Onxeo S.A. provides an update on the clinical development program of its first-in-class drug candidate AsiDNATM. Onxeo activated its first US clinical study site, Next Oncology San Antonio. This phase 1b/2 multicenter, basket trial intends to assess the safety and preliminary activity of AsiDNATM in combination with olaparib in patients with recurrent ovarian, breast and metastatic castration-resistant prostate cancer (mCRPC) who have progressed on previous PARP inhibitor therapy.

The primary endpoint of the study will assess the safety and tolerability of the combination as well as to determine the recommended Phase 2 dose. Key secondary endpoints will assess the preliminary activity and duration of response for the combination. The REVOCAN study is an open label, multicenter, phase 1b/2 study evaluating the safety and efficacy of AsiDNATM, in combination with PARP inhibitors in patients with relapsed platinum sensitive ovarian cancer already under treatment with a PARP inhibitor.

The study is sponsored by Gustave Roussy Cancer Campus, Grand Paris, led by Dr. Patricia PAUTIER and supported by ONXEO. The study team recently completed its first interim analysis (IA) of 10 patients. The combination of AsiDNATM and PARPi was generally well tolerated with no new safety signals or dose limiting toxicities.

The IA also demonstrated encouraging clinical activity with six patients achieving a stable disease (SD) and one patient demonstrating a complete response (CR) with disease control rate of around 70%. The study continues to enroll patients. The detailed results of the IA will be published by the investigator.

Additionally, AsiDNATMis being evaluated in Children and young adults with recurrent high-grade glioma (HGG). This phase 1b/2 trial, sponsored by Institut Curie, is being conducted within the framework of the European ITCC consortium. The trial is evaluating the safety and clinical activity of AsiDNATM in combination with radiotherapy in children or young adults with recurrent HGG.

The trial has already been opened at 8 clinical trial sites in France and 5 patients have been enrolled. To date, the combination has been well tolerated. Further trial site activation is planned for 2023 in Italy, the Netherlands, and Germany.