CytoDyn Inc. has announced FDA clearance to proceed with a Phase II oncology trial investigating leronlimab in patients with relapsed/refractory microsatellite stable colorectal cancer (CRC). This regulatory milestone follows constructive feedback sessions with the FDA and the submission of the final study protocol in September 2024. The trial, conducted in partnership with Syneos Health, is set to commence patient enrollment in early 2025, with a kickoff meeting planned for late November 2024.
The Phase II trial will evaluate the efficacy of leronlimab, a humanized IgG4 monoclonal antibody (mAb) designed to bind to C-C chemokine receptor type 5 (CCR5). CCR5 is a protein expressed on certain immune system cells and is implicated in various disease processes, including cancer and inflammation. By blocking CCR5, leronlimab aims to modulate the immune response and potentially inhibit tumor growth in microsatellite stable colorectal cancer.
"We have appreciated the opportunity to work constructively with the FDA on the review and finalization of our CRC protocol," said Dr. Jacob Lalezari, CEO of CytoDyn. "With the agency’s input and our partnership with Syneos Health, we are well positioned to advance our clinical evaluation of leronlimab for oncology and make real strides towards developing the treatment paths of tomorrow."
About the Trial and Leronlimab
The Phase II trial is designed to assess the safety and efficacy of leronlimab in patients with relapsed/refractory microsatellite stable CRC. Colorectal cancer is a significant global health burden, and microsatellite stable tumors represent a particularly challenging subset due to their limited response to conventional immunotherapies. Leronlimab's mechanism of action as a CCR5 antagonist suggests a potential to address this unmet need by modulating the tumor microenvironment and enhancing anti-tumor immunity.
Leronlimab is an investigational humanized IgG4 monoclonal antibody (mAb) that is designed to bind to C-C chemokine receptor type 5 (CCR5). CytoDyn is exploring leronlimab for oncology and inflammation, as well as other potential indications, including but not limited to HIV and MASH.
