CytoDyn Marks Milestone In Oncology Program With First Patient Dosed In Phase II Trial Of Leronlimab For Colorectal Cancer

CytoDyn Inc., a biotechnology company focused on developing leronlimab, a CCR5 antagonist with potential for multiple therapeutic uses has announced that the first patient has been dosed in its clinical trial evaluating leronlimab for relapsed or refractory microsatellite stable colorectal cancer. The trial is being conducted in collaboration with Syneos Health, with eight clinical sites already engaged and additional sites being added as patient enrollment continues. Dr. Ben Weinberg, MD, of Georgetown University and the MedStar Health Alliance, is serving as the lead principal investigator.

Colorectal cancer remains a major global health concern. According to the World Health Organization’s International Agency for Research on Cancer (IARC), it is the third most commonly diagnosed cancer worldwide and the second leading cause of cancer-related deaths. Each year, approximately 1.9 million new cases are reported globally, with over 900,000 deaths. The IARC also highlights a growing concern around rising incidence rates in individuals under the age of 50, a trend that has been ongoing for at least two decades.

Dr. Jacob Lalezari, CEO of CytoDyn, mentioned, “Dosing the first patient in our Phase II CRC trial is a significant step forward in our mission to bring innovative treatment options to patients facing this challenging disease. This milestone reflects the dedication of our team and clinical partners, and we look forward to advancing this study to better understand the potential impact of our therapy across solid tumor oncology.”

The current study builds on earlier CytoDyn research, which showed potential clinical benefit of leronlimab in patients with relapsed colorectal cancer. It will also further evaluate a newly proposed mechanism of action for leronlimab in solid tumors. CytoDyn is hopeful that this research, along with encouraging results previously observed in studies involving metastatic triple-negative breast cancer, will help determine the broader application of leronlimab across various solid tumor types.