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CytoDyn Inc, a clinical-stage biotechnology company focused on the development and commercialization of leronlimab, an investigational humanized IgG4 monoclonal antibody (mAb) that is designed to bind to C-C chemokine receptor type 5 (CCR5), a protein on the surface of certain immune system cells that is believed to play a role in numerous disease processes, announced an encouraging clinical findings among patients with advanced metastatic colorectal cancer (mCRC) previously treated with leronlimab.
The final results indicate that 3/5 patients treated with leronlimab had at least a partial response, as measured by radiologic criteria, including one patient with a complete response who remains alive five years later.
Dr. Benjamin Weinberg, Associate Professor at Georgetown University and Principal Investigator of CytoDyn’s colorectal cancer program, will present the company’s clinical data at the ESMO Gastrointestinal Cancers Congress 2025, which will take place in Barcelona, Spain from July 2-5, 2025.
The results, from patients treated under a compassionate use protocol, reiterate a favorable safety profile of leronlimab as well as its potential for clinical benefit in patients with mCRC. They also support the rationale for the design and therapeutic potential of CytoDyn’s ongoing phase II trial in patients with relapsed/refractory microsatellite stable CRC. CytoDyn recently announced the dosing of the first patient in this study, and is now enrolling additional patients across multiple clinical sites.
If the observed results in the previously treated CRC patients are confirmed prospectively, the Company believes leronlimab could be used effectively to treat a wide range of solid tumor types. In addition to its potential as a “stand-alone” agent in oncology, the Company presented exciting evidence of leronlimab’s activity as a “priming” agent for cancer patients with low levels of PD-L1 who were previously unresponsive to, or ineligible for, checkpoint inhibitors at the 2025 ESMO Breast Cancer meeting. The data driving this working theory has shown particular promise in the treatment of patients with advanced metastatic triple-negative breast cancer (mTNBC).
“At the 2025 ESMO Gastrointestinal Cancers Congress, Dr. Weinberg will share the data and evidence that form the basis for our belief in the potential of leronlimab as a treatment in CCR5 positive solid tumor oncology,” said Dr. Jacob Lalezari, CEO of CytoDyn. “Our ongoing phase II trial in patients with mCRC was designed to prospectively confirm these observations, and we look forward to enrolling additional patients as we pursue clinical confirmation of our working theory.”
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