On February 9, 2023 Artios Pharma Limited (Artios), a clinical-stage biotech company pioneering the development of novel small molecule therapeutics that target the DNA damage response ("DDR") process in order to treat patients with a broad range of cancers, reported the initiation of a randomized, 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 (Press release, Artios Pharma, FEB 9, 2023, View Source [SID1234626988]).

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The initiation of the Phase 2 trial follows the successful Phase 1 dose escalation demonstrating a favorable safety and tolerability profile, clinical activity, and preferred pharmacokinetics with ART0380 in advanced solid tumors. 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 tumors harboring DDR deficiencies as predicted through Artios’ DcoDeR platform.

Dr. Niall Martin, Chief Executive Officer at Artios, 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 favorable 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."

Antonio Gonzalez-Martin, MD, PhD, President and Founding member of the Spanish Ovarian Cancer Research Group (GEICO), Principal Investigator for the trial, said: "Ovarian cancer continues to be a difficult to treat cancer that ultimately leads to relapse. We are excited to collaborate with Artios to help bring an ATR targeted therapy with the potential to be highly effective in patients with platinum-resistant disease who are in much need of innovative treatment options. The favorable pharmacokinetic profile enabling combination with DNA damaging agents offers the potential of a new treatment option for patients with platinum resistant ovarian cancer. We at GEICO are looking forward to offering this novel treatment approach to our patients in the trial."

The ongoing global, open-label, multi-center, Phase 1/2 study is investigating the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of ART0380 (GEICO-114-O trial) as a monotherapy or in combination with gemcitabine or irinotecan. The randomized, Phase 2 portion is designed to evaluate intermittent dosing of ART0380 in combination with gemcitabine in 21-day cycles in patients with high grade serous ovarian, primary peritoneal or fallopian tube carcinoma. The Phase 2 expansion in combination with gemcitabine is expected to enroll up to 60 patients and will be conducted at multiple oncology centers across the United States and Spain.

ART0380 is a potent, selective, oral inhibitor of ATR, a master regulator of DNA replication stress response. ART0380 is being developed as an oral anti-cancer agent for the treatment of cancers that harbor 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.