Alligator Bioscience has appointed Theradex Oncology, a global contract research organization (CRO) with expertise in oncology clinical development, as CRO for the planned phase I study of ATOR-1015 for the treatment of metastatic cancer. The study is expected to commence in the second half of 2018.
The upcoming clinical phase I study with ATOR-1015 is a first-in-human dose escalation study in patients with metastatic cancer. The study will be conducted at five sites in Sweden and Denmark.
"Engaging Theradex is a key step towards starting our clinical phase I study with ATOR-1015 later this year", said Per Norlén, CEO of Alligator Bioscience. "We have worked previously with Theradex on the ADC-1013 clinical phase I trial and, based on their robust delivery and extensive expertise in clinical oncology research, we are confident in their ability to assist us in executing high-quality studies and we look forward to continuing our successful collaboration".
ATOR-1015 is a first-in-class bispecific antibody that targets CTLA-4 and OX40 and was created with Alligator's unique bispecific technology. Alligator has advanced ATOR-1015 through preclinical development and is now preparing for the start of a clinical phase I study. Production of clinical trial material has already been completed and the final clinical trial authorization (CTA) enabling activities required for study initiation will be completed in H1 2018.