CytoDyn (CYDY) announced that it has received clearance from the FDA to commence its Phase II oncology trial. The study will evaluate the efficacy of leronlimab in patients with relapsed/refractory microsatellite stable colorectal cancer, CRC. This milestone reflects the continued positive development of the Company’s improved relationship with the FDA. Clearance for the Phase II oncology trial was achieved following productive feedback sessions with the FDA over the past few months and the submission of a final study protocol to the FDA in September 2024. As previously announced, the trial will be conducted in partnership with Syneos Health. A trial kickoff meeting has been set for late November 2024 and patient enrollment will begin in early 2025.
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