Onxeo Announces Positive Interim Results from Phase 1 Study of AsiDNA™, a First-In-Class DNA Damage Response Inhibitor

  • Robust biological target engagement in patient tumor cells confirms the activity of AsiDNA™ when administered intravenously
  • Favorable safety profile with no drug-related serious adverse event and no dose-limiting toxicity
  • Company intends to expand AsiDNA™ clinical program in combination in targeted indications as soon as H1 2019

Company to host a conference call for analysts and investors today at 5.30 pm CET

Paris (France), November 5, 2018 – 7.30 am CET – Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO),
a clinical-stage biotechnology company specializing in the development of innovative drugs in oncology targeting tumor DNA Damage Response (DDR) to fight resistant cancers, today announced positive interim results from the first three dose levels already evaluated out of six planned in its Phase 1 DRIIV-1 study of AsiDNA™, the Company’s first-in-class DNA Damage Response inhibitor.

A total of 10 patients with advanced solid tumors received 112 infusions of AsiDNA™ ranging from 200mg (DL1) to 600mg (DL3). The administration of DL4 (900mg) is ongoing and the full data set from DRIIV-1 is expected to be available in the first half of 2019.

Judith Greciet, Chief Executive Officer of Onxeo, said: “We are very pleased to report highly compelling interim results from our DRIIV-1 study. Beyond the safety endpoints of all phase 1 studies, DRIIV-1 was foremost designed to demonstrate that AsiDNA™ administered intravenously activates in patients’ tumors cells the intended DNA Damage Response biological targets. Midway through the study, data show that robust target engagement was demonstrated as early as the second dose level, which represents a meaningful proof-of-mechanism of AsiDNA™ in man. In addition, the results indicate a favorable safety profile for AsiDNA™ in a difficult-to-treat patient population. These proof-of-mechanism and activity results further support the clinical potential of AsiDNA™ in solid tumors and represent a major value catalyst in the development of our first-in-class drug candidate.”

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