Ona Therapeutics, a clinical-stage biotechnology company, has announced new advancements in the phase 1a clinical development of its lead therapeutic candidate, ONA-255. This pioneering antibody-drug conjugate (ADC) is designed for the treatment of advanced cancers, and over half of the planned study patients have already been recruited, with the trial progressing through its dose escalation phase.
This progress marks a significant milestone for Ona Therapeutics, located at the Barcelona Science Park of the University of Barcelona (PCB-UB), following its $86.6 million Series B financing round earlier this year. The company is also developing ONA-389 for colorectal and hepatocellular cancer, with clinical development expected to commence in the second half of 2027, and ONA-418, a third ADC program featuring innovative technology.
To support its pipeline advancement, Ona has appointed Aleix Prat, MD, PhD, as its new Chief Medical Officer (CMO). Dr. Prat, internationally recognized as a medical oncologist and clinical researcher, brings extensive experience in breast cancer and precision oncology. He currently serves as the Director of the Clínic Barcelona Comprehensive Cancer Center and is a Professor of Medicine at the University of Barcelona.
“"This has been a transformative year for Ona. Bringing ONA-255 into the clinic and achieving such rapid recruitment in our phase 1a study are very important milestones for the company. Aleix brings exceptional expertise in the clinical, translational, and drug development space, which will be key to continuing to advance ONA-255 and the rest of our ADC pipeline."
ONA-255 is a first-in-class ADC designed to target biological mechanisms responsible for treatment resistance. Its initial development focuses on advanced HR+/HER2-negative breast cancer and gastric cancer. The ongoing phase 1a study is evaluating safety, tolerability, preliminary efficacy, pharmacokinetics, and pharmacodynamics.
“"I have been collaborating closely with Ona for several years and am delighted to take on this role at such an important time for the clinical advancement of ONA-255. The ongoing phase 1a study represents a significant opportunity to deepen our understanding of ONA-255's clinical profile and generate the necessary evidence to guide its future development."
In her role as Chief Development Officer, Jutta Amersdorffer, MD, MBA, will continue to lead clinical development execution, working closely with Dr. Prat.
