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Actuate Therapeutics Receives FDA Approval for Oral Elraglusib Clinical Trial
Actuate Therapeutics announced the FDA has cleared its investigational new drug application to conduct a Phase 1/2 study of oral elraglusib in advanced cancer patients. The study is designed to demonstrate that a higher overall exposure to elraglusib can be achieved with the oral formulation compared to the IV formulation and will evaluate the safety and potential efficacy of the oral formulation as a monotherapy in solid tumor patients, including those with metastatic melanoma, NSCLC, colorectal, and pancreatic cancers. "Advancing the elraglusib oral tablet is an important element to the success of our overall development strategy," said Daniel Schmitt, president and CEO of Actuate. Initiation of the clinical development is planned for the second half of 2026.
Actuate Therapeutics Launches GSK-3beta Inhibitor Research Initiative
Actuate Therapeutics announced the launch of an expanded research initiative evaluating combinations of its clinical-stage GSK-3beta inhibitor elraglusib with emerging RAS-targeted therapies. Despite recent advances in RAS-targeted therapies, adaptive resistance mechanisms and pathway reactivation remain some of the key barriers to achieving durable responses in patients. Based on the mechanisms of action, GSK-3 inhibition may represent a critical complementary strategy capable of enhancing RAS-targeted therapies by suppressing downstream survival signaling and resistance pathways, including NF-kB-mediated survival signaling; MYC-driven transcriptional programs; metabolic adaptation and oxidative stress buffering; tumor microenvironment immune suppression. In addition, RAS-mutant tumors - particularly pancreatic cancer - are widely considered immunologically resistant. Preclinical research suggests that GSK-3beta inhibition may enhance antigen presentation, activate T cells and NK cells, and reduce exhausted T-cells. By simultaneously targeting tumor intrinsic survival pathways and modulating the tumor immune microenvironment, the combination of elraglusib and RAS inhibitors has the potential to create a multi-modal therapeutic strategy designed to overcome resistance and expand clinical benefit in RAS-driven cancers.
Actuate Therapeutics Initiates Elraglusib Clinical Trial
Actuate Therapeutics announced plans to initiate a Phase 1/2 clinical program evaluating the oral tablet dosage form of elraglusib in patients with advanced cancer. The phase 1 portion of the planned Phase 1/2 program aims to determine the maximum tolerated dose or maximum administered dose and dose-limiting toxicities of elraglusib tablets administered once daily and will investigate the pharmacokinetics of elraglusib tablets as well as the preliminary anti-tumor activity of elraglusib when administered as tablets. The goal of the phase 1 portion of the program will be to establish the recommended dose of elraglusib tablets for expansion in subsequent development
Actuate Therapeutics Reports New Data Showing Elraglusib Improves Survival in Pancreatic Cancer Patients
Actuate Therapeutics announced that new additional and promising patient survival and biomarker data from treatment with elraglusib for metastatic pancreatic cancer were featured in oral and poster presentations at the 2026 American Society of Clinical Oncology Gastrointestinal Cancers Symposium on January 9, 2026. The presentations highlighted new, expanded data from the company's Phase 2 clinical program evaluating elraglusib in combination with gemcitabine/nab-paclitaxel, a first-line chemotherapy regimen for metastatic pancreatic cancer, providing additional evidence that suggests that elraglusib combined with GnP is associated with improved survival when compared with GnP alone. The primary efficacy endpoints were met in this study: The median overall survival showed significant benefit in the elraglusib/GnP vs GnP alone arms; 12-month survival rate doubled to 44.4% vs 22.3%; 24-month survival rate increased fivefold to 12.9% in the elraglusib/GnP arm compared to 2.6% in the GnP arm, emphasizing the potential for long-term clinical benefit. The safety and tolerability profile of elraglusib was consistent with previously reported data at the 9.3 mg/kg dose, and no new safety signals were identified: Serious TEAE were similar between the elraglusib/GnP and the GnP alone arm, TEAE resulting in death were similar between treatment arms: elraglusib/GnP and GnP alone; Grade-3 or higher TEAE leading to stoppage of any study drug: elraglusib/GnP and GnP alone.
Actuate Therapeutics Announces Pediatric Cancer Trial Results
Actuate Therapeutics announced results from the phase 1 portion of its phase 1/2 clinical study evaluating elraglusib as a monotherapy or in combination with irinotecan, irinotecan plus temozolomide, or with cyclophosphamide plus topotecan in pediatric patients with refractory malignancies. The Actuate-1902 trial was an open-label, multicenter phase 1/2 study evaluating the safety and efficacy of elraglusib in 40 pediatric patients ages 3 - 21 with relapsed/refractory cancers, including Ewing sarcoma, neuroblastoma, Central Nervous System tumors, non-EWS sarcomas, and other refractory pediatric malignancies. Summary: Two Complete Metabolic Responses observed in patients with relapsed/refractory metastatic Ewing sarcoma and one Complete Response observed in a patient with relapsed/refractory metastatic neuroblastoma; Clinical responses and disease control observed in 15 of 40 patients with difficult-to-treat refractory pediatric cancers, including 10 of 19 patients treated with elraglusib plus cyclophosphamide/topotecan; Data support advancing clinical development of elraglusib in Ewing sarcoma and potentially neuroblastoma in 2026; Company has been granted Rare Pediatric Designations from the FDA for both indications
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