On October 15, 2019 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: 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, reported 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 (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in Boston (Press release, Onxeo, OCT 15, 2019, View Source [SID1234542263]).
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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.
Biological activity was evidenced by the increase of gH2AX and pHSP90, two intratumoral biomarkers of DNA-PK, one of the DDR proteins targeted by AsiDNA. The product candidate’s favorable safety profile was confirmed, with 90% of all product-related adverse events being non-specific grade 1 and 2 events. The maximum tolerated dose was not reached. The 600 mg dose has been identified as the optimal biological dose for further development due to the favorable safety and pharmacokinetic profile, as well as robust target engagement, demonstrated at this dosage level. Disease stabilization was achieved in two patients with advanced colorectal cancer.