Onxeo S.A. announced that the U.S. Food and Drug Administration (FDA) has cleared the initial IND for its first-in-class drug candidate AsiDNA. This is the first US IND Onxeo filed since the US team came on board in April 2022. This FDA decision enables the Company to initiate a Phase 1b/2 multicenter, basket trial to assess the safety and efficacy of AsiDNA in combination with the PARP inhibitor Olaparib in patients with epithelial ovarian cancer, breast cancer and metastatic castration-resistant prostate cancer (mCRPC) who have demonstrated progression on previous PARP inhibitor therapy.

The Company plans to initiate the trial in the second half of 2022 at 3-5 potential clinical sites across the United States.