Onxeo Announces Initiation of DRIIV Phase I Clinical Trial of AsiDNA™ for Treatment of Advanced Solid Tumor

  • First patient has been dosed with AsiDNA™, Company’s first-in-class DNA Repair Inhibitor
  • Study approved in France and Belgium, and conducted in three internationally-renowned clinical centers
  • Interim results expected in second half of 2018

Paris (France), April 24, 2018 – 06:00 pm CEST – Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO FR0010095596), a biotechnology company specializing in the development of innovative drugs in oncology, notably against rare or resistant forms of cancer, today announced the initiation of DRIIV (DNA Repair Inhibitor administered IntraVenously) phase I clinical trial of AsiDNA™, its “first-in-class” DNA repair inhibitor. The aim of the study is to assess AsiDNA™ safety profile and identify its optimal clinical dose, as well as determine its active dose at the tumor level, in patients with advanced solid cancer.

First patient has been enrolled and dosed with AsiDNA™.

AsiDNA™ has a unique and innovative mechanism of action that inhibits the repair of tumor DNA damages through a decoy process by activating the enzymes involved in the signaling and repairing of tumor DNA lesions and harnessing them, thus making them unable to repair the tumor damages, which leads to the mitotic death of the cell.

The DRIIV study is being conducted at three of the most prestigious centers in France and Belgium and interim results are expected in the second half of 2018.

The DNA-damage response approach to cancer treatment is a highly compelling approach which has been already validated with the approval of PARP inhibitors, which belongs to the same general class of DDR. AsiDNA™ has a unique mechanism of action and the potential to provide patients with an attractive therapeutic option. I look forward to further evaluating AsiDNA in this important clinical trial,” said Professor Christophe Le Tourneau of the Institut Curie in Paris, principal investigator of DRIIV.

The initiation of DRIIV represents a significant milestone in the development of this unique asset and in enhancing the therapeutic potential of AsiDNA™,” said Judith Greciet, CEO of Onxeo. “Importantly, while AsiDNA has previously shown clinical activity when injected directly into the tumor, demonstrating similar activity via systemic administration will provide the opportunity to target a vast range of cancers. We look forward to evaluating AsiDNA in this phase I clinical trial in order to establish the clinical benefit of this promising product candidate when administered systemically, which represents a strong value catalyst for this key asset.”

Olivier de Beaumont, Chief Medical Officer of Onxeo, added, “Thanks to the pre-clinical data generated to date, we have established the optimal clinical trial protocol for this phase I study and we look forward to conducting the DRIIV study with experienced oncology investigators. DRIIV is the first step in men that will enable us to effectively characterize AsiDNA™’s safety profile and determine the optimal clinical dose in order to further develop AsiDNA™, whether combined with other anticancer agents or as a monotherapy.”