Actuate Therapeutics received the FDA ODD for Elraglusib for the treatment of Pancreatic Cancer

CAR-T Digest - August 2020

01 Aug 2023: Elraglusib / Pancreatic Cancer / Acutate Therapeutics: Orphan Drug Designation by the FDA (ODD)

Elraglusib is Actuate’s proprietary small molecule glycogen synthase kinase-3 beta (GSK-3β) inhibitor, which is being developed for adults and children with advanced refractory cancers
Actuate first enrolled patients with advanced pancreatic cancer on a Phase 2 study for 9-ING-41 + gemcitabine/nab-paclitaxel, as an additional arm of the Phase 1/2 1801 trial of 9-ING-41
Additional investigator-led Phase 2 studies for the 1L treatment of patients with advanced pancreatic cancer in combination with a checkpoint inhibitor (NCT05239182) and in patients with metastatic pancreatic cancer in combination with FOLFIRINOX (NCT05077800) are progressing
“Based on the promising final data from our completed single-arm Phase 2 study, we have initiated an open-label, randomized Phase 2 study of Elraglusib in combination with gemcitabine/nab-paclitaxel for the frontline treatment of patients with metastatic pancreatic cancer,” said Dr. Andrew Mazar, Actuate’s COO