Phase 2 study to evaluate ATX-101 in advanced sarcoma patients.

Offentlig prosjektsammendrag

APIM Therapeutics is currently developing ATX-101, an investigational anti-cancer agent based on a novel mechanism of action highly relevant for cancer escape and resistance. In preclinical studies, ATX-101 shows single agent activity and potentiation of the action of several anti-cancer agents across multiple tumor indications. After successfully completing preclinical development, ATX-101 has been tested in a first-in-human phase 1 clinical study in advanced cancer patients. The study has proven the excellent safety profile of the drug and provided indications of clinical activity in patients. These included two patients with sarcoma one of which was treated with ATX-101 for over 15.6 months and remained stable 2.4 years after the start of ATX-101 treatment. These results together with promising preclinical results obtained in a series of patient-derived sarcoma cell lines conducted in collaboration with Columbia University, US resulted in a decision to pursue further clinical and preclinical work in this indication. The current project is therefore based on new sarcoma-specific drug development of the company’s drug ATX-101 hoping to address the high unmet medical need in these patients. Overall, the planned study is expected to further validate the company's novel therapeutic approach and catalyze future clinical development of ATX-101 in this cancer indication.