Actuate Therapeutics Inc Dossier
Qualitative Analysis
Business overview
Actuate Therapeutics, Inc. (NASDAQ: ACTU) is a clinical-stage biopharmaceutical company focused on developing novel small-molecule therapies for high-impact, difficult-to-treat cancers. The company's lead product candidate is elraglusib (formerly 9-ING-41), an ATP-competitive small-molecule inhibitor of glycogen synthase kinase-3 beta (GSK-3β). GSK-3β is a master regulator of complex biological signaling cascades, including the NF-ΰB and DNA Damage Response (DDR) pathways, which promote tumor cell survival, growth, migration, and chemoresistance. Elraglusib is designed to enter cancer cells, block GSK-3β function, and restore balance to these pathways, thereby inducing cancer cell death and enhancing anti-tumor immunity. The drug is being evaluated as both a monotherapy and in combination regimens across multiple solid tumors and hematologic malignancies.
Research as of 20 Jun 2026
Strategic Initiatives
Growth programs, investments, and their expected impact
Prioritizing the development of an oral tablet formulation of elraglusib to enhance patient convenience, broaden clinical utility, and improve pharmacokinetic exposure across multiple oncology indications.
Expected impact: Aims to demonstrate that higher overall drug exposure can be achieved with the oral formulation compared to the IV formulation, positioning it as a potential backbone agent.
Actively exploring elraglusib's combination potential with RAS inhibitors in RAS-driven cancers, targeting key survival and resistance pathways to address adaptive resistance.
Expected impact: Establishment of a strong mechanistic rationale to position oral elraglusib as a backbone agent in combination regimens for RAS-mutant tumors.
Mergers, Acquisitions & Partnerships
Recent deals and strategic collaborations
Strategic Partnerships
Collaborating on the Phase 1b RiLEY trial evaluating elraglusib in combination with Incyte's PD-1 inhibitor, retifanlimab, and modified FOLFIRINOX as frontline therapy in advanced pancreatic adenocarcinoma.
Terms: Specific financial terms were not publicly disclosed; Incyte provides retifanlimab for the study.
UPMC Hillman Cancer Center is conducting and leading the investigator-initiated Phase 1b RiLEY trial of elraglusib in combination with retifanlimab and mFOLFIRINOX.
Terms: Investigator-initiated trial framework.
Collaborating on the Phase 2 trial (NCT05077800) evaluating elraglusib in combination with FOLFIRINOX and losartan in untreated mPDAC patients.
Terms: Supported by the Lustgarten Foundation and Actuate Therapeutics.