Actuate Therapeutics, Inc. is a private biopharmaceutical company focused on the development of small molecule compounds for use in the treatment of cancer, and inflammatory diseases leading to fibrosis.
Led by a senior management and scientific team with decades of industry and therapeutic developmental experience, Actuate Therapeutics is developing novel small molecule agents that target Glycogen Synthase Kinase-3β (GSK-3β).
Competitive analysis shows our lead compound to Best-in-Class. Published studies demonstrate that our GSK-3β inhibitors are active as monotherapy and demonstrate significant synergy in combination in chemo -resistant tumors. Pre-clinical studies conducted across multiple institutions show our clinical lead compound, 9-ING-41, has significant activity across a number of histologies of solid tumors and lymphomas.
We have completed all IND-enabling manufacturing and in vivo toxicology studies. 9-ING-41 demonstrated very favorable pharmacokinetic and tox profiles. We received the FDA approval of our IND in 1Q18. In addition, the FDA has granted us Orphan Drug Designations in Glioblastoma and a Rare Pediatric Disease Designation for Neuroblastoma.
A groundbreaking Phase 1/2 trial across multiple histologies is ready to commence in 2018, with
world-leading clinical sites already recruited and qualified in the US and EU. We anticipate going forward into clinical trials in pulmonary fibrosis and other fibrotic diseases in 2020.