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CytoDyn Receives FDA Clearance to Begin Phase II Trial of Leronlimab for Colorectal Cancer

NextEdge Admin

04 Nov 2024

2 min 14 sec

CytoDyn Inc. , a biotechnology company advancing leronlimab—a CCR5 antagonist with potential across various therapeutic areas—announced today that it has received FDA clearance to initiate its Phase II oncology trial. This study will focus on assessing leronlimab’s efficacy in patients with relapsed/refractory microsatellite stable colorectal cancer (CRC).

Achieving this milestone follows productive discussions with the FDA over recent months, culminating in the submission of a finalized study protocol in September 2024. The Phase II trial will be conducted in collaboration with Syneos Health, a leading biopharmaceutical solutions provider. A kickoff meeting is scheduled for late November 2024, with patient enrollment beginning in early 2025.

“We value the constructive feedback from the FDA on our CRC protocol,” said Dr. Jacob Lalezari, CEO of CytoDyn. “With the agency’s guidance and our partnership with Syneos Health, we are well positioned to advance leronlimab in oncology and work toward new treatment options.”

CytoDyn, a clinical-stage biotechnology company, is focused on developing leronlimab, a humanized IgG4 monoclonal antibody designed to target CCR5, a receptor on immune cells involved in multiple disease processes. Leronlimab is currently under investigation for use in oncology, inflammation, and other indications, including HIV and NASH.

Syneos Health® is an integrated biopharmaceutical solutions organization that leverages clinical, medical, and commercial expertise to expedite client success, bringing transformative therapies to patients while fostering a diverse, inclusive culture.