Onxeo : Initial IND application for AsiDNA Granted “Study May Proceed” by the U.S. FDA

Onxeo to initiate its first phase 1b/2 trial in the United States in patients with solid tumors

Paris (France), June 30, 2022- 07:00 pm CEST - Onxeo S.A. (Euronext Growth Paris: ALONX, Nasdaq First North Copenhagen: ONXEO), hereafter "Onxeo" or the "Company", a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage Response (DDR), today 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.

"I am very proud that our team has been able to file and obtain FDA clearance of its first US IND in a very short period. We are now ready to start our first clinical trial with AsiDNA in the US, with the full support of our clinical and regulatory teams," said Dr. Shefali Agarwal, Chairwoman of the Board of Directors and CEO. "We believe that our drug candidate has the potential to meaningfully impact the lives of patients with recurrent solid tumors who have progressed on an initial treatment with a PARP inhibitor. This is consistent with the preclinical findings of AsiDNA, which increased our understanding of its potential against acquired resistance to PARP inhibitors and which formed the basis for our first-in-human study."

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