- ART0380 demonstrated a tolerable and manageable safety profile, with monotherapy clinical activity in tumors predicted to be sensitive to ATR inhibition in Phase 1 dose escalation
- First of three Phase 2 solid tumor expansion cohorts evaluating ART0380 as a monotherapy and in combination with chemotherapy
- Initial Phase 2 data in patients with platinum resistant ovarian cancer expected in 1H 2025
CAMBRIDGE, UK and NEW YORK, USA, 9 February 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, announces 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.
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.
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About Artios
Artios is on a mission to kill cancer by exploiting DNA damage repair (DDR) responses that are leveraged by cancer cells to promote their survival. Our specialized DcoDeR platform integrates Artios’ leadership capabilities, expertise and experience in DNA damage biology and drug discovery to systematically discover and develop medicines targeting the totality of the DDR. We have built an extensive DDR focused pipeline designed to address areas of high unmet needs across solid tumour indications including our ATR inhibitor, ART0380, and our Polθ inhibitor, ART4215, as a monotherapy and with combination treatments. Together with our world-class strategic partnerships with Merck KGaA and Novartis, and research collaborations with premiere institutions like Cancer Research UK, The Institute of Cancer Research, The Netherlands Cancer Institute, and the Crick Institute we are pioneering validated approaches to DDR drug discovery. Visit our website at https://www.artios.com/ for more information about the company and our pipeline.
About ART0380
ART0380 is a potential best-in-class oral, highly potent, and selective ATR inhibitor. Ataxia telangiectasia and Rad3-related (ATR) is a master regulator of DNA replication stress response that promotes cell death by destabilizing replication forks, inducing DNA damage, or inhibiting checkpoint activation. ART0380 has broad clinical potential and is being investigated alone and in combination with other targeted therapies, chemotherapies or radiosensitizer opportunities in DDR deficient and high replication stress tumors. In a completed Phase 1a dose escalation study, ART0380 demonstrated RECIST confirmed responses, a favorable safety and tolerability profile, and a favorable PK profile.
About the DcoDeR platform
Artios has developed a specialized DcoDeR (“Decoding the DNA Damage Response”) platform which exploits its expertise and experience in DNA damage biology and drug discovery to systematically discover and develop medicines targeting the totality of the DDR. Our world class DNA damage response discovery platform allows us to understand disease biology, identify novel targets, develop new medicines, and select and treat patients who will benefit most. DcoDeR is being leveraged in ongoing research collaborations and licensing agreements with Merck KGaA to identify novel DDR nuclease inhibitors and with Novartis to identify DDR targets to use in combination with radioligand therapies.
About GEICO
The Spanish Ovarian Cancer Research Group (GEICO) is a non-profit organization, whose main purposes are to promote and develop research, training, and education in Gynecological Cancer. GEICO is a leader in clinical and translational research, particularly ovarian cancer. It currently enjoys international prestige and is an active member of the Gynecologic Cancer InterGroup (GCIG) and the European Network of Gynecological Oncological Trial Groups (ENGOT). It is currently made up of more than 300 experts working in around 130 hospitals throughout Spain. Since its constitution in 1999, GEICO has participated in more than 100 research projects and is highly committed to the fight against this disease. Visit our website at www.geicogroup.com for more information about the group and its activities.