Artios Pharma steps up ovarian cancer fight
Artios Pharma in Cambridge is steering a fresh initiative to fight ovarian cancer.
The company is pioneering the development of novel small molecule therapeutics that target the DNA damage response (DDR) process to treat patients with a broad range of cancers – but the new mission is special even by its own uncompromising standards.
Artios has triggered a randomised, Phase 2 expansion cohort in the ongoing Phase 1/2 trial evaluating its ataxia telangiectasia and Rad3-related (ATR) Inhibitor, ART0380, in combination with gemcitabine for the treatment of platinum resistant ovarian cancer.
The initiation of the Phase 2 trial follows the successful Phase 1 dose escalation demonstrating a favourable safety and tolerability profile, clinical activity and preferred pharmacokinetics with ART0380 in advanced solid tumours.
The recommended Phase 2 dose of ART0380 monotherapy has been defined for both intermittent and continuous daily dosing schedules together with the regimen of ART0380 in combination with gemcitabine.
Clinically active RECIST confirmed responses occurred across doses and in tumours harboring DDR deficiencies as predicted through Artios’ DcoDeR platform.
Artios CEO Dr Niall Martin said: “This is the first of three proof of concept Phase 2 studies planned to evaluate our potentially best-in-class ATR inhibitor, ART0380, that has demonstrated a favourable safety and tolerability profile and clinical activity in the Phase 1 dose escalation.
“We are delighted to be collaborating with ovarian cancer experts at GEICO in Spain on this important study that will help bolster our understanding of the therapeutic potential of ART0380 and further inform our clinical development strategy. We look forward to initial Phase 2 data expected in the first half of 2025.”
The ongoing global multi-centre Phase 1/2 study is investigating the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of ART0380 as a monotherapy or in combination with gemcitabine or irinotecan.
The Phase 2 expansion in combination with gemcitabine is expected to enrol up to 60 patients and will be conducted at multiple oncology centres across the United States and Spain.
ART0380 is described as a potent, selective, oral inhibitor of ATR, a master regulator of DNA replication stress response. It is being developed as an oral anti-cancer agent for the treatment of cancers that harbour defects in DNA repair and in combination with agents including those that cause DNA damage.
ART0380 was originally in-licensed by Artios from The University of Texas MD Anderson Cancer Center and ShangPharma Innovation in 2019. The molecule was jointly developed as part of a collaboration between ShangPharma and MD Anderson’s Therapeutics Discovery Division.