CytoDyn Inc. has obtained FDA clearance to initiate a Phase II oncology trial assessing the efficacy of leronlimab in patients with relapsed/refractory (r/r) microsatellite stable colorectal cancer (CRC). This development signals a strengthened relationship between CytoDyn and the FDA, paving the way for further clinical evaluation of leronlimab in oncology. The trial is set to begin patient enrollment in early 2025.
The FDA's clearance follows several productive feedback sessions and the submission of a final study protocol in September 2024. Dr. Jacob Lalezari, CEO of CytoDyn, expressed appreciation for the collaborative engagement with the FDA during the CRC protocol review. The trial will be conducted in partnership with Syneos Health, a biopharmaceutical solutions organization. A trial kickoff meeting is scheduled for late November 2024.
Leronlimab: A CCR5 Antagonist
Leronlimab is an investigational humanized IgG4 monoclonal antibody (mAb) designed to bind to C-C chemokine receptor type 5 (CCR5). CCR5, a protein found on the surface of certain immune system cells, is implicated in various disease processes. By blocking CCR5, leronlimab aims to modulate the immune response and potentially inhibit disease progression.
Trial Design and Objectives
The Phase II trial will evaluate the efficacy of leronlimab in patients with relapsed/refractory microsatellite stable colorectal cancer. Microsatellite stable CRC represents a subset of colorectal cancers that do not exhibit microsatellite instability, a characteristic associated with better responses to certain immunotherapies. The trial aims to address the unmet medical need for effective treatments in this patient population.
CytoDyn is focused on the development and commercialization of leronlimab for multiple therapeutic indications. The initiation of this Phase II oncology trial represents a significant step forward in exploring the potential of leronlimab in cancer treatment.
