Cambridge, UK, and New York City, USA, 11 February 2021: Artios Pharma Limited (“Artios”), a leading DNA Damage Response (DDR) company developing a broad pipeline of precision medicines for the treatment of cancer, today announced the start of a clinical trial of its small-molecule ATR inhibitor, ART0380, in patients with advanced or metastatic solid tumors. ART0380 was originally in-licensed 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.

The clinical trial of the ATR (Ataxia telangiectasia and Rad3-related kinase) inhibitor is an open-label, multi-center, Phase I/IIa study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ART0380 as a monotherapy and in combination with gemcitabine in patients with advanced or metastatic solid cancers. The study will enroll up to 180 patients and will be conducted at multiple oncology centers across the USA, UK, and Europe. Full details can be found at www.clinicaltrials.gov under the identifier NCT04657068.

Niall Martin, Chief Executive Officer at Artios Pharma, said: “Our vision is to build on the success of PARP inhibition to enable more patients to benefit from DDR targeting medicines. By using insights gained from our longstanding experience in this field, we believe that our approach will address the challenges of resistance to targeted therapy, identify patients with sensitive cancers, and optimize the therapeutic index. We have done extensive preclinical work to characterise and differentiate our lead candidates and will have two programs, ART0380 and ART4215, a first in class Pol theta inhibitor, in the clinic by end of 2021. Following the recent strategic collaboration with Merck KGaA, Darmstadt, Germany, taking ART0380 into the clinic is another major milestone for Artios in the development of next generation DNA Damage Response treatments for hard-to-treat cancers.”

Melissa Johnson, MD, Program Director, Lung Cancer Research, Sarah Cannon Research Institute at Tennessee Oncology, Principal Investigator for the trial, said: “We have a strong heritage in developing novel cancer therapies. We see DDR as an exciting and promising area of research and are excited to collaborate with Artios on this important clinical trial."

ART0380 is a new investigational medicinal product that is a potent and selective inhibitor of ATR. ATR is an important signalling protein in the cellular DNA damage response to replication stress and DNA double-strand breaks that occur as cells multiply.

ART0380 is being developed as an oral anti-cancer agent for the treatment of patients with cancers harbouring defects in DNA repair and in combination with agents including established and novel agents that cause DNA damage and/or suppress a cancer’s ability to repair DNA damage.