Jan 27, 2023

Photo/Shutterstock French biotech company Onxeo S.A. has given an update on the clinical development program of its first-in-class drug candidate AsiDNA. Onxeo has activated its first U.S. clinical study site, Next Oncology San Antonio. This phase 1b/2 multicenter, basket trial intends to assess the safety and preliminary activity of AsiDNA 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. ‘Important next step’ Shefali Agarwal, chairwoman of the board of directors and CEO, said: “We are delighted with the initiation of this important clinical trial in the U.S. to further explore the potential of our first-in-class drug candidate, AsiDNA. This investigational product has been in clinical development in Europe for the last few years, in recurrent solid tumors. In clinical studies AsiDNA appears to be well tolerated with encouraging clinical activity in the studied patients till date. The activation of this first study in the U.S. is an important next step towards its global clinical development. “The recent encouraging activity observed from the preliminary data in the REVOCAN study indicates the potential of AsiDNA to re sensitize patients to PARP therapy which potentially addresses an unmet need and could meaningfully impact patients living with recurrent ovarian cancer who have progressed on an initial treatment with a PARP inhibitor. “Additionally, this lays a strong foundation for our next first in class drug candidate OX425 which is sourced from the same proprietary PlatON platform and is a PARP/DDR specific decoy agonist thereby possibly not inducing tumor resistance to treatment. This profile represents a potential differentiation in safety and activity from other targeted therapies such as PARP inhibitors and we are on track to file an IND in mid- 2023.” Content continues below