Atonco and University of Michigan Announce Collaboration on Phase 1-2a Clinical Study of ATO-101™

Bladder cancer ranks among the most prevalent cancers globally, standing at the 10th position overall and the 6th most common in men. In 2020, it accounted for over 573,000 incident cases and approximately 212,000 deaths around the world. 

While Bacillus Calmette-Guérin (BCG) therapy is the standard of care, it fails in approximately 40% of cases leading to consequential radical bladder ablation procedures and while more recent therapies, such as immune checkpoint inhibitors, have entered the clinic realm, more options are needed.

Atonco’s ATO-101™ ([211At] At-anti-CA-IX antibody) is a targeted radiopharmaceutical composed of the alpha-emitting radionuclide astatine-211 (²¹¹At) conjugated with the CAIX specific monoclonal antibody Girentuximab (TLX250) designed to deliver the radioisotope to target cancer cells. 

The study will be led by Benjamin Viglianti, MD, PhD in collaboration with Peter Scott, PhD.  “The transformative potential of targeted radiopharmaceutical therapies in the field of cancer treatment is substantial as these therapies have the ability to deliver radiation directly and specifically to cancer cells, potentially reducing the risk of complications as compared to traditional BCG therapy in our clinical study” notes Viglianti, Nuclear Medicine Clinical Service Chief at University of Michigan Health.

"We are thrilled to partner with the University of Michigan Health and leverage their world-class expertise in radiopharmaceutical clinical research towards discovering the safety and activity profile of ATO-101™. Atonco’s team will include Mrs. Aurélie Moreau and Mr. Denis Bilodeau, a seasoned clinical research expert who is guiding our clinical team for North America and Europe." said Jean-François Chatal, MD, founder and Chief Medical Officer of Atonco.

The Phase 1-2a trial will be conducted at the University of Michigan Health and will involve a number of satellite sites. The study is expected to begin enrollment in the coming months once the FDA has cleared the study design.

1. Bladder cancer statistics: World cancer research fund international. WCRF International. (2022, April 14). https://www.wcrf.org/cancer-trends/bladder-cancer-statistics/