FDA Clears CytoDyn's Phase II Trial of Leronlimab in Colorectal Cancer
Key Insights
CytoDyn (search) has received FDA clearance to begin a Phase II oncology trial evaluating leronlimab in patients with relapsed/refractory microsatellite stable colorectal cancer (search).
The trial, conducted in partnership with Syneos Health, follows productive feedback sessions with the FDA and submission of a final study protocol in September 2024.
Patient enrollment is scheduled to begin in early 2025, with a trial kickoff meeting planned for late November 2024 to initiate the study.
CytoDyn (search) Inc. has announced FDA clearance for its Phase II oncology trial evaluating leronlimab in patients with relapsed/refractory microsatellite stable colorectal cancer (search) (r/r MSS CRC). This regulatory milestone marks a significant step forward in the development of leronlimab for cancer treatment.
The Phase II trial clearance was achieved following collaborative discussions with the FDA and the submission of the final study protocol in September 2024. CytoDyn (search) is partnering with Syneos Health to conduct the trial. A trial kickoff meeting is scheduled for late November 2024, with patient enrollment expected to commence in early 2025.
Leronlimab's Mechanism of Action
Leronlimab is an investigational humanized IgG4 monoclonal antibody (mAb) designed to bind to C-C chemokine receptor type 5 (CCR5 (search)). CCR5, a protein found on the surface of certain immune system cells, is implicated in various disease processes, including cancer and inflammation. By targeting CCR5, leronlimab aims to modulate the immune response and potentially inhibit tumor growth and metastasis.
Potential Applications Beyond Colorectal Cancer
CytoDyn (search) is exploring leronlimab's potential in other therapeutic areas, including HIV (search) and MASH (search) (metabolic dysfunction-associated steatohepatitis), highlighting the broad applicability of CCR5 (search) modulation in different disease settings.