CytoDyn Inc. issued a shareholder letter on March 18, 2025, reiterating the impressive survival observations in metastatic Triple-Negative Breast Cancer (mTNBC) patients treated with leronlimab, which were announced in February 2025. The company confirmed the submission of these findings as an abstract to the European Society for Medical Oncology meeting in May 2025 and initiated a follow-up protocol to monitor surviving patients.
For the Phase II colorectal cancer (CRC) study, CytoDyn reported that eight clinical sites have been approved, with patient screening expected to commence shortly. Dr. Ben Weinberg from Georgetown University remains the lead Principal Investigator, and the dosing regimen details were reconfirmed, starting with 350 mg weekly for the first five patients.
In inflammation, the company clarified that while final results from SMC Laboratories confirmed statistically significant reversal of liver fibrosis (p<0.01) in all three studies, leronlimab did not show a significant effect on fat accumulation (steatosis) in the MASH model. Consequently, CytoDyn will pause MASH development in the near term to focus on organ fibrosis, engaging potential partners for funding studies in this area.
CytoDyn also announced a new collaboration with Dr. Tom Carmichael (UCLA) and Dr. Kate Schunke (University of Hawaii) to conduct a preclinical study of stroke in transgenic mice expressing human CCR5. This initiative explores leronlimab's potential in a new therapeutic area, with Dr. Carmichael also advising on the fully funded Alzheimer’s Disease pilot study at Cornell Medical Center, for which the protocol is finalized and moving through institutional review and FDA submission.
Preclinical studies in TNBC are underway to identify treatment strategies and examine the mechanism behind observed survival increases, with discussions ongoing for an abbreviated follow-up clinical study. A preclinical study in glioblastoma (GBM) sequencing temozolomide and leronlimab is also underway, and the company continues to prioritize the publication of its oncology manuscripts.
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