine/nab-paclitaxel (GnP) in 286 patients with first-line metastatic pancreatic ductal adenocarcinoma (mPDAC). Results indicated a median overall survival increase of 10.1 months—a 37% reduction in the risk of death compared to GnP alone.
Among 29 efficacy evaluable patients, elraglusib demonstrated a median overall survival of 15.3 months, with two patients achieving complete responses (CR) and nine showing partial responses. This performance surpasses the 8.5 months median overall survival noted in the 2013 MPACT trial and the 11.1 months from the 2020-21 NAPOLI 3 trial.
Daniel M. Schmitt, Actuate’s President and CEO, stated, “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.” He also noted that no significant advancements in pancreatic cancer treatments have emerged in the past 13 years.
Actuate has filed an amended investigational new drug (IND) application and plans to submit regulatory filings to the FDA and the European Medicines Agency (EMA) by year-end. The company is also pursuing the FDA’s Breakthrough Therapy designation, which requires elraglusib to demonstrate substantial improvement over existing treatments.
The Actuate-1801 trial remains ongoing, and preliminary results reveal that 22 patients in the elraglusib plus GnP arm are either in active treatment or follow-up, with treatment durations ranging from 20 to 42 months. This contrasts sharply with just three patients in the GnP arm, whose treatment times were significantly shorter.
Actuate Therapeutics is not alone in its fight against pancreatic cancer. Ongoing collaborations with institutions like Harvard Medical School and UPMC Hillman Cancer Center are exploring elraglusib in various combinations with chemotherapy drugs, showcasing a broader potential for this promising drug.
Elraglusib, a selective small-molecule inhibitor of glycogen synthase kinase-3 beta (GSK-3β), could signify a breakthrough in pancreatic cancer treatment. With its unique mechanism targeting tumor growth and resistance pathways, elraglusib’s promising results could pave the way for its use against other cancers, including colorectal cancer and melanoma.
Despite the positive trial outcomes, Actuate faces financial challenges. The company reported a net loss of $5.407 million in Q3 2024, though this is an improvement from the previous year. Actuate’s cash reserves are projected to sustain operations only until the second quarter of 2026, unless additional funding is secured.
Actuate’s future hinges on FDA feedback regarding elraglusib. Schmitt emphasized a dual strategy: pursuing organic growth while engaging with pharmaceutical partners for potential mergers or acquisitions. “We’re going to run a two-prong approach here,” he said, aiming to secure the drug’s future while exploring collaboration opportunities.
As Actuate Therapeutics forges ahead, the hope is that elraglusib could become a cornerstone in the fight against one of the deadliest forms of cancer, offering new hope to patients and families affected by pancreatic cancer.
