Onxeo to Present Final Results of DRIIV-1 Phase 1 Study of AsiDNA in Advanced Solid Tumors at AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

Regulatory News:

Onxeo S.A. (Paris:ONXEO) (NASDAQ OMX:ONXEO), (“Onxeo” or “the Company”), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage Response (DDR) in oncology, in particular against rare or resistant cancers, today announced that the Company will present the final results of its DRIIV-1 Phase 1 study of AsiDNA, the Company’s first-in-class DDR inhibitor, in a poster session on October 27, 2019, during the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston.

Olivier de Beaumont, Medical Director of Onxeo, commented: "DRIIV-1 demonstrated AsiDNA’s favorable safety profile and validated its mechanism of action in patients’ tumor cells through the activation of its biological targets. Most importantly, the optimal active dose of AsiDNA of 600 mg was determined and is currently being utilized in our ongoing DRIIV-1b study, which is evaluating AsiDNA in combination with chemotherapy. DRIIV-1 was the foundation of our clinical development strategy for AsiDNA via intravenous administration and we look forward to presenting and discussing the compelling results of this important study, as well as reviewing our anticipated next steps, with the international oncology community."

The poster, titled “Phase I dose escalation study evaluating the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of AsiDNA, a first-in-class DNA Repair Inhibitor, administered intravenously (IV) in patients with advanced solid tumors,” will be presented by Professor Christophe Le Tourneau, principal investigator of the study and Head of the Department of Drug Development and Innovation at the Curie Institute (Paris, France).

> Session Title	Clinical Trials
> Session Date	Sunday, October 27
> Session Start Time	12:30
> Session End Time	16:00
> Location	Hall D, Hynes Convention Center
> Permanent Abstract Number	A076

The primary objective of this open label, dose escalation study, was to establish dose-limiting toxicities and identify the maximum tolerated dose of AsiDNA administered intravenously (IV). Other objectives included evaluating the product candidate’s safety profile, pharmacokinetic and pharmacodynamic parameters and preliminary efficacy data. Twenty-two patients with advanced solid tumors having failed previous anticancer therapies received a loading dose of AsiDNA for three consecutive days, followed by a one-hour IV-infusion once per week in 21 day cycles. In each subsequent cycle, AsiDNA was given weekly and administered until disease progression, unacceptable toxicity or patient’s decision.