CytoDyn Bags FDA Nod for Phase II Trial of Leronlimab in Colorectal Cancer

CytoDyn Inc., a biotech firm working on leronlimab, a CCR5 inhibitor with possible therapeutic uses, revealed that it has obtained approval from the US FDA to begin its phase II cancer trial. The research will assess how effective leronlimab is for patients with relapsed/refractory (r/r) microsatellite stable colorectal cancer (CRC).

This achievement shows the ongoing positive progress of the company's enhanced rapport with the FDA. Approval for the phase II cancer study was obtained after constructive discussions with the FDA and submitting the final research plan in September 2024. As mentioned before, the trial will be carried out in collaboration with Syneos Health. A trial kick-off meeting is scheduled for the end of November 2024, and patient recruitment will start in early 2025.

“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. “With the agency’s input and our partnership with Syneos Health, we are well positioned to advance our clinical evaluation of leronlimab for oncology and make real strides towards developing the treatment paths of tomorrow.”

CytoDyn Inc., a biotech company working on leronlimab, a CCR5 antagonist with various potential therapeutic uses, disclosed that it has obtained approval from the US FDA to begin its phase II oncology study.