CytoDyn completes FDA meeting on Phase II Study of leronlimab

CytoDyn completed a meeting with the U.S. Food and Drug Administration to gain alignment on the rationale and proposed dosing for the Company’s Phase II study that will investigate the preliminary safety and activity of leronlimab in combination with trifluridine plus tipiracil and bevacizumab in participants with CCR5+, microsatellite stable, relapsed or refractory metastatic colorectal cancer. The Company intends to proceed with a submission of its final study protocol to the FDA, formal engagement of a clinical research organization, and related preparatory work towards initiating the proposed trial. This open label, randomized, multicenter trial will evaluate the anti-tumor activity of leronlimab at doses of 350 mg and 700 mg in combination TAS-102 and bevacizumab in approximately 60 patients with CCR5+, microsatellite stable metastatic CRC. Patients enrolled in the trial must have measurable disease per RECIST v1.1 and have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy. CCR5 tumor expression will be determined by immunohistochemistry assay and diagnosis of MSS CRC will be confirmed by IHC or next-generation sequencing. TAS-102 and bevacizumab will be administered for three of four weeks in a four-week cycle, and leronlimab will be administered weekly. The study will include a safety lead-in treating five patients in the 350 mg leronlimab arm prior to beginning enrollment to the 700 mg leronlimab arm.