Leronlimab has been granted 2 other Fast Track designations as a combination therapy with HAART for HIV and as a treatment for metastatic triple-negative breast cancer.
A pre-print version of a manuscript about the development of leronlimab describes the immunological mechanism by which leronlimab restores immune function and impacts the coronavirus disease 2019 (COVID-19), according to a CytoDen press release.
The manuscript, entitled “Disruption of the CCL5/RANTES-CCR5 Pathway Restores Immune Homeostasis and Reduces Plasma Viral Load in Critical COVID-19,” has been submitted for publication and is currently under peer review.
The pre-print describes a cohort of 10 critically ill patients after treatment with leronlimab who experienced reversed hyper immune activation and inflammation, as well as reversed immunosuppression, facilitating a more effective immune response correlated with decreases in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) level in blood.
“Our study shows that COVID-19 is very much a RANTES disease demonstrating 100 times normal levels of RANTES in these critically ill patients and 5 times normal levels of RANTES even in mild-moderate COVID-19 disease,” said Bruce Patterson, MD, founder of IncelDx and advisor to CytoDen, in the press release. “When RANTES is blocked from binding to CCR5 expressed on immune cells, statistically significant increases of CD8 T-cells were seen as early as 7 days post-therapy. IL-6, which was less consistently elevated than RANTES in these patients was significantly decreased by Day 7.”
Patterson further elaborated on the restoration of immune homeostasis resulting in statistically significant decreases in plasma viral load, a quantitative measure using cell-free cancer technology and reported for the first time in this study, according to the press release.
Leronlimab has been granted a Fast Track designation for 2 potential indications, first as a combination therapy with HAART for HIV-infected patients and second as a treatment for metastatic triple-negative breast cancer. The drug has been in 9 clinical trials in more than 800 people, including meeting its primary endpoints in a pivotal phase 3 trial, in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients.
Manuscript Describes How CytoDyn’s Leronlimab Disrupts CCL5/RANTES-CCR5 Pathway, Thereby Restoring Immune Homeostasis, Reducing Plasma Viral Load, Reversing Hyper Immune Activation and Inflammation in Critical COVID-19 Patients [news release]. Vancouver, Washington; CytoDen: May 5, 2020. https://www.cytodyn.com/newsroom/press-releases/detail/426/manuscript-describes-how-cytodyns-leronlimab-disrupts. Accessed May 6, 2020.