CytoDyn Receives FDA Clearance for Phase II Trial of Leronlimab in Colorectal Cancer
Key Insights
CytoDyn (search) has obtained FDA clearance to initiate a Phase II oncology trial evaluating leronlimab in patients with relapsed/refractory microsatellite stable colorectal cancer (search).
The trial follows productive feedback sessions with the FDA and submission of a final study protocol in September 2024, marking a positive development in the company's relationship with the agency.
The Phase II trial will be conducted in partnership with Syneos Health, with a trial kickoff meeting scheduled for late November 2024 and patient enrollment beginning in early 2025.
CytoDyn (search) Inc. has announced that the FDA has cleared its Phase II oncology trial to evaluate leronlimab in patients with relapsed/refractory microsatellite stable colorectal cancer (search) (CRC). The trial, conducted in partnership with Syneos Health, is set to begin patient enrollment in early 2025, following a kickoff meeting in late November 2024.
The FDA's clearance follows constructive feedback sessions and the submission of a final study protocol in September 2024. "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 (search).
Trial Design and Objectives
The Phase II trial aims to assess the efficacy of leronlimab in treating patients with relapsed/refractory microsatellite stable CRC. This patient population often faces limited treatment options, highlighting the unmet medical need that this trial seeks to address. The study will evaluate leronlimab's impact on tumor response, progression-free survival, and overall survival.
Leronlimab: A CCR5 Antagonist
Leronlimab is an investigational humanized IgG4 monoclonal antibody (mAb) designed to bind to C-C chemokine receptor type 5 (CCR5 (search)), a protein on the surface of certain immune system cells. CCR5 is believed to play a role in numerous disease processes, including oncology and inflammation. CytoDyn (search) is also studying leronlimab for other potential indications, including HIV (search) and MASH (search).
Collaboration with Syneos Health
CytoDyn (search)'s partnership with Syneos Health, a biopharmaceutical solutions organization, will support the execution of the Phase II trial. Syneos Health brings expertise in clinical development and patient and physician behaviors, which will be crucial for accelerating the delivery of leronlimab to patients if the trial is successful.